A Team Model of Hypertension Care in African Americans
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Team Model of Hypertension Care in African Americans|
- Proportion of patients achieving hypertension control [ Time Frame: 6 months after enrollment ] [ Designated as safety issue: No ]
- change in systolic and diastolic blood pressure [ Time Frame: 6 months after enrollment ] [ Designated as safety issue: No ]
- patient adherence to drug regimen [ Time Frame: 6 months after enrollment ] [ Designated as safety issue: No ]
- pharmacist adherence to TEAM protocol (intervention fidelity) [ Time Frame: 6 months after enrollment ] [ Designated as safety issue: No ]
- change in drug prescribing [ Time Frame: 6 months after enrollment ] [ Designated as safety issue: No ]
- patient-reported barriers to adherence (e.g. bothersome side effects) [ Time Frame: 6 months after enrollment ] [ Designated as safety issue: No ]
- cost-effectiveness of pharmacy intervention [ Time Frame: 6 months after intervention ] [ Designated as safety issue: No ]
|Study Start Date:||December 2006|
|Study Completion Date:||February 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
Experimental: TEAM Care
Intervention pharmacies implement 6-month TEAM program.
Behavioral: Pharmacy TEAM monitoring and counseling
Pharmacy team monitors and counsels patient using automatic BP monitors and special TEAM tools for assessing and improving patient adherence, barriers to adherence, lifestyle, drug therapy, BP control, and collaboration with physicians.
No Intervention: Usual Care
Control pharmacies provide "usual care" only.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00205153
|United States, Wisconsin|
|University of Wisconsin School of Pharmacy|
|Madison, Wisconsin, United States, 53705|
|Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States|
|Principal Investigator:||Bonnie L Svarstad, PhD||University of Wisconsin, Madison|