A Collaborative Model to Improve Blood Pressure (BP) Control and Minimize Racial Disparities
- Conditions
- HypertensionAsthma
- Interventions
- Other: PPCM AsthmaOther: 9 Month PPCM BPOther: 24 Month PPCM BP
- Registration Number
- NCT00935077
- Lead Sponsor
- University of Iowa
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1441
- English or Spanish speaking males or females, over 18 years of age with a diagnosis of hypertension,
- 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
- receive care from one of the participating clinics.
- current signs of hypertensive emergency (acute angina, stroke, or renal failure;
- severe HTN (systolic BP >200 or diastolic BP > 114 mm Hg);
- history of MI, stroke, or unstable angina in the prior 6 months;
- systolic dysfunction with a LV ejection fraction < 35% documented by echocardiography, nuclear medicine study, or ventriculography;
- renal insufficiency, defined by a glomerular filtration rate less than 20 ml/min or previously documented proteinuria > 1 gram per day;
- 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;
- pregnancy;
- diagnoses of pulmonary hypertension or sleep apnea (unless treated by continuous positive pressure ventilation);
- poor prognosis with a life expectancy estimated less than 2 years;
- residence in a nursing home or diagnosis of dementia; and
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PPCM Asthma PPCM Asthma A 9 month long physician/pharmacist collaborative intervention is implemented to manage asthma 9 Month PPCM BP 9 Month PPCM BP A 9 month long physician/pharmacist collaborative intervention is implemented to manage hypertension 24 Month PPCM BP 24 Month PPCM BP A 24 month long physician/pharmacist collaborative intervention is implemented to manage hypertension
- Primary Outcome Measures
Name Time Method Blood Pressure Control 9 Months
- Secondary Outcome Measures
Name Time Method Blood Pressure Control 24 Months
Trial Locations
- Locations (28)
University of Florida
๐บ๐ธGainesville, Florida, United States
University of South Florida
๐บ๐ธTampa, Florida, United States
Siouxland Medical Education Foundation
๐บ๐ธSioux City, Iowa, United States
Temple University
๐บ๐ธPhiladelphia, Pennsylvania, United States
St. Francis Hospital Medical Center
๐บ๐ธHartford, Connecticut, United States
University of California San Diego
๐บ๐ธSan Diego, California, United States
SUNY-University of Buffalo
๐บ๐ธBuffalo, New York, United States
Northeast Iowa Medical Education Foundation
๐บ๐ธWaterloo, Iowa, United States
University of North Carolina at Chapel Hill
๐บ๐ธChapel Hill, North Carolina, United States
Spartanburg Regional Health Service District
๐บ๐ธSpartanburg, South Carolina, United States
Memorial Hermann Hospital System
๐บ๐ธHouston, Texas, United States
Medical University of South Carolina
๐บ๐ธCharleston, South Carolina, United States
Texas Tech University Health Science Center
๐บ๐ธAmarillo, Texas, United States
University of Texas at El Paso
๐บ๐ธEl Paso, Texas, United States
Seton Healthcare
๐บ๐ธAustin, Texas, United States
The University of Iowa
๐บ๐ธIowa City, Iowa, United States
Broadlawns Medical Center
๐บ๐ธDes Moines, Iowa, United States
University of Pittsburgh
๐บ๐ธPittsburgh, Pennsylvania, United States
University of Texas Health Science Center at San Antonio
๐บ๐ธSan Antonio, Texas, United States
University of Wisconsin
๐บ๐ธMadison, Wisconsin, United States
Wheaton Franciscan Medical Group
๐บ๐ธMilwaukee, Wisconsin, United States
Idaho State University
๐บ๐ธPocatello, Idaho, United States
Genesis Health System
๐บ๐ธDavenport, Iowa, United States
Cambridge Health Alliance
๐บ๐ธCambridge, Massachusetts, United States
University of Utah
๐บ๐ธSalt Lake City, Utah, United States
Duke University
๐บ๐ธDurham, North Carolina, United States
Wake Forest University Health Sciences
๐บ๐ธWinston-Salem, North Carolina, United States
Midwestern University
๐บ๐ธDowners Grove, Illinois, United States