A Collaborative Model to Improve Blood Pressure (BP) Control and Minimize Racial Disparities
1 other identifier
interventional
1,441
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hypertension
Started Jan 2010
Longer than P75 for phase_3 hypertension
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2009
CompletedFirst Posted
Study publicly available on registry
July 8, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedJuly 10, 2014
July 1, 2014
4.2 years
July 6, 2009
July 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood Pressure Control
9 Months
Secondary Outcomes (1)
Blood Pressure Control
24 Months
Study Arms (4)
24 Month PPCM BP
EXPERIMENTALA 24 month long physician/pharmacist collaborative intervention is implemented to manage hypertension
9 Month PPCM BP
EXPERIMENTALA 9 month long physician/pharmacist collaborative intervention is implemented to manage hypertension
PPCM Asthma
SHAM COMPARATORA 9 month long physician/pharmacist collaborative intervention is implemented to manage asthma
BP Control Arm
NO INTERVENTIONNo PPCM intervention
Interventions
Pharmacists collaborate with physicians for 24 months to manage hypertension.
Pharmacists collaborate with pharmacists for 9 months to manage hypertension
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
University of California San Diego
San Diego, California, 92093, United States
St. Francis Hospital Medical Center
Hartford, Connecticut, 06105, United States
University of Florida
Gainesville, Florida, 32601, United States
University of South Florida
Tampa, Florida, 33612, United States
Idaho State University
Pocatello, Idaho, 83209, United States
Midwestern University
Downers Grove, Illinois, 60515, United States
Genesis Health System
Davenport, Iowa, 52803, United States
Broadlawns Medical Center
Des Moines, Iowa, 50314, United States
The University of Iowa
Iowa City, Iowa, 52242-1112, United States
Siouxland Medical Education Foundation
Sioux City, Iowa, 51104, United States
Northeast Iowa Medical Education Foundation
Waterloo, Iowa, 50702, United States
Cambridge Health Alliance
Cambridge, Massachusetts, 02139, United States
SUNY-University of Buffalo
Buffalo, New York, 14260, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27559, United States
Duke University
Durham, North Carolina, 27705, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Spartanburg Regional Health Service District
Spartanburg, South Carolina, 29303, United States
Texas Tech University Health Science Center
Amarillo, Texas, 79106, United States
Seton Healthcare
Austin, Texas, 78701, United States
University of Texas at El Paso
El Paso, Texas, 79968, United States
Memorial Hermann Hospital System
Houston, Texas, 77030, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
University of Utah
Salt Lake City, Utah, 84112-5820, United States
University of Wisconsin
Madison, Wisconsin, 53715, United States
Wheaton Franciscan Medical Group
Milwaukee, Wisconsin, 53210, United States
Related Publications (8)
Anderegg MD, Gums TH, Uribe L, MacLaughlin EJ, Hoehns J, Bazaldua OV, Ives TJ, Hahn DL, Coffey CS, Carter BL. Pharmacist Intervention for Blood Pressure Control in Patients with Diabetes and/or Chronic Kidney Disease. Pharmacotherapy. 2018 Mar;38(3):309-318. doi: 10.1002/phar.2083. Epub 2018 Feb 23.
PMID: 29331037DERIVEDAnderegg MD, Gums TH, Uribe L, Coffey CS, James PA, Carter BL. Physician-Pharmacist Collaborative Management: Narrowing the Socioeconomic Blood Pressure Gap. Hypertension. 2016 Nov;68(5):1314-1320. doi: 10.1161/HYPERTENSIONAHA.116.08043. Epub 2016 Sep 6.
PMID: 27600181DERIVEDCarter BL. Primary Care Physician-Pharmacist Collaborative Care Model: Strategies for Implementation. Pharmacotherapy. 2016 Apr;36(4):363-73. doi: 10.1002/phar.1732. Epub 2016 Apr 6.
PMID: 26931738DERIVEDIsetts BJ, Buffington DE, Carter BL, Smith M, Polgreen LA, James PA. Evaluation of Pharmacists' Work in a Physician-Pharmacist Collaborative Model for the Management of Hypertension. Pharmacotherapy. 2016 Apr;36(4):374-84. doi: 10.1002/phar.1727. Epub 2016 Mar 18.
PMID: 26893135DERIVEDCarter BL, Coffey CS, Ardery G, Uribe L, Ecklund D, James P, Egan B, Vander Weg M, Chrischilles E, Vaughn T. Cluster-randomized trial of a physician/pharmacist collaborative model to improve blood pressure control. Circ Cardiovasc Qual Outcomes. 2015 May;8(3):235-43. doi: 10.1161/CIRCOUTCOMES.114.001283. Epub 2015 Mar 24.
PMID: 25805647DERIVEDCarter BL, Coffey CS, Uribe L, James PA, Egan BM, Ardery G, Chrischilles EA, Ecklund D, Vander Weg M, Vaughn T; Collaboration Among Pharmacists and Physicians to Improve Outcomes Now (CAPTION) trial investigators. Similar blood pressure values across racial and economic groups: baseline data from a group randomized clinical trial. J Clin Hypertens (Greenwich). 2013 Jun;15(6):404-12. doi: 10.1111/jch.12091. Epub 2013 Apr 1.
PMID: 23730989DERIVEDDemik DE, Vander Weg MW, Lundt ES, Coffey CS, Ardery G, Carter BL. Using theory to predict implementation of a physician-pharmacist collaborative intervention within a practice-based research network. Res Social Adm Pharm. 2013 Nov-Dec;9(6):719-30. doi: 10.1016/j.sapharm.2013.01.003. Epub 2013 Mar 16.
PMID: 23506651DERIVEDCarter 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. doi: 10.1161/CIRCOUTCOMES.109.908038.
PMID: 20647575DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barry L. Carter, PharmD
University of Iowa
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2009
First Posted
July 8, 2009
Study Start
January 1, 2010
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
July 10, 2014
Record last verified: 2014-07