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

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ClinicalTrials.gov Identifier: NCT00935077
Recruitment Status : Completed
First Posted : July 8, 2009
Last Update Posted : July 10, 2014
Sponsor:
Information provided by (Responsible Party):
University of Iowa

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Hypertension Asthma Other: PPCM Asthma Other: 24 Month PPCM BP Other: 9 Month PPCM BP Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1441 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Collaborative Model to Improve BP Control and Minimize Racial Disparities-CCC
Study Start Date : January 2010
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Blood Pressure Control [ Time Frame: 9 Months ]

Secondary Outcome Measures :
  1. Blood Pressure Control [ Time Frame: 24 Months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00935077


Locations
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Sponsors and Collaborators
University of Iowa
Investigators
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Principal Investigator: Barry L. Carter, PharmD University of Iowa
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Iowa
ClinicalTrials.gov Identifier: NCT00935077    
Other Study ID Numbers: 1R01HL091841 ( U.S. NIH Grant/Contract )
First Posted: July 8, 2009    Key Record Dates
Last Update Posted: July 10, 2014
Last Verified: July 2014
Keywords provided by University of Iowa:
Hypertension
Pharmacist Physician Collaborative Management of Hypertension
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases