Acceptability of a multilevel intervention to improve blood pressure control among patients with chronic kidney disease in a public health care delivery system

Acceptability of a multilevel intervention to improve blood pressure control among patients with... Background: The Kidney Awareness Registry and Education (KARE) trial examined the impact of a multilevel intervention on blood pressure control among patients with chronic kidney disease (CKD) in a public health care delivery system. KARE consisted of a clinic-based intervention (a primary care CKD registry with point-of-care provider notifications and quarterly feedback related to CKD management) and a patient-directed intervention [a CKD self-management support (CKD-SMS) program that included low literacy educational materials, automated telephone-administered self-management modules and telephone health coaching]. We explored the acceptability of these interventions among end users. Methods: At trial conclusion, we surveyed 39 primary care providers (PCPs) to identify preferences about components of the clinic intervention, conducted two focus groups among non-PCP staff to elicit in-depth attitudes and experiences with operationalizing the team-based CKD registry, and conducted eight focus groups with English- and Spanish-speaking patients to hear about their experiences with the CKD-SMS program. Focus group transcripts were analyzed using thematic analysis. Self-reported participation and data from the automated telephone program were used to evaluate patient engagement. Results: Most PCPs (94%) believed that the point-of-care notifications benefited clinic workflow and agreed that quarterly feedback enhanced their ability to identify (89.5%) and manage (73.7%) CKD. Staff confirmed usefulness of point-of-care notifications. Patients suggested the automated telephone system was impersonal, though easy to use; that frequent automated calls were helpful to reinforce self-management behaviors; and that telephone health coaching was convenient. Nearly 40% of patients completed >80% of automated phone calls, 95% participated in calls with their health coach and 77% created at least one action plan. Conclusions: A CKD registry is acceptable to primary care health care teams and has potential to enhance identification and management of CKD in primary care. Low-income patients appreciated and engaged with a telephone-based CKD-SMS Received: August 23, 2017. Editorial decision: November 9, 2017 V C The Author 2017. Published by Oxford University Press on behalf of ERA-EDTA. This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/ licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com Downloaded from https://academic.oup.com/ckj/article-abstract/11/4/540/4762253 by Ed 'DeepDyve' Gillespie user on 07 August 2018 Acceptability of CKD interventions | 541 program, demonstrating its potential for increasing awareness and health engagement among populations with CKD within a public health care delivery system. Key words: acceptability, awareness, chronic kidney disease, CKD, registry, safety-net, self-management support both a CKD primary care registry and a CKD-SMS program Introduction within a public health care delivery system. Chronic kidney disease (CKD) affects more than 10% of the US population and is a pressing public health problem [1, 2]. Materials and methods Despite this, awareness of CKD among those with the disease remains very low, with studies reporting that <10% of individu- Study design, setting and participants als with CKD are aware of their disease [3, 4]. Among providers, KARE was a non-blinded, randomized controlled trial with a 2 awareness of CKD management guidelines is also suboptimal 2 factorial design implemented in two primary care clinics [4]. Low patient and provider awareness of CKD likely limit the within a public health care delivery system. Provider teams, delivery of, and adherence to, evidence-based CKD care, thus consisting of primary care providers (PCPs), nurses, nurse prac- impeding efforts to slow CKD progression and negatively affect- titioners, medical assistants and behaviorists were randomized ing health outcomes. There is a clear need for solutions that to receive either the primary care CKD registry or usual care. sustainably enhance the detection and management of CKD at the primary care level, which may also offer a critical vantage Patients were subsequently randomized to participate in a CKD- point for narrowing known disparities in CKD outcomes and SMS program or usual care. Details of the KARE study protocol, care delivery [5]. including an evaluation of educational materials used in the CKD-SMS, have been previously reported [6, 15]. For this mixed- The Kidney Awareness Registry and Education (KARE) study is a 2  2 randomized controlled trial (ClinicalTrials.gov: methods study examining acceptability of the multilevel inter- NCT01530958) that aimed to improve blood pressure control vention using surveys, focus groups and interviews, only mem- through enhanced patient and provider awareness of CKD. bers of the primary care clinic teams randomized to receive the KARE examined the impact of a multilevel intervention consist- KARE registry and patients randomized to receive the CKD-SMS ing of a primary care CKD registry and a CKD self-management program were eligible for participation. support (CKD-SMS) program [6]. At the primary care level, a team-based patient CKD registry supported the identification Study procedures and management of individuals with CKD and uncontrolled PCP survey. Acceptability of the clinic-level intervention was blood pressure. The CKD registry was comprised of an ‘in-reach’ assessed among study teams in the intervention arm; eligible element (e.g. point-of-care notifications) and an ‘out-reach’ PCPs were asked to complete a survey at the end of the 12- component (e.g. quarterly feedback reports), and built on prior month study that elicited preferences toward the ‘in-reach’ and CKD registry efforts [7–9]. At the patient level, the comprehen- ‘out-reach’ components of the primary care CKD registry in a sive, telephone-based CKD-SMS program encouraged patients quantitative fashion to facilitate comparisons. The survey also to engage in their health care and adopt healthy behaviors. The asked whether or not providers agreed that point-of-care alerts self-management support program included low literacy writ- and quarterly feedback patient lists had changed their ability to ten educational materials, automated telephone administered identify and deliver CKD care using 5-point Likert scales and self-management modules and telephone health coaching, and whether they had altered their interactions with patients and/ was based on previous self-management support initiatives or clinic staff. PCP surveys were distributed via e-mail, [10–14]. The KARE trial took place within a public health care mailboxes and were handed out in-person. delivery system and enrolled a low-income patient population that was linguistically and racially diverse. Clinic staff focus groups. Two focus groups with non-PCP clinic While registries and self-management support programs staff were organized between June and October 2015. Focus have independently been shown to improve uptake of health groups were chosen instead of one-on-one interviews to elicit knowledge and disease self-management among patients with in-depth attitudes and experiences with operationalizing the various chronic diseases [13, 14], much less is known about their team-based CKD registry and to promote shared conversation. potential to affect change within the CKD population, or their Focus groups were held in a clinic conference room and were acceptability within a public health care delivery system. Few CKD studies have involved the primary care setting and even facilitated by three members of the research team who had fewer have targeted a diverse, lower-income population. received training in facilitation, including a health coach and two study investigators (A.V., K.L.). Facilitators used a focus Examining the acceptability of the provider-level and patient- group guide designed to encourage staff to discuss their atti- level KARE interventions could offer valuable insight into key tudes and experiences, using open-ended questions informed facilitators of implementing similar interventions among health systems and populations that shoulder a high burden of chronic by social cognitive theory [16], which describes a dynamic proc- disease. The objectives of this study were thus: (i) to explore the ess of how personal factors, environmental variables and acceptability of a primary care CKD registry with both ‘in-reach’ human behavior reciprocally exert influence on each other to and ‘out-reach’ among health care teams in clinics in a public enable behavior change and posits that individuals with health care delivery system; (ii) to investigate patient opinions self-efficacy can enact behavior change, even when faced with and beliefs about the CKD-SMS program; and (iii) to determine obstacles (Supplementary data A). Participants provided written factors that could facilitate the sustainable implementation of consent to participate. Downloaded from https://academic.oup.com/ckj/article-abstract/11/4/540/4762253 by Ed 'DeepDyve' Gillespie user on 07 August 2018 542 | A. Strait et al. Patient focus groups. Eight focus groups with English- and Ethics Spanish-speaking patients who had been randomized to partici- The study was approved by the UCSF Committee on Human pate in the CKD-SMS program were organized between June and Research (Protocol number 11-07399) and participant anonym- October 2015. Participants were recruited by telephone, pro- ity was preserved. No patient or provider names were included vided written consent for participation and completed brief in the focus group audio recordings or the accompanying tran- demographic surveys on the day of focus group facilitation. scripts. Focus group participants agreed to maintain confiden- Patient focus groups were conducted in community clinic con- tiality of other participants during the formal consent process. ference rooms, ranged in size from two to six participants, and PCP surveys were anonymous unless individuals willingly pro- lasted between 1 and 2 h. They were facilitated by three mem- vided their names for subsequent contact. bers of the research team who were trained in facilitation, including a KARE health coach and two study investigators (A.V., K.L). They used a focus group guide informed by social Results cognitive theory that encouraged patients to draw upon their personal experiences with the three different components of Characteristics of study participants the CKD-SMS intervention: low-literacy, language-concordant A total of 21 (54%) PCPs randomized to the registry arm written patient education materials; bimonthly, language- responded to the survey. A majority (81%) of the registry PCPs concordant automated telephone self-management calls; and worked in the academic training clinic and most (61.9%) were telephone health coaching (Supplementary data B). female. PCP respondents had a varied amount of clinical experi- Patient engagement data. Self-reported patient engagement ence and included diverse provider types: 25% (n ¼ 5) were with each component of the CKD-SMS program and socio- trainees, 55% (n ¼ 11) were attending providers and 20% (n ¼ 4) demographic data were collected during standardized research were nurse practitioners (Table 1). calls for all patients randomized to the intervention (n ¼ 74). A total of eight (42%) of the non-PCP clinic staff randomized Additional data from the automated telephone self- to the registry participated in a focus group. While registry team management program identified the number of patients with members served various roles on the health care team (e.g. an average call completion rate above 80% throughout the health workers, panel managers, nurses), all of the registry course of the 50-week program; these patients were a priori focus group attendees were medical assistants. They were determined to be ‘high utilizers’ of the automated portion of the racially/ethnically diverse, with 37.5% self-identifying as Asian CKD-SMS program. Records from health coaching calls were and 62.5% self-identifying as Hispanic (Table 1). The majority reviewed to identify the number of patients who developed at (75%) of the non-PCP clinic staff focus group participants were least one action plan during the study’s duration. from the academic training clinic. Of the 74 patients randomized to receive the CKD-SMS pro- Analysis gram and from whom engagement data were obtained, 26 (35%) participated in a focus group. Similar to the overall KARE study All focus groups were audio-recorded and professionally tran- population and the population randomized to receive CKD-SMS, scribed. Spanish focus group transcripts were professionally focus group patients were racially/ethnically diverse, with translated and transcribed into English prior to the coding proc- ess. No field notes taken during the focus groups contributed to 53.9% (n ¼ 14) self-identifying as Hispanic, 34.6% (n ¼ 9) self- the analysis. Transcripts were analyzed using thematic analysis identifying as Black and 11.5% (n ¼ 3) self-identifying as White. with an iterative and collaborative process, drawing themes A majority (76.9%) of patient focus group participants received from the primary data rather than relying an a priori conceptual care from the academic training clinic and most (60%) spoke model [17]. Three investigators (K.L., A.N. and A.S.) independ- Spanish as their primary language (Table 1). ently coded one transcript for each language group and agreed upon initial codes. Only one of these individuals was involved in focus group facilitation, thus minimizing the impact of facili- PCP attitudes toward the primary care CKD registry tator–participant interactions on the analytic process. They Most (94.1%) PCPs believed that the ‘in-reach’ component of the used the preliminary codebook to independently analyze registry, with point-of-care notifications, benefited clinic work- another subset of transcripts, and then compared independent flow and 88.2% reported that these notifications influenced the coding results, resolved inconsistencies through adjustment of way in which they managed CKD (Figure 1). PCP respondents also the codebook and developed a set of specific code definitions. reported positive attitudes toward the ‘out-reach’ component of The remaining transcripts were independently coded by two of the registry, consisting of quarterly feedback, with a majority the three investigators who had done the initial coding. Any dis- stating it enhanced their ability to identify patients who had crepancies in coding were resolved by consensus. As additional CKD, needed better blood pressure control or were due for albu- concepts emerged, team members collaboratively modified the minuria quantification (89.5%, 78.9% and 78.9%, respectively). In codebook. After analyzing all of the transcripts, the analytic addition, 73.7% reported that the quarterly feedback reports team felt that thematic saturation was achieved among the enhanced their ability to manage patients with CKD. When asked non-PCP staff and patient focus groups. to compare the two different registry components, a majority of PCP survey data and patient engagement data were analyzed PCPs stated that the point-of-care notifications were more help- using StataSE Version 14 (StataCorp, College Station, Texas, ful than the quarterly feedback reports, though similar numbers USA). PCP responses were categorized into binary variables that reported that having both types of notifications were helpful in reflected agreement and complete agreement with statements identifying CKD and supporting the delivery of guideline- about the different registry components. Chi-squared tests were concordant care (Figure 2). Responses were similar among PCPs used to evaluate potential differences in PCP responses by clinic site (academic versus community). from the two different clinics (data not shown). Downloaded from https://academic.oup.com/ckj/article-abstract/11/4/540/4762253 by Ed 'DeepDyve' Gillespie user on 07 August 2018 Acceptability of CKD interventions | 543 Table 1. Characteristics of study participants Patients randomized Focus group Participant characteristics PCP Non-PCP clinic staff to CKD-SMS patient participants (n ¼ 21) (n ¼ 8) (n ¼ 74) (n ¼ 26) n (%) n (%) n (%) n (%) Clinic Academic training clinic 17 (81.0) 6 (75.0) 48 (64.9) 20 (76.9) Community clinic 4 (19.0) 2 (25.0) 26 (35.1) 6 (23.1) Female 13 (61.9) 7 (87.5) 39 (52.7) 12 (46.2) Race/ethnicity White 9 (42.9) 0 (0.0) 7 (9.6) 3 (11.5) Asian 6 (28.6) 3 (37.5) 11 (15.1) 0 (0.0) Black 1 (4.8) 0 (0.0) 30 (41.1) 9 (34.6) Hispanic 4 (19.0) 5 (62.5) 25 (34.3) 14 (53.8) Other 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) More than one race 1 (4.8) 0 (0.0) 0 (0.0) 0 (0.0) Non-English language – – 27 (36.5) 15 (60.0) Age 20–44 years – – 14 (18.9) 5 (19.2) 45–64 years – – 48 (64.9) 15 (57.7) 65þ years – – 12 (16.2) 6 (23.1) Provider type or clinic role Trainee 5 (25.0) – – – Attending provider 11 (55.0) – – – Nurse practitioner 4 (20.0) – – – Medical assistant – 7 (100.0) – – Other (e.g. health worker, etc.) – 0 (0.0) – – Years of experience after degree <5 years 7 (33.3) – – – 5–15 years 7 (33.3) – – – 16 years 7 (33.3) – – – One PCP and one staff member did not answer this question, resulting in denominators of n ¼ 20 and n ¼ 7. 100 94.1 89.5 88.2 78.9 78.9 73.7 Benefited clinic work Changed the way the Enhanced PCP's ability Enhanced PCP's ability Enhanced PCP's ability Enhanced PCP's ability flow PCP managed kidney to identify patients to manage patients to identify patients to identify patients disease with CKD with CKD who needed better due for albuminuria blood pressure control quantification Attitudes towards point- of-care notifications Attitudes towards quarterly feedback (n = 17) reports (n = 19) Fig. 1. PCP attitudes toward the CKD registry. Non-PCP clinic staff attitudes toward the primary care members to check for overdue diagnostic tests (i.e. albumin:- CKD registry creatinine ratio), allowing them to deliver better care to patients with CKD. Theme 1: CKD registries can aid health care teams in delivering guideline-concordant CKD care. Non-PCP clinic staff acknowl- I think it reminded a lot of the providers what they needed to do, edged the benefits of a primary care CKD registry. They stated including us... So when we had time to actually do it, those orders that the point-of-care alerts reminded the health care team would be carried out. (Participant #1) Downloaded from https://academic.oup.com/ckj/article-abstract/11/4/540/4762253 by Ed 'DeepDyve' Gillespie user on 07 August 2018 Percentage 544 | A. Strait et al. Point-of-care notifications Quarterly feedback reports Both 100.0 80.0 52.4 60.0 47.6 42.9 38.1 40.0 20.0 9.5 9.5 0.0 More helpful in identifying patients More helpful in ensuring delivery of with CKD guideline concordant care for patients with CKD Fig. 2. PCP attitudes toward the registry components. It was really good for early detection for kidney disease ’cause Theme 2: Patients generally agreed that the automated calls we all know people who have chronic kidney disease on dialysis were easy to understand, practical and convenient, though but I think it’s so nice to catch it early on and educate the patient, some patients felt that the automated calls were impersonal. see if they have some options and maybe try and control it. To press the numbers and to make the call. It was easy. (S. #5) (Participant #3) The way they explained it was very nice because it seemed as if we were having a conversation. It was easy to understand for any Theme 2: Suggestions for promoting registry uptake in a of us. At any educational level. (S. #3) public health care delivery health system. Non-PCP clinic staff believed that there were several factors that would promote Those patients that did not appreciate the automated nature of the telephone calls expressed a preference for more personal registry uptake. Specifically, they mentioned that better com- interaction and the health coaching component of the CKD-SMS munication among the providers within each health care team program. would help avoid duplication of services and streamline activities. Talking to the [telephone]; it’s impersonal and if you have a ques- tion right then, then you can’t get a response. (E. #1) [The registry] was a reminder... It’s like I need to do my home- work, just sometimes I end up doing [the providers’] homework And I think you could learn more from people if you can offer many times. (Participant #4) them a back and forth, you know, a real confidant. (E. #2) They also stated that a smaller workload would allow them to take advantage of the ‘in-reach’ component of the registry Theme 3: Patients universally enjoyed their health coaches, (e.g. the point-of-care alerts) in a more sustainable way. appreciating their accessibility as well as the support that they provided. Patients mentioned that their health coaches were We don’t really actually review [the alerts] anymore... that’s one very