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Clinical Trials/NCT02604901
NCT02604901CompletedNot Applicable

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

University of Pittsburgh2 sites in 1 country1,091 target enrollmentStarted: June 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
1,091
Locations
2
Primary Endpoint
Change in medication adherence using the PDC metric, for adult patients with diabetes or hyperlipidemia.

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Masking
None

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

  • Not provided

Arms & Interventions

Standard Care (SC)

No Intervention

The Standard Care (SC) arm administered traditional dispensing and counseling by Rite Aid® pharmacists.

Screening and Brief Intervention (BI)

Experimental

Screening and Brief Intervention (BI) at initial prescription fill and at each additional refill.

Intervention: Screening and Brief Intervention (BI) (Behavioral)

Pill Box (PB)

Experimental

Pill Box (PB) and information about their medications at the initial fill and at each additional refill.

Intervention: Pill Box (PB) (Behavioral)

Brief Intervention + Pill Box (BI+PB)

Experimental

Screening and Brief Intervention (BI) and Pill Box (PB) at initial prescription fill and at each additional refill.

Intervention: Screening and Brief Intervention (BI) (Behavioral)

Brief Intervention + Pill Box (BI+PB)

Experimental

Screening and Brief Intervention (BI) and Pill Box (PB) at initial prescription fill and at each additional refill.

Intervention: Pill Box (PB) (Behavioral)

Outcomes

Primary Outcomes

Change in medication adherence using the PDC metric, for adult patients with diabetes or hyperlipidemia.

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.

Secondary Outcomes

  • Change in triglyerceride levels from baseline to 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.(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.(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.(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.(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.(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.(At baseline and nine-months post-enrollment into the study.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jan Pringle

Associate Professor

University of Pittsburgh

Study Sites (2)

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