NCT00205153

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
576

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Dec 2006

Typical duration for not_applicable hypertension

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.2 years until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

December 23, 2014

Status Verified

December 1, 2014

Enrollment Period

2.2 years

First QC Date

September 13, 2005

Last Update Submit

December 18, 2014

Conditions

Hypertension

Keywords

hypertension in African Americans

Outcome Measures

Primary Outcomes (2)

  • Proportion of patients achieving hypertension control

    6 months after enrollment

  • change in systolic and diastolic blood pressure

    6 months after enrollment

Secondary Outcomes (5)

  • patient adherence to drug regimen

    6 months after enrollment

  • pharmacist adherence to TEAM protocol (intervention fidelity)

    6 months after enrollment

  • change in drug prescribing

    6 months after enrollment

  • patient-reported barriers to adherence (e.g. bothersome side effects)

    6 months after enrollment

  • cost-effectiveness of pharmacy intervention

    6 months after intervention

Study Arms (2)

TEAM Care

EXPERIMENTAL

Intervention pharmacies implement 6-month TEAM program.

Behavioral: Pharmacy TEAM monitoring and counseling

Usual Care

NO INTERVENTION

Control pharmacies provide "usual care" only.

Interventions

Pharmacy TEAM monitoring and counselingBEHAVIORAL

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.

TEAM Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Wisconsin School of Pharmacy

Madison, Wisconsin, 53705, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Location

Related Publications (3)

  • 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.

    PMID: 35120864DERIVED

  • 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.

    PMID: 27184784DERIVED

  • 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.

    PMID: 24030130DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Counseling

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Bonnie L Svarstad, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

December 1, 2006

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

December 23, 2014

Record last verified: 2014-12

Locations

US(2)