TY - JOUR
AU - Brateanu, Andrei
AB - Abstract Purpose Studies have supported the use of packaging interventions such as pillboxes or blister packs to improve medication adherence but have not evaluated the efficacy of these interventions in a population of low socioeconomic status. The aim of this study was to assess the effect of home-delivered pill packs on medication adherence in a low-income Black American population with Medicaid insurance. Methods This study was an open-label, randomized, controlled trial. The patient population studied included 80 patients followed by primary care physicians at the Cleveland Clinic. Patients were randomized to a study group who received delivery of their multidrug medical therapy, defined as a minimum of 4 medications daily, in prepackaged blisters or a control group who obtained their prescriptions from their routine pharmacy. Results The primary analysis compared the mean percentage of missed pills between the 2 groups using t-test analysis. The percentage of missed pills in the study group was significantly lower than in the control group (mean [SD]: 3.7% [6.0%] vs 17.4% [16.6%] missed daily pills; P < 0.001). The number of daily missed doses was also significantly lower in the study group (0.3 [0.5] vs 0.7 [0.6]; P = 0.002). Patients were on a mean of 8.1 (SD, 2.3) and 8.1 (SD, 2.6) medications in the study and control groups, respectively (P = 0.96). Conclusion Delivery of prepackaged medications in a low-income Black American community was demonstrated to improve medication adherence. The use of prepackaged blisters for medication home delivery is a model that can be utilized on a larger scale for patients on multidrug medical therapy. low-income population, medication adherence, medication compliance, patient compliance, pharmacy distribution Key Points Home delivery of prepackaged pill packs helped to improve medication adherence among patients in a low-income primary care setting. The benefit of this model could be seen in patients on multidrug medical therapy, with 4 or more medications, and this approach may help to maintain long-term compliance. Home delivery of prepackaged pill packs can be provided at no additional cost to the patient and is a scalable model for medication delivery in the United States. Chronic medical conditions have a significant impact on health care in the United States. In part, this is due to multidrug regimens. One quarter of American patients over the age of 18 have a minimum of 2 chronic medical conditions,1,2 often requiring patients to take multiple medications with multiple doses. 3-5 In 2015 to 2016, approximately 40% of American patients over the age of 65 were taking 5 or more prescription drugs.6 Multidrug medical therapy contributes to medication nonadherence and therefore worsening control of chronic medical conditions.7-13 Medication nonadherence is frequently the cause of medication-related hospital admissions10 and contributes to higher healthcare spending.9-11,14 Many factors affect adherence, including asymptomatic disease, poor follow-up, lack of insight, missed appointments, polypharmacy, and cost.10,11,15 The most common reasons for nonadherence are forgetfulness and decisions not to take medication. Race, gender, and socioeconomics have also been significantly associated with adherence.10 Medication nonadherence is more common in non-Caucasian patients and patients receiving low-income subsidies.11,16,17 Diseases such as hypertension and diabetes mellitus are also more prevalent and less controlled in Black Americans when compared to Caucasians.17-20 Notably, two-thirds of Black American patients above the age of 65 are prescribed 3 or more daily drugs, leading to greater difficulty in maintaining medication adherence.3,21,22 Several interventions to improve medication adherence have been studied, including improving patient education, drug delivery, and packaging methods, improving dosing schedules, increasing clinic hours, and improving patient and healthcare communication.9,10,23,24 One study found that blister packs improved medication adherence compared to days-of-the-week pillboxes; however, these findings were more notable in younger patients.25 Studies that focused on behavior-driven interventions showed more improved outcomes than those that focused on counseling or challenging beliefs. The objective of this randomized controlled trial was to use a behavior-driven intervention to improve medication adherence among low-income Black Americans. The intervention in this study was home delivery and packaging of prescribed medications. Methods The study design, randomization, and participant flow are summarized in Figure 1. Figure 1. Open in new tabDownload slide Enrollment, randomization, and follow-up. PCP indicates primary care provider; STJHC, XXX. Figure 1. Open in new tabDownload slide