helpful because they followed up with solutions and con- thing that .. . we’ve taken off our plate in order to accommodate other stuff that has been put on our plate. (Participant #8) nected patients with various community resources. I didn’t feel I was talking to someone from the hospital related to the illness I suffer, I felt like she was my friend, she was someone I Patient attitudes toward the CKD-SMS program could talk to and clarify any doubts I could have. (S. #3) Theme 1. Patients appreciated a language-concordant CKD- I enjoyed it because each time you had any questions, they were always available and they always found a solution or an answer SMS program. Patients voiced appreciation for the low-literacy for you... (E. #7) patient education materials and the educational benefits of the CKD-SMS program overall. Participants mentioned that throughout the course of the program, they had learned how to Theme 4: System enhancements may improve patient take better care of their kidneys and how to eat a healthier diet. experience with the CKD-SMS program and increase uptake of For the most part, patients found the automated telephone calls health knowledge and behaviors. Focus group participants to be informative and reported that the calls helped to reinforce requested that educational materials include more dietary the importance of various health behaviors such as remember- advice. They also expressed a shared desire for the automated ing to take their medication and doing more physical activity. phone calls to provide the user with options to repeat prompts This was particularly true among Spanish-speaking partici- and confirm responses. Finally, they mentioned that the calls pants, who emphasized the benefit of receiving new informa- would be most useful if they could be delivered on a weekly tion from the CKD-SMS program and voiced an appreciation for basis, rather than the 50-week program structure that they had the written educational materials more than their English- received, which involved weekly calls for the first 4 weeks fol- lowed by a biweekly call for the remainder of the program. speaking counterparts. I would like for the calls to be weekly because –, it just keeps it on Those questions are giving you information so you don’t feel they your mind then, because when you get older we have a tendency are long. You feel the call is informative. [Spanish (S.) #1] to kind of forget things and you go oh, we discussed something I felt like it worked ’cause it managed to beat some things into my really, really important and then the following couple days it goes head that people have been trying for a long time. [English (E.) #1] right out of your mind. (E. #1) Downloaded from https://academic.oup.com/ckj/article-abstract/11/4/540/4762253 by Ed 'DeepDyve' Gillespie user on 07 August 2018 Percentage Acceptability of CKD interventions | 545 Patients voiced mixed opinions when asked about their support program ranged from 49% to 92% and increased option of a reminder text to alert users to the time of their auto- throughout the program duration (Figure 3). A majority of mated call and provide information for calling into the system. patients who reported having read the education materials gave One reservation expressed by focus group participants was that them an 8 or higher on a 1–10 scale in terms of readability and patients did not always have a phone plan that accommodates helpfulness (88% and 85%, respectively). Nearly 40% of the 74 text messages. Participants voiced no desire to include video- CKD-SMS program participants were high utilizers of the auto- conferencing functionality. mated portion of the CKD-SMS system, with an average automated-phone call completion rate >80%. Additionally, over Theme 5: Despite voicing appreciation for their health coaches, 95% of CKD-SMS participants participated in phone calls with there was disagreement among participants about the merits of their health coaches. The most common topics discussed dur- in-person versus telephone health coaching. Those participants ing the health coaching phone calls were physical activity, diet, that voiced a preference for in-person health coaching believed blood pressure control and medication adherence. A majority that the in-person interaction would make them feel even more (77%) of CKD-SMS participants created at least one action plan comfortable, thus providing a better environment for their with his/her health coach over the course of the study interven- questions to be answered. tion. The most frequent action plan themes were increasing People that do okay over the phone with questions but I’d rather physical activity, improving diet and enhancing patient–pro- do it in-person.. . you know I’ve got to see the person who I’m talk- vider communication. ing to and get more time to understand what you’re talking about. (E. #10) And the more we talk face to face, the more comfortable we get in talking with each other. So again, through that aspect you stand to Discussion learn more as well. (E. #2) Using a mixed-methods approach with quantitative and quali- My questions are better asked in person. (E. #4) tative methods, we demonstrated high acceptability of both Other participants expressed a preference for the telephone KARE interventions among PCPs, other primary care medical health coaching because of the convenience it offered. One staff and patients. Our approach was multifaceted, using vari- English speaker in particular stated the following: ous types of acceptability data. The Theoretical Framework of Acceptability for health care system interventions proposed by It was very convenient. You know, if I missed a call, I could call Sekhon et al. provides a useful context for interpreting and them back... I could call them back even if it was the next day. So organizing these different data [18]. This framework is benefi- it was very convenient for me, rather than going out and transpor- tation and all of that. (E. #7) cial for the evaluation of multi-level, complex interventions because it breaks acceptability into seven different constructs, each of which emerge from a validated theory. The four frame- Patient engagement with the CKD-SMS program work constructs most relevant to our acceptability analysis are: affective attitude, self-efficacy, ethicality and perceived effec- Over 90% of patients completed the month 4 research calls and 89% completed the month 8 research calls, providing ample tiveness. When evaluated together, these constructs provide a data about engagement with the CKD-SMS program. Self- holistic view of the KARE interventions’ acceptability and the reported participation with each component self-management likelihood that they can be incorporated into routine practice. 100.0 92.4 90.9 89.6 89.4 86.5 80.3 80.0 60.0 55.2 Month 4 49.3 Month 8 40.0 20.0 0.0 Do you receive the Do you receive Have you had a Do you have a automated Patient Education chance to read the health coach? telephone calls Materials? information? (Automated Telephone Self-Management)? Fig. 3. Self-reported patient engagement with the CKD-SMS program. Downloaded from https://academic.oup.com/ckj/article-abstract/11/4/540/4762253 by Ed 'DeepDyve' Gillespie user on 07 August 2018 Percentage of CKD-SMS program patients who completed interview 546 | A. Strait et al. Affective attitude and self-efficacy vulnerable populations in chronic disease management [22, 24]. The high levels of self-reported patient engagement with the Affective attitude refers to how an individual feels about an patient education materials also suggest that language- intervention and self-efficacy is defined by a participant’s confi- concordant, low-literacy education pamphlets offer another key dence that he/she can participate in the intervention. In our method for increasing health awareness to ‘hard-to-reach’, pop- study, PCPs and their team members demonstrated positive ulations. This is consistent with prior studies that identified attitudes toward both the ‘in-reach’ and ‘out-reach’ compo- that low-literacy education materials for diabetes, CKD and con- nents of the CKD registry and voiced confidence that the regis- gestive heart failure were associated with higher usability rat- try enhanced their ability to manage kidney disease in a public ings than materials with higher literacy levels [15, 25–27]. health care delivery system. These findings support a growing body of evidence suggesting that registries are effective at Perceived effectiveness enhancing provider self-efficacy of chronic disease manage- ment at the population level. Prior registries with ‘in-reach’ Perceived effectiveness is the extent to which an intervention is and/or ‘out-reach’ components have also been shown to suc- perceived as likely to achieve its purpose. Our study results indi- cessfully enhance the delivery of guideline-concordant care for cate the majority of patients and providers were satisfied with populations with hypertension and diabetes [19–21]. Our their respective intervention and believed in its efficacy. acceptability results demonstrate that a CKD registry comprised Importantly, however, several key suggestions emerged from of both components has a similar potential to help health care focus groups about how the interventions could be strength- providers more confidently identify and manage CKD in the pri- ened to further enhance effectiveness. For example, PCPs noted mary care setting. A prior study identified that a key facilitator that the registry and the electronic health record should be inte- to implementing a primary care CKD registry was the inclusion grated to ensure the accuracy and usefulness of point-of-care of roles for non-PCP staff due to the increased workload intro- patient alerts, as well as facilitate enhanced provider team user duced by the registry [8]. It is, therefore, particularly notable experience. Additionally, adequate clinic staffing and provider that both the PCPs and the non-PCP health care team members teamwork should be prioritized to more effectively align use of in the KARE study reported positive attitudes toward the CKD the registry with clinic workflow. Patient participants identified registry, reinforcing the benefit of sharing the workload burden several facilitators to improve engagement and efficacy, includ- that a registry may introduce. ing increasing the frequency of automated CKD-SMS phone Patients reported positive beliefs about the CKD-SMS pro- calls and providing additional support to educate and assist gram and noted that it provided helpful health knowledge and patients to successfully interface with the