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Improving Adherence to Blood Pressure Guidelines

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00201019
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : December 2, 2015
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Iowa

Brief Summary:
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 or disease Intervention/treatment Phase
Hypertension Behavioral: Physician-pharmacist collaborative intervention Not Applicable

Detailed Description:


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.


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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 623 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Adherence to Blood Pressure Guidelines
Study Start Date : August 2003
Actual Primary Completion Date : April 2008
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Blood pressure control [ Time Frame: Measured at baseline, 3 months, and 6 months ]
  2. Physician knowledge [ Time Frame: Measured prior to the start of the study and at the end of the study ]
  3. Patient medication adherence [ Time Frame: Measured at the time of enrollment and when the participant completes the study ]
  4. Physician-pharmacist relationship [ Time Frame: Measured prior to the start of the study and at the end of the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00201019

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United States, Iowa
University of Iowa College of Pharmacy
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Barry L. Carter, PharmD University of Iowa
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Iowa Identifier: NCT00201019    
Other Study ID Numbers: 272
R01HL070740 ( U.S. NIH Grant/Contract )
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases