A Collaborative Model to Improve Blood Pressure (BP) Control and Minimize Racial Disparities - Full Text View

Sponsor:	University of Iowa
Information provided by (Responsible Party):	Barry L. Carter, University of Iowa
ClinicalTrials.gov Identifier:	NCT00935077

Purpose

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	Intervention	Phase
Hypertension Asthma	Other: PPCM Asthma Other: 24 Month PPCM BP Other: 9 Month PPCM HTN	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research
Official Title:	A Collaborative Model to Improve BP Control and Minimize Racial Disparities-CCC

Resource links provided by NLM:

MedlinePlus related topics: Asthma High Blood Pressure

U.S. FDA Resources

Further study details as provided by University of Iowa:

Primary Outcome Measures:

Blood Pressure Control [ Time Frame: 9 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Blood Pressure Control [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

Estimated Enrollment:	1134
Study Start Date:	January 2010
Estimated Study Completion Date:	February 2014
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 HTN 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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00935077

Contacts

Contact: Barry L. Carter, PharmD	319-335-8456	barry-carter@uiowa.edu
Contact: Gail Ardery, PhD	319-384-4128	gail-ardery@uiowa.edu

Locations

United States, California
University of California San Diego	Recruiting
San Diego, California, United States, 92093
Principal Investigator: Grace Kuo, PharmD
Sub-Investigator: Dustin Lillie, MD
Sub-Investigator: Nathan Painter, PharmD
Sub-Investigator: Sarah McBane, PharmD
Sub-Investigator: Carlos Rojas, MD
United States, Connecticut
St. Francis Hospital Medical Center	Recruiting
Hartford, Connecticut, United States, 06105
Principal Investigator: Eric Jackson, PharmD
Sub-Investigator: Alan Cementina, MD
United States, Florida
University of Florida	Recruiting
Gainesville, Florida, United States, 32601
Principal Investigator: Karen Hall, MD
Sub-Investigator: Steven Smith, PharmD
Sub-Investigator: Timothy Ives, PharmD
University of South Florida	Recruiting
Tampa, Florida, United States, 33612
Principal Investigator: Kevin Sneed, PharmD
Sub-Investigator: Glenn Whelan, PharmD
Sub-Investigator: Eduardo Gonzalez, MD
United States, Idaho
Idaho State University	Recruiting
Pocatello, Idaho, United States, 83209
Principal Investigator: Rex Force, PharmD
Sub-Investigator: John Holmes, PharmD
Sub-Investigator: Brandon Mickelsen, MD
United States, Iowa
Genesis Health System	Recruiting
Davenport, Iowa, United States, 52803
Principal Investigator: Andrew Andresen, MD
Sub-Investigator: Mark Jones, PharmD
Broadlawns Medical Center	Recruiting
Des Moines, Iowa, United States, 50314
Principal Investigator: Larry Severidt, MD
Sub-Investigator: CoraLynn Trewet, PharmD
The University of Iowa	Active, not recruiting
Iowa City, Iowa, United States, 52242-1112
Northeast Iowa Medical Education Foundation	Recruiting
Waterloo, Iowa, United States, 50702
Principal Investigator: James J. Poock, MD
Sub-Investigator: James Hoehns, PharmD
United States, Massachusetts
Cambridge Health Alliance	Recruiting
Cambridge, Massachusetts, United States, 02139
Principal Investigator: Greg Sawin, MD
Sub-Investigator: Jennifer Goldman-Levine, PharmD
United States, New York
SUNY-University of Buffalo	Recruiting
Buffalo, New York, United States, 14260
Principal Investigator: Vinod Patel, MD
Sub-Investigator: Angela Wisniewski, PharmD
Sub-Investigator: Jeanette Figueroa, MD
United States, North Carolina
University of North Carolina at Chapel Hill	Recruiting
Chapel Hill, North Carolina, United States, 27559
Principal Investigator: Tim Ives, PharmD
Sub-Investigator: Paul Chelminski, MD