Enrollment, randomization, and follow-up. PCP indicates primary care provider; STJHC, XXX. Study design. This study was a single-center, open-label, randomized controlled trial conducted at the Stephanie Tubbs Jones Health Center (STJHC) between January and October of 2015. STJHC is a multispecialty outpatient clinic facility of the Cleveland Clinic that provides care to approximately 46,000 patients every year, of whom 91% are Black Americans, the majority of whom reside in Cleveland. The medicine research committee and the institutional review board at the Cleveland Clinic approved the study design and supervised the implementation of the study (study number 14-1554). Participants. All primary care physicians (PCPs) at STJHC participated in the study. The electronic medical record (EMR) was reviewed to identify patients who met the inclusion criteria: age of 18 years or older, covered by Medicaid insurance, seen in the clinic at least 2 times within the past year, follow-up appointment scheduled between January and May of 2015, and prescribed a minimum of 4 medications daily (multidrug medical therapy). Nursing home patients, patients with planned hospital stays during the study period, and patients who were already receiving medications in prepacked blisters or pill packs were excluded. Eligible patients received a telephone call from one of the study investigators and were invited to come to their subsequent PCP appointment 30 minutes early for further explanation of the study and informed consent. A total of 114 patients were recruited to the study. Randomization. Patients willing to participate in the study were randomized after they provided written informed consent. A block scheme with a block size of 4 was used to randomly assign patients to the study group or the control group. Patients in the study group received medications in pill packs delivered to their homes. Patients in the control group continued to acquire medications from their pharmacies. Intervention. For patients in the study group, new prescriptions with 3 refills were electronically scripted to a packaging pharmacy, ExactCare Pharmacy LLC (Valley View, OH), that delivers medications nationally. ExactCare is a local packaging pharmacy that prepacks medications for patients so that each day’s medications come in a separate plastic compartment that can be discarded after daily use. They also deliver medications to patients’ homes. At the initiation of the study, ExactCare supplied 30-day medications in pill packs for each patient (Figure 2). Patients in the control group continued to receive their medications the same way they had before being enrolled in this study. Figure 2. Open in new tabDownload slide Pill pack example. Figure 2. Open in new tabDownload slide Pill pack example. Patients from both groups had a PCP follow-up visit approximately 4 months after enrollment. During the appointment, the study investigators counted the medications remaining in the pill packs for the study group patients and the pills remaining in pill bottles for the control group patients. This information was used to calculate the total number of missed pills. New medications, discontinued medications, and modified-dose medications were not included in the study analysis. Statistical analysis. Baseline patient characteristics are summarized in Table 1. Continuous characteristics were compared using t tests, and categorical characteristics were compared using χ 2 tests. The numbers and percentages of missed pills for each patient were computed and summarized by group. Table 1. Baseline Demographic Characteristics and Clinical Variables Characteristica . Control Group (n = 41) . Study Group (n = 39) . P Value . Male, % 53.8 53.6 0.99 Black American, % 98 100 0.33 Age, mean (SD), years 56.4 (8.0) 54.1 (10.1) 0.27 Chronic medical conditions per patient, mean (SD) 6.1 (2.8) 6.3 (2.3) 0.72 Chronic medical conditions  Hypertension 40 37  Dyslipidemia 20 21  Diabetes mellitus 19 18  Cardiovascular diseaseb 16 15  Lung diseasec 13 14  Rheumatologic/autoimmune diseased 26 18  Chronic kidney disease 7 8  Psychiatric diseasee 6 8 Patients using tobacco 18 15 Patients using alcohol 13 17 Total medications per patient at time of enrollment, mean (SD) 7.4 (2.5) 8.0 (2.2) 0.34 Total medications per patient at end of study, mean (SD) 8.1 (2.6) 8.1 (2.3) 0.96 Characteristica . Control Group (n = 41) . Study Group (n = 39) . P Value . Male, % 53.8 53.6 0.99 Black American, % 98 100 0.33 Age, mean (SD), years 56.4 (8.0) 54.1 (10.1) 0.27 Chronic medical conditions per patient, mean (SD) 6.1 (2.8) 6.3 (2.3) 0.72 Chronic medical conditions  Hypertension 40 37  Dyslipidemia 20 21  Diabetes mellitus 19 18  Cardiovascular diseaseb 16 15  Lung diseasec 13 14  Rheumatologic/autoimmune diseased 26 18  Chronic kidney disease 7 8  Psychiatric diseasee 6 8 Patients using tobacco 18 15 Patients using alcohol 13 17 Total medications per patient at time of enrollment, mean (SD) 7.4 (2.5) 8.0 (2.2) 0.34 Total medications per patient at end of study, mean (SD) 8.1 (2.6) 8.1 (2.3) 0.96 aData are shown as the number of patients unless indicated otherwise. bCardiovascular diseases included coronary artery disease, congestive heart failure, atrial fibrillation, stroke, and peripheral vascular disease. cRespiratory conditions included asthma, chronic obstructive lung disease, and obstructive sleep apnea. dRheumatologic/autoimmune conditions included all arthritis, autoimmune diseases, vasculitis, fibromyalgia, vitamin D deficiency, and osteoporosis. ePsychiatric conditions included depression, psychosis, schizophrenia, and bipolar disorders. Open in new tab Table 1. Baseline Demographic Characteristics and Clinical Variables Characteristica . Control Group (n = 41) . Study Group (n = 39) . P Value . Male, % 53.8 53.6 0.99 Black American, % 98 100 0.33 Age, mean (SD), years 56.4 (8.0) 54.1 (10.1) 0.27 Chronic medical conditions per patient, mean (SD) 6.1 (2.8) 6.3 (2.3) 0.72 Chronic medical conditions  Hypertension 40 37  Dyslipidemia 20 21  Diabetes mellitus 19 18  Cardiovascular diseaseb 16 15  Lung diseasec 13 14  Rheumatologic/autoimmune diseased 26 18  Chronic kidney disease 7 8  Psychiatric diseasee 6 8 Patients using tobacco 18 15 Patients using alcohol 13 17 Total medications per patient at time of enrollment, mean (SD) 7.4 (2.5) 8.0 (2.2) 0.34 Total medications per patient at end of study, mean (SD) 8.1 (2.6) 8.1 (2.3) 0.96 Characteristica . Control Group (n = 41) . Study Group (n = 39) . P Value . Male, % 53.8 53.6 0.99 Black American, % 98 100 0.33 Age, mean (SD), years 56.4 (8.0) 54.1 (10.1) 0.27 Chronic medical conditions per patient, mean (SD) 6.1 (2.8) 6.3 (2.3) 0.72 Chronic medical conditions  Hypertension 40 37  Dyslipidemia 20 21  Diabetes mellitus 19 18  Cardiovascular diseaseb 16 15  Lung diseasec 13 14  Rheumatologic/autoimmune diseased 26 18  Chronic kidney disease 7 8  Psychiatric diseasee 6 8 Patients using tobacco 18 15 Patients using alcohol 13 17 Total medications per patient at time of enrollment, mean (SD) 7.4 (2.5) 8.0 (2.2) 0.34 Total medications per patient at end of study, mean (SD) 8.1 (2.6) 8.1 (2.3) 0.96 aData are shown as the number of patients unless indicated otherwise. bCardiovascular diseases included coronary artery disease, congestive heart failure, atrial fibrillation, stroke, and peripheral vascular disease. cRespiratory conditions included asthma, chronic obstructive lung disease, and obstructive sleep apnea. dRheumatologic/autoimmune conditions included all arthritis, autoimmune diseases, vasculitis, fibromyalgia, vitamin D deficiency, and osteoporosis. ePsychiatric conditions included depression, psychosis, schizophrenia, and bipolar disorders. Open in new tab A t test was used to compare the percentage of missed pills between the 2 groups. Similar analyses were performed for other outcomes regarding medication use. All analyses were conducted using R (R Foundation for Statistical Computing, Vienna, Austria), and a 2-sided P value less than 0.05 was considered statistically significant. With the enrolled sample size, the study had 80% power to detect an effect size of 0.64 when comparing the 2 groups (2-sided type I error, 0.05). Results Of the 2,519 patients screened from January 2, 2015, to March 30, 2015, 353 patients met the inclusion criteria and 114 patients provided consent to participate in the study. At the end of the study, 80 patients (70%) completed the study, 39 from the study group and 41 from the control group. The mean age (SD) of the patients in the study and control groups was 56.4 (8) years and 54.1 (10) years, respectively. The total number of female patients in the study was 43 (54%), 21 of whom were in the study group and 22 of whom were in the control group. Apart from 1 patient with Asian ethnicity, all patients in the study were Black American. Thirty-four patients did not complete the study, including 19 from the study group and 15 from the control group. Of the 19 patients from the study group who did not complete the study, 1 patient was admitted to a long-term care facility, 10 patients withdrew before they received their first medication box, and 8 patients either withdrew after they had received their first medication box or were lost to follow-up. Of the 15 patients from the control group who did not complete the study, 5 withdrew and 10 were lost to follow-up (Table 1). Patients in the study group had a mean (SD) of 6.3 (2.3) chronic medical conditions, while those in the control group had 6.1 (2.8) chronic medical conditions (P = 0.72). The most common chronic medical condition was hypertension, followed by dyslipidemia and diabetes mellitus. Approximately 38.5% and 43.9% of patients were smokers and 43.6% and 31.7% of