Improving Adherence to Blood Pressure Guidelines

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by National Heart, Lung, and Blood Institute (NHLBI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00201019
First received: September 12, 2005
Last updated: November 5, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention Phase
Hypertension
Behavioral: Physician-pharmacist collaborative intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improving Adherence to Blood Pressure Guidelines

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood pressure control [ Time Frame: Measured at baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
  • Physician knowledge [ Time Frame: Measured prior to the start of the study and at the end of the study ] [ Designated as safety issue: No ]
  • Patient medication adherence [ Time Frame: Measured at the time of enrollment and when the participant completes the study ] [ Designated as safety issue: No ]
  • Physician-pharmacist relationship [ Time Frame: Measured prior to the start of the study and at the end of the study ] [ Designated as safety issue: No ]

Enrollment: 623
Study Start Date: August 2003
Estimated Study Completion Date: July 2009
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00201019

Locations
United States, Iowa
University of Iowa College of Pharmacy
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Investigators
Principal Investigator: Barry L. Carter, PharmD University of Iowa
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Barry L. Carter, PharmD, The University of Iowa
ClinicalTrials.gov Identifier: NCT00201019     History of Changes
Other Study ID Numbers: 272, R01 HL70740
Study First Received: September 12, 2005
Last Updated: November 5, 2009
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014