A Collaborative Model to Improve Blood Pressure (BP) Control and Minimize Racial Disparities

July 9, 2014 updated by: University of Iowa

A Collaborative Model to Improve BP Control and Minimize Racial Disparities-CCC

The purpose of the study is to determine the degree to which pharmacist-physician collaborative management (PPCM) of hypertension can be adopted and implemented in clinics with geographic and racial diversity and whether patients in clinics which implement PPCM achieve greater blood pressure control than patients in clinics which do not implement PPCM.

Primary Hypothesis: BP control at 9 months will be significantly greater in patients from clinics randomized to the two PPCM BP intervention groups compared to the control group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Blood pressure (BP) is controlled in only 34% of patients with high BP, leading to unnecessary strokes, myocardial infarctions and other cardiovascular events. BP control can be improved with physician/ pharmacist collaborative management (PPCM). Our long-range goal is to achieve excellent BP control rates using PPCM that can be implemented in private practices in diverse communities. The objective of this application is to conduct a large multi-center clinical trial in clinics with geographic, racial and ethnic diversity to determine the extent to which the model is implemented. This practice-based research network (PBRN) is unique with a large minority population and great diversity in operation and community size. This prospective, cluster-randomized trial uses 27 clinics, matched and randomized to the active intervention (2 groups) or a control group in 648 patients. Following 9 months of the intervention, one intervention group will continue the intervention following 9 months while the other will discontinue it. We will also randomize 18 patients per clinic into a passive observation group (n=486) to determine if PPCM is implemented more broadly in the clinic. Patients in all three groups will be followed for 24 months. We will accomplish our objectives and test our central hypothesis by pursing the following aims:

Aim 1: To determine if patients in clinics randomized to PPCM can achieve better BP control at 9 months compared to patients in clinics randomized to the control group.

Primary Hypothesis: BP control at 9 months will be significantly greater in patients from clinics randomized to the two PPCM BP intervention groups compared to the control group.

Aim 2: To determine if patients in clinics randomized to continuation of PPCM achieve better long-term BP control compared to patients in clinics randomized to discontinuation of PPCM after 9 months and to patients in control clinics.

Our innovative approach addresses critical organizational barriers and challenges existing approaches to achieving better BP control. This study is novel because it will: 1) be the largest study to test this model, 2) use a cluster randomized design to include many more clinics than previously used, 3) use a diverse group of clinics with broad geographic distribution, 4) include large numbers of patients from minority groups to assess potential health disparities, 5) evaluate whether the effect can be sustained long-term, 6) include standardized BP measurements rather than error-prone office BPs, 7) minimize selection bias, and 8) evaluate a "passive observation group" to evaluate dissemination of PPCM throughout the practice. We expect that our study will find a 6-8 mm Hg difference in systolic BP which would lead to 20-30% fewer coronary deaths and 25-40% fewer stroke deaths if applied across broadly across similar settings.

Study Type

Interventional

Enrollment (Actual)

1441

Phase

  • Phase 3

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
    • California
      • San Diego, California, United States, 92093
        • University of California San Diego
    • Connecticut
      • Hartford, Connecticut, United States, 06105
        • St. Francis Hospital Medical Center
    • Florida
      • Gainesville, Florida, United States, 32601
        • University of Florida
      • Tampa, Florida, United States, 33612
        • University of South Florida
    • Idaho
      • Pocatello, Idaho, United States, 83209
        • Idaho State University
    • Illinois
      • Downers Grove, Illinois, United States, 60515
        • Midwestern University
    • Iowa
      • Davenport, Iowa, United States, 52803
        • Genesis Health System
      • Des Moines, Iowa, United States, 50314
        • Broadlawns Medical Center
      • Iowa City, Iowa, United States, 52242-1112
        • The University of Iowa
      • Sioux City, Iowa, United States, 51104
        • Siouxland Medical Education Foundation
      • Waterloo, Iowa, United States, 50702
        • Northeast Iowa Medical Education Foundation
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02139
        • Cambridge Health Alliance
    • New York
      • Buffalo, New York, United States, 14260
        • SUNY-University of Buffalo
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27559
        • University of North Carolina at Chapel Hill
      • Durham, North Carolina, United States, 27705
        • Duke University
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Regional Health Service District
    • Texas
      • Amarillo, Texas, United States, 79106
        • Texas Tech University Health Science Center
      • Austin, Texas, United States, 78701
        • Seton Healthcare
      • El Paso, Texas, United States, 79968
        • University of Texas at El Paso
      • Houston, Texas, United States, 77030
        • Memorial Hermann Hospital System
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center at San Antonio
    • Utah
      • Salt Lake City, Utah, United States, 84112-5820
        • University of Utah
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • University of Wisconsin
      • Milwaukee, Wisconsin, United States, 53210
        • Wheaton Franciscan Medical Group

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. English or Spanish speaking males or females, over 18 years of age with a diagnosis of hypertension,
  2. have uncontrolled BP defined as > 140 mm Hg SBP or > 90 mm Hg DBP for patients with uncomplicated hypertension; or > 130 mm Hg SBP or > 80 mm Hg DBP for patients with diabetes or chronic kidney disease, and
  3. receive care from one of the participating clinics.

Exclusion Criteria:

  1. current signs of hypertensive emergency (acute angina, stroke, or renal failure;
  2. severe HTN (systolic BP >200 or diastolic BP > 114 mm Hg);
  3. history of MI, stroke, or unstable angina in the prior 6 months;
  4. systolic dysfunction with a LV ejection fraction < 35% documented by echocardiography, nuclear medicine study, or ventriculography;
  5. renal insufficiency, defined by a glomerular filtration rate less than 20 ml/min or previously documented proteinuria > 1 gram per day;
  6. significant hepatic disease, including prior diagnoses of cirrhosis, Hepatitis B or C infection, or laboratory abnormalities (serum ALT or AST > 2 times control or total bilirubin > 1.5 mg/dl) in the prior 6 months;
  7. pregnancy;
  8. diagnoses of pulmonary hypertension or sleep apnea (unless treated by continuous positive pressure ventilation);
  9. poor prognosis with a life expectancy estimated less than 2 years;
  10. residence in a nursing home or diagnosis of dementia; and
  11. inability to give informed consent or impaired cognitive function (defined as > 3 errors on the 10-item Pfeiffer Portable Mental Status Questionnaire, administered during study intake).

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 24 Month PPCM BP
A 24 month long physician/pharmacist collaborative intervention is implemented to manage hypertension
Other: 24 Month PPCM BP
Pharmacists collaborate with physicians for 24 months to manage hypertension.
Experimental: 9 Month PPCM BP
A 9 month long physician/pharmacist collaborative intervention is implemented to manage hypertension
Other: 9 Month PPCM BP
Pharmacists collaborate with pharmacists for 9 months to manage hypertension
Sham Comparator: PPCM Asthma
A 9 month long physician/pharmacist collaborative intervention is implemented to manage asthma
Other: PPCM Asthma
Pharmacists collaborate with physicians to manage asthma
No Intervention: BP Control Arm
No PPCM intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood Pressure Control
Time Frame: 9 Months
9 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood Pressure Control
Time Frame: 24 Months
24 Months

Collaborators and Investigators

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

Sponsor

University of Iowa

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

January 1, 2010

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

July 6, 2009

First Submitted That Met QC Criteria

July 7, 2009

First Posted (Estimate)

July 8, 2009

Study Record Updates

Last Update Posted (Estimate)

July 10, 2014

Last Update Submitted That Met QC Criteria

July 9, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01HL091841 (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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