Improving Adherence to Blood Pressure Guidelines

November 30, 2015 updated by: University of Iowa
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

623

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa College of Pharmacy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Active intervention participants receive a physician-pharmacist collaborative intervention.
Behavioral: Physician-pharmacist collaborative intervention
Participants receive assessment and medication and lifestyle recommendations from a clinical pharmacist.
No Intervention: 2
Control participants do not receive recommendations from a clinical pharmacist.
No Intervention: 3
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adherence to hypertension guidelines
Time Frame: Measured for two 6 month periods: the first is prior to the participant's enrollment in the study and the second is while the participant is enrolled in the study
Measured for two 6 month periods: the first is prior to the participant's enrollment in the study and the second is while the participant is enrolled in the study

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood pressure control
Time Frame: Measured at baseline, 3 months, and 6 months
Measured at baseline, 3 months, and 6 months
Physician knowledge
Time Frame: Measured prior to the start of the study and at the end of the study
Measured prior to the start of the study and at the end of the study
Patient medication adherence
Time Frame: Measured at the time of enrollment and when the participant completes the study
Measured at the time of enrollment and when the participant completes the study
Physician-pharmacist relationship
Time Frame: Measured prior to the start of the study and at the end of the study
Measured prior to the start of the study and at the end of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Iowa

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Barry L. Carter, PharmD, University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 272
  • R01HL070740 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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