self-management management strategies. While prior studies have demonstrated support system. Some patient participants voiced a preference that health coaching interventions and automated communica- for telephone health coaching because of its convenience; tion programs are effective methods for improving patient others voiced a preference for the personal touch inherent to in- awareness and management of hypertension and diabetes, person health coaching. It is quite possible that the observed including those who receive medical care in a public health care difference in participant attitudes toward health-coaching delivery system, this study is one of the first to examine these modalities is informed by demographic factors such as patient types of interventions within the CKD context [10, 11, 13]. The age and health conditions, such as mobility status. For example, positive attitudes that patients had toward all three compo- it is possible that patients who are less mobile would find tele- nents of the CKD-SMS program demonstrate the desire of CKD phone health-coaching to be preferable to in-person coaching patients to receive additional education, knowledge and because patients can do it within their own homes; in contrast, support. older patients who are less mobile may be less comfortable with technology and might prefer in-person health-coaching. Future Ethicality self-management support interventions may want to include both coaching options to optimize patient-centeredness. Lastly, Ethicality is the extent to which an intervention has good fit linkage between the provider-level and patient-level interven- with an individual’s value system. Focus group data from the tions is key for sustainability. One way to do this is by leverag- non-physician primary care staff demonstrated that the CKD ing the electronic health record for more frequent and optimal registry was aligned with primary care team goals and communication among providers and health coaches. enhanced the opportunity for team-based care delivery. Patient Evaluating KARE’s interventions within each of these con- participation data illustrated high levels of patient engagement structs is critical, since evidence suggests that high provider with all components of the CKD-SMS program. This is impor- and patient satisfaction are essential to the successful imple- tant because patient populations within the public health care mentation of CKD interventions [28, 29]. Additionally, behavio- delivery system, which are disproportionately comprised of individuals with minority or immigrant status and individuals ral interventions with high patient acceptability have been associated with better clinical outcomes than those that do not who live in economically disadvantaged communities, tend to be less engaged in health care, resulting in poorer health out- garner high patient satisfaction [18, 30, 31]. While acceptability is gaining recognition as a necessary consideration for the comes [22, 23]. Increasing health awareness and engagement among these populations is, therefore, an important public design and implementation of effective health care system interventions, few studies in the USA have comprehensively health strategy to curb the complications associated with chronic diseases. Our results suggest that a phone-based self- examined this construct [18]. Our article addresses this gap and management support program may provide a critical vantage serves as a model that can be employed during evaluations of point for increasing CKD awareness and activating health future chronic disease interventions. engagement in racially and linguistically diverse populations Additionally, our acceptability findings are important within a public health care delivery system. This conclusion is because CKD is a pressing public health concern, with large further supported by previous studies that have shown mobile challenges related to low patient and provider awareness of health technology to offer an untapped potential for engaging CKD [4] as well as existing ethnic/racial and socioeconomic Downloaded from https://academic.oup.com/ckj/article-abstract/11/4/540/4762253 by Ed 'DeepDyve' Gillespie user on 07 August 2018 Acceptability of CKD interventions | 547 disparities associated with CKD clinical outcomes and quality of in the design of the study, or in the collection, analysis and care delivery [32]. The positive end-user comments and high interpretation of data. engagement and satisfaction levels among providers and patients within this setting speak to the potential of programs Conflict of interest statement that improve CKD knowledge within vulnerable populations and their health care providers. Previous studies have demon- None declared. strated that CKD discussions during primary care encounters are lacking [33]. A team-based primary care CKD registry may Supplementary data offer a valuable and acceptable way to improve provider aware- ness and detection of CKD. In turn, this could lead to more CKD Supplementary data are available at ckj online. discussions with patients during primary care encounters, thus reinforcing CKD knowledge that patients may gain through self- References management support programs. Limitations of this study include a small sample size and a 1. Murphy D, McCulloch CE, Lin F et al. Trends in prevalence of moderately low survey completion rate among PCPs and focus chronic kidney disease in the United States. Ann Intern Med group participation rate among patients. Nonresponse bias may 2016; 165: 473–481 2. Coresh J, Selvin E, Stevens LA et al. Prevalence of chronic kid- have thus influenced the positive perception of the interven- tions reported by PCPs and patients. However, a review of physi- ney disease in the United States. JAMA 2007; 298: 2038–2047 cian survey response behaviors found that nonresponse bias 3. Tuot DS, Plantinga LC, Hsu C-Y et al. Chronic kidney disease may not be an important factor contributing to the validity of awareness among individuals with clinical markers of kid- physician surveys [34]. Additionally, while the findings suggest ney dysfunction. Clin J Am Soc Nephrol 2011; 6: 1838–1844 4. Plantinga LC, Tuot DS, Powe NR. Awareness of chronic kid- that a primary care CKD registry and CKD-SMS program are ney disease among patients and providers. Adv Chronic acceptable within a public health care delivery system, it is not Kidney Dis 2010; 17: 225–236 clear whether the same outcomes would be observed in other 5. Greer RC, Ameling JM, Cavanaugh KL et al. Specialist and pri- types of health care settings. Also, a few constructs from mary care physicians’ views on barriers to adequate prepa- Sekhon’s theoretical framework were not available for our anal- ysis, including burden, intervention coherence and opportunity ration of patients for renal replacement therapy: a costs. Future acceptability studies may want to include these qualitative study. BMC Nephrol 2015; 16: 37 6. Tuot DS, Velasquez A, McCulloch CE. The Kidney Awareness variables in their evaluation. Registry and Education (KARE) study: protocol of a random- ized controlled trial to enhance provider and patient engage- Conclusion ment with chronic kidney disease. BMC Nephrol 2015; 16: 166 Overall, we demonstrate that a primary care CKD registry is 7. Navaneethan SD, Jolly SE, Schold JD et al. Development and acceptable to health care teams that work in a public health validation of an electronic health record-based chronic kid- care delivery system and has the potential to improve CKD ney disease registry. Clin J Am Soc Nephrol 2011; 6: 40–49 identification and management efforts at the population level. 8. McBride D, Dohan D, Handley MA et al. Developing a CKD Additionally, a language-concordant CKD-SMS program is well- registry in primary care: provider attitudes and input. Am J received by diverse, low-income patients, suggesting a great Kidney Dis 2014; 63: 577–583 potential for programs that leverage similar combinations of 9. Drawz PE, Miller RT, Singh S et al. Impact of a chronic kidney automated communication, low-literacy patient education disease registry and provider education on guideline materials and telephone health coaching, to improve this popu- adherence–a cluster randomized controlled trial. BMC Med lation’s engagement with health. Multi-component CKD-SMS Inform Decis Mak 2012; 12: 62 programs could serve as a key tool for activating populations 10. Dennis SM, Harris M, Lloyd J et al. Do people with existing within a public health care delivery system that often experi- chronic conditions benefit from telephone coaching? A rapid ence poor health outcomes, perhaps leading to increased review. Aust Health Rev 2013; 37: 381–388 patient awareness of CKD, better health outcomes and reduced 11. Thom DH, Willard-Grace R, Hessler D et al. The impact of health care costs. Finally, the demonstrated feasibility of health coaching on medication adherence in patients with KARE’s provider-level and patient-level interventions suggest poorly controlled diabetes, hypertension, and/or hyperlipi- great potential in the use of technology in multilevel interven- demia: a randomized controlled trial. J Am Board Fam Med tions to improve awareness and care delivery in public health 2015; 28: 38–45 care systems. Given the significant disparities that exist in CKD, 12. Halladay JR, DeWalt DA, Wise A et al. More extensive imple- future initiatives should continue to investigate the ways in mentation of the chronic care model is associated with bet- which technology can be successfully harnessed to provide bet- ter lipid control in diabetes. J Am Board Fam Med 2014; 27: ter care and outcomes within the primary care settings that 34–41 serve the most vulnerable. 