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

September 12, 2005
March 26, 2014
July 2003
Not Provided
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 ]
Not Provided
Complete list of historical versions of study NCT00201045 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Team Management of High Blood Pressure
Collaborative Management of Hypertension

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
Other: Physician/Pharmacist Collaborative Teams
The patient's physician collaborates with a clinical pharmacist to improve management of hypertension
  • Experimental: Intervention
    Intervention patients receive care from a clinical pharmacist to improve blood pressure.
    Intervention: Other: Physician/Pharmacist Collaborative Teams
  • No Intervention: Control
    Control patients receive usual care and do not have a clinical pharmacist included in their care.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
179
October 2006
Not Provided

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
Both
21 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00201045
271, R01HL069801, R01 HL69801
Yes
Barry L. Carter, The University of Iowa
University of Iowa
National Heart, Lung, and Blood Institute (NHLBI)
Study Chair: Barry L. Carter University of Iowa
University of Iowa
December 2007

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