Facilitating primary care provider use in a patient-centered medical home intervention study for chronic hemodialysis patients

Facilitating primary care provider use in a patient-centered medical home intervention study for... Abstract Patients with chronic kidney disease have a high disease burden may benefit from primary care services and care coord A medical home model with direct access to primary care services is one approach that may address this need, yet has not been examined. As a substudy of the Patient-Centered Outcomes Research Institute (PCORI) patient-centered medical home for kidney disease (PCMH-KD) health system intervention study, we examined the uptake of free primary care physician (PCP) services. The PCORI PCMH-KD study was an initial step toward integrating PCPs, a nurse coordinator, a pharmacist, and community health workers (CHWs) within the health care delivery team. Adult chronic hemodialysis (CHD) at two urban dialysis centers were enrolled in the intervention. We examined trends and factors associated with the use of the PCMH-KD PCP among two groups of patients based on their report of having a regular physician for at least six months (established-PCP) or not (no-PCP). Of the 173 enrolled patients, 91 (53%) patients had at least one visit with the PCMH-KD PCP. The rate of visits was higher in those in the no-PCP group compared with those in the established-PCP group (62% vs. 41%, respectively). Having more visits with the CHW was positively associated with having a visit with the PCMH-KD PCPs for both groups. Embedded CHWs within the care team played a role in facilithe uptake of PCMH-KD PCP. Lessons from this health system intervention can inform future approaches on the integration of PCPs and care coordination for CHD patients. Implications Results from this health system intervention study showed that an embedded community health worker had a positive impact in facilitating the uptake of new primary care provider services at the dialysis center may inform future efforts to improve primary care provider use and care coordination for chronic hemodialysis (CHD) patients. Practice: Integrating support for primary care services in dialysis centers could improve care coordination and primary care use for chronic hemodialysis (CHD) patients. Policy: Policies affecting the design of the health care team for CHD patients in the future should consider new care models that improve access to a primary care physician. Research: Future research should focus on identifying the most effective components of health care delivery models that contribute to optimal outcomes for high-risk patients with complex chronic conditions, such as CHD patients. INTRODUCTION Over the past two decades, the health care community has come to recognize the importance of medical homes for primary care and care coordination for patients with chronic disease [1–3]. While approaches have varied to include team-based care, chronic disease model, collaborative care, patient navigation, and medical home models facilitating care coordination with a primary care physician (PCP) has remained a central theme. Methods of facilitating care coordination with PCPs have involved the use of patient navigators, community health workers (CHWs), and other ancillary health care providers in areas related to cancer, diabetes, and pediatric populations [4–8]. These varied methods of care coordination have resulted in mixed success. Until recently, kidney disease has not been highlighted in care coordination approaches [9–11], yet kidney disease represents a significant public health problem. Notably, the number of affected individuals with end-stage renal disease (ESRD) increases annually with more than 670,000 cases per year [12, 13]. A large proportion of these patients are dependent upon chronic hemodialysis (CHD) treatment and/or are in need of kidney transplantation [13]. Extensive health care use and high costs have placed a significant burden on the health care system [14–16] with Medicare spending approaching $32.80 billion in 2014 for ESRD alone [13]. There is also a substantial burden on the patient, including physical and emotional symptoms of ESRD [17], significant health care use [18, 19], length and frequency of dialysis treatment [20], multiple comorbidities [21], and adverse treatment effects related to dialysis and kidney transplant [22, 23]. The burden of care on the health care system and the patient underscores the need for coordination of care in managing the complex health care needs of patients with ESRD, which is particularly challenging as disease stage advances, and symptoms become more severe. With a focus on the kidney disease treatment and symptom management, primary care needs can often be overlooked, while paradoxically contributing to disease progression, increased health care costs, and poor health outcomes [24–27]. Given the complex medical needs of these patients, it can become confusing as to whether the nephrologist or PCP should take the lead in treating the various comorbid conditions most dialysis patients experience [27, 28]. Understandably, coordination of care can become challenging. For example, in one study poor communication between nephrologists and PCPs contributed to increased fragmentation and reduced continuity of care [28]. Relationship building between PCPs and subspecialty care providers has been cited among Veterans Affairs physicians as an “improvement opportunity” [29]. This suggests that even in integrated health systems there can be gaps in effective communication. McDonald [2] defines care coordination as “the deliberate organization of patient care activities between two or more participants (including the patient) involved in a patient’s care, in order to facilitate the appropriate delivery of healthcare services.” The patient-centered medical home (PCMH) model of care aims to strengthen primary care, a core element of coordinated care [30–32]. This coordination is especially important for patients with multiple health care providers [33, 34] and complex needs, such as ESRD patients, and may require formal agreements between providers [35]. Importantly, the inclusion of a PCP has been shown to increase patient satisfaction and referral adherence [36]; however, the effect of having a PCP involved has not been well studied in ESRD populations. Additionally, the role of ancillary health care providers has also been shown to enhance care coordination by improving primary care utilization [37], although their potential role in the care of ESRD patients has not been empirically addressed. In this article, we describe the role of a PCP in an adaptation of a medical home model for ESRD patients, known as the patient-centered medical home for kidney disease (PCMH-KD) study [11, 38]. We also describe the facilitating role of CHWs and explore other factors associated with PCMH-KD PCP visits by patients in the study. Bringing care to patients: the PCMH-KD study The Patient-Centered Outcomes Research Institute (PCORI) PCMH-KD study was the first application of this model for ESRD patients on chronic hemodialysis (CHD) and has been described previously [11, 14, 20]. Briefly, the study sought to design, implement, and compare an adaptation of the PCMH to the Medicare-mandated care team model in two dialysis centers using a before–after design with repeated measures. The Medicare-mandated dialysis care team currently includes a nephrologist, a nurse, a dietician, a dialysis technician, and a social worker [39]. The PCMH-KD model of care aimed to augment the dialysis care team to improve access to primary care and care coordination through the inclusion of a PCP, a nurse coordinator, a clinical pharmacist, and a CHW [14, 20]. The PCMH-KD PCP made patient rounds with the nephrologist and had individual visits with patients, as needed. The CHWs served as health promoters or navigators, coordinated their work with the social workers and other care team members to support patients’ compliance, and mediate certain barriers affecting adequate dialysis treatment such as scheduling medical appointments, transportation, and other unforeseen supportive care. The primary outcome of the parent study was patient-reported quality of life [11, 40]. The intervention was conducted from January 2015 to August 2016, and the main outcome results are pending. This article describes a substudy to examine factors associated with PCP visits by adult CHD patients. The University of Illinois at Chicago Institutional Review Board and Fresenius, Inc. approved the study. All participants provided written informed consent. METHODS Study design In this study, we explored the role of the study PCP (PCMH-KD PCP) and the factors that influenced the use of the PCMH-KD PCP services; we used the Andersen health behavior model [41], the chronic care model (CCM) [42], and prior research in kidney disease [43, 44] to guide this study. Building on the parent study before–after repeated measures design, we examined the free health care services provided by the PCMH-KD PCP and the role of the CHW in patients’ use of these services. We also considered patient demographics, self-efficacy regarding their chronic disease management, enabling factors that might impact availability and access to general health care, and clinical need factors related to patients’ health status and specific to CHD care [45, 46]. We also explored the content of the CHW visits and patient satisfaction with primary care services. Study procedures The study procedures, population, design of the intervention, roles of the PCMH-KD augmented personnel, and earlier results have been described previously [14, 20]. Briefly, recruitment into the study was on a rolling basis over 14 months. Eligible patients were either English- or Spanish-speaking adults (≥18 years) receiving chronic hemodialysis at one of the two sites. Once consented, trained study staff informed patients of the services provided by the augmented personnel during the intervention. After baseline data were collected, patients were immediately eligible to schedule visits with the PCMH-KD PCP and other services. The patients were also assigned to one of the two CHWs based on the patient’s preference for English or Spanish. Patients had an initial visit with their assigned CHW and monthly check-in visits; more in-depth follow-up visits were at the patient’s discretion. Patients contacted their CHW or the dialysis staff to schedule appointments with the PCMH-KD PCP. Although the study did not monitor the activities of the social workers in the clinics, the CHW coordinated with the social workers to reduce any overlap in the study participants’ care. The social workers continued their roles as case managers. The PCMH-KD intervention was conducted from January 2015 to August 2016. Interviews were administered at baseline and every 6 months with enrolled patients. Anticipating that a patient with an a priori established relationship with a PCP might affect uptake of the PCMH-KD PCP visits; for this study, we classified patients based on their response at baseline to two questions in the Primary Care Assessment Survey (PCAS) [47]: (a) Is there one particular doctor that you consider to be your regular personal doctor? (b) How long has this person been your doctor? Patients who reported having a PCP at baseline and had seen the PCP within at least the past 6 months were classified as having an established PCP (established-PCP group). Patients who reported no PCP or had a PCP for less than 6 months were classified as not having an established PCP (no-PCP group). Measures The number of patient visits with the PCMH-KD PCP was tracked and documented by the study team. The visits included office visits, performed at the PCP's office, and chairside visits, performed in the dialysis center during patient's dialysis treatment. Continuous counts and dichotomous values (any visits with the PCMH-KD PCP or not) were used. Demographic factors included age, race/ethnicity, and interview language. Age (in years) was divided at the median into two categories (≥55 or <55 years). Race/ethnicity included two categories: African-American and non–African-Americans (included Hispanics and non-Hispanic Whites). All African-Americans in the study were not of Hispanic origin. Interview language was either English or Spanish. We included self-efficacy, measured using the Self-Efficacy for Managing Chronic Disease (SEMCD) survey [48], and categorized at the median as high (≥7.5) or low (<7.5). The SEMCD is a six-item survey, with responses rated from 1 (not confident) to 10 (totally confident), to measure the participants’ level of confidence in performing tasks to manage their chronic disease such as dealing with fatigue, emotional distress, and symptoms associated with the disease; performing activities to reduce doctors’ visits; and taking medication to reduce the