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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 24 Month PPCM BP | Experimental | A 24 month long physician/pharmacist collaborative intervention is implemented to manage hypertension |
|
| 9 Month PPCM BP | Experimental | A 9 month long physician/pharmacist collaborative intervention is implemented to manage hypertension |
|
| PPCM Asthma | Sham Comparator | A 9 month long physician/pharmacist collaborative intervention is implemented to manage asthma |
|
| BP Control Arm | No Intervention | No PPCM intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PPCM Asthma | Other | Pharmacists collaborate with physicians to manage asthma |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure Control | 9 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure Control | 24 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barry L. Carter, PharmD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | San Diego | California | 92093 | United States | ||
| St. Francis Hospital Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29331037 | Derived | 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. | |
| 27600181 | Derived | 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. |
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| 24 Month PPCM BP |
| Other |
Pharmacists collaborate with physicians for 24 months to manage hypertension. |
|
| 9 Month PPCM BP | Other | Pharmacists collaborate with pharmacists for 9 months to manage hypertension |
|
| 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 |
| 26931738 | Derived | 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. |
| 26893135 | Derived | 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. |
| 25805647 | Derived | 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. |
| 23730989 | Derived | 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. |
| 23506651 | Derived | 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. |
| 20647575 | Derived | 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. |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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