patients consumed alcohol in the study and control groups, respectively (Table 1). More detailed demographics regarding chronic medical conditions have also been summarized in Table 1. At the time of enrollment, patients were on a mean (SD) of 8.0 (2.2) and 7.4 (2.5) medications in the study and control groups, respectively (P = 0.34). At the end of the study, patients were on 8.1 (2.3) and 8.1 (2.6) medications in the study and control groups (P = 0.96; Table 1). At the end of the study, the mean percentage (SD) of missed medications was 3.7% (6.0%) in the study group and 17.4% (16.6%) in the control group (P < 0.001). Patients in the study group missed fewer medications than patients in the control group. The mean number (SD) of daily medications missed by patients in the study group was 0.3 (0.5) compared to 0.7 (0.6) in the control group (P = 0.002; Table 2). Table 2. Outcomes of Compliance Packaging Intervention Variablea . Control Group (n = 41) . Study Group (n = 39) . P Value . Medications in “pill” format included in the study per patient 5.0 (1.9) 6.5 (1.8) <0.001 Total pills per patient 625 (335) 898 (395) 0.001 Total missed pills per patient 84 (69) 25 (37) <0.001 Missed pills per patient, % 17.4 (16.6) 3.7 (6.0) <0.001 Missed pills per patient (men), % 13.4 (11.5) 3.8 (7.2) 0.005 Missed pills per patient (women), % 20.9 (19.6) 3.6 (4.8) 0.001 Daily medication doses missed per patient 0.7 (0.6) 0.3 (0.5) 0.002 Variablea . Control Group (n = 41) . Study Group (n = 39) . P Value . Medications in “pill” format included in the study per patient 5.0 (1.9) 6.5 (1.8) <0.001 Total pills per patient 625 (335) 898 (395) 0.001 Total missed pills per patient 84 (69) 25 (37) <0.001 Missed pills per patient, % 17.4 (16.6) 3.7 (6.0) <0.001 Missed pills per patient (men), % 13.4 (11.5) 3.8 (7.2) 0.005 Missed pills per patient (women), % 20.9 (19.6) 3.6 (4.8) 0.001 Daily medication doses missed per patient 0.7 (0.6) 0.3 (0.5) 0.002 aData are shown as mean (SD). Open in new tab Table 2. Outcomes of Compliance Packaging Intervention Variablea . Control Group (n = 41) . Study Group (n = 39) . P Value . Medications in “pill” format included in the study per patient 5.0 (1.9) 6.5 (1.8) <0.001 Total pills per patient 625 (335) 898 (395) 0.001 Total missed pills per patient 84 (69) 25 (37) <0.001 Missed pills per patient, % 17.4 (16.6) 3.7 (6.0) <0.001 Missed pills per patient (men), % 13.4 (11.5) 3.8 (7.2) 0.005 Missed pills per patient (women), % 20.9 (19.6) 3.6 (4.8) 0.001 Daily medication doses missed per patient 0.7 (0.6) 0.3 (0.5) 0.002 Variablea . Control Group (n = 41) . Study Group (n = 39) . P Value . Medications in “pill” format included in the study per patient 5.0 (1.9) 6.5 (1.8) <0.001 Total pills per patient 625 (335) 898 (395) 0.001 Total missed pills per patient 84 (69) 25 (37) <0.001 Missed pills per patient, % 17.4 (16.6) 3.7 (6.0) <0.001 Missed pills per patient (men), % 13.4 (11.5) 3.8 (7.2) 0.005 Missed pills per patient (women), % 20.9 (19.6) 3.6 (4.8) 0.001 Daily medication doses missed per patient 0.7 (0.6) 0.3 (0.5) 0.002 aData are shown as mean (SD). Open in new tab Discussion In this study, delivery of prepackaged medications to predominantly low-income Black Americans with Medicaid insurance was associated with improved medication adherence. The study focused on Black Americans because this population has been shown to have higher numbers of medications, increased prevalence of comorbid medical conditions, and higher rates of nonadherence. The intervention was behavioral, targeted at improving compliance by improving ease of self-administration of medications. Prior studies have shown that interventions linked to improving behaviors have better outcomes than interventions based on provider instruction.25 In many of the studies targeting behavior, such interventions have improved medication adherence and clinical outcomes, resulting in, for example, better blood pressure control and a reduction in low-density lipoprotein (LDL) cholesterol levels. In a review article, Conn et al25 demonstrated that interventions that target behaviors or habits, such as special packaging or labeling, improve outcomes more than interventions delivered by providers, such as counseling or provider training. These findings were echoed by a meta-analysis on blood pressure medication adherence in a Black American population.26 This study reviewed intervention strategies, showing that blister packaging and pillbox organizers improved adherence in comparison to nonpackaging interventions, such as provider training, social support, and counseling. Medication nonadherence is highest among Black American and American Indian/Alaskan populations, with rates of 35.7% and 38.1%, respectively, while the rate in Caucasians is 24.3%.11 Medication nonadherence is also higher among patients receiving low-income subsidies and