A Team Model of Hypertension Care in African Americans

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University of Wisconsin, Madison.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00205153
First received: September 13, 2005
Last updated: February 5, 2009
Last verified: February 2009

September 13, 2005
February 5, 2009
October 2007
December 2009   (final data collection date for primary outcome measure)
  • 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 ]
the cost-effectiveness of an organizational-level intervention in treating hypertensive African Americans in Milwaukee and Chicago
Complete list of historical versions of study NCT00205153 on ClinicalTrials.gov Archive Site
  • 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 ]
how did the intervention affect the process of care (including pharmacists behavior, patient-reported barriers, prescribed regimens, patient adherence)
Not Provided
Not Provided
 
A Team Model of Hypertension Care in African Americans
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Hypertension
  • 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.
  • Other: Usual care with printed information only
    Pharmacy staff, patients, and physicians receive printed information only. Patients receive "usual care" from pharmacy staff.
  • Experimental: TEAM Care
    Intervention pharmacies implement 6-month TEAM program.
    Intervention: Behavioral: Pharmacy TEAM monitoring and counseling
  • No Intervention: Usual Care
    Control pharmacies provide "usual care" only.
    Intervention: Other: Usual care with printed information only
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
600
December 2009
December 2009   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00205153
M-2000-0284, NIH R01 HL78580
Yes
Bonnie L. Svarstad, Ph.D., University of Wisconsin - Madison, School of Pharmacy
University of Wisconsin, Madison
National Institutes of Health (NIH)
Principal Investigator: Bonnie L Svarstad, PhD University of Wisconsin, Madison
University of Wisconsin, Madison
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP