A Brief Intervention to Improve Medication Knowledge and Adherence Among Family Medicine Patients in South Texas

An Intervention to Improve Medication Knowledge & Compliance Among Family Practice Patients in South Texas: An RRNEST Study.

This study examines a brief physician counseling intervention to improved medication knowledge and compliance in family medicine patients who have diabetes, hypertension or high cholesterol.

Study Overview

Detailed Description

This study examined a brief intervention to improve medication knowledge and compliance in family medicine patients. The study was conducted in a network of six family medicine residency programs in South Texas, funded by a grant from the Health Research Services Administration. Family medicine patients were invited to participate in the study if they took medicines for type 2 diabetes, hypertension, or hyperlipidemia and responded "yes" to the screening question: "Do you sometimes have trouble taking all your medications as prescribed?"

At enrollment, clinic staff administered a Medication Survey to patients to assess the variables: readiness to change, reported medication knowledge; reported compliance, and predictors of knowledge and compliance. Self-reports of compliance were validated with a social desirability scale, and with physician impressions. Six and twelve weeks post-enrollment, interviewers administered followup surveys by telephone to assess change over time in medication knowledge and compliance. One year post-enrollment, investigators conducted a chart review to examine changes in health outcomes: blood pressure or HbA1c or cholesterol levels, and number of hospitalizations.

Three physicians per clinic site (18 total) conducted medication interventions for the purpose of this study. This intervention was brief behavior change counseling done in the context of a routine office visit, guided by simple strategies outlined in Rollnick et al (1999). First, physicians reviewed subjects= medication regimen and addressed their concerns. We selected a simple strategy from Rollnick et al. - a brainstorming session - that built patients' confidence to change health behaviors. Afterward, physicians offered pillboxes to patients who desired them, and reviewed potential adverse reactions to medicines. One week after the intervention, physicians telephoned patients to reinforce behavior change and to answer questions about the medications. Prior to training physicians to conduct this intervention, we enrolled five subjects per physician into a control group. We attempted to blind physicians to these patients= enrollment status; usual care was provided to control subjects. After training, enrollees' charts were flagged so that physicians knew to conduct the intervention. We sought five patients per physician to receive the intervention.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

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

    • Texas
      • Corpus Christi, Texas, United States, 78405
        • Christus Memorial Hospital
      • Harlingen, Texas, United States, 78550
        • Valley Baptist Family Medicine Residency Program
      • Laredo, Texas, United States
        • Laredo Medical Group
      • McAllen, Texas, United States, 78503
        • McAllen Family Medicine Residency Program
      • San Antonio, Texas, United States, 78207
        • Family Medicine Residency Program, Christus Santa Rosa Hospital
      • San Antonio, Texas, United States, 78229
        • Dept Family & Community Medicine, UTHSCSA

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

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Sometimes has trouble taking medicines as they're prescribed
  • Has diabetes type 2, or hypertension, or high cholesterol for which they take prescription medicines
  • Is a patient of 18 doctors conducting the intervention

Exclusion Criteria:

  • Subjects under age 18

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: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in self-reported medication knowledge
Time Frame: 6 and 12 weeks post-intervention
6 and 12 weeks post-intervention
Change in self-reported medication compliance
Time Frame: 6 and 12 weeks post intervention
6 and 12 weeks post intervention
Change in HbA1c for patients with Diabetes
Time Frame: 1 year post intervention
1 year post intervention
Change in Lipids
Time Frame: 1 year post intervention
1 year post intervention
Change in blood pressure
Time Frame: 1 year post intervention
1 year post intervention

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Sandra Burge, Ph.D., University of Texas Health Science Center - San Antonio

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

August 1, 2001

Primary Completion (ACTUAL)

May 1, 2003

Study Completion (ACTUAL)

May 1, 2003

Study Registration Dates

First Submitted

February 17, 2009

First Submitted That Met QC Criteria

February 17, 2009

First Posted (ESTIMATE)

February 18, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 8, 2015

Last Update Submitted That Met QC Criteria

October 7, 2015

Last Verified

October 1, 2015

More Information

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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