Clinical trial NCT00846300: A Brief Intervention to Improve Medication Knowledge and Adherence Among Family Medicine Patients in South Texas
Official title: An Intervention to Improve Medication Knowledge & Compliance Among Family Practice Patients in South Texas: An RRNEST Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Hyperlipidemia
Hypertension
Keywords: Patient compliance
Hispanics
Health Behavior
Family Physicians
Primary Healthcare
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2009-02-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in self-reported medication knowledge
timeFrame: 6 and 12 weeks post-intervention
measure: Change in self-reported medication compliance
timeFrame: 6 and 12 weeks post intervention
measure: Change in HbA1c for patients with Diabetes
timeFrame: 1 year post intervention
measure: Change in Lipids
timeFrame: 1 year post intervention
measure: Change in blood pressure
timeFrame: 1 year post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Corpus Christi
country: United States
facility: Christus Memorial Hospital
state: Texas
city: Harlingen
country: United States
facility: Valley Baptist Family Medicine Residency Program
state: Texas
city: Laredo
country: United States
facility: Laredo Medical Group
state: Texas
city: McAllen
country: United States
facility: McAllen Family Medicine Residency Program
state: Texas
city: San Antonio
country: United States
facility: Family Medicine Residency Program, Christus Santa Rosa Hospital
state: Texas
city: San Antonio
country: United States
facility: Dept Family & Community Medicine, UTHSCSA
state: Texas
Study officials:
affiliation: University of Texas Health Science Center San Antonio
name: Sandra Burge, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: