A Team Model of Hypertension Care in African Americans
December 18, 2014 updated by: University of Wisconsin, Madison
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
576
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
-
-
Wisconsin
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Madison, Wisconsin, United States, 53705
- University of Wisconsin School of Pharmacy
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Milwaukee, Wisconsin, United States
- Medical College of Wisconsin
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-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TEAM Care
Intervention pharmacies implement 6-month TEAM program.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Proportion of patients achieving hypertension control
Time Frame: 6 months after enrollment
|
6 months after enrollment
|
|
change in systolic and diastolic blood pressure
Time Frame: 6 months after enrollment
|
6 months after enrollment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
patient adherence to drug regimen
Time Frame: 6 months after enrollment
|
6 months after enrollment
|
|
pharmacist adherence to TEAM protocol (intervention fidelity)
Time Frame: 6 months after enrollment
|
6 months after enrollment
|
|
change in drug prescribing
Time Frame: 6 months after enrollment
|
6 months after enrollment
|
|
patient-reported barriers to adherence (e.g. bothersome side effects)
Time Frame: 6 months after enrollment
|
6 months after enrollment
|
|
cost-effectiveness of pharmacy intervention
Time Frame: 6 months after intervention
|
6 months after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Bonnie L Svarstad, PhD, University of Wisconsin, Madison
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Svarstad BL, Brown RL, Shireman TI. A successful intervention to improve medication adherence in Black patients with hypertension: Mediation analysis of 28-site TEAM trial. J Am Pharm Assoc (2003). 2022 May-Jun;62(3):800-808.e3. doi: 10.1016/j.japh.2022.01.002. Epub 2022 Jan 6.
- Shireman TI, Svarstad BL. Cost-effectiveness of Wisconsin TEAM model for improving adherence and hypertension control in black patients. J Am Pharm Assoc (2003). 2016 Jul-Aug;56(4):389-96. doi: 10.1016/j.japh.2016.03.002. Epub 2016 May 13.
- Svarstad BL, Kotchen JM, Shireman TI, Brown RL, Crawford SY, Mount JK, Palmer PA, Vivian EM, Wilson DA. Improving refill adherence and hypertension control in black patients: Wisconsin TEAM trial. J Am Pharm Assoc (2003). 2013 Sep-Oct;53(5):520-9. doi: 10.1331/JAPhA.2013.12246.
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
December 1, 2006
Primary Completion (Actual)
February 1, 2009
Study Completion (Actual)
February 1, 2009
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Estimate)
December 23, 2014
Last Update Submitted That Met QC Criteria
December 18, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- M-2000-0284
- NIH R01 HL78580
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