13. Willard-Grace R, Chen EH, Hessler D. Health coaching by medical assistants to improve control of diabetes, hyperten- sion, and hyperlipidemia in low-income patients: a random- Funding ized controlled trial. Ann Fam Med 2015; 13: 130–138 The KARE study was funded by grant numbers 14. Posadzki P, Mastellos N, Ryan R et al. Automated telephone R01DK104130, R34DK093992 and K23DK094850, all from the communication systems for preventive healthcare and National Institute of Diabetes and Digestive and Kidney management of long-term conditions. Cochrane Database Disease, Bethesda, MD, USA. The funding body had no role Syst Rev 2016; 12: CD009921 Downloaded from https://academic.oup.com/ckj/article-abstract/11/4/540/4762253 by Ed 'DeepDyve' Gillespie user on 07 August 2018 548 | A. Strait et al. 25. Hill-Briggs F, Renosky R, Lazo M et al. Development and pilot 15. Tuot DS, Davis E, Velasquez A et al. Assessment of printed patient-educational materials for chronic kidney disease. evaluation of literacy-adapted diabetes and CVD education Am J Nephrol 2013; 38: 184–194 in urban, diabetic African Americans. J Gen Intern Med 2008; 16. Painter JE, Borba CP, Hynes M et al. The use of theory in 23: 1491–1494 health behavior research from 2000 to 2005: a systematic 26. Wallace AS, Seligman HK, Davis TC et al. Literacy-appropri- review. Ann Behav Med 2008; 35: 358–362 ate educational materials and brief counseling improve dia- 17. Glaser BG, Strauss AL. The Discovery of Grounded Theory: Strategies betes self-management. Patient Educ Couns 2009; 75: 328–333 for Qualitative Research. Chicago, IL: Aldine Pub. Co., 1967 27. Hill-Briggs F, Smith AS. Evaluation of diabetes and cardio- 18. Sekhon M, Cartwright M, Francis JJ. Acceptability of health- vascular disease print patient education materials for use care interventions: an overview of reviews and develop- with low-health literate populations. Diabetes Care 2008; 31: ment of a theoretical framework. BMC Health Serv Res 2017; 667–671 17: 88 28. Tsang JY, Blakeman T, Hegarty J et al. Understanding the 19. Peterson KA, Radosevich DM, O’Connor PJ et al. Improving implementation of interventions to improve the manage- diabetes care in practice: findings from the TRANSLATE trial. ment of chronic kidney disease in primary care: a rapid real- ist review. Implement Sci 2016; 11: 47 Diabetes Care 2008; 31: 2238–2243 20. Grant RW, Hamrick HE, Sullivan CM et al. Impact of popula- 29. Davy C, Bleasel J, Liu H et al. Factors influencing the imple- tion management with direct physician feedback on care of mentation of chronic care models: a systematic literature patients with type 2 diabetes. Diabetes Care 2003; 26: review. BMC Fam Pract 2015; 16: 102 2275–2280 30. Hommel KA, Hente E, Herzer M et al. Telehealth behavioral 21. Jaffe MG, Lee GA, Young JD et al. Improved blood pressure treatment for medication nonadherence: a pilot and feasibil- control associated with a large-scale hypertension program. ity study. Eur J Gastroenterol Hepatol 2013; 25: 469–473 JAMA 2013; 310: 699–705 31. Fisher P, McCarney R, Hasford C et al. Evaluation of specific 22. Sigler BE. Investigating the perceptions of care coordinators and non-specific effects in homeopathy: feasibility study for on using behavior theory-based mobile health technology a randomised trial. Homeopathy 2006; 95: 215–222 with medicaid populations: a grounded theory study. JMIR 32. Tuot DS, Grubbs V. Chronic kidney disease care in the US Mhealth Uhealth 2017; 5: e36 safety net. Adv Chronic Kidney Dis 2015; 22: 66–73 23. Lewin ME, SH A. America’s Health Care Safety Net: Intact But 33. Greer RC, Cooper LA, Crews DC et al. Quality of patient- Endangered. Washington, DC: Institute of Medicine, 2000 physician discussions about CKD in primary care: a cross- 24. Broderick A, Haque F. Mobile health and patient engagement sectional study. Am J Kidney Dis 2011; 57: 583–591 in the safety net: a survey of community health centers and 34. Kellerman SE, Herold J. Physician response to surveys. A clinics. Issue Brief (Commonw Fund) 2015; 9: 1–9 review of the literature. Am J Prev Med 2001; 20: 61–67 Downloaded from https://academic.oup.com/ckj/article-abstract/11/4/540/4762253 by Ed 'DeepDyve' Gillespie user on 07 August 2018 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Clinical Kidney Journal Oxford University Press

Acceptability of a multilevel intervention to improve blood pressure control among patients with chronic kidney disease in a public health care delivery system

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© The Author 2017. Published by Oxford University Press on behalf of ERA-EDTA.
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2048-8505
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10.1093/ckj/sfx141
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Abstract

Background: The Kidney Awareness Registry and Education (KARE) trial examined the impact of a multilevel intervention on blood pressure control among patients with chronic kidney disease (CKD) in a public health care delivery system. KARE consisted of a clinic-based intervention (a primary care CKD registry with point-of-care provider notifications and quarterly feedback related to CKD management) and a patient-directed intervention [a CKD self-management support (CKD-SMS) program that included low literacy educational materials, automated telephone-administered self-management modules and telephone health coaching]. We explored the acceptability of these interventions among end users. Methods: At trial conclusion, we surveyed 39 primary care providers (PCPs) to identify preferences about components of the clinic intervention, conducted two focus groups among non-PCP staff to elicit in-depth attitudes and experiences with operationalizing the team-based CKD registry, and conducted eight focus groups with English- and Spanish-speaking patients to hear about their experiences with the CKD-SMS program. Focus group transcripts were analyzed using thematic analysis. Self-reported participation and data from the automated telephone program were used to evaluate patient engagement. Results: Most PCPs (94%) believed that the point-of-care notifications benefited clinic workflow and agreed that quarterly feedback enhanced their ability to identify (89.5%) and manage (73.7%) CKD. Staff confirmed usefulness of point-of-care notifications. Patients suggested the automated telephone system was impersonal, though easy to use; that frequent automated calls were helpful to reinforce self-management behaviors; and that telephone health coaching was convenient. Nearly 40% of patients completed >80% of automated phone calls, 95% participated in calls with their health coach and 77% created at least one action plan. Conclusions: A CKD registry is acceptable to primary care health care teams and has potential to enhance identification and management of CKD in primary care. Low-income patients appreciated and engaged with a telephone-based CKD-SMS Received: August 23, 2017. Editorial decision: November 9, 2017 V C The Author 2017. Published by Oxford University Press on behalf of ERA-EDTA. This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/ licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com Downloaded from https://academic.oup.com/ckj/article-abstract/11/4/540/4762253 by Ed 'DeepDyve' Gillespie user on 07 August 2018 Acceptability of CKD interventions | 541 program, demonstrating its potential for increasing awareness and health engagement among populations with CKD within a public health care delivery system. Key words: acceptability, awareness, chronic kidney disease, CKD, registry, safety-net, self-management support both a CKD primary care registry and a CKD-SMS program Introduction within a public health care delivery system. Chronic kidney disease (CKD) affects more than 10% of the US population and is a pressing public health problem [1, 2]. Materials and methods Despite this, awareness of CKD among those with the disease remains very low, with studies reporting that <10% of individu- Study design, setting and participants als with CKD are aware of their disease [3, 4]. Among providers, KARE was a non-blinded, randomized controlled trial with a 2 awareness of CKD management guidelines is also suboptimal 2 factorial design implemented in two primary care clinics [4]. Low patient and provider awareness of CKD likely limit the within a public health care delivery system. Provider teams, delivery of, and adherence to, evidence-based CKD care, thus consisting of primary care providers (PCPs), nurses, nurse prac- impeding efforts to slow CKD progression and negatively affect- titioners, medical assistants and behaviorists were randomized ing health outcomes. There is a clear need for solutions that to receive either the primary care CKD registry or usual care. sustainably enhance the detection and management of CKD at the primary care level, which may also offer a critical vantage Patients were subsequently randomized to participate in a CKD- point for narrowing known disparities in CKD outcomes and SMS program or usual care. Details of the KARE study protocol, care delivery [5]. including an evaluation of educational materials used in the CKD-SMS, have been previously reported [6, 15]. For this mixed- The Kidney Awareness Registry and Education (KARE) study is a 2  2 randomized controlled trial (ClinicalTrials.gov: methods study examining acceptability of the multilevel inter- NCT01530958) that aimed to improve blood pressure control vention using surveys, focus groups and interviews, only mem- through enhanced patient and provider awareness of CKD. bers of the primary care clinic teams randomized to receive the KARE examined the impact of a multilevel intervention consist- KARE registry and patients randomized to receive the CKD-SMS ing of a primary care CKD registry and a CKD self-management program were eligible for participation. support (CKD-SMS) program [6]. At the primary care level, a team-based patient CKD registry supported the identification Study procedures and management of individuals with CKD and uncontrolled PCP survey. Acceptability of the clinic-level intervention was blood pressure. The CKD registry was comprised of an ‘in-reach’ assessed among study teams in the intervention arm; eligible element (e.g. point-of-care notifications) and an ‘out-reach’ PCPs were asked to complete a survey at the end of the 12- component (e.g. quarterly feedback reports), and built on prior month study that elicited preferences toward the ‘in-reach’ and CKD registry efforts [7–9]. At the patient level, the comprehen- ‘out-reach’ components of the primary care CKD registry in a sive, telephone-based CKD-SMS program encouraged patients quantitative fashion to facilitate comparisons. The survey also to engage in their health care and adopt healthy behaviors. The asked whether or not providers agreed that point-of-care alerts self-management support program included low literacy writ- and quarterly feedback patient lists had changed their ability to ten educational materials, automated telephone administered identify and deliver CKD care using 5-point Likert scales and self-management modules and telephone health coaching, and whether they had altered their interactions with patients and/ was based on previous self-management support initiatives or clinic staff. PCP surveys were distributed via e-mail, [10–14]. The KARE trial took place within a public health care mailboxes and were handed out in-person. delivery system and enrolled a low-income patient