Effect of Community Pharmacist Intervention on Adherence to Long-Term Medications

Study Overview
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Brief Summary
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The 4-arm factorial design RCT tested the impact of a behavioral intervention (SBI or BI), a reminder device (Pillbox), and the combination of the two on adherence in adult patients who filled a prescription for oral medications to treat diabetes or hyperlipidemia.

Detailed Description
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Patients diagnosed with chronic diseases often fail to follow their prescribed medication regimens, (16355071,19954264,16732693,23111664) which accounts for up to 290 billion dollars per year in unnecessary medical costs, largely because medication nonadherence increases their risk of disease progression, hospitalization, and premature death.(16355071, 23373139, 23032359) A number of studies have investigated ways to improve medication adherence; (18425859, 18537843) however, few studies on interventions have demonstrated large improvements in adherence and few have used scientifically rigorous study methods such as randomized controlled trials (RCTs).(24422970) A recent systematic review identified a need for adherence interventions and suggested the use of factorial designs in RCTs to study multiple interventions and combinations within large patient populations.(24422970) This study used a factorial-designed, four-armed, RCT to examine the impact of three pharmacy-based interventions versus standard care on improving medication adherence and health outcomes in patients with diabetes and hyperlipidemia. The three interventions used in this study were a behavioral intervention, a pillbox weekly reminder, and the combination of the two. Pillboxes (PB) used in this study had compartments for each day (7X1) and for participants taking multiple medications, sub-compartments for each medication per day (7X4). The behavioral intervention, called Screening and Brief Intervention (SBI or BI), consisted of a short 2-5 minute conversation between the patient and the provider aimed to encourage modification in the patient's health behavior. While BI has primarily been used to address unhealthy alcohol use in patients (11), the researchers hypothesized that this patient-centered approach can be particularly useful for improving medication adherence in chronically ill patients. In this study, motivational interviewing counseling principles were used for motivating patients to take more active roles in self-managing their health. Motivational interviewing can take many forms, however, in this study, the BIs used a schema of motivational interviewing originally developed by the principal investigator titled POLAR*S™ . The specific aims of this research study included testing the impact of three community pharmacy intervention for adult patients with diabetes or hyperlipidemia on: (1) medication adherence; (2) biologic outcomes associated with medication adherence; (3) self-reported health and psychosocial status; and (4) pharmacists' impressions on how BI could be scalable to community pharmacy settings.

Official Title
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Effect of Community Pharmacist Intervention on Adherence to Long-Term Medications

Conditions
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Medication Adherence

Intervention / Treatment
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* Behavioral: Screening and Brief Intervention (BI)
* Behavioral: Pill Box (PB)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients taking oral medications for diabetes or hyperlipidemia 30-85 years of age Comfortable speaking in English Not institutionalized Not diagnosed with psychosis or dementia. Needed at least one prescription refill with the index medication picked up within 14 days of the index prescription fill Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Screening and Brief Intervention (BI)<br>Screening and Brief Intervention (BI) at initial prescription fill and at each additional refill. | Behavioral: Screening and Brief Intervention (BI)<br>* Rite Aid® pharmacists screened patients at the time of the initial fill with the Adherence Estimator™ and using the screening results, provided the behavioral intervention, Brief Intervention using motivational interviewing principles based on POLAR*S (BI). BI was considered an active intervention method.<br>|
| Experimental: Pill Box (PB)<br>Pill Box (PB) and information about their medications at the initial fill and at each additional refill. | Behavioral: Pill Box (PB)<br>* Rite Aid® pharmacists provided patients with a Pill Box (PB) and information about their medications. However, pharmacists did not use motivational interviewing principles for engaging patients in direct interventions to modify behavior. PB was considered a passive intervention method.<br>|
| Experimental: Brief Intervention + Pill Box (BI+PB)<br>Screening and Brief Intervention (BI) and Pill Box (PB) at initial prescription fill and at each additional refill. | Behavioral: Screening and Brief Intervention (BI)<br>* Rite Aid® pharmacists screened patients at the time of the initial fill with the Adherence Estimator™ and using the screening results, provided the behavioral intervention, Brief Intervention using motivational interviewing principles based on POLAR*S (BI). BI was considered an active intervention method.<br>Behavioral: Pill Box (PB)<br>* Rite Aid® pharmacists provided patients with a Pill Box (PB) and information about their medications. However, pharmacists did not use motivational interviewing principles for engaging patients in direct interventions to modify behavior. PB was considered a passive intervention method.<br>|
| No Intervention: Standard Care (SC)<br>The Standard Care (SC) arm administered traditional dispensing and counseling by Rite Aid® pharmacists. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in medication adherence using the PDC metric, for adult patients with diabetes or hyperlipidemia. | Medication adherence was measured as a Proportion of Days Covered (PDC) by calculating (at the patient level) the denominator as the number of days between the first fill of the medication during a measurement period and the end of the measurement period and the numerator is calculated as the number of days covered by prescription fill date and days of supply. For each patient, the PDC was calculated at baseline and 9-months. The baseline PDC was compared to that at 9-months. | At baseline and nine-months post-enrollment into the study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in triglyerceride levels from baseline to 6- and 9-months. | Triglyeride levels were measured for patients who had regular blood samples drawn, at baseline, 6-months, and 9-months, by their physician during the course of the study. The baseline measure was compared to that at 6- and 9-months. | At baseline, six months and nine-months post-enrollment into the study. | 
| Change in cholesterol levels from baseline to 6- and 9-months. | Cholesterol levels were measured for patients who had regular blood samples drawn, at baseline, 6-months, and 9-months, by their physician during the course of the study. The baseline measure was compared to that at 6- and 9-months. | At baseline, six months and nine-months post-enrollment into the study. | 
| Change in high-density lipoprotein (HDL) levels from baseline to 6- and 9-months. | High-density lipoprotein (HDL) levels were measured for patients who had regular blood samples drawn, at baseline, 6-months, and 9-months, by their physician during the course of the study. The baseline measure was compared to that at 6- and 9-months. | At baseline, six months and nine-months post-enrollment into the study. | 
| Change in low-density lipoprotein (LDL) levels from baseline to 6- and 9-months. | Low-density lipoprotein (LDL) levels were measured for patients who had regular blood samples drawn, at baseline, 6-months, and 9-months, by their physician during the course of the study. The baseline measure was compared to that at 6- and 9-months. | At baseline, six months and nine-months post-enrollment into the study. | 
| Change in glycated hemoglobin (HbA1c) levels from baseline to 6- and 9-months. | Glycated hemoglobin (HbA1c) levels were measured for patients who had regular blood samples drawn, at baseline, 6-months, and 9-months, by their physician during the course of the study. The baseline measure was compared to that at 6- and 9-months. | At baseline, six months and nine-months post-enrollment into the study. | 
| Change in self-reported healthcare utilization, using a study-designed standardized questionnaire, from baseline to 9-months. | Self-reported healthcare utilization information was collected upon enrollment during the baseline interview using a standardized questionnaire developed bv the PI for the study. These interviews were repeated for the 9-month follow-up period. | At baseline and nine-months post-enrollment into the study. | 
| Change in self-reported psychosocial status, using a study-designed standardized questionnaire, from baseline to 9-months. | Self-reported psychosocial status information was collected upon enrollment during the baseline interview using a standardized questionnaire developed bv the PI for the study. These interviews were repeated for the 9-month follow-up period. | At baseline and nine-months post-enrollment into the study. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medication adherence, community pharmacies, screening and brief intervention