effect of the disease. The mean of the six items was scored, and a higher score indicated higher efficacy. We also included a dichotomous measure for stressful life events in the past 6 months (such as hospitalization, loss of employment, or the loss of a family member) (Yes/No). Health literacy scores [49] were split into two tiers at the median: adequate (3–8) and marginal or inadequate (9–15). We included a self-reported measure of social support indicating whether a family member or a friend was involved with dialysis care (Yes/No). Patients provided information on their primary means of transportation to dialysis by responding to the question, “How do you usually get to and from the dialysis clinic?” Transportation to dialysis treatment was categorized into medically arranged transportation mode or other transportation modes. The number of patient visits with the CHWs was also tracked and documented by the study staff. We included a measure indicating the uptake of the CHW using three progressive categories of the number of CHW visits (≤7, 8–11, and ≥12). The CHW also documented the main topics discussed at each visit. Clinical need factors comprised two measures: whether patients self-reported that they had diabetes (Yes/No) and dialysis vintage, that is, the length of time on dialysis, divided into two categories based on the median value (≥36 months or ˂36 months). Time in the study (months) was included as a covariate in all multivariable regression models as patients had varying lengths of time in the study. We included an indicator for the dialysis centers (academic or corporate). Additionally, we also explored the content of the CHW visits recorded by the CHWs in a templated report. Finally, item responses in the PCAS, an 11–summary scale measure, were used to characterize patient perceptions of primary care related to five of the summary scales that measure the duration of patient’s relationship with their PCP (longitudinal continuity); PCP knowledge of patient’s medical history and responsibilities and health concerns (comprehensive knowledge); PCP’s thorough physical examination of and attention given to the patient (communication); amount of time and care patient receives from their PCP (interpersonal treatment); and PCP’s role in referring and coordinating the patient’s care with other specialists (integration of care) [47]. Using a six-point Likert response scale (1 = very poor, 2 = poor, 3 = fair, 4 = good, 5 = very good, and 6 = excellent), the PCAS scales were scored ranging from 0 to 100 points with higher score signifying a higher attribute. The mean score for each of the five PCAS scales was obtained for every six months. Statistical analysis Descriptive statistics, chi-square test, and logistic regression models were used to understand the influence of factors on whether patients utilized a PCMH-KD PCP. To examine any PCMH-KD PCP visits, we performed separate logistic regression models for those with established-PCP or no-PCP. RESULTS Of the 285 patients screened on a rolling basis over 14 months at the clinical sites, 248 patients were eligible to participate in the study; 185 patients consented. Ten patients were not able to complete the baseline survey, and 175 patients moved into the enrollment phase. Two of these patients did not complete the PCAS instrument and were excluded yielding 173 patients included in this substudy (Figure 1). The mean age was 54 years, and the median dialysis vintage was 3 years. A majority of the patients were men (55%), had a high school diploma (65%), were unemployed (82%), reported a household income of <$20,000 (61%), received dialysis at the current dialysis center for more than 6 months (75%), had a fistula for their vascular access (51%), completed the surveys in English (67%), received dialysis at the academic center (62%), reported a diabetes diagnosis (53%), obtained an adequate health literacy score (60%), drove themselves or someone drove them to the dialysis center (58%), and reported no stressful event in the past 6 months (55%) (data not shown). Fifty percent of the patients were African-Americans; 47% of patients in the “other” category were Hispanic and only 3% identified as non-Hispanic White. Fig 1 View largeDownload slide Study participants by baseline primary care physician (PCP) groups (no-PCP and established-PCP) and use of the study PCP (patient-centered medical home for kidney disease [PCMH-KD] PCP). Fig 1 View largeDownload slide Study participants by baseline primary care physician (PCP) groups (no-PCP and established-PCP) and use of the study PCP (patient-centered medical home for kidney disease [PCMH-KD] PCP). The PCMH-KD PCPs conducted 346 visits with 91 study participants. The frequency of visits for any individual patient ranged from no visits to 16 visits. Half of patient visits with the PCMH-KD PCP were performed chairside during dialysis (50%), followed by clinic appointments (41%). Figure 2 shows the frequencies of PCMH-KD PCP visits for the entire intervention. Among patients with one or more PCMH-KD PCP visit(s), those with no-PCP at study entry had consistently more visits. As seen in Table 1, 53% of the patients had at least one visit with a PCMH-KD PCP during the 18-month intervention. Patients in the no-PCP group were significantly more likely to see a PCMH-KD PCP than patients in the established-PCP group: 62% versus 41%, respectively. Patients in the no-PCP group had a greater proportion of the PCMH-KD PCP visits (72%) as well as a greater number of visits per person. Patients in the no-PCP group and participating for 14 months or longer were significantly more likely to have a PCMH-KD PCP visit than those who were enrolled less than 14 months. Additionally, patients at the corporate center were more likely to have a PCMH-KD PCP visit (Table 1). Fig 2 View largeDownload slide Number of visits with study primary care physician (PCP) (patient-centered medical home for kidney disease [PCMH-KD PCP]) by baseline PCP group (no-PCP and established PCP). Fig 2 View largeDownload slide Number of visits with study primary care physician (PCP) (patient-centered medical home for kidney disease [PCMH-KD PCP]) by baseline PCP group (no-PCP and established PCP). Table 1 Number of Visits with the Study Primary Care Physician (PCMH-KD PCP) by Patient Characteristics, Stratified by Baseline PCP Group (No-PCP and Established PCP)   No-PCP  Established-PCP  Total number of PCMH-KD visits, n (%)  249 (72)  97 (28)    n  Any visitsan (%)  Number of visitsb Median  n  Any visitsan (%)  Number of visitsb Median  All participants  95  59 (62)  3.0  78  32 (41)  2.0  Age, years   ≥ 55  39  23 (59)  4.0  46  16 (35)  2.0   < 55  56  36 (64)  3.0  32  16 (50)  2.0  Gender   Male  61  35 (57)  3.0  35  13 (37)  2.0   Female  34  24 (71)  4.5  43  19 (44)  2.0  Race/ethnicity   African American  49  31 (63)  4.0  37  18 (49)  2.0   Hispanic, other  46  28 (61)  2.5  41  14 (34)  2.0  Interview language   Spanish  25  14 (56)  2.0  32  9 (28)  3.0   English  70  45 (64)  3.0  46  23 (50)  2.0  Self-efficacy (SEMCD)   >=7.5 (median)  49  30 (61)  3.0  40  14 (35)  2.0   < 7.5  46  29 (63)  3.0  38  18 (47)  2.0  Stressful life events in 6 months   Yes  39  25 (64)  4.0  39  16 (41)  2.5   No  56  34 (61)  2.5  39  16 (41)  2.0  Community Health Worker (CHW) visits   ≤7  28  11 (39)*  2.0  28  4 (14)*  1.5   8–11  37  24 (65)  2.0  32  15 (47)  2.0   ≥12  30  24 (25)  5.0  18  13 (72)  2.0  Health literacy   Marginal/inadequate (9–15)  33  19 (58)  3.0  35  11 (31)  3.0   Adequate (3–8)  62  40 (65)  3.0  43  21 (49)  2.0  Family member/friend involved with dialysis care   Yes  45  32 (71)  3.0  49  22 (45)  2.0   No  50  27 (54)  3.0  29  10 (34)  2.0  Transportation to dialysis center   Medically arranged transporter  37  22 (59)  4.5  35  15 (43)  1.0   Other (car, transit, bicycle)  58  37 (64)  2.0  43  17 (40)  2.0  Diabetes (self-report)   Yes  43  24 (56)  5.0  49  21 (43)  2.0   No  52  35 (67)  2.0  29  11 (38)  2.0  Dialysis vintage   ≥ 36 months (median)  52  33 (63)  3.0  38  15 (39)  3.0   < 36 months  43  26 (60)  4.5  40  17 (43)  2.0  Months in study   ≥ 14 months (median)  45  34 (76)*  3.0  42  20 (48)  2.5   < 14 months  50  25 (50)  2.0  36  12 (33)  2.0  Center   Corporate  36  15 (42)*  2.0  30  9 (30)  2.0   Academic  59  44 (75)  3.0  48  23 (48)  2.0    No-PCP  Established-PCP  Total number of PCMH-KD visits, n (%)  249 (72)  97 (28)    n  Any visitsan (%)  Number of visitsb Median  n  Any visitsan (%)  Number of visitsb Median  All participants  95  59 (62)  3.0  78  32 (41)  2.0  Age, years   ≥ 55  39  23 (59)  4.0  46  16 (35)  2.0   < 55  56  36 (64)  3.0  32  16 (50)  2.0  Gender   Male  61  35 (57)  3.0  35  13 (37)  2.0   Female  34  24 (71)  4.5  43  19 (44)  2.0  Race/ethnicity   African American  49  31 (63)  4.0  37  18 (49)  2.0   Hispanic, other  46  28 (61)  2.5  41  14 (34)  2.0  Interview language   Spanish  25  14 (56)  2.0  32  9 (28)  3.0   English  70  45 (64)  3.0  46  23 (50)  2.0  Self-efficacy (SEMCD)   >=7.5 (median)  49  30 (61)  3.0  40  14 (35)  2.0   < 7.5  46  29 (63)  3.0  38  18 (47)  2.0  Stressful life events in 6 months   Yes  39  25 (64)  4.0  39  16 (41)  2.5   No  56  34 (61)  2.5  39  16 (41)  2.0  Community Health Worker (CHW) visits   ≤7  28  11 (39)*  2.0  28  4 (14)*  1.5   8–11  37  24 (65)  2.0  32  15 (47)  2.0   ≥12  30  24 (25)  5.0  18  13 (72)  2.0  Health literacy   Marginal/inadequate (9–15)  33  19 (58)  3.0  35  11 (31)  3.0   Adequate (3–8)  62  40 (65)  3.0  43  21 (49)  2.0  Family member/friend involved with dialysis care   Yes  45  32 (71)  3.0  49  22 (45)  2.0   No  50  27 (54)  3.0  29  10 (34)  2.0  Transportation to dialysis center   Medically arranged transporter  37  22 (59)  4.5  35  15 (43)  1.0   Other (car, transit, bicycle)  58  37 (64)  2.0  43  17 (40)  2.0  Diabetes (self-report)   Yes  43  24 (56)  5.0  49  21 (43)  2.0   No  52  35 (67)  2.0  29  11 (38)  2.0  Dialysis vintage   ≥ 36 months (median)  52  33 (63)  3.0  38  15 (39)  3.0   < 36 months  43  26 (60)  4.5  40  17 (43)  2.0  Months in study   ≥ 14 months (median)  45  34 (76)*  3.0  42  20 (48)  2.5   < 14 months  50  25 (50)  2.0  36  12 (33)  2.0  Center   Corporate  36  15 (42)*  2.0  30  9 (30)  2.0   Academic  59  44 (75)  3.0  48  23 (48)  2.0  aPatients with one or more visit with PCMH-KD PCP bNumber of PCMH-KD PCP visits *Significance for Chi Square tests: (p-value <0.05) View Large Table 1 Number of Visits with the Study Primary Care Physician (PCMH-KD PCP) by Patient Characteristics, Stratified by Baseline PCP Group (No-PCP and Established PCP)   No-PCP  Established-PCP  Total number of PCMH-KD visits, n (%)  249 (72)  97 (28)    n  Any visitsan (%)  Number of visitsb Median  n  Any visitsan (%)  Number of visitsb Median  All participants  95  59 (62)  3.0  78  32 (41)  2.0  Age, years   ≥ 55  39  23 (59)  4.0  46  16 (35)  2.0   < 55  56  36 (64)  3.0  32  16 (50)  2.0  Gender   Male  61  35 (57)  3.0  35  13 (37)  2.0   Female  34  24 (71)  4.5  43  19 (44)  2.0  Race/ethnicity   African American  49  31 (63)  4.0  37  18 (49)  2.0   Hispanic, other  46  28 (61)  2.5  41  14 (34)  2.0  Interview language   Spanish  25  14 (56)  2.0  32  9 (28)  3.0   English  70  45 (64)  3.0  46  23 (50)  2.0  Self-efficacy (SEMCD)   >=7.5 (median)  49  30 (61)  3.0  40  14 (35)  2.0   < 7.5  46  29 (63)  3.0  38  18 (47)  2.0  Stressful life events in 6 months   Yes  39  25 (64)  4.0  39  16 (41)  2.5   No  56  34 (61)  2.5  39  16 (41)  2.0  Community Health Worker (CHW) visits   ≤7  28  11 (39)*  2.0  28  4 (14)*  1.5   8–11  37  24 (65)  2.0  32  15 (47)  2.0   ≥12  30  24 (25)  5.0  18  13 (72)  2.0  Health literacy   Marginal/inadequate (9–15)  33  19 (58)  3.0  35  11 (31)  3.0   Adequate (3–8)  62  40 (65)  3.0  43  21 (49)  2.0  Family member/friend involved with dialysis care   Yes  45  32 (71)  3.0  49  22 (45)  2.0   No  50  27 (54)  3.0  29  10 (34)  2.0  Transportation to dialysis center   Medically arranged transporter  37  22 (59)  4.5  35  15 (43)  1.0   Other (car, transit, bicycle)  58  37 (64)  2.0  43  17 (40)  2.0  Diabetes (self-report)   Yes  43  24 (56)  5.0  49  21 (43)  2.0   No  52  35 (67)  2.0  29  11 (38)  2.0  Dialysis vintage   ≥ 36 months (median)  52  33 (63)  3.0  38  15 (39)  3.0   < 36 months  43  26 (60)  4.5  40  17 (43)  2.0  Months in study   ≥ 14 months (median)  45  34 (76)*  3.0  42  20 (48)  2.5   < 14 months  50  25 (50)  2.0  36  12 (33)  2.0  Center   Corporate  36  15 (42)*  2.0  30  9 (30)  2.0   Academic  59  44 (75)  3.0  48  23 (48)  2.0    No-PCP  Established-PCP  Total number of PCMH-KD visits, n (%)  249 (72)  97 (28)    n  Any visitsan (%)  Number of visitsb Median  n  Any visitsan (%)  Number of visitsb Median  All participants  95  59 (62)  3.0  78  32 (41)  2.0  Age, years   ≥ 55  39  23 (59)  4.0  46  16 (35)  2.0   < 55  56  36 (64)  3.0  32  16 (50)  2.0  