Overview

This trial is active, not recruiting.

Condition hypertension
Treatments pharmacy team monitoring and counseling, usual care with printed information only
Sponsor University of Wisconsin, Madison
Collaborator National Institutes of Health (NIH)
Start date October 2007
End date December 2009
Trial size 600 participants
Trial identifier NCT00205153, M-2000-0284, NIH R01 HL78580

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Intervention pharmacies implement 6-month TEAM program.
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)
Control pharmacies provide "usual care" only.
usual care with printed information only
Pharmacy staff, patients, and physicians receive printed information only. Patients receive "usual care" from pharmacy staff.

Primary Outcomes

Measure
Proportion of patients achieving hypertension control
time frame: 6 months after enrollment
change in systolic and diastolic blood pressure
time frame: 6 months after enrollment

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Team Model of Hypertension Care in African Americans
Principal investigator Bonnie L Svarstad, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.