NCT Number: NCT02604901
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.
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Notify Me18 year–85 year
All sexes
Interventional
Not applicable
Rite Aid® Corporation, Marietta, Georgia, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-
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.
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.
Time frame: At baseline and nine-months post-enrollment into the study.
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.
Time frame: At baseline, six months and nine-months post-enrollment into the study.
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.
Time frame: At baseline, six months and nine-months post-enrollment into the study.
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.
Time frame: At baseline, six months and nine-months post-enrollment into the study.
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.
Time frame: At baseline, six months and nine-months post-enrollment into the study.
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.
Time frame: At baseline, six months and nine-months post-enrollment into the study.
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.
Time frame: At baseline and nine-months post-enrollment into the study.
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.
Time frame: At baseline and nine-months post-enrollment into the study.
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.
University of Pittsburgh
Other
Acronym: ECO-PHIL
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