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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00846300
• Other study ID #: HP000016-01
• Status: Completed
• Phase: N/A
• First received: February 17, 2009
• Last updated: October 7, 2015
• Start date: August 2001
• Est. completion date: May 2003

Study information

• Verified date: October 2015
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 2003
• Est. primary completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Hyperlipidemia
• Hyperlipidemias
• Hypertension

Intervention

Behavioral:
• Physician counseling for health behavior change
Physician counseling for health behavior change, compared to a no-counseling comparison group

Locations

Country	Name	City	State
United States	Christus Memorial Hospital	Corpus Christi	Texas
United States	Valley Baptist Family Medicine Residency Program	Harlingen	Texas
United States	Laredo Medical Group	Laredo	Texas
United States	McAllen Family Medicine Residency Program	McAllen	Texas
United States	Dept Family & Community Medicine, UTHSCSA	San Antonio	Texas
United States	Family Medicine Residency Program, Christus Santa Rosa Hospital	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in self-reported medication knowledge		6 and 12 weeks post-intervention	No
Primary	Change in self-reported medication compliance		6 and 12 weeks post intervention	No
Primary	Change in HbA1c for patients with Diabetes		1 year post intervention	No
Primary	Change in Lipids		1 year post intervention	No
Primary	Change in blood pressure		1 year post intervention	No