Effect of Community Pharmacist Intervention on Adherence to Long-Term Medications (ECO-PHIL)

University of Pittsburgh

Status: Completed

Conditions: Medication Adherence

Treatments: Behavioral: Pill Box (PB); Behavioral: Screening and Brief Intervention (BI)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02604901

ECOPHIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,091 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1,091 participants in 4 patient groups

Screening and Brief Intervention (BI)

Experimental group

Description:

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

Treatment:

Behavioral: Screening and Brief Intervention (BI)

Pill Box (PB)

Experimental group

Description:

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

Treatment:

Behavioral: Pill Box (PB)

Brief Intervention + Pill Box (BI+PB)

Experimental group

Description:

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

Treatment:

Behavioral: Pill Box (PB)

Behavioral: Screening and Brief Intervention (BI)

Standard Care (SC)

No Intervention group

Description:

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