A Team Model of Hypertension Care in African Americans

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Behavioral: Pharmacy TEAM monitoring and counseling

• Registration Number: NCT00205153
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

This Team Education and Adherence Monitoring (TEAM) trial will evaluate the cost-effectiveness of a pharmacy-based intervention in a randomized controlled trial involving 597 treated hypertensive African American patients in five Wisconsin cities. The study involves 28 community pharmacies (14 intervention, 14 control) owned by two pharmacy corporations. Intervention pharmacists and pharmacy technicians implemented a 6-month blood pressure (BP) monitoring program that involved working together as a team with patients and their physicians to achieve improved medication adherence, healthy lifestyles, drug therapy, and hypertension control.

Detailed Description

Researchers screened and enrolled 20-25 subjects in each study pharmacy. Intervention pharmacists and technicians attended a 7-hour TEAM training program on BP monitoring, JNC 7 guidelines, and specially designed tools for assessing and improving medication adherence, lifestyle, patient scheduling and retention, and collaboration with physicians. Intervention teams received specially designed tools, automatic BP monitors, and furniture for setting up and implementing a blood pressure clinic at their pharmacy. Staff from control pharmacies received printed information only and provided "usual care". Outcomes will be determined by blinded data collectors who will re-check patients' BPs and administer follow-up surveys after 6 and 12 months. Researchers also will survey pharmacy staff and review pharmacy records to determine changes in refill adherence and prescribing.

Study Timeline

• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Study Start: 2006-12
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-18
• Last Update Posted: 2014-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 576

Inclusion Criteria

is African American and 18 years old or older; has active prescription for BP drug; obtains all BP drugs at the study pharmacy; is able to read and fill out short questionnaires; is able to come to pharmacy for 6 monthly pharmacy visits if needed; has screening BP between 140/90 mm Hg and 210/115 mm Hg.

Exclusion Criteria

history of organ transplant or kidney dialysis, symptoms of advanced congestive heart failure, memory impairment that interferes with daily functioning,terminal illness,pregnancy, alcohol or substance abuse problem,physician recommendation of exclusion for other condition that may require special care or limit participation in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TEAM Care	Pharmacy TEAM monitoring and counseling	Intervention pharmacies implement 6-month TEAM program.

Primary Outcome Measures

Name	Time	Method
Proportion of patients achieving hypertension control	6 months after enrollment
change in systolic and diastolic blood pressure	6 months after enrollment

Secondary Outcome Measures

Name	Time	Method
patient adherence to drug regimen	6 months after enrollment
pharmacist adherence to TEAM protocol (intervention fidelity)	6 months after enrollment
change in drug prescribing	6 months after enrollment
patient-reported barriers to adherence (e.g. bothersome side effects)	6 months after enrollment
cost-effectiveness of pharmacy intervention	6 months after intervention

Trial Locations

Locations (2)

University of Wisconsin School of Pharmacy; 🇺🇸 Madison, Wisconsin, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States