Clinical trial NCT00205153: A Team Model of Hypertension Care in African Americans
Official title: A Team Model of Hypertension Care in African Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: hypertension in African Americans
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2005-09-20
Enrollment: 576
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients achieving hypertension control
timeFrame: 6 months after enrollment
measure: change in systolic and diastolic blood pressure
timeFrame: 6 months after enrollment
Secondary outcomes:
measure: patient adherence to drug regimen
timeFrame: 6 months after enrollment
measure: pharmacist adherence to TEAM protocol (intervention fidelity)
timeFrame: 6 months after enrollment
measure: change in drug prescribing
timeFrame: 6 months after enrollment
measure: patient-reported barriers to adherence (e.g. bothersome side effects)
timeFrame: 6 months after enrollment
measure: cost-effectiveness of pharmacy intervention
timeFrame: 6 months after intervention
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin School of Pharmacy
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Bonnie L Svarstad, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.