Gender   Male  61  35 (57)  3.0  35  13 (37)  2.0   Female  34  24 (71)  4.5  43  19 (44)  2.0  Race/ethnicity   African American  49  31 (63)  4.0  37  18 (49)  2.0   Hispanic, other  46  28 (61)  2.5  41  14 (34)  2.0  Interview language   Spanish  25  14 (56)  2.0  32  9 (28)  3.0   English  70  45 (64)  3.0  46  23 (50)  2.0  Self-efficacy (SEMCD)   >=7.5 (median)  49  30 (61)  3.0  40  14 (35)  2.0   < 7.5  46  29 (63)  3.0  38  18 (47)  2.0  Stressful life events in 6 months   Yes  39  25 (64)  4.0  39  16 (41)  2.5   No  56  34 (61)  2.5  39  16 (41)  2.0  Community Health Worker (CHW) visits   ≤7  28  11 (39)*  2.0  28  4 (14)*  1.5   8–11  37  24 (65)  2.0  32  15 (47)  2.0   ≥12  30  24 (25)  5.0  18  13 (72)  2.0  Health literacy   Marginal/inadequate (9–15)  33  19 (58)  3.0  35  11 (31)  3.0   Adequate (3–8)  62  40 (65)  3.0  43  21 (49)  2.0  Family member/friend involved with dialysis care   Yes  45  32 (71)  3.0  49  22 (45)  2.0   No  50  27 (54)  3.0  29  10 (34)  2.0  Transportation to dialysis center   Medically arranged transporter  37  22 (59)  4.5  35  15 (43)  1.0   Other (car, transit, bicycle)  58  37 (64)  2.0  43  17 (40)  2.0  Diabetes (self-report)   Yes  43  24 (56)  5.0  49  21 (43)  2.0   No  52  35 (67)  2.0  29  11 (38)  2.0  Dialysis vintage   ≥ 36 months (median)  52  33 (63)  3.0  38  15 (39)  3.0   < 36 months  43  26 (60)  4.5  40  17 (43)  2.0  Months in study   ≥ 14 months (median)  45  34 (76)*  3.0  42  20 (48)  2.5   < 14 months  50  25 (50)  2.0  36  12 (33)  2.0  Center   Corporate  36  15 (42)*  2.0  30  9 (30)  2.0   Academic  59  44 (75)  3.0  48  23 (48)  2.0  aPatients with one or more visit with PCMH-KD PCP bNumber of PCMH-KD PCP visits *Significance for Chi Square tests: (p-value <0.05) View Large There were two CHWs on the study staff, an English-speaking CHW and a bilingual CHW (English- and Spanish-speaking). The English-speaking CHW was assigned 89 patients (51%), while the bilingual CHW was assigned 84 (49%). All 57 of the Hispanic participants who completed their interviews in Spanish were assigned to the bilingual CHW. The 24 Hispanic participants who completed their interviews in English were distributed evenly between the CHWs: 11 to the bilingual CHW and 13 to the English-speaking CHW. Most of the 92 non-Hispanic participants, who were mostly African-American, were assigned to the English-speaking CHW: 76 (83%) and 16 (17%) to the bilingual CHW. Of the 89 participants assigned to the English-speaking CHW, 35 (39%) had an established PCP at baseline. On the other hand, of the 84 assigned to the bilingual CHW, 43 (51%) had an established PCP at baseline. The difference between CHW assignment and prior PCP status was not statistically significant (p = .12). The CHWs conducted 1,508 visits with 166 patients. Sixty-six percent of the CHW visits were in-depth follow-up visits. Table 2 shows the distribution of the CHW follow-up visits. The most frequent topics discussed during these follow-up visits were related to aid with scheduling appointments (38%), followed by social support (19%), primary care (18%), and emotional support (17%). Scheduling appointments was the most frequent topic. This indicates that the additional resources provided in the CHW visit helped to activate patients to use health care services when needed, which is consistent with the CCM model [42]. Table 2 Topics discussed during community health worker follow-up visits Topic  Percent of visits (n = 990)a    %  Clinical appointments  38  Social support  19  Primary care  18  Emotions or stress  17  Major or stressful life changes  10  Medication adherence  7  Economic situation  6  Relationship with health care providers  6  Dialysis treatment  5  Diet, nutrition, fluid intake  3  Barriers to taking medications  2  Transportation  2  Topic  Percent of visits (n = 990)a    %  Clinical appointments  38  Social support  19  Primary care  18  Emotions or stress  17  Major or stressful life changes  10  Medication adherence  7  Economic situation  6  Relationship with health care providers  6  Dialysis treatment  5  Diet, nutrition, fluid intake  3  Barriers to taking medications  2  Transportation  2  aTotal number of follow-up visits with community health workers. View Large Table 2 Topics discussed during community health worker follow-up visits Topic  Percent of visits (n = 990)a    %  Clinical appointments  38  Social support  19  Primary care  18  Emotions or stress  17  Major or stressful life changes  10  Medication adherence  7  Economic situation  6  Relationship with health care providers  6  Dialysis treatment  5  Diet, nutrition, fluid intake  3  Barriers to taking medications  2  Transportation  2  Topic  Percent of visits (n = 990)a    %  Clinical appointments  38  Social support  19  Primary care  18  Emotions or stress  17  Major or stressful life changes  10  Medication adherence  7  Economic situation  6  Relationship with health care providers  6  Dialysis treatment  5  Diet, nutrition, fluid intake  3  Barriers to taking medications  2  Transportation  2  aTotal number of follow-up visits with community health workers. View Large Patient perceptions of primary care Table 3 shows comparisons of patients on the five scales of the PCAS. Notably, over the period of the intervention, the percentage of patients reporting they had someone they considered their personal doctor grew to 81%; however, the trend was statistically significant only at 6 months. Although longitudinal care seemed to remain somewhat flat over time, comprehensive knowledge, communication, interpersonal treatment, and integration of care ratings all improved over the period of the intervention. These improvements in four out of five PCAS scales over time suggest that patients were satisfied with the primary care they were receiving during the study. Table 3 Primary care assessment survey (PCAS) mean scale scores at baseline, 6, 12, and 18 months   Baseline n = 174  6 months n = 155  12 months n = 123  18 months n = 103  Has regular personal doctor, n (%)  104 (60%)  110 (71%)  92 (75%)  83 (81%)    Baseline n = 174  6 months n = 155  12 months n = 123  18 months n = 103  Has regular personal doctor, n (%)  104 (60%)  110 (71%)  92 (75%)  83 (81%)  PCAS scale scores (0–100)a    Mean (SD)   Longitudinal continuity  52.9 (37.2)  43.9 (36.2)  51.4 (32.0)  49.4 (30.5)   Comprehensive knowledge  65.4 (21.3)  70.3 (19.6)  68.8 (19.6)  74.1 (20.6)   Communication  74.3 (18.8)  80.5 (16.3)  79.9 (17.2)  81.0 (17.4)   Interpersonal treatment  75.2 (17.3)  79.5 (17.0)  78.7 (17.7)  81.5 (18.1)  Received referral from personal doctor, n (%)  64 (62%)  45 (41%)  37 (41%)  45 (55%)  PCAS scale scores (0–100)a    Mean (SD)   Longitudinal continuity  52.9 (37.2)  43.9 (36.2)  51.4 (32.0)  49.4 (30.5)   Comprehensive knowledge  65.4 (21.3)  70.3 (19.6)  68.8 (19.6)  74.1 (20.6)   Communication  74.3 (18.8)  80.5 (16.3)  79.9 (17.2)  81.0 (17.4)   Interpersonal treatment  75.2 (17.3)  79.5 (17.0)  78.7 (17.7)  81.5 (18.1)  Received referral from personal doctor, n (%)  64 (62%)  45 (41%)  37 (41%)  45 (55%)  PCAS scale scores (0–100)b  Mean (SD)  Integration of care  67.8 (22.2)  76.5 (19.0)  76.8 (19.1)  81.8 (19.6)  PCAS scale scores (0–100)b  Mean (SD)  Integration of care  67.8 (22.2)  76.5 (19.0)  76.8 (19.1)  81.8 (19.6)  Numbers differ slightly for some scales due to missing data. A six-point Likert scale (1 = very poor to 6 = excellent) scored from 0 to 100 points. Higher scores indicate a higher attribute. SD, standard deviation. aScale scores are only calculated for patients who have a regular personal doctor. bScale scores (integration of care) are only calculated for patients who have a regular personal doctor and reported receiving referrals. View Large Table 3 Primary care assessment survey (PCAS) mean scale scores at baseline, 6, 12, and 18 months   Baseline n = 174  6 months n = 155  12 months n = 123  18 months n = 103  Has regular personal doctor, n (%)  104 (60%)  110 (71%)  92 (75%)  83 (81%)    Baseline n = 174  6 months n = 155  12 months n = 123  18 months n = 103  Has regular personal doctor, n (%)  104 (60%)  110 (71%)  92 (75%)  83 (81%)  PCAS scale scores (0–100)a    Mean (SD)   Longitudinal continuity  52.9 (37.2)  43.9 (36.2)  51.4 (32.0)  49.4 (30.5)   Comprehensive knowledge  65.4 (21.3)  70.3 (19.6)  68.8 (19.6)  74.1 (20.6)   Communication  74.3 (18.8)  80.5 (16.3)  79.9 (17.2)  81.0 (17.4)   Interpersonal treatment  75.2 (17.3)  79.5 (17.0)  78.7 (17.7)  81.5 (18.1)  Received referral from personal doctor, n (%)  64 (62%)  45 (41%)  37 (41%)  45 (55%)  PCAS scale scores (0–100)a    Mean (SD)   Longitudinal continuity  52.9 (37.2)  43.9 (36.2)  51.4 (32.0)  49.4 (30.5)   Comprehensive knowledge  65.4 (21.3)  70.3 (19.6)  68.8 (19.6)  74.1 (20.6)   Communication  74.3 (18.8)  80.5 (16.3)  79.9 (17.2)  81.0 (17.4)   Interpersonal treatment  75.2 (17.3)  79.5 (17.0)  78.7 (17.7)  81.5 (18.1)  Received referral from personal doctor, n (%)  64 (62%)  45 (41%)  37 (41%)  45 (55%)  PCAS scale scores (0–100)b  Mean (SD)  Integration of care  67.8 (22.2)  76.5 (19.0)  76.8 (19.1)  81.8 (19.6)  PCAS scale scores (0–100)b  Mean (SD)  Integration of care  67.8 (22.2)  76.5 (19.0)  76.8 (19.1)  81.8 (19.6)  Numbers differ slightly for some scales due to missing data. A six-point Likert scale (1 = very poor to 6 = excellent) scored from 0 to 100 points. Higher scores indicate a higher attribute. SD, standard deviation. aScale scores are only calculated for patients who have a regular personal doctor. bScale scores (integration of care) are only calculated for patients who have a regular personal doctor and reported receiving referrals. View Large Factors associated with having any PCMH-KD PCP visit Results of the separate logistic regression models showing predictors of having any PCMH-KD PCP visit are in Table 4. One factor, a greater number of CHW visits, stands out as a significant predictor. Among those in the no-PCP group, patients receiving 8–11 CHW visits compared with patients receiving 0–7 CHW visits had an increase in the probability of visiting the PCMH-KD PCP by 32% (p = .0528). Patients receiving 12 or more CHW visits compared to patients receiving 8–11 CHW visits had an additional increase in the probability of visiting the PCMH-KD PCP of 32% (p = .0031). Table 4 Logistic regression resultsa of visits with the study primary care physician (PCMH-KD PCP) for each baseline PCP group   No-PCP (n = 95)  Established-PCP (n = 78)  Adjusted odds ratio (95% CI)  Age, years   ≥55, <55b  2.23 (0.61–8.15)  0.21 (0.05–0.86)*  Gender   Male, femaleb  0.55 (0.17–1.82)  0.65 (0.19–2.19)  Race/ethnicity   African-American, Hispanic/otherb  1.77 (0.41–7.60)  1.36 (0.14–13.17)  Interview language   Spanish, Englishb  2.47 (0.41–14.99)  0.33 (0.02–5.34)  Self-efficacy, median score   ≥7.5, <7.5b  0.98 (0.33–2.98)  0.36 (0.1–1.31)  Stressful life events   Yes, Nob  1.25 (0.42–3.69)  1.03 (0.27–3.90)  CHW visits, number   8–11, ≤7b  5.40 (0.98–29.78)  18.00 (2.37–136.67)*   ≥12, ≤7b  22.88 (2.87–182.52)*  170.94 (10.26–999.99)*  Health literacy, score   Marginal/inadequate, adequateb  0.68 (0.18–2.59)  2.40 (0.39–14.60)  Family/friend involved with dialysis care   Yes, Nob  2.20 (0.71–6.77)  0.53 (0.14-2.05)  Transportation   Medically arranged, otherb  0.56 (0.17–1.84)  0.89 (0.25–3.20)  Diabetes (self-report)   Yes, nob  0.38 (0.11–1.26)  2.90 (0.63–13.28)  Dialysis vintage   ≥36, <36b  0.47 (0.13–1.66)  1.34 (0.37–4.85)    No-PCP (n = 95)  Established-PCP (n = 78)  Adjusted odds ratio (95% CI)  Age, years   ≥55, <55b  2.23 (0.61–8.15)  0.21 (0.05–0.86)*  Gender   Male, femaleb  0.55 (0.17–1.82)  0.65 (0.19–2.19)  Race/ethnicity   African-American, Hispanic/otherb  1.77 (0.41–7.60)  1.36 (0.14–13.17)  Interview language   Spanish, Englishb  2.47 (0.41–14.99)  0.33 (0.02–5.34)  Self-efficacy, median score   ≥7.5, <7.5b  0.98 (0.33–2.98)  0.36 (0.1–1.31)  Stressful life events   Yes, Nob  1.25 (0.42–3.69)  1.03 (0.27–3.90)  CHW visits, number   8–11, ≤7b  5.40 (0.98–29.78)  18.00 (2.37–136.67)*   ≥12, ≤7b  22.88 (2.87–182.52)*  170.94 (10.26–999.99)*  Health literacy, score   Marginal/inadequate, adequateb  0.68 (0.18–2.59)  2.40 (0.39–14.60)  Family/friend involved with dialysis care   Yes, Nob  2.20 (0.71–6.77)  0.53 (0.14-2.05)  Transportation   Medically arranged, otherb  0.56 (0.17–1.84)  0.89 (0.25–3.20)  Diabetes (self-report)   Yes, nob  0.38 (0.11–1.26)  2.90 (0.63–13.28)  Dialysis vintage   ≥36, <36b  0.47 (0.13–1.66)  1.34 (0.37–4.85)  CHW, community health worker; PCMH-KD PCP, patient-centered medical home for kidney disease primary care physician. Separate regression models were run for each baseline PCP group. All models were adjusted for length of time in study and dialysis center (covariates not shown). aFrom logistic regression with any PCMH-KD PCP visits versus no PCMH-KD PCP visits as the dependent variable. bReference group coded 0 (other group coded 1). *Significance for logistic regression models (p < .05). View Large Table 4 Logistic regression resultsa of visits with the study primary care physician (PCMH-KD PCP) for each baseline PCP group   No-PCP (n = 95)  Established-PCP (n = 78)  Adjusted odds ratio (95% CI)  Age, years   ≥55, <55b  2.23 (0.61–8.15)  0.21 (0.05–0.86)*  Gender   Male, femaleb  0.55 (0.17–1.82)  0.65 (0.19–2.19)  Race/ethnicity   African-American, Hispanic/otherb  1.77 (0.41–7.60)  1.36 (0.14–13.17)  Interview language   Spanish, Englishb  2.47 (0.41–14.99)  0.33 (0.02–5.34)  Self-efficacy, median score   ≥7.5, <7.5b  0.98 (0.33–2.98)  0.36 (0.1–1.31)  Stressful life events   Yes, Nob  1.25 (0.42–3.69)  1.03 (0.27–3.90)  CHW visits, number   8–11, ≤7b  5.40 (0.98–29.78)  18.00 (2.37–136.67)*   ≥12, ≤7b  22.88 (2.87–182.52)*  170.94 (10.26–999.99)*  Health literacy, score   Marginal/inadequate, adequateb  0.68 (0.18–2.59)  2.40 (0.39–14.60)  Family/friend involved with dialysis care   Yes, Nob  2.20 (0.71–6.77)  0.53 (0.14-2.05)  Transportation   Medically arranged, otherb  0.56 (0.17–1.84)  0.89 (0.25–3.20)  Diabetes (self-report)   Yes, nob  0.38 (0.11–1.26)  2.90 (0.63–13.28)  Dialysis vintage   ≥36, <36b  0.47 (0.13–1.66)  1.34 (0.37–4.85)    No-PCP (n = 95)  Established-PCP (n = 78)  Adjusted odds ratio (95% CI)  Age, years   ≥55, <55b  2.23 (0.61–8.15)  0.21 (0.05–0.86)*  Gender   Male, femaleb  0.55 (0.17–1.82)  0.65 (0.19–2.19)  Race/ethnicity   African-American, Hispanic/otherb  1.77 (0.41–7.60)  1.36 (0.14–13.17)  Interview language   Spanish, Englishb  2.47 (0.41–14.99)  0.33 (0.02–5.34)  Self-efficacy, median score   ≥7.5, <7.5b  0.98 (0.33–2.98)  0.36 (0.1–1.31)  Stressful life events   Yes, Nob  1.25 (0.42–3.69)  1.03 (0.27–3.90)  CHW visits, number   8–11, ≤7b  5.40 (0.98–29.78)  18.00 (2.37–136.67)*   ≥12, ≤7b  22.88 (2.87–182.52)*  170.94 (10.26–999.99)*  Health literacy, score   Marginal/inadequate, adequateb  0.68 (0.18–2.59)  2.40 (0.39–14.60)  Family/friend involved with dialysis care   Yes, Nob  2.20 (0.71–6.77)  0.53 (0.14-2.05)  Transportation   Medically arranged, otherb  0.56 (0.17–1.84)  0.89 (0.25–3.20)  Diabetes (self-report)   Yes, nob  0.38 (0.11–1.26)  2.90 (0.63–13.28)  Dialysis vintage   ≥36, <36b  0.47 (0.13–1.66)  1.34 (0.37–4.85)  CHW, community health worker; PCMH-KD PCP, patient-centered medical home for kidney disease primary care physician. Separate regression models were run for each baseline PCP group. All models were adjusted for length of time in study and dialysis center (covariates not shown). aFrom logistic regression with any PCMH-KD PCP visits versus no PCMH-KD PCP visits as the dependent variable. bReference group coded 0 (other group coded 1). *Significance for logistic regression models (p < .05). View Large Among those in the established-PCP group, patients receiving 8–11 CHW visits compared with patients receiving 0–7 CHW visits had an increase in the probability of visiting the PCMH-KD PCP of 2% (p = .0052). Patients receiving 12 or more CHW visits compared to patients receiving 8–11 CHW visits had an additional increase in the probability of visiting the PCMH-KD PCP of 13% (p = .0003). Note that the CHW visit effect is substantial and statistically significant, even while the length of time in study is controlled, thus suggesting an association between CHW visits and PCMH-KD PCP uptake independent of study exposure time and site. Our results are consistent with the health behavior model and the chronic care model; both note important influences of interest in self-care as might be indicated by patients scheduling appointments with the CHWs and which in turn also influence use of the PCP services [41, 42]. Also consistent with the CCM model, effective self-management support and links to patient-oriented resources, such as that offered by the CHWs in the PCMH-KD intervention, may have helped to activate and inform patients about the value of the PCMH-KD PCP services [42]. DISCUSSION This study examined the trends in the PCMH-KD PCP uptake by CHD patients with and without an established PCP. We found that the majority of patients elected to schedule visits with the PCMH-KD PCP, and those without an established PCP saw the PCMH-KD PCP at a higher rate than those with an established PCP. The findings suggest that when provided with the opportunity of access to a PCP at no economic cost, most patients without an established PCP took advantage of it. This result is consistent with prior reports that showed the potential benefit of comprehensive and coordinated care [50, 51]. Half of the overall visits in our study were performed at the chairside during dialysis. Mandel et al. [52] also recently reported that some CHD patients opted to have serious illness conversations with physicians, including PCPs, at the chair during dialysis treatments. For these patients, having a PCP visit during dialysis could positively influence their number of outpatient visits while still providing needed and expedient care. Although patients with no established PCP had higher levels of the PCMH-KD uptake, not all patients opted for this choice. While we provided informational sessions for patients to understand the options and services throughout the study, it is possible that a patient’s lack of a prior PCP may reflect a prior choice that was not influenced by convenience factors or costs, and which persisted during our study. This interpretation is consistent with research on prior health care use influencing continued use patterns [41], although we are not aware of other studies of CHD patients’ primary care use. With the recent call for reform in the Medicare End Stage Renal Disease program to improve patient-centeredness of care [53], further research is needed to better understand whether care coordination through the integration of primary care is adequate to address patient preferences. Not surprisingly, there was less uptake of the PCMH-KD PCP among those patients with an established PCP. This may be due to the patients’ desire to maintain continuity of care and already established relationships with their PCPs prior to the study. Yet, some patients with an established PCP did choose to have individual visits with a PCMH-KD PCP. We postulate that prior experience with the benefits of having an established PCP, as well as time and convenience factors within the dialysis center, could have been key to this decision. Anecdotal reports from our patient stakeholder discussion groups support this supposition. On the other hand, for patients who already had an established PCP and also used our PCMH-KD PCP, there is concern that an additional PCP may have worsened fragmentation of primary care. In this regard, it is noteworthy that the PCAS longitudinal continuity scale score was steady over time. Additionally, patients who received a referral from their personal doctor reported improved PCAS integration of care scale scores over time. Taken together, these PCAS results suggest that care fragmentation was not compromised, and in cases when additional providers were consulted, care integration improved. The role of the CHW was an important factor contributing to the uptake of the PCMH-KD PCP. The effect of CHW visit on PCP uptake was independent of study exposure time and site. Our results are consistent with other studies that have reported that CHWs have significantly improved primary care utilization [54, 55] while decreasing the use of inpatient hospital stays and emergency department visits [37]. Notably among the topics, the CHW visits addressed included scheduling visits and primary care. We know from the CHW anecdotal reports that often they helped patients schedule their appointments, including the PCP appointments. In some cases, the CHWs alerted the PCMH-KD PCP if a patient was willing to have a chairside visit during rounds, which may have had an influence on the use of chairside visits, in particular. A better understanding of how CHWs support patients’ appropriate use of primary care providers and the extent to which they support patient self-efficacy and activation skills is needed [56, 57]. In contrast to prior research [58, 59], we did not find a significant relationship between self-efficacy and the uptake of the PCP services offered. Others have begun to explore the role of patient activation, which relates to patients' knowledge, skill, and confidence to manage their health and health care; patient activation has been associated with certain health care behaviors and health care utilization [56, 57]. Future research in kidney disease and dialysis education should consider the explicit role of patient activation in influencing desired health behaviors and health service use. Our study had several potential limitations. The primary limitation was the nonrandomized design at two sites with participants serving as historical controls under the Medicare-mandated dialysis care model. As a health system intervention, it was not practical to randomize patients to the intervention. Also, we did not track whether patients saw another PCP during the study beyond patient self-report, although the use of another PCP would also have been evident from visits with the CHW; therefore, we presume other PCP visits to be low. For this study, we did not include quality of life, and comorbidity assessment was limited to diabetes. Future research should explore these relationships. CONCLUSION This study is the first to examine the uptake of a PCP integrated into an adaptation of a PCMH model among CHD patients, a heterogeneous population with highly complex medical and resource needs. Patients with no established PCP were most likely to utilize these services. For all the CHD patients in our study, the CHWs played an important role in influencing PCP uptake, independent of patients’ prior relationships with a PCP. The role of CHWs in care coordination for CHD patients warrants further study. Understanding the relationships among providers is critical in enhancing patient-centered care and improving care coordination and outcomes for patients with complex chronic diseases. Compliance with Ethical Standards Primary Data: The findings reported in this manuscript have not been previously published and the manuscript is not simultaneously submitted elsewhere. The authors have presented earlier versions of this work at: (i) AcademyHealth Annual Research Meeting, New Orleans, LA (June 26, 2017) and (ii) Society of Behavioral Medicine (SBM) 38th Annual Meeting, San Diego, CA (March 29, 2017). The authors have full control of all primary data, and we agree to allow the journal to review the reported data if requested. Conflict of Interest: None of the authors listed in this manuscript have any actual or potential conflicts of interest. Financial conflict of interest (FCOI) and disclosures have been made to the University of Illinois at Chicago to meet federal guidelines for the 2011 PHS FCOI regulations, as well as to the sponsor PCORI. Ethical Approval: All procedures performed in this study, which involved human participants, were in accordance with the ethical standards of the University of Illinois at Chicago Institutional Review Board based on the Belmont Report and the Common Rule. The approval was maintained throughout the study period. The research described in this article did not include any studies with animals. Informed Consent: Informed consent was obtained from all study participants using protocols and materials approved by the University of Illinois at Chicago Institutional Review Board. Acknowledgments The Patient-Centered Outcomes Research Institute (PCORI), contract #IH-12-11-5420, provided funding for this work. Dr. Hynes also receives individual support from the United States Department of Veterans Affairs (VA) Health Services Research and Development Research Career Scientist Award (RCS-98–352). Ms. Chukwudozie is supported by the GUIDE Cancer Research Training Project (NCI: 1P20CA202908). Data for this study provided in part by the University of Illinois at Chicago (UIC) Center for Clinical and Translational Science (CCTS), funded by National Center for Advancing Translational Sciences, National Institutes of Health (UL1TR002003). The content is solely the responsibility of the authors and does not necessarily reflect the views of PCORI, the VA or the NIH. The authors wish to acknowledge the assistance and support of the PCMH-KD study clinical and research team, University of Illinois Hospital and Health Sciences System, and Frenova Renal Research and most especially the study participants. References 1. Boyd CM, Darer J, Boult C, Fried LP, Boult L, Wu AW. Clinical practice guidelines and quality of care for older patients with multiple comorbid diseases: Implications for pay for performance. JAMA . 2005; 294( 6): 716– 724. Google Scholar CrossRef Search ADS PubMed  2. McDonald KM, Sundaram V, Bravata DMet al.   Closing the quality gap: A critical analysis of quality improvement strategies (Vol. 7: Care coordination ). AHRQ Technical Reviews and Summaries . Report No. 04(07)-0051-7. Rockville (MD): Agency for Healthcare Research and Quality (US); 2007. https://www.ncbi.nlm.nih.gov/books/NBK44015/. Accessibility verified February 20, 2018. 3. Alidina S, Rosenthal M, Schneider E, Singer S. 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Facilitating primary care provider use in a patient-centered medical home intervention study for chronic hemodialysis patients