population that was linguistically and racially diverse. Clinic staff focus groups. Two focus groups with non-PCP clinic While registries and self-management support programs staff were organized between June and October 2015. Focus have independently been shown to improve uptake of health groups were chosen instead of one-on-one interviews to elicit knowledge and disease self-management among patients with in-depth attitudes and experiences with operationalizing the various chronic diseases [13, 14], much less is known about their team-based CKD registry and to promote shared conversation. potential to affect change within the CKD population, or their Focus groups were held in a clinic conference room and were acceptability within a public health care delivery system. Few CKD studies have involved the primary care setting and even facilitated by three members of the research team who had fewer have targeted a diverse, lower-income population. received training in facilitation, including a health coach and two study investigators (A.V., K.L.). Facilitators used a focus Examining the acceptability of the provider-level and patient- group guide designed to encourage staff to discuss their atti- level KARE interventions could offer valuable insight into key tudes and experiences, using open-ended questions informed facilitators of implementing similar interventions among health systems and populations that shoulder a high burden of chronic by social cognitive theory [16], which describes a dynamic proc- disease. The objectives of this study were thus: (i) to explore the ess of how personal factors, environmental variables and acceptability of a primary care CKD registry with both ‘in-reach’ human behavior reciprocally exert influence on each other to and ‘out-reach’ among health care teams in clinics in a public enable behavior change and posits that individuals with health care delivery system; (ii) to investigate patient opinions self-efficacy can enact behavior change, even when faced with and beliefs about the CKD-SMS program; and (iii) to determine obstacles (Supplementary data A). Participants provided written factors that could facilitate the sustainable implementation of consent to participate. Downloaded from https://academic.oup.com/ckj/article-abstract/11/4/540/4762253 by Ed 'DeepDyve' Gillespie user on 07 August 2018 542 | A. Strait et al. Patient focus groups. Eight focus groups with English- and Ethics Spanish-speaking patients who had been randomized to partici- The study was approved by the UCSF Committee on Human pate in the CKD-SMS program were organized between June and Research (Protocol number 11-07399) and participant anonym- October 2015. Participants were recruited by telephone, pro- ity was preserved. No patient or provider names were included vided written consent for participation and completed brief in the focus group audio recordings or the accompanying tran- demographic surveys on the day of focus group facilitation. scripts. Focus group participants agreed to maintain confiden- Patient focus groups were conducted in community clinic con- tiality of other participants during the formal consent process. ference rooms, ranged in size from two to six participants, and PCP surveys were anonymous unless individuals willingly pro- lasted between 1 and 2 h. They were facilitated by three mem- vided their names for subsequent contact. bers of the research team who were trained in facilitation, including a KARE health coach and two study investigators (A.V., K.L). They used a focus group guide informed by social Results cognitive theory that encouraged patients to draw upon their personal experiences with the three different components of Characteristics of study participants the CKD-SMS intervention: low-literacy, language-concordant A total of 21 (54%) PCPs randomized to the registry arm written patient education materials; bimonthly, language- responded to the survey. A majority (81%) of the registry PCPs concordant automated telephone self-management calls; and worked in the academic training clinic and most (61.9%) were telephone health coaching (Supplementary data B). female. PCP respondents had a varied amount of clinical experi- Patient engagement data. Self-reported patient engagement ence and included diverse provider types: 25% (n ¼ 5) were with each component of the CKD-SMS program and socio- trainees, 55% (n ¼ 11) were attending providers and 20% (n ¼ 4) demographic data were collected during standardized research were nurse practitioners (Table 1). calls for all patients randomized to the intervention (n ¼ 74). A total of eight (42%) of the non-PCP clinic staff randomized Additional data from the automated telephone self- to the registry participated in a focus group. While registry team management program identified the number of patients with members served various roles on the health care team (e.g. an average call completion rate above 80% throughout the health workers, panel managers, nurses), all of the registry course of the 50-week program; these patients were a priori focus group attendees were medical assistants. They were determined to be ‘high utilizers’ of the automated portion of the racially/ethnically diverse, with 37.5% self-identifying as Asian CKD-SMS program. Records from health coaching calls were and 62.5% self-identifying as Hispanic (Table 1). The majority reviewed to identify the number of patients who developed at (75%) of the non-PCP clinic staff focus group participants were least one action plan during the study’s duration. from the academic training clinic. Of the 74 patients randomized to receive the CKD-SMS pro- Analysis gram and from whom engagement data were obtained, 26 (35%) participated in a focus group. Similar to the overall KARE study All focus groups were audio-recorded and professionally tran- population and the population randomized to receive CKD-SMS, scribed. Spanish focus group transcripts were professionally focus group patients were racially/ethnically diverse, with translated and transcribed into English prior to the coding proc- ess. No field notes taken during the focus groups contributed to 53.9% (n ¼ 14) self-identifying as Hispanic, 34.6% (n ¼ 9) self- the analysis. Transcripts were analyzed using thematic analysis identifying as Black and 11.5% (n ¼ 3) self-identifying as White. with an iterative and collaborative process, drawing themes A majority (76.9%) of patient focus group participants received from the primary data rather than relying an a priori conceptual care from the academic training clinic and most (60%) spoke model [17]. Three investigators (K.L., A.N. and A.S.) independ- Spanish as their primary language (Table 1). ently coded one transcript for each language group and agreed upon initial codes. Only one of these individuals was involved in focus group facilitation, thus minimizing the impact of facili- PCP attitudes toward the primary care CKD registry tator–participant interactions on the analytic process. They Most (94.1%) PCPs believed that the ‘in-reach’ component of the used the preliminary codebook to independently analyze registry, with point-of-care notifications, benefited clinic work- another subset of transcripts, and then compared independent flow and 88.2% reported that these notifications influenced the coding results, resolved inconsistencies through adjustment of way in which they managed CKD (Figure 1). PCP respondents also the codebook and developed a set of specific code definitions. reported positive attitudes toward the ‘out-reach’ component of The remaining transcripts were independently coded by two of the registry, consisting of quarterly feedback, with a majority the three investigators who had done the initial coding. Any dis- stating it enhanced their ability to identify patients who had crepancies in coding were resolved by consensus. As additional CKD, needed better blood pressure control or were due for albu- concepts emerged, team members collaboratively modified the minuria quantification (89.5%, 78.9% and 78.9%, respectively). In codebook. After analyzing all of the transcripts, the analytic addition, 73.7% reported that the quarterly feedback reports team felt that thematic saturation was achieved among the enhanced their ability to manage patients with CKD. When asked non-PCP staff and patient focus groups. to compare the two different registry components, a majority of PCP survey data and patient engagement data were analyzed PCPs stated that the point-of-care notifications were more help- using StataSE Version 14 (StataCorp, College Station, Texas, ful than the quarterly feedback reports, though similar numbers USA). PCP responses were categorized into binary variables that reported that having both types of notifications were helpful in reflected agreement and complete agreement with statements identifying CKD and supporting the delivery of guideline- about the different registry components. Chi-squared tests were concordant care (Figure 2). Responses were similar among PCPs used to evaluate potential differences in PCP responses by clinic site (academic versus community). from the two different clinics (data not shown). Downloaded from https://academic.oup.com/ckj/article-abstract/11/4/540/4762253 by Ed 'DeepDyve' Gillespie user on 07 August 2018 Acceptability of CKD interventions | 543 Table 1. Characteristics of study participants Patients randomized Focus group Participant characteristics PCP Non-PCP clinic staff to CKD-SMS patient participants (n ¼ 21) (n ¼ 8) (n ¼ 74) (n ¼ 26) n (%) n (%) n (%) n (%) Clinic Academic training clinic 17 (81.0) 6 (75.0) 48 (64.9) 20 (76.9) Community clinic 4 (19.0) 2 (25.0) 26 (35.1) 6 (23.1) Female 13 (61.9) 7 (87.5) 39 (52.7) 12 (46.2) Race/ethnicity White 9 (42.9) 0 (0.0) 7 (9.6) 3 (11.5) Asian 6 (28.6) 3 (37.5) 11 (15.1) 0 (0.0) Black 1 (4.8) 0 (0.0) 30 (41.1) 9 (34.6) Hispanic 4 (19.0) 5 (62.5) 25 (34.3) 14 (53.8) Other 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) More than one race 1 (4.8) 0 (0.0) 0 (0.0) 0 (0.0) Non-English language – – 27 (36.5) 15 (60.0) Age 20–44 years – – 14 (18.9) 5 (19.2) 45–64 years – – 48 (64.9) 15 (57.7) 65þ years – – 12 (16.2) 6 (23.1) Provider type or clinic role Trainee 5 (25.0) – – – Attending provider 11 (55.0) – – – Nurse practitioner 4 (20.0) – – – Medical assistant – 7 (100.0) – – Other (e.g. health worker, etc.) – 0 (0.0) – – Years of experience after degree <5 years 7 (33.3) – – – 5–15 years 7 (33.3) – – – 16 years 7 (33.3) – – – One PCP and one staff member did not answer this question, resulting in denominators of n ¼ 20 and n ¼ 7. 