Team Management of High Blood Pressure

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Collaborative Management of Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Other: Physician/Pharmacist Collaborative Teams


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Intervention patients receive care from a clinical pharmacist to improve blood pressure. | Other: Physician/Pharmacist Collaborative Teams<br>* The patient's physician collaborates with a clinical pharmacist to improve management of hypertension<br>|
| No Intervention: Control<br>Control patients receive usual care and do not have a clinical pharmacist included in their care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure control |  | Measured by zero blood pressure measurements at baseline and 2, 4, 6, 8, and 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean number of antihypertensives |  | Measured when each patient completed the study. | 
| Side effect score |  | Measured when each patient completed the study. | 
| Physician knowledge |  | Measured at the beginning and at the end of the study. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension management, Pharmacist management, Physician pharmacist collaboration, Blood pressure control