Team Management of High Blood Pressure

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00201045
First received: September 12, 2005
Last updated: March 26, 2014
Last verified: December 2007
  Purpose

The purpose of this study is to test whether blood pressure control can be improved by physician education and feedback provided through the development of physician/pharmacist collaborative teams.


Condition Intervention
Hypertension
Other: Physician/Pharmacist Collaborative Teams

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Collaborative Management of Hypertension

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Blood pressure control [ Time Frame: Measured by zero blood pressure measurements at baseline and 2, 4, 6, 8, and 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean number of antihypertensives [ Time Frame: Measured when each patient completed the study. ] [ Designated as safety issue: No ]
  • Side effect score [ Time Frame: Measured when each patient completed the study. ] [ Designated as safety issue: Yes ]
  • Physician knowledge [ Time Frame: Measured at the beginning and at the end of the study. ] [ Designated as safety issue: No ]

Enrollment: 179
Study Start Date: July 2003
Study Completion Date: October 2006
Arms Assigned Interventions
Experimental: Intervention
Intervention patients receive care from a clinical pharmacist to improve blood pressure.
Other: Physician/Pharmacist Collaborative Teams
The patient's physician collaborates with a clinical pharmacist to improve management of hypertension
No Intervention: Control
Control patients receive usual care and do not have a clinical pharmacist included in their care.

Detailed Description:

BACKGROUND:

The Healthy People 2010 target calls for controlled BP in 50% of the 50 million Americans with hypertension. BP is currently controlled in only 27% of the population. These population figures are in contrast to data from clinical trials (efficacy) in which BP has been controlled in 70 to 80% of study participants. Poor BP control exists in spite of six sets of guidelines generated over the last 30 years in the United States. While there are many causes for poor control, several studies have found that physicians are frequently satisfied with uncontrolled BPs. Numerous strategies exist to assist physicians with achieving better BP control, but a consistent, effective approach to solving the problem has not been found.

DESIGN NARRATIVE:

The objective of this study is to test whether BP control can be improved by physician education and feedback provided through the development of physician/pharmacist collaborative teams. The rationale for this proposal is generated from studies demonstrating that physician knowledge, quality of prescribing, and attainment of treatment goals can be improved when physicians collaborate with clinical pharmacists. Previous studies have suffered from insufficient sample size and controls and did not include a structured intervention. This study will address these gaps in knowledge by conducting a randomized, prospective study in 5 clinics (2 intervention and 3 control) with 27 physicians who care for 180 patients with uncontrolled BP. The structured intervention will involve clinical pharmacists who evaluate BP therapy and treatment strategies and make specific recommendations to the physician. Patients will be seen at baseline and at 2, 4, 6, 8, and 9 months, at which time random zero BP measurements will be performed. The specific aims of this study are (1) to determine if better BP control can be achieved by the use of physician/pharmacist teams that utilize physician education and feedback when compared to usual care, (2) to determine if improvements in BP control are related to an increase in physician knowledge of and adherence to BP guidelines when they are involved in physician/pharmacist teams, and (3) to determine if changes in BP control are associated with the level and scope of the physician/pharmacist relationships. This model utilizes an innovative system approach to improve BP control. This intervention has the potential to achieve marked improvements in BP control. This model could become one additional strategy to help achieve the BP goals for Healthy People 2010.

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females, age 21-85
  • Taking 0-3 antihypertensive medications with no changes in regimen or dose within the past 4 weeks
  • Non-diabetic with clinic BP 145-179 / 95-109 or diabetic with BP greater than 135/85

Exclusion Criteria:

  • Previous 24 hour BP monitoring consult service within the past 6 months
  • Stage 3 hypertension greater than 180/110
  • Recent MI or stroke within the past 6 months
  • Class III or IV congestive heart failure
  • Unstable angina
  • Uncontrolled atrial fibrillation
  • Serious renal disease (serum creatinine greater than 3.5)
  • Serious hepatic disease (total bilirubin greater than 3.0)
  • Pregnancy
  • Poor prognosis with less than a 3 year life expectancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00201045

Locations
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Investigators
Study Chair: Barry L. Carter University of Iowa
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Barry L. Carter, The University of Iowa
ClinicalTrials.gov Identifier: NCT00201045     History of Changes
Other Study ID Numbers: 271, R01HL069801, R01 HL69801
Study First Received: September 12, 2005
Last Updated: March 26, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Iowa:
Hypertension management
Pharmacist management
Physician pharmacist collaboration
Blood pressure control

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014