100 94.1 89.5 88.2 78.9 78.9 73.7 Benefited clinic work Changed the way the Enhanced PCP's ability Enhanced PCP's ability Enhanced PCP's ability Enhanced PCP's ability flow PCP managed kidney to identify patients to manage patients to identify patients to identify patients disease with CKD with CKD who needed better due for albuminuria blood pressure control quantification Attitudes towards point- of-care notifications Attitudes towards quarterly feedback (n = 17) reports (n = 19) Fig. 1. PCP attitudes toward the CKD registry. Non-PCP clinic staff attitudes toward the primary care members to check for overdue diagnostic tests (i.e. albumin:- CKD registry creatinine ratio), allowing them to deliver better care to patients with CKD. Theme 1: CKD registries can aid health care teams in delivering guideline-concordant CKD care. Non-PCP clinic staff acknowl- I think it reminded a lot of the providers what they needed to do, edged the benefits of a primary care CKD registry. They stated including us... So when we had time to actually do it, those orders that the point-of-care alerts reminded the health care team would be carried out. (Participant #1) Downloaded from https://academic.oup.com/ckj/article-abstract/11/4/540/4762253 by Ed 'DeepDyve' Gillespie user on 07 August 2018 Percentage 544 | A. Strait et al. Point-of-care notifications Quarterly feedback reports Both 100.0 80.0 52.4 60.0 47.6 42.9 38.1 40.0 20.0 9.5 9.5 0.0 More helpful in identifying patients More helpful in ensuring delivery of with CKD guideline concordant care for patients with CKD Fig. 2. PCP attitudes toward the registry components. It was really good for early detection for kidney disease ’cause Theme 2: Patients generally agreed that the automated calls we all know people who have chronic kidney disease on dialysis were easy to understand, practical and convenient, though but I think it’s so nice to catch it early on and educate the patient, some patients felt that the automated calls were impersonal. see if they have some options and maybe try and control it. To press the numbers and to make the call. It was easy. (S. #5) (Participant #3) The way they explained it was very nice because it seemed as if we were having a conversation. It was easy to understand for any Theme 2: Suggestions for promoting registry uptake in a of us. At any educational level. (S. #3) public health care delivery health system. Non-PCP clinic staff believed that there were several factors that would promote Those patients that did not appreciate the automated nature of the telephone calls expressed a preference for more personal registry uptake. Specifically, they mentioned that better com- interaction and the health coaching component of the CKD-SMS munication among the providers within each health care team program. would help avoid duplication of services and streamline activities. Talking to the [telephone]; it’s impersonal and if you have a ques- tion right then, then you can’t get a response. (E. #1) [The registry] was a reminder... It’s like I need to do my home- work, just sometimes I end up doing [the providers’] homework And I think you could learn more from people if you can offer many times. (Participant #4) them a back and forth, you know, a real confidant. (E. #2) They also stated that a smaller workload would allow them to take advantage of the ‘in-reach’ component of the registry Theme 3: Patients universally enjoyed their health coaches, (e.g. the point-of-care alerts) in a more sustainable way. appreciating their accessibility as well as the support that they provided. Patients mentioned that their health coaches were We don’t really actually review [the alerts] anymore... that’s one very helpful because they followed up with solutions and con- thing that .. . we’ve taken off our plate in order to accommodate other stuff that has been put on our plate. (Participant #8) nected patients with various community resources. I didn’t feel I was talking to someone from the hospital related to the illness I suffer, I felt like she was my friend, she was someone I Patient attitudes toward the CKD-SMS program could talk to and clarify any doubts I could have. (S. #3) Theme 1. Patients appreciated a language-concordant CKD- I enjoyed it because each time you had any questions, they were always available and they always found a solution or an answer SMS program. Patients voiced appreciation for the low-literacy for you... (E. #7) patient education materials and the educational benefits of the CKD-SMS program overall. Participants mentioned that throughout the course of the program, they had learned how to Theme 4: System enhancements may improve patient take better care of their kidneys and how to eat a healthier diet. experience with the CKD-SMS program and increase uptake of For the most part, patients found the automated telephone calls health knowledge and behaviors. Focus group participants to be informative and reported that the calls helped to reinforce requested that educational materials include more dietary the importance of various health behaviors such as remember- advice. They also expressed a shared desire for the automated ing to take their medication and doing more physical activity. phone calls to provide the user with options to repeat prompts This was particularly true among Spanish-speaking partici- and confirm responses. Finally, they mentioned that the calls pants, who emphasized the benefit of receiving new informa- would be most useful if they could be delivered on a weekly tion from the CKD-SMS program and voiced an appreciation for basis, rather than the 50-week program structure that they had the written educational materials more than their English- received, which involved weekly calls for the first 4 weeks fol- lowed by a biweekly call for the remainder of the program. speaking counterparts. I would like for the calls to be weekly because –, it just keeps it on Those questions are giving you information so you don’t feel they your mind then, because when you get older we have a tendency are long. You feel the call is informative. [Spanish (S.) #1] to kind of forget things and you go oh, we discussed something I felt like it worked ’cause it managed to beat some things into my really, really important and then the following couple days it goes head that people have been trying for a long time. [English (E.) #1] right out of your mind. (E. #1) Downloaded from https://academic.oup.com/ckj/article-abstract/11/4/540/4762253 by Ed 'DeepDyve' Gillespie user on 07 August 2018 Percentage Acceptability of CKD interventions | 545 Patients voiced mixed opinions when asked about their support program ranged from 49% to 92% and increased option of a reminder text to alert users to the time of their auto- throughout the program duration (Figure 3). A majority of mated call and provide information for calling into the system. patients who reported having read the education materials gave One reservation expressed by focus group participants was that them an 8 or higher on a 1–10 scale in terms of readability and patients did not always have a phone plan that accommodates helpfulness (88% and 85%, respectively). Nearly 40% of the 74 text messages. Participants voiced no desire to include video- CKD-SMS program participants were high utilizers of the auto- conferencing functionality. mated portion of the CKD-SMS system, with an average automated-phone call completion rate >80%. Additionally, over Theme 5: Despite voicing appreciation for their health coaches, 95% of CKD-SMS participants participated in phone calls with there was disagreement among participants about the merits of their health coaches. The most common topics discussed dur- in-person versus telephone health coaching. Those participants ing the health coaching phone calls were physical activity, diet, that voiced a preference for in-person health coaching believed blood pressure control and medication adherence. A majority that the in-person interaction would make them feel even more (77%) of CKD-SMS participants created at least one action plan comfortable, thus providing a better environment for their with his/her health coach over the course of the study interven- questions to be answered. tion. The most frequent action plan themes were increasing People that do okay over the phone with questions but I’d rather physical activity, improving diet and enhancing patient–pro- do it in-person.. . you know I’ve got to see the person who I’m talk- vider communication. ing to and get more time to understand what you’re talking about. (E. #10) And the more we talk face to face, the more comfortable we get in talking with each other. So again, through that aspect you stand to Discussion learn more as well. (E. #2) Using a mixed-methods approach with quantitative and quali- My questions are better asked in person. (E. #4) tative methods, we demonstrated high acceptability of both Other participants expressed a preference for the telephone KARE interventions among PCPs, other primary care medical health coaching because of the convenience it offered. One staff and patients. Our approach was multifaceted, using vari- English speaker in particular stated the following: ous types of acceptability data. The Theoretical Framework of Acceptability for health care system interventions proposed by It was very convenient. You know, if I missed a call, I could call Sekhon et al. provides a useful context for interpreting and them back... I could call them back even if it was the next day. So organizing these different data [18]. This framework is benefi- it was very convenient for me, rather than going out and transpor- tation and all of that. (E. #7) cial for the evaluation of multi-level, complex interventions because it breaks acceptability into seven different constructs, each of which emerge from a validated theory. The four frame- Patient engagement with the CKD-SMS program work constructs most relevant to our acceptability analysis are: affective attitude, self-efficacy, ethicality and perceived effec- Over 90% of patients completed the month 4 research calls and 89% completed the month 8 research calls, providing ample tiveness. When evaluated together, these constructs provide a data about engagement with the CKD-SMS program. Self- holistic view of the KARE interventions’ acceptability and the reported participation with each component self-management likelihood that they can be incorporated into routine practice. 100.0 92.4 90.9 89.6 89.4 86.5 80.3 80.0 60.0 55.2 Month 4 49.3 Month 8 40.0 20.0 0.0 Do you receive the Do you receive Have you had a Do you have a automated Patient Education chance to read the health coach? telephone calls Materials? information? (Automated Telephone Self-Management)? Fig. 3. Self-reported patient engagement with the CKD-SMS program. Downloaded from https://academic.oup.com/ckj/article-abstract/11/4/540/4762253 by Ed 'DeepDyve' Gillespie user on 07 August 2018 Percentage of CKD-SMS program patients who completed interview 546 | A. Strait et al. Affective attitude and self-efficacy vulnerable populations in chronic disease management [22, 24]. The high levels of self-reported patient engagement with the Affective attitude refers to how an individual feels about an patient education materials also suggest that language- intervention and self-efficacy is defined by a participant’s confi- concordant, low-literacy education pamphlets offer another key dence that he/she can participate in the intervention. In our method for increasing health awareness to ‘hard-to-reach’, pop- study, PCPs and their team members demonstrated positive ulations. This is consistent with prior studies that identified attitudes toward both the ‘in-reach’ and ‘out-reach’ compo- that low-literacy education materials for diabetes, CKD and con- nents of the CKD registry and voiced confidence that the regis- gestive heart failure were associated with higher usability rat- try enhanced their ability to manage kidney disease in a public ings than materials with higher literacy levels [15, 25–27]. health care delivery system. These findings support a growing body of evidence suggesting that registries are effective at Perceived effectiveness enhancing provider self-efficacy of chronic disease manage- ment at the population level. Prior registries with ‘in-reach’ Perceived effectiveness is the extent to which an intervention is and/or ‘out-reach’ components have also been shown to suc- perceived as likely to achieve its purpose. Our study results indi- cessfully enhance the delivery of guideline-concordant care for cate the majority of patients and providers were satisfied with populations with hypertension and diabetes [19–21]. Our their respective intervention and believed in its efficacy. acceptability results demonstrate that a CKD registry comprised Importantly, however, several key suggestions emerged from of both components has a similar potential to help health care focus groups about how the interventions could be strength- providers more confidently identify and manage CKD in the pri- ened to further enhance effectiveness. For example, PCPs noted mary care setting. A prior study identified that a key facilitator that the registry and the electronic health record should be inte- to implementing a primary care CKD registry was the inclusion grated to ensure the accuracy and usefulness of point-of-care of roles for non-PCP staff due to the increased workload intro- patient alerts, as well as facilitate enhanced provider team user duced by the registry [8]. It is, therefore, particularly notable experience. Additionally, adequate clinic staffing and provider that both the PCPs and the non-PCP health care team members teamwork should be prioritized to more effectively align use of in the KARE study reported positive attitudes toward the CKD the registry with clinic workflow. Patient participants identified registry, reinforcing the benefit of sharing the workload burden several facilitators to improve engagement and efficacy, includ- that a registry may introduce. ing increasing the frequency of automated CKD-SMS phone Patients reported positive beliefs about the CKD-SMS pro- calls and providing additional support to educate and assist gram and noted that it provided helpful health knowledge and patients to successfully interface with the self-management management strategies. While prior studies have demonstrated support system. Some patient participants voiced a preference that health coaching interventions and automated communica- for telephone health coaching because of its convenience; tion programs are effective methods for improving patient others voiced a preference for the personal touch inherent to in- awareness and management of hypertension and diabetes, person health coaching. It is quite possible that the observed including those who receive medical care in a public health care difference in participant attitudes toward health-coaching delivery system, this study is one of the first to examine these modalities is informed by demographic factors such as patient types of interventions within the CKD context [10, 11, 13]. The age and health conditions, such as mobility status. For example, positive attitudes that patients had toward all three compo- it is possible that patients who are less mobile would find tele- nents of the CKD-SMS program demonstrate the desire of CKD phone health-coaching to be preferable to in-person coaching patients to receive additional education, knowledge and because patients can do it within their own homes; in contrast, support. older patients who are less mobile may be less comfortable with technology and might prefer in-person health-coaching. Future Ethicality self-management support interventions may want to include both coaching options to optimize patient-centeredness. Lastly, Ethicality is the extent to which an intervention has good fit linkage between the provider-level and patient-level interven- with an individual’s value system. Focus group data from the tions is key for sustainability. One way to do this is by leverag- non-physician primary care staff demonstrated that the CKD ing the electronic health record for more frequent and optimal registry was aligned with primary care team goals and communication among providers and health coaches. enhanced the opportunity for team-based care delivery. Patient Evaluating KARE’s interventions within each of these con- participation data illustrated high levels of patient engagement structs is critical, since evidence suggests that high provider with all components of the CKD-SMS program. This is impor- and patient satisfaction are essential to the successful imple- tant because patient populations within the public health care mentation of CKD interventions [28, 29]. Additionally, behavio- delivery system, which are disproportionately comprised of individuals with minority or immigrant status and individuals ral interventions with high patient acceptability have been associated with better clinical outcomes than those that do not who live in economically disadvantaged communities, tend to be less engaged in health care, resulting in poorer health out- garner high patient satisfaction [18, 30, 31]. While acceptability is gaining recognition as a necessary consideration for the comes [22, 23]. Increasing health awareness and engagement among these populations is, therefore, an important public design and implementation of effective health care system interventions, few studies in the USA have comprehensively health strategy to curb the complications associated with chronic diseases. Our results suggest that a phone-based self- examined this construct [18]. Our article addresses this gap and management support program may provide a critical vantage serves as a model that can be employed during evaluations of point for increasing CKD awareness and activating health future chronic disease interventions. engagement in racially and linguistically diverse populations Additionally, our acceptability findings are important within a public health care delivery system. This conclusion is because CKD is a pressing public health concern, with large further supported by previous studies that have shown mobile challenges related to low patient and provider awareness of health technology to offer an untapped potential for engaging CKD [4] as well as existing ethnic/racial and socioeconomic Downloaded from https://academic.oup.com/ckj/article-abstract/11/4/540/4762253 by Ed 'DeepDyve' Gillespie user on 07 August 2018 Acceptability of CKD interventions | 547 disparities associated with CKD clinical outcomes and quality of in the design of the study, or in the collection, analysis and care delivery [32]. The positive end-user comments and high interpretation of data. engagement and satisfaction levels among providers and patients within this setting speak to the potential of programs Conflict of interest statement that improve CKD knowledge within vulnerable populations and their health care providers. Previous studies have demon- None declared. strated that CKD discussions during primary care encounters are lacking [33]. A team-based primary care CKD registry may Supplementary data offer a valuable and acceptable way to improve provider aware- ness and detection of CKD. In turn, this could lead to more CKD Supplementary data are available at ckj online. discussions with patients during primary care encounters, thus reinforcing CKD knowledge that patients may gain through self- References management support programs. Limitations of this study include a small sample size and a 1. Murphy D, McCulloch CE, Lin F et al. Trends in prevalence of moderately low survey completion rate among PCPs and focus chronic kidney disease in the United States. Ann Intern Med group participation rate among patients. Nonresponse bias may 2016; 165: 473–481 2. Coresh J, Selvin E, Stevens LA et al. Prevalence of chronic kid- have thus influenced the positive perception of the interven- tions reported by PCPs and patients. However, a review of physi- ney disease in the United States. JAMA 2007; 298: 2038–2047 cian survey response behaviors found that nonresponse bias 3. Tuot DS, Plantinga LC, Hsu C-Y et al. Chronic kidney disease may not be an important factor contributing to the validity of awareness among individuals with clinical markers of kid- physician surveys [34]. Additionally, while the findings suggest ney dysfunction. Clin J Am Soc Nephrol 2011; 6: 1838–1844 4. Plantinga LC, Tuot DS, Powe NR. Awareness of chronic kid- that a primary care CKD registry and CKD-SMS program are ney disease among patients and providers. Adv Chronic acceptable within a public health care delivery system, it is not Kidney Dis 2010; 17: 225–236 clear whether the same outcomes would be observed in other 5. Greer RC, Ameling JM, Cavanaugh KL et al. 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Issue Brief (Commonw Fund) 2015; 9: 1–9 review of the literature. Am J Prev Med 2001; 20: 61–67 Downloaded from https://academic.oup.com/ckj/article-abstract/11/4/540/4762253 by Ed 'DeepDyve' Gillespie user on 07 August 2018

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Clinical Kidney JournalOxford University Press

Published: Aug 1, 2018

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