Pharmacy Interventions to Improve Chronic Disease Medication Refill

November 25, 2008 updated by: Medical University of South Carolina

A Randomized Controlled Trial of Two Pharmacy Interventions to Improve Refill Adherence for Chronic Disease Medications

Compare the effectiveness of 3 strategies by pharmacists to decrease the time to refill of prescriptions for common chronic diseases (diabetes, hypertension, hyperlipidemia, heart failure, depression, psychoses).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The design was a multi-site 8-month randomized, controlled clinical trial with the patient as the unit of randomization. The Institutional Review Board at the Medical University of South Carolina approved the study. The setting included 9 pharmacies within a medium-sized grocery store chain in South Carolina. The 9 pharmacies were selected to ensure an adequate sample size and sufficient representation by patients with respect to geographic region (urban, suburban, and rural), race/ethnicity, and socioeconomic background. Individual pharmacy staff were informed by their district manager (P.P.) that they were required to participate in the project. Beginning January 16, 2006 and continuing through August 29, 2006, all patients who were at least 7 days overdue for a qualified prescription were identified on a weekly basis (i.e. every Monday morning) using the centralized computer database. Patients identified as being overdue for a qualified medication were assigned a unique study identification number and randomized using a simple randomization technique operationalized within a Microsoft® Access® database. The randomization was based on a permuted block design with a block size of 3, with each patient thus having a one-third chance of being placed in any one of the 3 treatment arms.After eligible patients were identified and randomized each week, there were 3 different protocols followed, depending on the assigned treatment arm. The 3 treatment arms included 1) pharmacist contact with the patient via telephone, 2) pharmacist contact with the prescribing physician via facsimile, and 3) usual care.There were a total of 3,048 patients into arms 1 (n=1018), 2 (n=1016), and 3 (n= 1014). The study was designed to detect relatively small differences in the outcomes of interest. Baseline comparisons across treatment arms in the characteristics of patients and medications were made using t-tests and chi-square tests, as appropriate. For the analyses of study outcomes, an intent-to-treat approach was used. Statistical models were constructed to compare outcomes among the 3 treatment arms, after first examining whether significant interaction between treatment arm and medication disease classification was present. For the analyses of secondary outcomes, all of which were binary in nature, multivariable logistic regression models were used, with treatment arm as the key independent variable of interest, adjusting for the same covariates used in the primary analyses.

Study Type

Interventional

Enrollment (Actual)

3048

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients who were at least 7 days overdue for a qualified prescription were identified on a weekly basis (i.e. every Monday morning) using the centralized computer database. A qualified prescription was defined as having at least 2 refills remaining, a duration of at least a 30 days' supply, and having been written for any one of a number of chronic disease medications identified by a clinical pharmacist (A.M.W.). The medications of interest were those indicated for chronic treatment of diabetes mellitus, hypertension, hyperlipidemia, heart failure, depression, and psychoses. Medications that treat any combination of the specified diseases were allowed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary outcome was the number of days from the index date until the next date on which the patient filled a prescription for any qualified medication, or until the end of the study follow-up period.

Secondary Outcome Measures

Outcome Measure
Secondary outcomes included indicators for whether the patient filled any medication within 30 days for their chronic disease, and whether the patient filled any medication within 30 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

Agency for Healthcare Research and Quality (AHRQ)

Investigators

  • Principal Investigator: Paul J Nietert, PhD, Medical University of South Carolina
  • Study Director: Barbara C Tilley, PhD, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

May 3, 2007

First Submitted That Met QC Criteria

May 3, 2007

First Posted (Estimate)

May 4, 2007

Study Record Updates

Last Update Posted (Estimate)

November 26, 2008

Last Update Submitted That Met QC Criteria

November 25, 2008

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P01HS010871 (U.S. AHRQ Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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