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Abstract

Abstract Patients with chronic kidney disease have a high disease burden may benefit from primary care services and care coord A medical home model with direct access to primary care services is one approach that may address this need, yet has not been examined. As a substudy of the Patient-Centered Outcomes Research Institute (PCORI) patient-centered medical home for kidney disease (PCMH-KD) health system intervention study, we examined the uptake of free primary care physician (PCP) services. The PCORI PCMH-KD study was an initial step toward integrating PCPs, a nurse coordinator, a pharmacist, and community health workers (CHWs) within the health care delivery team. Adult chronic hemodialysis (CHD) at two urban dialysis centers were enrolled in the intervention. We examined trends and factors associated with the use of the PCMH-KD PCP among two groups of patients based on their report of having a regular physician for at least six months (established-PCP) or not (no-PCP). Of the 173 enrolled patients, 91 (53%) patients had at least one visit with the PCMH-KD PCP. The rate of visits was higher in those in the no-PCP group compared with those in the established-PCP group (62% vs. 41%, respectively). Having more visits with the CHW was positively associated with having a visit with the PCMH-KD PCPs for both groups. Embedded CHWs within the care team played a role in facilithe uptake of PCMH-KD PCP. Lessons from this health system intervention can inform future approaches on the integration of PCPs and care coordination for CHD patients. Implications Results from this health system intervention study showed that an embedded community health worker had a positive impact in facilitating the uptake of new primary care provider services at the dialysis center may inform future efforts to improve primary care provider use and care coordination for chronic hemodialysis (CHD) patients. Practice: Integrating support for primary care services in dialysis centers could improve care coordination and primary care use for chronic hemodialysis (CHD) patients. Policy: Policies affecting the design of the health care team for CHD patients in the future should consider new care models that improve access to a primary care physician. Research: Future research should focus on identifying the most effective components of health care delivery models that contribute to optimal outcomes for high-risk patients with complex chronic conditions, such as CHD patients. INTRODUCTION Over the past two decades, the health care community has come to recognize the importance of medical homes for primary care and care coordination for patients with chronic disease [1–3]. While approaches have varied to include team-based care, chronic disease model, collaborative care, patient navigation, and medical home models facilitating care coordination with a primary care physician (PCP) has remained a central theme. Methods of facilitating care coordination with PCPs have involved the use of patient navigators, community health workers (CHWs), and other ancillary health care providers in areas related to cancer, diabetes, and pediatric populations [4–8]. These varied methods of care coordination have resulted in mixed success. Until recently, kidney disease has not been highlighted in care coordination approaches [9–11], yet kidney disease represents a significant public health problem. Notably, the number of affected individuals with end-stage renal disease (ESRD) increases annually with more than 670,000 cases per year [12, 13]. A large proportion of these patients are dependent upon chronic hemodialysis (CHD) treatment and/or are in need of kidney transplantation [13]. Extensive health care use and high costs have placed a significant burden on the health care system [14–16] with Medicare spending approaching $32.80 billion in 2014 for ESRD alone [13]. There is also a substantial burden on the patient, including physical and emotional symptoms of ESRD [17], significant health care use [18, 19], length and frequency of dialysis treatment [20], multiple comorbidities [21], and adverse treatment effects related to dialysis and kidney transplant [22, 23]. The burden of care on the health care system and the patient underscores the need for coordination of care in managing the complex health care needs of patients with ESRD, which is particularly challenging as disease stage advances, and symptoms become more severe. With a focus on the kidney disease treatment and symptom management, primary care needs can often be overlooked, while paradoxically contributing to disease progression, increased health care costs, and poor health outcomes [24–27]. Given the complex medical needs of these patients, it can become confusing as to whether the nephrologist or PCP should take the lead in treating the various comorbid conditions most dialysis patients experience [27, 28]. Understandably, coordination of care can become challenging. For example, in one study poor communication between nephrologists and PCPs contributed to increased fragmentation and reduced continuity of care [28]. Relationship building between PCPs and subspecialty care providers has been cited among Veterans Affairs physicians as an “improvement opportunity” [29]. This suggests that even in integrated health systems there can be gaps in effective communication. McDonald [2] defines care coordination as “the deliberate organization of patient care activities between two or more participants (including the patient) involved in a patient’s care, in order to facilitate the appropriate delivery of healthcare services.” The patient-centered medical home (PCMH) model of care aims to strengthen primary care, a core element of coordinated care [30–32]. This coordination is especially important for patients with multiple health care providers [33, 34] and complex needs, such as ESRD patients, and may require formal agreements between providers [35]. Importantly, the inclusion of a PCP has been shown to increase patient satisfaction and referral adherence [36]; however, the effect of having a PCP involved has not been well studied in ESRD populations. Additionally, the role of ancillary health care providers has also been shown to enhance care coordination by improving primary care utilization [37], although their potential role in the care of ESRD patients has not been empirically addressed. In this article, we describe the role of a PCP in an adaptation of a medical home model for ESRD patients, known as the patient-centered medical home for kidney disease (PCMH-KD) study [11, 38]. We also describe the facilitating role of CHWs and explore other factors associated with PCMH-KD PCP visits by patients in the study. Bringing care to patients: the PCMH-KD study The Patient-Centered Outcomes Research Institute (PCORI) PCMH-KD study was the first application of this model for ESRD patients on chronic hemodialysis (CHD) and has been described previously [11, 14, 20]. Briefly, the study sought to design, implement, and compare an adaptation of the PCMH to the Medicare-mandated care team model in two dialysis centers using a before–after design with repeated measures. The Medicare-mandated dialysis care team currently includes a nephrologist, a nurse, a dietician, a dialysis technician, and a social worker [39]. The PCMH-KD model of care aimed to augment the dialysis care team to improve access to primary care and care coordination through the inclusion of a PCP, a nurse coordinator, a clinical pharmacist, and a CHW [14, 20]. The PCMH-KD PCP made patient rounds with the nephrologist and had individual visits with patients, as needed. The CHWs served as health promoters or navigators, coordinated their work with the social workers and other care team members to support patients’ compliance, and mediate certain barriers affecting adequate dialysis treatment such as scheduling medical appointments, transportation, and other unforeseen supportive care. The primary outcome of the parent study was patient-reported quality of life [11, 40]. The intervention was conducted from January 2015 to August 2016, and the main outcome results are pending. This article describes a substudy to examine factors associated with PCP visits by adult CHD patients. The University of Illinois at Chicago Institutional Review Board and Fresenius, Inc. approved the study. All participants provided written informed consent. METHODS Study design In this study, we explored the role of the study PCP (PCMH-KD PCP) and the factors that influenced the use of the PCMH-KD PCP services; we used the Andersen health behavior model [41], the chronic care model (CCM) [42], and prior research in kidney disease [43, 44] to guide this study. Building on the parent study before–after repeated measures design, we examined the free health care services provided by the PCMH-KD PCP and the role of the CHW in patients’ use of these services. We also considered patient demographics, self-efficacy regarding their chronic disease management, enabling factors that might impact availability and access to general health care, and clinical need factors related to patients’ health status and specific to CHD care [45, 46]. We also explored the content of the CHW visits and patient satisfaction with primary care services. Study procedures The study procedures, population, design of the intervention, roles of the PCMH-KD augmented personnel, and earlier results have been described previously [14, 20]. Briefly, recruitment into the study was on a rolling basis over 14 months. Eligible patients were either English- or Spanish-speaking adults (≥18 years) receiving chronic hemodialysis at one of the two sites. Once consented, trained study staff informed patients of the services provided by the augmented personnel during the intervention. After baseline data were collected, patients were immediately eligible to schedule visits with the PCMH-KD PCP and other services. The patients were also assigned to one of the two CHWs based on the patient’s preference for English or Spanish. Patients had an initial visit with their assigned CHW and monthly check-in visits; more in-depth follow-up visits were at the patient’s discretion. Patients contacted their CHW or the dialysis staff to schedule appointments with the PCMH-KD PCP. Although the study did not monitor the activities of the social workers in the clinics, the CHW coordinated with the social workers to reduce any overlap in the study participants’ care. The social workers continued their roles as case managers. The PCMH-KD intervention was conducted from January 2015 to August 2016. Interviews were administered at baseline and every 6 months with enrolled patients. Anticipating that a patient with an a priori established relationship with a PCP might affect uptake of the PCMH-KD PCP visits; for this study, we classified patients based on their response at baseline to two questions in the Primary Care Assessment Survey (PCAS) [47]: (a) Is there one particular doctor that you consider to be your regular personal doctor? (b) How long has this person been your doctor? Patients who reported having a PCP at baseline and had seen the PCP within at least the past 6 months were classified as having an established PCP (established-PCP group). Patients who reported no PCP or had a PCP for less than 6 months were classified as not having an established PCP (no-PCP group). Measures The number of patient visits with the PCMH-KD PCP was tracked and documented by the study team. The visits included office visits, performed at the PCP's office, and chairside visits, performed in the dialysis center during patient's dialysis treatment. Continuous counts and dichotomous values (any visits with the PCMH-KD PCP or not) were used. Demographic factors included age, race/ethnicity, and interview language. Age (in years) was divided at the median into two categories (≥55 or <55 years). Race/ethnicity included two categories: African-American and non–African-Americans (included Hispanics and non-Hispanic Whites). All African-Americans in the study were not of Hispanic origin. Interview language was either English or Spanish. We included self-efficacy, measured using the Self-Efficacy for Managing Chronic Disease (SEMCD) survey [48], and categorized at the