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

NCT ID: NCT00935077

Last Updated: 2014-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1441 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2014-03-31

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.

Conditions

Hypertension; Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

24 Month PPCM BP

A 24 month long physician/pharmacist collaborative intervention is implemented to manage hypertension

Group Type: EXPERIMENTAL

24 Month PPCM BP

Intervention Type: OTHER

Pharmacists collaborate with physicians for 24 months to manage hypertension.

9 Month PPCM BP

A 9 month long physician/pharmacist collaborative intervention is implemented to manage hypertension

Group Type: EXPERIMENTAL

9 Month PPCM BP

Intervention Type: OTHER

Pharmacists collaborate with pharmacists for 9 months to manage hypertension

PPCM Asthma

A 9 month long physician/pharmacist collaborative intervention is implemented to manage asthma

Group Type: SHAM_COMPARATOR

PPCM Asthma

Intervention Type: OTHER

Pharmacists collaborate with physicians to manage asthma

BP Control Arm

No PPCM intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PPCM Asthma

Pharmacists collaborate with physicians to manage asthma

Intervention Type: OTHER

24 Month PPCM BP

Pharmacists collaborate with physicians for 24 months to manage hypertension.

Intervention Type: OTHER

9 Month PPCM BP

Pharmacists collaborate with pharmacists for 9 months to manage hypertension

Intervention Type: OTHER

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Iowa

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barry L. Carter, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of California San Diego

San Diego, California, United States

St. Francis Hospital Medical Center

Hartford, Connecticut, United States

University of Florida

Gainesville, Florida, United States

University of South Florida

Tampa, Florida, United States

Idaho State University

Pocatello, Idaho, United States

Midwestern University

Downers Grove, Illinois, United States

Genesis Health System

Davenport, Iowa, United States

Broadlawns Medical Center

Des Moines, Iowa, United States

The University of Iowa

Iowa City, Iowa, United States

Siouxland Medical Education Foundation

Sioux City, Iowa, United States

Northeast Iowa Medical Education Foundation

Waterloo, Iowa, United States

Cambridge Health Alliance

Cambridge, Massachusetts, United States

SUNY-University of Buffalo

Buffalo, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Duke University

Durham, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Temple University

Philadelphia, Pennsylvania, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Spartanburg Regional Health Service District

Spartanburg, South Carolina, United States

Texas Tech University Health Science Center

Amarillo, Texas, United States

Seton Healthcare

Austin, Texas, United States

University of Texas at El Paso

El Paso, Texas, United States

Memorial Hermann Hospital System

Houston, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

University of Utah

Salt Lake City, Utah, United States

University of Wisconsin

Madison, Wisconsin, United States

Wheaton Franciscan Medical Group

Milwaukee, Wisconsin, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29331037 (View on PubMed)

Anderegg 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.

Reference Type: DERIVED

PMID: 27600181 (View on PubMed)

Carter 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.

Reference Type: DERIVED

PMID: 26931738 (View on PubMed)

Isetts 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.

Reference Type: DERIVED

PMID: 26893135 (View on PubMed)

Carter 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.

Reference Type: DERIVED

PMID: 25805647 (View on PubMed)

Carter 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.

Reference Type: DERIVED

PMID: 23730989 (View on PubMed)

Demik 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.

Reference Type: DERIVED

PMID: 23506651 (View on PubMed)

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. doi: 10.1161/CIRCOUTCOMES.109.908038.

Reference Type: DERIVED

PMID: 20647575 (View on PubMed)

Other Identifiers

1R01HL091841

Identifier Type: NIH

Identifier Source: org_study_id

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