Improving Adherence to Blood Pressure Guidelines

University of Iowa

Status: Completed

Conditions: Hypertension

Treatments: Behavioral: Physician-pharmacist collaborative intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00201019

272

R01HL070740 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to evaluate the impact of physician/pharmacist collaborative teams on hypertension guideline adherence for patients with uncontrolled hypertension in six family medicine practice sites in Iowa.

Full description

BACKGROUND:

Hypertension is a prevalent chronic condition that, if left untreated, can lead to significant cardiovascular morbidity and premature mortality. There are established, evidence-based guidelines for the treatment of hypertension. However, these guidelines are not routinely adhered to by all providers for reasons that are not well known or understood. In addition, inadequate control of BP nationwide has been well documented. This study will explore barriers to guideline adherence (Phase I) and evaluate, via a randomized controlled trial, a new approach to enhancing guideline adherence and ultimately BP control.

DESIGN NARRATIVE:

The long-range goal of the principal investigator is to develop and evaluate collaborative relationships between physicians and pharmacists that improve pharmacotherapy. This will be a 5-year, multicenter study to evaluate the impact of physician/pharmacist collaborative teams on adherence to hypertension guidelines (JNC-VI) in six community-based family practice sites. There will be two study phases. Phase I comprises a needs assessment to identify barriers to guideline adherence and design intervention implementation refinement strategies. Phase II will be a prospective, randomized trial to assess the impact of physician/pharmacist collaborative teams on hypertension guideline adherence and BP control. The specific aims of Phase I are (1) to identify the scope and nature of physician and patient variables that may contribute to poor guideline adherence and (2) to refine the intervention implementation strategy and design tools for assessing guideline adherence and barriers to adherence. The specific aims of Phase II are (1) to determine if there is a change in guideline adherence and knowledge of hypertension when physicians are involved in physician/pharmacist teams and 2) to determine if physician/pharmacist teams can achieve better BP control compared to usual care. The investigators expect that the improvement in guideline adherence and reduction in BP with this intervention will significantly impact patients with hypertension. Because there are more than 37 million Americans with uncontrolled hypertension, this model has the potential to become an important strategy to help achieve the BP goals for Healthy People 2010.

Enrollment: 623 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Phase II:

• Poorly controlled blood pressure based on clinic blood pressures
• Males or females, over 21 years of age
• Taking zero to three BP medications with no change in the regimen or dose within the past 4 weeks
• Have established medical care at the Family Medicine Clinic
• Nondiabetic patients with clinic BP values (average of the last three clinic readings during the previous 12 months) of 140 to 179 mm Hg systolic BP or 90 to 109 mm Hg diastolic BP, or diabetic patients with clinic BP values of 130 to 179 systolic or 80 to 109 diastolic

Exclusion Criteria for Phase II:

• Stage 3 hypertension (BPs greater than 180/110 mm Hg), or any evidence of hypertensive urgency or emergency
• Recent myocardial infarction or stroke (within the past 6 months prior to enrollment)
• New York Heart Association Class III or IV congestive heart failure
• Unstable angina
• Serious renal or hepatic disease, including greater than or equal to 1 gram of proteinuria per day
• Pregnancy
• Poor prognosis with a life expectancy estimated at less than 3 years
• Dementia or cognitive impairment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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623 participants in 3 patient groups

1

Experimental group

Description:

Active intervention participants receive a physician-pharmacist collaborative intervention.

Treatment:

Behavioral: Physician-pharmacist collaborative intervention

2

No Intervention group

Description:

Control participants do not receive recommendations from a clinical pharmacist.

3

No Intervention group

Description:

Passive intervention participants receive care by the same physicians caring for participants in the active intervention arm but are not seen by a clinical pharmacist. They are not actively enrolled in the study and do not have study visits for measuring blood pressure.