Heart Diseases |
Cardiac Arrest; Cardiac Diseases; Endocarditis; Heart Disease; Heart Disease and the Mind-Body Constitution; Heart Disease, Congenital; Heart Diseases (General); Heart Diseases--Prevention; Heart Infection, Endocarditis |
Clinical Trial: Improving Adherence to Blood Pressure Guidelines
This study is not yet open for patient recruitment.
Verified by National Heart, Lung, and Blood Institute (NHLBI) September 2005
Purpose
| Condition | Intervention |
|---|---|
| Cardiovascular Diseases Heart Diseases Hypertension | Drug: antihypertensive drugs |
MedlinePlus related topics: Heart Diseases; High Blood Pressure; Vascular Diseases
Study Type: Interventional
Study Design: Treatment, Randomized
Study start: August 2003; Expected completion: July 2008
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 blood pressure nation-wide 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 blood pressure control.
DESIGN NARRATIVE:
The long-range goal of the principal investigator is to develop and evaluate collaborative relationships between physicians and pharmacists that improve pharmaco-therapy. This will be a five-year, multi-center, 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 blood pressure (BP) control. The specific aims of Phase I are to: 1) 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 to potential to become an important strategy to help achieve the BP goals for Healthy People 2010.
Eligibility
Patient Inclusion in Phase-II: Seven hundred twenty patients with poorly controlled blood pressure will be enrolled. Poor blood pressure control will be determined based on clinic blood pressures. Patients will be eligible for Phase-II if they are:
- males or females, over 21 years of age, and
- taking one to three BP medications with no change in the regimen or dose within the past four weeks,
- received care from the same Family Medicine physician for at least two consecutive visits, and
- nondiabetic patients with clinic BP values (average of the last three clinic readings during the previous 12 months) of between 145-179 mm Hg systolic BP or 95-109 mm Hg diastolic BP, or diabetic patients with clinic BP values between 135-179 systolic or 90-109 diastolic.
Patient Exclusion in Phase-II: Patients will be excluded from Phase-II if they have:
- stage 3 hypertension (BPs > 180/110 mm Hg), or any evidence of hypertensive urgency or emergency,
- had a 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 _>1gram of proteinuria per day,
- pregnancy,
- poor prognosis with a life expectancy estimated at less than 3 years, or
- dementia or cognitive impairment.
Location and Contact Information
Barry Carter, University of Iowa
More Information
Last Updated: September 19, 2005
Record first received: September 12, 2005
ClinicalTrials.gov Identifier: NCT00201019
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-20

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