Sub-Investigator: Rob Malone, PharmD
Duke University	Recruiting
Durham, North Carolina, United States, 27705
Principal Investigator: Philip Rodgers, PharmD
Sub-Investigator: Lynn Bowlby, MD
Wake Forest University Health Sciences	Recruiting
Winston-Salem, North Carolina, United States, 27157
Principal Investigator: Rebecca Edwards, PharmD
Sub-Investigator: Karen Oles, PharmD
Sub-Investigator: David Townsend, MD
United States, Pennsylvania
University of Pittsburgh	Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Principal Investigator: Roberta Farrah, PharmD
Sub-Investigator: Sandra Saureisen, MD
Sub-Investigator: Patricia Klatt, PharmD
United States, South Carolina
Medical University of South Carolina	Recruiting
Charleston, South Carolina, United States, 29425
Principal Investigator: Lori M. Dickerson, PharmD
Sub-Investigator: Kelly Ragucci, PharmD
Sub-Investigator: Eric Matheson, MD
Sub-Investigator: Sarah Shrader, PharmD
Sub-Investigator: Carek Peter, MD
Spartanburg Regional Health Service District	Recruiting
Spartanburg, South Carolina, United States, 29303
Principal Investigator: I.S. Simon, MD
Sub-Investigator: Adrienne Ables, PharmD
United States, Texas
Texas Tech University Health Science Center	Recruiting
Amarillo, Texas, United States, 79106
Principal Investigator: Eric MacLaughlin, PharmD
Sub-Investigator: Rodney Young, MD
Seton Healthcare	Recruiting
Austin, Texas, United States, 78701
Principal Investigator: Terrence Benold, MD
Sub-Investigator: Debra Lopez, PharmD
University of Texas at El Paso	Recruiting
El Paso, Texas, United States, 79968
Principal Investigator: Margie Perez-Padilla, PharmD
Principal Investigator: Jeri Sias, PharmD
Sub-Investigator: Marco Diaz, MD
Sub-Investigator: Jose Luna, MD
Memorial Hermann Hospital System	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Julie Adkison, PharmD
Sub-Investigator: Michael Crouch, MD
University of Texas Health Science Center at San Antonio	Recruiting
San Antonio, Texas, United States, 78229
Principal Investigator: Oralia Bazaldua, PharmD
Sub-Investigator: John Tovar, PharmD
Sub-Investigator: Ramin Pousani, MD
United States, Wisconsin
University of Wisconsin	Not yet recruiting
Madison, Wisconsin, United States, 53715
Principal Investigator: Louis Sanner, MD
Sub-Investigator: Carrie Stoltenberg, PharmD
Principal Investigator: Casey Gallimore, PharmD
Sub-Investigator: Connie Kraus, PharmD
Sub-Investigator: Beth Potter, MD
Wheaton Franciscan Medical Group	Recruiting
Milwaukee, Wisconsin, United States, 53210
Principal Investigator: Beth Musil, PharmD
Sub-Investigator: Jesse DeGroat, MD

Sponsors and Collaborators

University of Iowa

Investigators

Principal Investigator:

Barry L. Carter, PharmD

University of Iowa

More Information

No publications provided by University of Iowa

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Carter BL, Clarke W, Ardery G, Weber CA, James PA, Vander Weg M, Chrischilles EA, Vaughn T, Egan BM; Collaboration Among Pharmacists Physicians To Improve Outcomes Now (CAPTION) Trial Investigators. A cluster-randomized effectiveness trial of a physician-pharmacist collaborative model to improve blood pressure control. Circ Cardiovasc Qual Outcomes. 2010 Jul;3(4):418-23.

Responsible Party:	Barry L. Carter, Principal Investigator, University of Iowa
ClinicalTrials.gov Identifier:	NCT00935077 History of Changes
Other Study ID Numbers:	1 R01 HL091841
Study First Received:	July 6, 2009
Last Updated:	January 9, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Iowa:

Hypertension
Pharmacist Physician Collaborative Management of Hypertension

Additional relevant MeSH terms:

Asthma
Hypertension
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases

Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012