median as high (≥7.5) or low (<7.5). The SEMCD is a six-item survey, with responses rated from 1 (not confident) to 10 (totally confident), to measure the participants’ level of confidence in performing tasks to manage their chronic disease such as dealing with fatigue, emotional distress, and symptoms associated with the disease; performing activities to reduce doctors’ visits; and taking medication to reduce the effect of the disease. The mean of the six items was scored, and a higher score indicated higher efficacy. We also included a dichotomous measure for stressful life events in the past 6 months (such as hospitalization, loss of employment, or the loss of a family member) (Yes/No). Health literacy scores [49] were split into two tiers at the median: adequate (3–8) and marginal or inadequate (9–15). We included a self-reported measure of social support indicating whether a family member or a friend was involved with dialysis care (Yes/No). Patients provided information on their primary means of transportation to dialysis by responding to the question, “How do you usually get to and from the dialysis clinic?” Transportation to dialysis treatment was categorized into medically arranged transportation mode or other transportation modes. The number of patient visits with the CHWs was also tracked and documented by the study staff. We included a measure indicating the uptake of the CHW using three progressive categories of the number of CHW visits (≤7, 8–11, and ≥12). The CHW also documented the main topics discussed at each visit. Clinical need factors comprised two measures: whether patients self-reported that they had diabetes (Yes/No) and dialysis vintage, that is, the length of time on dialysis, divided into two categories based on the median value (≥36 months or ˂36 months). Time in the study (months) was included as a covariate in all multivariable regression models as patients had varying lengths of time in the study. We included an indicator for the dialysis centers (academic or corporate). Additionally, we also explored the content of the CHW visits recorded by the CHWs in a templated report. Finally, item responses in the PCAS, an 11–summary scale measure, were used to characterize patient perceptions of primary care related to five of the summary scales that measure the duration of patient’s relationship with their PCP (longitudinal continuity); PCP knowledge of patient’s medical history and responsibilities and health concerns (comprehensive knowledge); PCP’s thorough physical examination of and attention given to the patient (communication); amount of time and care patient receives from their PCP (interpersonal treatment); and PCP’s role in referring and coordinating the patient’s care with other specialists (integration of care) [47]. Using a six-point Likert response scale (1 = very poor, 2 = poor, 3 = fair, 4 = good, 5 = very good, and 6 = excellent), the PCAS scales were scored ranging from 0 to 100 points with higher score signifying a higher attribute. The mean score for each of the five PCAS scales was obtained for every six months. Statistical analysis Descriptive statistics, chi-square test, and logistic regression models were used to understand the influence of factors on whether patients utilized a PCMH-KD PCP. To examine any PCMH-KD PCP visits, we performed separate logistic regression models for those with established-PCP or no-PCP. RESULTS Of the 285 patients screened on a rolling basis over 14 months at the clinical sites, 248 patients were eligible to participate in the study; 185 patients consented. Ten patients were not able to complete the baseline survey, and 175 patients moved into the enrollment phase. Two of these patients did not complete the PCAS instrument and were excluded yielding 173 patients included in this substudy (Figure 1). The mean age was 54 years, and the median dialysis vintage was 3 years. A majority of the patients were men (55%), had a high school diploma (65%), were unemployed (82%), reported a household income of <$20,000 (61%), received dialysis at the current dialysis center for more than 6 months (75%), had a fistula for their vascular access (51%), completed the surveys in English (67%), received dialysis at the academic center (62%), reported a diabetes diagnosis (53%), obtained an adequate health literacy score (60%), drove themselves or someone drove them to the dialysis center (58%), and reported no stressful event in the past 6 months (55%) (data not shown). Fifty percent of the patients were African-Americans; 47% of patients in the “other” category were Hispanic and only 3% identified as non-Hispanic White. Fig 1 View largeDownload slide Study participants by baseline primary care physician (PCP) groups (no-PCP and established-PCP) and use of the study PCP (patient-centered medical home for kidney disease [PCMH-KD] PCP). Fig 1 View largeDownload slide Study participants by baseline primary care physician (PCP) groups (no-PCP and established-PCP) and use of the study PCP (patient-centered medical home for kidney disease [PCMH-KD] PCP). The PCMH-KD PCPs conducted 346 visits with 91 study participants. The frequency of visits for any individual patient ranged from no visits to 16 visits. Half of patient visits with the PCMH-KD PCP were performed chairside during dialysis (50%), followed by clinic appointments (41%). Figure 2 shows the frequencies of PCMH-KD PCP visits for the entire intervention. Among patients with one or more PCMH-KD PCP visit(s), those with no-PCP at study entry had consistently more visits. As seen in Table 1, 53% of the patients had at least one visit with a PCMH-KD PCP during the 18-month intervention. Patients in the no-PCP group were significantly more likely to see a PCMH-KD PCP than patients in the established-PCP group: 62% versus 41%, respectively. Patients in the no-PCP group had a greater proportion of the PCMH-KD PCP visits (72%) as well as a greater number of visits per person. Patients in the no-PCP group and participating for 14 months or longer were significantly more likely to have a PCMH-KD PCP visit than those who were enrolled less than 14 months. Additionally, patients at the corporate center were more likely to have a PCMH-KD PCP visit (Table 1). Fig 2 View largeDownload slide Number of visits with study primary care physician (PCP) (patient-centered medical home for kidney disease [PCMH-KD PCP]) by baseline PCP group (no-PCP and established PCP). Fig 2 View largeDownload slide Number of visits with study primary care physician (PCP) (patient-centered medical home for kidney disease [PCMH-KD PCP]) by baseline PCP group (no-PCP and established PCP). Table 1 Number of Visits with the Study Primary Care Physician (PCMH-KD PCP) by Patient Characteristics, Stratified by Baseline PCP Group (No-PCP and Established PCP)   No-PCP  Established-PCP  Total number of PCMH-KD visits, n (%)  249 (72)  97 (28)    n  Any visitsan (%)  Number of visitsb Median  n  Any visitsan (%)  Number of visitsb Median  All participants  95  59 (62)  3.0  78  32 (41)  2.0  Age, years   ≥ 55  39  23 (59)  4.0  46  16 (35)  2.0   < 55  56  36 (64)  3.0  32  16 (50)  2.0  Gender   Male  61  35 (57)  3.0  35  13 (37)  2.0   Female  34  24 (71)  4.5  43  19 (44)  2.0  Race/ethnicity   African American  49  31 (63)  4.0  37  18 (49)  2.0   Hispanic, other  46  28 (61)  2.5  41  14 (34)  2.0  Interview language   Spanish  25  14 (56)  2.0  32  9 (28)  3.0   English  70  45 (64)  3.0  46  23 (50)  2.0  Self-efficacy (SEMCD)   >=7.5 (median)  49  30 (61)  3.0  40  14 (35)  2.0   < 7.5  46  29 (63)  3.0  38  18 (47)  2.0  Stressful life events in 6 months   Yes  39  25 (64)  4.0  39  16 (41)  2.5   No  56  34 (61)  2.5  39  16 (41)  2.0  Community Health Worker (CHW) visits   ≤7  28  11 (39)*  2.0  28  4 (14)*  1.5   8–11  37  24 (65)  2.0  32  15 (47)  2.0   ≥12  30  24 (25)  5.0  18  13 (72)  2.0  Health literacy   Marginal/inadequate (9–15)  33  19 (58)  3.0  35  11 (31)  3.0   Adequate (3–8)  62  40 (65)  3.0  43  21 (49)  2.0  Family member/friend involved with dialysis care   Yes  45  32 (71)  3.0  49  22 (45)  2.0   No  50  27 (54)  3.0  29  10 (34)  2.0  Transportation to dialysis center   Medically arranged transporter  37  22 (59)  4.5  35  15 (43)  1.0   Other (car, transit, bicycle)  58  37 (64)  2.0  43  17 (40)  2.0  Diabetes (self-report)   Yes  43  24 (56)  5.0  49  21 (43)  2.0   No  52  35 (67)  2.0  29  11 (38)  2.0  Dialysis vintage   ≥ 36 months (median)  52  33 (63)  3.0  38  15 (39)  3.0   < 36 months  43  26 (60)  4.5  40  17 (43)  2.0  Months in study   ≥ 14 months (median)  45  34 (76)*  3.0  42  20 (48)  2.5   < 14 months  50  25 (50)  2.0  36  12 (33)  2.0  Center   Corporate  36  15 (42)*  2.0  30  9 (30)  2.0   Academic  59  44 (75)  3.0  48  23 (48)  2.0    No-PCP  Established-PCP  Total number of PCMH-KD visits, n (%)  249 (72)  97 (28)    n  Any visitsan (%)  Number of visitsb Median  n  Any visitsan (%)  Number of visitsb Median  All participants  95  59 (62)  3.0  78  32 (41)  2.0  Age, years   ≥ 55  39  23 (59)  4.0  46  16 (35)  2.0   < 55  56  36 (64)  3.0  32  16 (50)  2.0  Gender   Male  61  35 (57)  3.0  35  13 (37)  2.0   Female  34  24 (71)  4.5  43  19 (44)  2.0  Race/ethnicity   African American  49  31 (63)  4.0  37  18 (49)  2.0   Hispanic, other  46  28 (61)  2.5  41  14 (34)  2.0  Interview language   Spanish  25  14 (56)  2.0  32  9 (28)  3.0   English  70  45 (64)  3.0  46  23 (50)  2.0  Self-efficacy (SEMCD)   >=7.5 (median)  49  30 (61)  3.0  40  14 (35)  2.0   < 7.5  46  29 (63)  3.0  38  18 (47)  2.0  Stressful life events in 6 months   Yes  39  25 (64)  4.0  39  16 (41)  2.5   No  56  34 (61)  2.5  39  16 (41)  2.0  Community Health Worker (CHW) visits   ≤7  28  11 (39)*  2.0  28  4 (14)*  1.5   8–11  37  24 (65)  2.0  32  15 (47)  2.0   ≥12  30  24 (25)  5.0  18  13 (72)  2.0  Health literacy   Marginal/inadequate (9–15)  33  19 (58)  3.0  35  11 (31)  3.0   Adequate (3–8)  62  40 (65)  3.0  43  21 (49)  2.0  Family member/friend involved with dialysis care   Yes  45  32 (71)  3.0  49  22 (45)  2.0   No  50  27 (54)  3.0  29  10 (34)  2.0  Transportation to dialysis center   Medically arranged transporter  37  22 (59)  4.5  35  15 (43)  1.0   Other (car, transit, bicycle)  58  37 (64)  2.0  43  17 (40)  2.0  Diabetes (self-report)   Yes  43  24 (56)  5.0  49  21 (43)  2.0   No  52  35 (67)  2.0  29  11 (38)  2.0  Dialysis vintage   ≥ 36 months (median)  52  33 (63)  3.0  38  15 (39)  3.0   < 36 months  43  26 (60)  4.5  40  17 (43)  2.0  Months in study   ≥ 14 months (median)  45  34 (76)*  3.0  42  20 (48)  2.5   < 14 months  50  25 (50)  2.0  36  12 (33)  2.0  Center   Corporate  36  15 (42)*  2.0  30  9 (30)  2.0   Academic  59  44 (75)  3.0  48  23 (48)  2.0  aPatients with one or more visit with PCMH-KD PCP bNumber of PCMH-KD PCP visits *Significance for Chi Square tests: (p-value <0.05) View Large Table 1 Number of Visits with the Study Primary Care Physician (PCMH-KD PCP) by Patient Characteristics, Stratified by Baseline PCP Group (No-PCP and Established PCP)   No-PCP  Established-PCP  Total number of PCMH-KD visits, n (%)  249 (72)  97 (28)    n  Any visitsan (%)  Number of visitsb Median  n  Any visitsan (%)  Number of visitsb Median  All participants  95  59 (62)  3.0  78  32 (41)  2.0  Age, years   ≥ 55  39  23 (59)  4.0  46  16 (35)  2.0   < 55  56  36 (64)  3.0  32  16 (50)  2.0  Gender   Male  61  35 (57)  3.0  35  13 (37)  2.0   Female  34  24 (71)  4.5  43  19 (44)  2.0  Race/ethnicity   African American  49  31 (63)  4.0  37  18 (49)  2.0   Hispanic, other  46  28 (61)  2.5  41  14 (34)  2.0  Interview language   Spanish  25  14 (56)  2.0  32  9 (28)  3.0   English  70  45 (64)  3.0  46  23 (50)  2.0  Self-efficacy (SEMCD)   >=7.5 (median)  49  30 (61)  3.0  40  14 (35)  2.0   < 7.5  46  29 (63)  3.0  38  18 (47)  2.0  Stressful life events in 6 months   Yes  39  25 (64)  4.0  39  16 (41)  2.5   No  56  34 (61)  2.5  39  16 (41)  2.0  Community Health Worker (CHW) visits   ≤7  28  11 (39)*  2.0  28  4 (14)*  1.5   8–11  37  24 (65)  2.0  32  15 (47)  2.0   ≥12  30  24 (25)  5.0  18  13 (72)  2.0  Health literacy   Marginal/inadequate (9–15)  33  19 (58)  3.0  35  11 (31)  3.0   Adequate (3–8)  62  40 (65)  3.0  43  21 (49)  2.0  Family member/friend involved with dialysis care   Yes  45  32 (71)  3.0  49  22 (45)  2.0   No  50  27 (54)  3.0  29  10 (34)  2.0  Transportation to dialysis center   Medically arranged transporter  37  22 (59)  4.5  35  15 (43)  1.0   Other (car, transit, bicycle)  58  37 (64)  2.0  43  17 (40)  2.0  Diabetes (self-report)   Yes  43  24 (56)  5.0  49  21 (43)  2.0   No  52  35 (67)  2.0  29  11 (38)  2.0  Dialysis vintage   ≥ 36 months (median)  52  33 (63)  3.0  38  15 (39)  3.0   < 36 months  43  26 (60)  4.5  40  17 (43)  2.0  Months in study   ≥ 14 months (median)  45  34 (76)*  3.0  42  20 (48)  2.5   < 14 months  50  25 (50)  2.0  36  12 (33)  2.0  Center   Corporate  36  15 (42)*  2.0  30  9 (30)  2.0   Academic  59  44 (75)  3.0  48  23 (48)  2.0    No-PCP  Established-PCP  Total number of PCMH-KD visits, n (%)  249 (72)  97 (28)    n  Any visitsan (%)  Number of visitsb Median  n  Any visitsan (%)  Number of visitsb Median  All participants  95  59 (62)  3.0  78  32 (41)  2.0  Age, years   ≥ 55  39  23 (59)  4.0  46  16 (35)  2.0   < 55  56  36 (64)  3.0  32  16 (50)  2.0  Gender   Male  61  35 (57)  3.0  35  13 (37)  2.0   Female  34  24 (71)  4.5  43  19 (44)  2.0  Race/ethnicity   African American  49  31 (63)  4.0  37  18 (49)  2.0   Hispanic, other  46  28 (61)  2.5  41  14 (34)  2.0  Interview language   Spanish  25  14 (56)  2.0  32  9 (28)  3.0   English  70  45 (64)  3.0  46  23 (50)  2.0  Self-efficacy (SEMCD)   >=7.5 (median)  49  30 (61)  3.0  40  14 (35)  2.0   < 7.5  46  29 (63)  3.0  38  18 (47)  2.0  Stressful life events in 6 months   Yes  39  25 (64)  4.0  39  16 (41)  2.5   No  56  34 (61)  2.5  39  16 (41)  2.0  Community Health Worker (CHW) visits   ≤7  28  11 (39)*  2.0  28  4 (14)*  1.5   8–11  37  24 (65)  2.0  32  15 (47)  2.0   ≥12  30  24 (25)  5.0  18  13 (72)  2.0  Health literacy   Marginal/inadequate (9–15)  33  19 (58)  3.0  35  11 (31)  3.0   Adequate (3–8)  62  40 (65)  3.0  43  21 (49)  2.0  Family member/friend involved with dialysis care   Yes  45  32 (71)  3.0  49  22 (45)  2.0   No  50  27 (54)  3.0  29  10 (34)  2.0  Transportation to dialysis center   Medically arranged transporter  37  22 (59)  4.5  35  15 (43)  1.0   Other (car, transit, bicycle)  58  37 (64)  2.0  43  17 (40)  2.0  Diabetes (self-report)   Yes  43  24 (56)  5.0  49  21 (43)  2.0   No  52  35 (67)  2.0  29  11 (38)  2.0  Dialysis vintage   ≥ 36 months (median)  52  33 (63)  3.0  38  15 (39)  3.0   < 36 months  43  26 (60)  4.5  40  17 (43)  2.0  Months in study   ≥ 14 months (median)  45  34 (76)*  3.0  42  20 (48)  2.5   < 14 months  50  25 (50)  2.0  36  12 (33)  2.0  Center   Corporate  36  15 (42)*  2.0  30  9 (30)  2.0   Academic  59  44 (75)  3.0  48  23 (48)  2.0  aPatients with one or more visit with PCMH-KD PCP bNumber of PCMH-KD PCP visits *Significance for Chi Square tests: (p-value <0.05) View Large There were two CHWs on the study staff, an English-speaking CHW and a bilingual CHW (English- and Spanish-speaking). The English-speaking CHW was assigned 89 patients (51%), while the bilingual CHW was assigned 84 (49%). All 57 of the Hispanic participants who completed their interviews in Spanish were assigned to the bilingual CHW. The 24 Hispanic participants who completed their interviews in English were distributed evenly between the CHWs: 11 to the bilingual CHW and 13 to the English-speaking CHW. Most of the 92 non-Hispanic participants, who were mostly African-American, were assigned to the English-speaking CHW: 76 (83%) and 16 (17%) to the bilingual CHW. Of the 89 participants assigned to the English-speaking CHW, 35 (39%) had an established PCP at baseline. On the other hand, of the 84 assigned to the bilingual CHW, 43 (51%) had an established PCP at baseline. The difference between CHW assignment and prior PCP status was not statistically significant (p = .12). The CHWs conducted 1,508 visits with 166 patients. Sixty-six percent of the CHW visits were in-depth follow-up visits. Table 2 shows the distribution of the CHW follow-up visits. The most frequent topics discussed during these follow-up visits were related to aid with scheduling appointments (38%), followed by social support (19%), primary care (18%), and emotional support (17%). Scheduling appointments was the most frequent topic. This indicates that the additional resources provided in the CHW visit helped to activate patients to use health care services when needed, which is consistent with the CCM model [42]. Table 2 Topics discussed during community health worker follow-up visits Topic  Percent of visits (n = 990)a    %  Clinical appointments  38  Social support  19  Primary care  18  Emotions or stress  17  Major or stressful life changes  10  Medication adherence  7  Economic situation  6  Relationship with health care providers  6  Dialysis treatment  5  Diet, nutrition, fluid intake  3  Barriers to taking medications  2  Transportation  2  Topic  Percent of visits (n = 990)a    %  Clinical appointments  38  Social support  19  Primary care  18  Emotions or stress  17  Major or stressful life changes  10  Medication adherence  7  Economic situation  6  Relationship with health care providers  6  Dialysis treatment  5  Diet, nutrition, fluid intake  3  Barriers to taking medications  2  Transportation  2  aTotal number of follow-up visits with community health workers. View Large Table 2 Topics discussed during community health worker follow-up visits Topic  Percent of visits (n = 990)a    %  Clinical appointments  38  Social support  19  Primary care  18  Emotions or stress  17  Major or stressful life changes  10  Medication adherence  7  Economic situation  6  Relationship with health care providers  6  Dialysis treatment  5  Diet, nutrition, fluid intake  3  Barriers to taking medications  2  Transportation  2  Topic  Percent of visits (n = 990)a    %  Clinical appointments  38  Social support  19  Primary care  18  Emotions or stress  17  Major or stressful life changes  10  Medication adherence  7  Economic situation  6  Relationship with health care providers  6  Dialysis treatment  5  Diet, nutrition, fluid intake  3  Barriers to taking medications  2  Transportation  2  aTotal number of follow-up visits with community health workers. View Large Patient perceptions of primary care Table 3 shows comparisons of patients on the five scales of the PCAS. Notably, over the period of the intervention, the percentage of patients reporting they had someone they considered their personal doctor grew to 81%; however, the trend was statistically significant only at 6 months. Although longitudinal care seemed to remain somewhat flat over time, comprehensive knowledge, communication, interpersonal treatment, and integration of care ratings all improved over the period of the intervention. These improvements in four out of five PCAS scales over time suggest that patients were satisfied with the primary care they were receiving during the study. Table 3 Primary care assessment survey (PCAS) mean scale scores at baseline, 6, 12, and 18 months   Baseline n = 174  6 months n = 155  12 months n = 123  18 months n = 103  Has regular personal doctor, n (%)  104 (60%)  110 (71%)  92 (75%)  83 (81%)    Baseline n = 174  6 months n = 155  12 months n = 123  18 months n = 103  Has regular personal doctor, n (%)  104 (60%)  110 (71%)  92 (75%)  83 (81%)  PCAS scale scores (0–100)a    Mean (SD)   Longitudinal continuity  52.9 (37.2)  43.9 (36.2)  51.4 (32.0)  49.4 (30.5)   Comprehensive knowledge  65.4 (21.3)  70.3 (19.6)  68.8 (19.6)  74.1 (20.6)   Communication  74.3 (18.8)  80.5 (16.3)  79.9 (17.2)  81.0 (17.4)   Interpersonal treatment  75.2 (17.3)  79.5 (17.0)  78.7 (17.7)  81.5 (18.1)  Received referral from personal doctor, n (%)  64 (62%)  45 (41%)  37 (41%)  45 (55%)  PCAS scale scores (0–100)a    Mean (SD)   Longitudinal continuity  52.9 (37.2)  43.9 (36.2)  51.4 (32.0)  49.4 (30.5)   Comprehensive knowledge  65.4 (21.3)  70.3 (19.6)  68.8 (19.6)  74.1 (20.6)   Communication  74.3 (18.8)  80.5 (16.3)  79.9 (17.2)  81.0 (17.4)   Interpersonal treatment  75.2 (17.3)  79.5 (17.0)  78.7 (17.7)  81.5 (18.1)  Received referral from personal doctor, n (%)  64 (62%)  45 (41%)  37 (41%)  45 (55%)  PCAS scale scores (0–100)b  Mean (SD)  Integration of care  67.8 (22.2)  76.5 (19.0)  76.8 (19.1)  81.8 (19.6)  PCAS scale scores (0–100)b  Mean (SD)  Integration of care  67.8 (22.2)  76.5 (19.0)  76.8 (19.1)  81.8 (19.6)  Numbers differ slightly for some scales due to missing data. A six-point Likert scale (1 = very poor to 6 = excellent) scored from 0 to 100 points. Higher scores indicate a higher attribute. SD, standard deviation. aScale scores are only calculated for patients who have a regular personal doctor. bScale scores (integration of care) are only calculated for patients who have a regular personal doctor and reported receiving referrals. View Large Table 3 Primary care assessment survey (PCAS) mean scale scores at baseline, 6, 12, and 18 months   Baseline n = 174  6 months n = 155  12 months n = 123  18 months n = 103  Has regular personal doctor, n (%)  104 (60%)  110 (71%)  92 (75%)  83 (81%)    Baseline n = 174  6 months n = 155  12 months n = 123  18 months n = 103  Has regular personal doctor, n (%)  104 (60%)  110 (71%)  92 (75%)  83 (81%)  PCAS scale scores (0–100)a    Mean (SD)   Longitudinal continuity  52.9 (37.2)  43.9 (36.2)  51.4 (32.0)  49.4 (30.5)   Comprehensive knowledge  65.4 (21.3)  70.3 (19.6)  68.8 (19.6)  74.1 (20.6)   Communication  74.3 (18.8)  80.5 (16.3)  79.9 (17.2)  81.0 (17.4)   Interpersonal treatment  75.2 (17.3)  79.5 (17.0)  78.7 (17.7)  81.5 (18.1)  Received referral from personal doctor, n (%)  64 (62%)  45 (41%)  37 (41%)  45 (55%)  PCAS scale scores (0–100)a    Mean (SD)   Longitudinal continuity  52.9 (37.2)  43.9 (36.2)  51.4 (32.0)  49.4 (30.5)   Comprehensive knowledge  65.4 (21.3)  70.3 (19.6)  68.8 (19.6)  74.1 (20.6)   Communication  74.3 (18.8)  80.5 (16.3)  79.9 (17.2)  81.0 (17.4)   Interpersonal treatment  75.2 (17.3)  79.5 (17.0)  78.7 (17.7)  81.5 (18.1)  Received referral from personal doctor, n (%)  64 (62%)  45 (41%)  37 (41%)  45 (55%)  PCAS scale scores (0–100)b  Mean (SD)  Integration of care  67.8 (22.2)  76.5 (19.0)  76.8 (19.1)  81.8 (19.6)  PCAS scale scores (0–100)b  Mean (SD)  Integration of care  67.8 (22.2)  76.5 (19.0)  76.8 (19.1)  81.8 (19.6)  Numbers differ slightly for some scales due to missing data. A six-point Likert scale (1 = very poor to 6 = excellent) scored from 0 to 100 points. Higher scores indicate a higher attribute. SD, standard deviation. aScale scores are only calculated for patients who have a regular personal doctor. bScale scores (integration of care) are only calculated for patients who have a regular personal doctor and reported receiving referrals. View Large Factors associated with having any PCMH-KD PCP visit Results of the separate logistic regression models showing predictors of having any PCMH-KD PCP visit are in Table 4. One factor, a greater number of CHW visits, stands out as a significant predictor. Among those in the no-PCP group, patients receiving 8–11 CHW visits compared with patients receiving 0–7 CHW visits had an increase in the probability of visiting the PCMH-KD PCP by 32% (p = .0528). Patients receiving 12 or more CHW visits compared to patients receiving 8–11 CHW visits had an additional increase in the probability of visiting the PCMH-KD PCP of 32% (p = .0031). Table 4 Logistic regression resultsa of visits with the study primary care physician (PCMH-KD PCP) for each baseline PCP group   No-PCP (n = 95)  Established-PCP (n = 78)  Adjusted odds ratio (95% CI)  Age, years   ≥55, <55b  2.23 (0.61–8.15)  0.21 (0.05–0.86)*  Gender   Male, femaleb  0.55 (0.17–1.82)  0.65 (0.19–2.19)  Race/ethnicity   African-American, Hispanic/otherb  1.77 (0.41–7.60)  1.36 (0.14–13.17)  Interview language   Spanish, Englishb  2.47 (0.41–14.99)  0.33 (0.02–5.34)  Self-efficacy, median score   ≥7.5, <7.5b  0.98 (0.33–2.98)  0.36 (0.1–1.31)  Stressful life events   Yes, Nob  1.25 (0.42–3.69)  1.03 (0.27–3.90)  CHW visits, number   8–11, ≤7b  5.40 (0.98–29.78)  18.00 (2.37–136.67)*   ≥12, ≤7b  22.88 (2.87–182.52)*  170.94 (10.26–999.99)*  Health literacy, score   Marginal/inadequate, adequateb  0.68 (0.18–2.59)  2.40 (0.39–14.60)  Family/friend involved with dialysis care   Yes, Nob  2.20 (0.71–6.77)  0.53 (0.14-2.05)  Transportation   Medically arranged, otherb  0.56 (0.17–1.84)  0.89 (0.25–3.20)  Diabetes (self-report)   Yes, nob  0.38 (0.11–1.26)  2.90 (0.63–13.28)  Dialysis vintage   ≥36, <36b  0.47 (0.13–1.66)  1.34 (0.37–4.85)    No-PCP (n = 95)  Established-PCP (n = 78)  Adjusted odds ratio (95% CI)  Age, years   ≥55, <55b  2.23 (0.61–8.15)  0.21 (0.05–0.86)*  Gender   Male, femaleb  0.55 (0.17–1.82)  0.65 (0.19–2.19)  Race/ethnicity   African-American, Hispanic/otherb  1.77 (0.41–7.60)  1.36 (0.14–13.17)  Interview language   Spanish, Englishb  2.47 (0.41–14.99)  0.33 (0.02–5.34)  Self-efficacy, median score   ≥7.5, <7.5b  0.98 (0.33–2.98)  0.36 (0.1–1.31)  Stressful life events   Yes, Nob  1.25 (0.42–3.69)  1.03 (0.27–3.90)  CHW visits, number   8–11, ≤7b  5.40 (0.98–29.78)  18.00 (2.37–136.67)*   ≥12, ≤7b  22.88 (2.87–182.52)*  170.94 (10.26–999.99)*  Health literacy, score   Marginal/inadequate, adequateb  0.68 (0.18–2.59)  2.40 (0.39–14.60)  Family/friend involved with dialysis care   Yes, Nob  2.20 (0.71–6.77)  0.53 (0.14-2.05)  Transportation   Medically arranged, otherb  0.56 (0.17–1.84)  0.89 (0.25–3.20)  Diabetes (self-report)   Yes, nob  0.38 (0.11–1.26)  2.90 (0.63–13.28)  Dialysis vintage   ≥36, <36b  0.47 (0.13–1.66)  1.34 (0.37–4.85)  CHW, community health worker; PCMH-KD PCP, patient-centered medical home for kidney disease primary care physician. Separate regression models were run for each baseline PCP group. All models were adjusted for length of time in study and dialysis center (covariates not shown). aFrom logistic regression with any PCMH-KD PCP visits versus no PCMH-KD PCP visits as the dependent variable. bReference group coded 0 (other group coded 1). *Significance for logistic regression models (p < .05). View Large Table 4 Logistic regression resultsa of visits with the study primary care physician (PCMH-KD PCP) for each baseline PCP group   No-PCP (n = 95)  Established-PCP (n = 78)  Adjusted odds ratio (95% CI)  Age, years   ≥55, <55b  2.23 (0.61–8.15)  0.21 (0.05–0.86)*  Gender   Male, femaleb  0.55 (0.17–1.82)  0.65 (0.19–2.19)  Race/ethnicity   African-American, Hispanic/otherb  1.77 (0.41–7.60)  1.36 (0.14–13.17)  Interview language   Spanish, Englishb  2.47 (0.41–14.99)  0.33 (0.02–5.34)  Self-efficacy, median score   ≥7.5, <7.5b  0.98 (0.33–2.98)  0.36 (0.1–1.31)  Stressful life events   Yes, Nob  1.25 (0.42–3.69)  1.03 (0.27–3.90)  CHW visits, number   8–11, ≤7b  5.40 (0.98–29.78)  18.00 (2.37–136.67)*   ≥12, ≤7b  22.88 (2.87–182.52)*  170.94 (10.26–999.99)*  Health literacy, score   Marginal/inadequate, adequateb  0.68 (0.18–2.59)  2.40 (0.39–14.60)  Family/friend involved with dialysis care   Yes, Nob  2.20 (0.71–6.77)  0.53 (0.14-2.05)  Transportation   Medically arranged, otherb  0.56 (0.17–1.84)  0.89 (0.25–3.20)  Diabetes (self-report)   Yes, nob  0.38 (0.11–1.26)  2.90 (0.63–13.28)  Dialysis vintage   ≥36, <36b  0.47 (0.13–1.66)  1.34 (0.37–4.85)    No-PCP (n = 95)  Established-PCP (n = 78)  Adjusted odds ratio (95% CI)  Age, years   ≥55, <55b  2.23 (0.61–8.15)  0.21 (0.05–0.86)*  Gender   Male, femaleb  0.55 (0.17–1.82)  0.65 (0.19–2.19)  Race/ethnicity   African-American, Hispanic/otherb  1.77 (0.41–7.60)  1.36 (0.14–13.17)  Interview language   Spanish, Englishb  2.47 (0.41–14.99)  0.33 (0.02–5.34)  Self-efficacy, median score   ≥7.5, <7.5b  0.98 (0.33–2.98)  0.36 (0.1–1.31)  Stressful life events   Yes, Nob  1.25 (0.42–3.69)  1.03 (0.27–3.90)  CHW visits, number   8–11, ≤7b  5.40 (0.98–29.78)  18.00 (2.37–136.67)*   ≥12, ≤7b  22.88 (2.87–182.52)*  170.94 (10.26–999.99)*  Health literacy, score   Marginal/inadequate, adequateb  0.68 (0.18–2.59)  2.40 (0.39–14.60)  Family/friend involved with dialysis care   Yes, Nob  2.20 (0.71–6.77)  0.53 (0.14-2.05)  Transportation   Medically arranged, otherb  0.56 (0.17–1.84)  0.89 (0.25–3.20)  Diabetes (self-report)   Yes, nob  0.38 (0.11–1.26)  2.90 (0.63–13.28)  Dialysis vintage   ≥36, <36b  0.47 (0.13–1.66)  1.34 (0.37–4.85)  CHW, community health worker; PCMH-KD PCP, patient-centered medical home for kidney disease primary care physician. Separate regression models were run for each baseline PCP group. All models were adjusted for length of time in study and dialysis center (covariates not shown). aFrom logistic regression with any PCMH-KD PCP visits versus no PCMH-KD PCP visits as the dependent variable. bReference group coded 0 (other group coded 1). *Significance for logistic regression models (p < .05). View Large Among those in the established-PCP group, patients receiving 8–11 CHW visits compared with patients receiving 0–7 CHW visits had an increase in the probability of visiting the PCMH-KD PCP of 2% (p = .0052). Patients receiving 12 or more CHW visits compared to patients receiving 8–11 CHW visits had an additional increase in the probability of visiting the PCMH-KD PCP of 13% (p = .0003). Note that the CHW visit effect is substantial and statistically significant, even while the length of time in study is controlled, thus suggesting an association between CHW visits and PCMH-KD PCP uptake independent of study exposure time and site. Our results are consistent with the health behavior model and the chronic care model; both note important influences of interest in self-care as might be indicated by patients scheduling appointments with the CHWs and which in turn also influence use of the PCP services [41, 42]. Also consistent with the CCM model, effective self-management support and links to patient-oriented resources, such as that offered by the CHWs in the PCMH-KD intervention, may have helped to activate and inform patients about the value of the PCMH-KD PCP services [42]. DISCUSSION This study examined the trends in the PCMH-KD PCP uptake by CHD patients with and without an established PCP. We found that the majority of patients elected to schedule visits with the PCMH-KD PCP, and those without an established PCP saw the PCMH-KD PCP at a higher rate than those with an established PCP. The findings suggest that when provided with the opportunity of access to a PCP at no economic cost, most patients without an established PCP took advantage of it. This result is consistent with prior reports that showed the potential benefit of comprehensive and coordinated care [50, 51]. Half of the overall visits in our study were performed at the chairside during dialysis. Mandel et al. [52] also recently reported that some CHD patients opted to have serious illness conversations with physicians, including PCPs, at the chair during dialysis treatments. For these patients, having a PCP visit during dialysis could positively influence their number of outpatient visits while still providing needed and expedient care. Although patients with no established PCP had higher levels of the PCMH-KD uptake, not all patients opted for this choice. While we provided informational sessions for patients to understand the options and services throughout the study, it is possible that a patient’s lack of a prior PCP may reflect a prior choice that was not influenced by convenience factors or costs, and which persisted during our study. This interpretation is consistent with research on prior health care use influencing continued use patterns [41], although we are not aware of other studies of CHD patients’ primary care use. With the recent call for reform in the Medicare End Stage Renal Disease program to improve patient-centeredness of care [53], further research is needed to better understand whether care coordination through the integration of primary care is adequate to address patient preferences. Not surprisingly, there was less uptake of the PCMH-KD PCP among those patients with an established PCP. This may be due to the patients’ desire to maintain continuity of care and already established relationships with their PCPs prior to the study. Yet, some patients with an established PCP did choose to have individual visits with a PCMH-KD PCP. We postulate that prior experience with the benefits of having an established PCP, as well as time and convenience factors within the dialysis center, could have been key to this decision. Anecdotal reports from our patient stakeholder discussion groups support this supposition. On the other hand, for patients who already had an established PCP and also used our PCMH-KD PCP, there is concern that an additional PCP may have worsened fragmentation of primary care. In this regard, it is noteworthy that the PCAS longitudinal continuity scale score was steady over time. Additionally, patients who received a referral from their personal doctor reported improved PCAS integration of care scale scores over time. Taken together, these PCAS results suggest that care fragmentation was not compromised, and in cases when additional providers were consulted, care integration improved. The role of the CHW was an important factor contributing to the uptake of the PCMH-KD PCP. The effect of CHW visit on PCP uptake was independent of study exposure time and site. Our results are consistent with other studies that have reported that CHWs have significantly improved primary care utilization [54, 55] while decreasing the use of inpatient hospital stays and emergency department visits [37]. Notably among the topics, the CHW visits addressed included scheduling visits and primary care. We know from the CHW anecdotal reports that often they helped patients schedule their appointments, including the PCP appointments. In some cases, the CHWs alerted the PCMH-KD PCP if a patient was willing to have a chairside visit during rounds, which may have had an influence on the use of chairside visits, in particular. A better understanding of how CHWs support patients’ appropriate use of primary care providers and the extent to which they support patient self-efficacy and activation skills is needed [56, 57]. In contrast to prior research [58, 59], we did not find a significant relationship between self-efficacy and the uptake of the PCP services offered. Others have begun to explore the role of patient activation, which relates to patients' knowledge, skill, and confidence to manage their health and health care; patient activation has been associated with certain health care behaviors and health care utilization [56, 57]. Future research in kidney disease and dialysis education should consider the explicit role of patient activation in influencing desired health behaviors and health service use. Our study had several potential limitations. The primary limitation was the nonrandomized design at two sites with participants serving as historical controls under the Medicare-mandated dialysis care model. As a health system intervention, it was not practical to randomize patients to the intervention. Also, we did not track whether patients saw another PCP during the study beyond patient self-report, although the use of another PCP would also have been evident from visits with the CHW; therefore, we presume other PCP visits to be low. For this study, we did not include quality of life, and comorbidity assessment was limited to diabetes. Future research should explore these relationships. CONCLUSION This study is the first to examine the uptake of a PCP integrated into an adaptation of a PCMH model among CHD patients, a heterogeneous population with highly complex medical and resource needs. Patients with no established PCP were most likely to utilize these services. For all the CHD patients in our study, the CHWs played an important role in influencing PCP uptake, independent of patients’ prior relationships with a PCP. The role of CHWs in care coordination for CHD patients warrants further study. Understanding the relationships among providers is critical in enhancing patient-centered care and improving care coordination and outcomes for patients with complex chronic diseases. Compliance with Ethical Standards Primary Data: The findings reported in this manuscript have not been previously published and the manuscript is not simultaneously submitted elsewhere. The authors have presented earlier versions of this work at: (i) AcademyHealth Annual Research Meeting, New Orleans, LA (June 26, 2017) and (ii) Society of Behavioral Medicine (SBM) 38th Annual Meeting, San Diego, CA (March 29, 2017). The authors have full control of all primary data, and we agree to allow the journal to review the reported data if requested. Conflict of Interest: None of the authors listed in this manuscript have any actual or potential conflicts of interest. Financial conflict of interest (FCOI) and disclosures have been made to the University of Illinois at Chicago to meet federal guidelines for the 2011 PHS FCOI regulations, as well as to the sponsor PCORI. Ethical Approval: All procedures performed in this study, which involved human participants, were in accordance with the ethical standards of the University of Illinois at Chicago Institutional Review Board based on the Belmont Report and the Common Rule. The approval was maintained throughout the study period. The research described in this article did not include any studies with animals. Informed Consent: Informed consent was obtained from all study participants using protocols and materials approved by the University of Illinois at Chicago Institutional Review Board. Acknowledgments The Patient-Centered Outcomes Research Institute (PCORI), contract #IH-12-11-5420, provided funding for this work. Dr. Hynes also receives individual support from the United States Department of Veterans Affairs (VA) Health Services Research and Development Research Career Scientist Award (RCS-98–352). Ms. Chukwudozie is supported by the GUIDE Cancer Research Training Project (NCI: 1P20CA202908). Data for this study provided in part by the University of Illinois at Chicago (UIC) Center for Clinical and Translational Science (CCTS), funded by National Center for Advancing Translational Sciences, National Institutes of Health (UL1TR002003). The content is solely the responsibility of the authors and does not necessarily reflect the views of PCORI, the VA or the NIH. 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Published: May 23, 2018

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