older populations.21,27-29 A study by Kripalani et al30 concluded that medical management capacity, ie, the ability to self-administer medications as prescribed, was significantly associated with health literacy among an inner city, elderly Black American population. In a randomized controlled trial among adults with coronary artery disease in urban primary care clinics, patients received illustrated medication schedules and refill reminder postcards.31 Adherence to medications did not improve significantly at 1 year; however, there was a greater trend toward adherence among patients with reported low adherence at baseline and those on more than 8 medications. The compliance packaging system used by the pharmacy in our study had some similarities and differences in comparison to the compliance packaging systems used in previous studies.32-34 The medications were packed on the basis of frequency and time of day, as in other packing trials.9,35,36 However, instead of the blister packs used in prior studies, the medications were packaged in small packets that were rolled into a 30-day supply. One of the significant and potentially confounding factors in this study was the home delivery mechanism for the medications with automatic refill. Automatic refill and delivery help to prevent lapses in filling medications. This study demonstrated that home-delivered pill packs containing prescribed medications improved adherence of patients to their prescribed medication regimens. There were several limitations in this study. The study was conducted over a short time period and was limited to a single center. Longer follow-up periods are needed to better reflect medication adherence behaviors and show the effect of compliance packaging on clinical outcomes. Additionally, some patients were lost to follow-up; however, the percentage of patients who completed the study was comparable to the show rate at this clinic for follow-up appointments. Furthermore, adherence rates were calculated on the basis of the pill packs, pill bottles, and medication strips that patients brought with them to their follow-up visits. To account for pills that were not brought in, refill information was collected from pharmacies for both the study and control patients. There was a small possibility of medications being added or discontinued by other providers that was not accounted for during the study follow-up. However, the patients included in the study had stable chronic medical conditions and we did not expect changes in their medication regimens during the 4 months of follow-up. Conclusion This is the first randomized controlled trial to show improved medication adherence through a packaging intervention among a low-income, primarily Black patient population. Prior studies have used a combination of interventions to improve medication adherence.12,35,37,38 Common interventions have included patient education, provider training, pharmacist participation, reminder postcards, illustrated instructions, and incentives.39-43 These interventions can be cumbersome and require significant resources. Among low-income Americans in resource-poor communities, financial support is limited. In this study, no additional resources were required to provide packaged medications to patients. The packaging pharmacy provided the pill packets and home delivery of medications to patients at no additional cost in accordance with their business model. Notably, this pharmacy delivers medications in the majority of states with approval pending in the remaining states. This medication delivery system was shown to increase medication adherence in our patient population. Because of this system’s low cost and ease of use, we believe these findings may be reproducible in the general population, potentially leading to long-term medication compliance for patients on multidrug medical therapy. Future studies should evaluate the impact of compliance interventions on clinical outcomes. Acknowledgments We would like to acknowledge Sarah Schramm, MA, for her contribution to research administration and coordination of this study. Disclosures The Huron Foundation provided funding for this study but did not have access to study data. The authors have declared no potential conflicts of interest. Additional information The dataset analyzed during this study is available from the corresponding author on reasonable request. 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TI - Impact on patients’ compliance with medication using prepacked blisters for multidrug medical therapy: I-COMPLY Study
JF - American Journal of Health-System Pharmacy
DO - 10.1093/ajhp/zxab193
DA - 2021-05-17
UR - https://www.deepdyve.com/lp/oxford-university-press/impact-on-patients-compliance-with-medication-using-prepacked-blisters-9DhqDmV0Yk
SP - 1
EP - 1
VL - Advance Article
IS - 
DP - DeepDyve
ER -