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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00935077
• Other study ID #: 1R01HL091841
• Status: Completed
• Phase: Phase 3
• First received: July 6, 2009
• Last updated: July 9, 2014
• Start date: January 2010
• Est. completion date: March 2014

Study information

• Verified date: July 2014
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1441
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Asthma
• Hypertension

Intervention

Other:
• PPCM Asthma
Pharmacists collaborate with physicians to manage asthma
• 24 Month PPCM BP
Pharmacists collaborate with physicians for 24 months to manage hypertension.
• 9 Month PPCM BP
Pharmacists collaborate with pharmacists for 9 months to manage hypertension

Locations

Country	Name	City	State
United States	Texas Tech University Health Science Center	Amarillo	Texas
United States	Seton Healthcare	Austin	Texas
United States	SUNY-University of Buffalo	Buffalo	New York
United States	Cambridge Health Alliance	Cambridge	Massachusetts
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Genesis Health System	Davenport	Iowa
United States	Broadlawns Medical Center	Des Moines	Iowa
United States	Midwestern University	Downers Grove	Illinois
United States	Duke University	Durham	North Carolina
United States	University of Texas at El Paso	El Paso	Texas
United States	University of Florida	Gainesville	Florida
United States	St. Francis Hospital Medical Center	Hartford	Connecticut
United States	Memorial Hermann Hospital System	Houston	Texas
United States	The University of Iowa	Iowa City	Iowa
United States	University of Wisconsin	Madison	Wisconsin
United States	Wheaton Franciscan Medical Group	Milwaukee	Wisconsin
United States	Temple University	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Idaho State University	Pocatello	Idaho
United States	University of Utah	Salt Lake City	Utah
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	University of California San Diego	San Diego	California
United States	Siouxland Medical Education Foundation	Sioux City	Iowa
United States	Spartanburg Regional Health Service District	Spartanburg	South Carolina
United States	University of South Florida	Tampa	Florida
United States	Northeast Iowa Medical Education Foundation	Waterloo	Iowa
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure Control		9 Months	No
Secondary	Blood Pressure Control		24 Months	No