Design of a pragmatic randomized implementation effectiveness trial testing a health system wide hypertension program for older adults

Hypertension control remains poor. Multiple barriers at the level of patients, providers, and health systems interfere with implementation of hypertension guidelines and effective lowering of BP. Some strategies such as self-measured blood pressure (SMBP) and remote management by pharmacists are saf...

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Published in:	Contemporary clinical trials Vol. 138; p. 107466
Main Authors:	Gupta, Aditi, Chouhdry, Hira, Ellis, Shellie D., Young, Kate, Mahnken, Jonathan, Comfort, Branden, Shanks, Denton, McGreevy, Sheila, Rudy, Courtney, Zufer, Tahira, Mabry, Sharissa, Woodward, Jennifer, Wilson, Amber, Anderson, Heidi, Loucks, Jennifer, Chandaka, Sravani, Abu-el-rub, Noor, Mazzotti, Diego R., Song, Xing, Schmitz, Nolan, Conroy, Molly, Supiano, Mark A., Waitman, Lemuel R., Burns, Jeffrey M.
Format:	Journal Article
Language:	English
Published:	United States Elsevier Inc 01.03.2024
Subjects:	Aged Alzheimer's disease Blood Pressure Blood Pressure Determination Cardiovascular Delivery of Health Care Hematology, Oncology, and Palliative Medicine Humans Hypertension Hypertension - diagnosis Hypertension - therapy Implementation Medicare Remote patient monitoring SMBP United States United States Hypertension Alzheimer's disease Implementation Remote patient monitoring SMBP
ISSN:	1551-7144, 1559-2030, 1559-2030
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Abstract	Hypertension control remains poor. Multiple barriers at the level of patients, providers, and health systems interfere with implementation of hypertension guidelines and effective lowering of BP. Some strategies such as self-measured blood pressure (SMBP) and remote management by pharmacists are safe and effectively lower BP but have not been effectively implemented. In this study, we combine such evidence-based strategies to build a remote hypertension program and test its effectiveness and implementation in large health systems. This randomized, controlled, pragmatic type I hybrid implementation effectiveness trial will examine the virtual collaborative care clinic (vCCC), a hypertension program that integrates automated patient identification, SMBP, remote BP monitoring by trained health system pharmacists, and frequent patient-provider communication. We will randomize 1000 patients with uncontrolled hypertension from two large health systems in a 1:1 ratio to either vCCC or control (usual care with education) groups for a 2-year intervention. Outcome measures including BP measurements, cognitive function, and a symptom checklist will be completed during study visits. Other outcome measures of cardiovascular events, mortality, and health care utilization will be assessed using Medicare data. For the primary outcome of proportion achieving BP control (defined as systolic BP < 130 mmHg) in the two groups, we will use a generalized linear mixed model analysis. Implementation outcomes include acceptability and feasibility of the program. This study will guide implementation of a hypertension program within large health systems to effectively lower BP.
AbstractList	Hypertension control remains poor. Multiple barriers at the level of patients, providers, and health systems interfere with implementation of hypertension guidelines and effective lowering of BP. Some strategies such as self-measured blood pressure (SMBP) and remote management by pharmacists are safe and effectively lower BP but have not been effectively implemented. In this study, we combine such evidence-based strategies to build a remote hypertension program and test its effectiveness and implementation in large health systems. This randomized, controlled, pragmatic type I hybrid implementation effectiveness trial will examine the virtual collaborative care clinic (vCCC), a hypertension program that integrates automated patient identification, SMBP, remote BP monitoring by trained health system pharmacists, and frequent patient-provider communication. We will randomize 1000 patients with uncontrolled hypertension from two large health systems in a 1:1 ratio to either vCCC or control (usual care with education) groups for a 2-year intervention. Outcome measures including BP measurements, cognitive function, and a symptom checklist will be completed during study visits. Other outcome measures of cardiovascular events, mortality, and health care utilization will be assessed using Medicare data. For the primary outcome of proportion achieving BP control (defined as systolic BP < 130 mmHg) in the two groups, we will use a generalized linear mixed model analysis. Implementation outcomes include acceptability and feasibility of the program. This study will guide implementation of a hypertension program within large health systems to effectively lower BP. AbstractHypertension control remains poor. Multiple barriers at the level of patients, providers, and health systems interfere with implementation of hypertension guidelines and effective lowering of BP. Some strategies such as self-measured blood pressure (SMBP) and remote management by pharmacists are safe and effectively lower BP but have not been effectively implemented. In this study, we combine such evidence-based strategies to build a remote hypertension program and test its effectiveness and implementation in large health systems. This randomized, controlled, pragmatic type I hybrid implementation effectiveness trial will examine the virtual collaborative care clinic (vCCC), a hypertension program that integrates automated patient identification, SMBP, remote BP monitoring by trained health system pharmacists, and frequent patient-provider communication. We will randomize 1000 patients with uncontrolled hypertension from two large health systems in a 1:1 ratio to either vCCC or control (usual care with education) groups for a 2-year intervention. Outcome measures including BP measurements, cognitive function, and a symptom checklist will be completed during study visits. Other outcome measures of cardiovascular events, mortality, and health care utilization will be assessed using Medicare data. For the primary outcome of proportion achieving BP control (defined as systolic BP < 130 mmHg) in the two groups, we will use a generalized linear mixed model analysis. Implementation outcomes include acceptability and feasibility of the program. This study will guide implementation of a hypertension program within large health systems to effectively lower BP. Hypertension control remains poor. Multiple barriers at the level of patients, providers, and health systems interfere with implementation of hypertension guidelines and effective lowering of BP. Some strategies such as self-measured blood pressure (SMBP) and remote management by pharmacists are safe and effectively lower BP but have not been effectively implemented. In this study, we combine such evidence-based strategies to build a remote hypertension program and test its effectiveness and implementation in large health systems. This randomized, controlled, pragmatic type I hybrid implementation effectiveness trial will examine the virtual collaborative care clinic (vCCC), a hypertension program that integrates automated patient identification, SMBP, remote BP monitoring by trained health system pharmacists, and frequent patient-provider communication. We will randomize 1000 patients with uncontrolled hypertension from two large health systems in a 1:1 ratio to either vCCC or control (usual care with education) groups for a 2-year intervention. Outcome measures including BP measurements, cognitive function, and a symptom checklist will be completed during study visits. Other outcome measures of cardiovascular events, mortality, and health care utilization will be assessed using Medicare data. For the primary outcome of proportion achieving BP control (defined as systolic BP < 130 mmHg) in the two groups, we will use a generalized linear mixed model analysis. Implementation outcomes include acceptability and feasibility of the program. This study will guide implementation of a hypertension program within large health systems to effectively lower BP. Hypertension control remains poor. Multiple barriers at the level of patients, providers, and health systems interfere with implementation of hypertension guidelines and effective lowering of BP. Some strategies such as self-measured blood pressure (SMBP) and remote management by pharmacists are safe and effectively lower BP but have not been effectively implemented. In this study, we combine such evidence-based strategies to build a remote hypertension program and test its effectiveness and implementation in large health systems. This randomized, controlled, pragmatic type I hybrid implementation effectiveness trial will examine the virtual collaborative care clinic (vCCC), a hypertension program that integrates automated patient identification, SMBP, remote BP monitoring by trained health system pharmacists, and frequent patient-provider communication. We will randomize 1000 patients with uncontrolled hypertension from two large health systems in a 1:1 ratio to either vCCC or control (usual care with education) groups for a 2-year intervention. Outcome measures including BP measurements, cognitive function, and a symptom checklist will be completed during study visits. Other outcome measures of cardiovascular events, mortality, and health care utilization will be assessed using Medicare data. For the primary outcome of proportion achieving BP control (defined as systolic BP < 130 mmHg) in the two groups, we will use a generalized linear mixed model analysis. Implementation outcomes include acceptability and feasibility of the program. This study will guide implementation of a hypertension program within large health systems to effectively lower BP.Hypertension control remains poor. Multiple barriers at the level of patients, providers, and health systems interfere with implementation of hypertension guidelines and effective lowering of BP. Some strategies such as self-measured blood pressure (SMBP) and remote management by pharmacists are safe and effectively lower BP but have not been effectively implemented. In this study, we combine such evidence-based strategies to build a remote hypertension program and test its effectiveness and implementation in large health systems. This randomized, controlled, pragmatic type I hybrid implementation effectiveness trial will examine the virtual collaborative care clinic (vCCC), a hypertension program that integrates automated patient identification, SMBP, remote BP monitoring by trained health system pharmacists, and frequent patient-provider communication. We will randomize 1000 patients with uncontrolled hypertension from two large health systems in a 1:1 ratio to either vCCC or control (usual care with education) groups for a 2-year intervention. Outcome measures including BP measurements, cognitive function, and a symptom checklist will be completed during study visits. Other outcome measures of cardiovascular events, mortality, and health care utilization will be assessed using Medicare data. For the primary outcome of proportion achieving BP control (defined as systolic BP < 130 mmHg) in the two groups, we will use a generalized linear mixed model analysis. Implementation outcomes include acceptability and feasibility of the program. This study will guide implementation of a hypertension program within large health systems to effectively lower BP.
ArticleNumber	107466
Author	Abu-el-rub, Noor Burns, Jeffrey M. Mahnken, Jonathan Chouhdry, Hira Zufer, Tahira Gupta, Aditi Wilson, Amber Ellis, Shellie D. Conroy, Molly Shanks, Denton Young, Kate Supiano, Mark A. Woodward, Jennifer Anderson, Heidi Song, Xing Waitman, Lemuel R. Loucks, Jennifer Schmitz, Nolan McGreevy, Sheila Chandaka, Sravani Mazzotti, Diego R. Rudy, Courtney Mabry, Sharissa Comfort, Branden
AuthorAffiliation	9 Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, University of Kansas Medical Center, Kansas City, KS 7 Department of Pharmacy, University of Kansas Health System, Kansas City, KS, United States 5 Division of General Internal Medicine, Department of Internal Medicine, University of Kansas Medical Center, Kansas City, KS, United States 10 Department of Biomedical Informatics, Biostatistics, and Medical Epidemiology, University of Missouri, Columbia, MO, United States 2 Department of Neurology, University of Kansas Medical Center, Kansas City, KS, United States 8 Division of Medical Informatics, Department of Internal Medicine, University of Kansas Medical Center, Kansas City, KS, United States 4 Department of Biostatistics and Data Science, University of Kansas Medical Center, Kansas City, KS, United States 12 Geriatrics Division, Department of Internal Medicine, University of Utah Spencer Fox Eccles School of Medicine and Center on Aging, University
AuthorAffiliation_xml	– name: 4 Department of Biostatistics and Data Science, University of Kansas Medical Center, Kansas City, KS, United States – name: 8 Division of Medical Informatics, Department of Internal Medicine, University of Kansas Medical Center, Kansas City, KS, United States – name: 9 Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, University of Kansas Medical Center, Kansas City, KS – name: 5 Division of General Internal Medicine, Department of Internal Medicine, University of Kansas Medical Center, Kansas City, KS, United States – name: 10 Department of Biomedical Informatics, Biostatistics, and Medical Epidemiology, University of Missouri, Columbia, MO, United States – name: 11 Division of General Internal Medicine, Department of Internal Medicine, University of Utah Spencer Fox Eccles School of Medicine, University of Utah, Salt Lake City, UT, United States – name: 2 Department of Neurology, University of Kansas Medical Center, Kansas City, KS, United States – name: 6 Department of Family Medicine, University of Kansas Medical Center, Kansas City, KS, United States – name: 7 Department of Pharmacy, University of Kansas Health System, Kansas City, KS, United States – name: 12 Geriatrics Division, Department of Internal Medicine, University of Utah Spencer Fox Eccles School of Medicine and Center on Aging, University of Utah, Salt Lake City, UT, United States – name: 1 Division of Nephrology and Hypertension, Department of Internal Medicine, University of Kansas Medical Center, Kansas City, KS, United States – name: 3 Department of Population Health, University of Kansas Medical Center, Kansas City, KS, United States
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Jeffrey M. organization: Department of Neurology, University of Kansas Medical Center, Kansas City, KS, United States
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Keywords	Hypertension Alzheimer's disease Implementation Remote patient monitoring SMBP
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Notes	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3 Hira Chouhdry: Wrote the first draft of the manuscript. Jennifer Loucks and Nolan Schmitz: Critically reviewed the protocol and manuscript with focus on the intervention. Lemuel R Waitman and Jeffrey M Burns: Secured funding and critically reviewed the protocol and manuscript. Branden Comfort, Denton Shanks, Sheila McGreevy, Courtney Rudy, Tahira Zufer, Sharissa Mabry, Jennifer Woodward: Critically reviewed the protocol and manuscript. Amber Wilson, Heidi Anderson: Drafted the protocol and critically reviewed the manuscript. Sravani Chandaka, Noor Abu-el-rub, Diego R Mazzotti, Xing Song: Critically reviewed the protocol and manuscript with focus on data collection, management, and analysis. Molly Conroy and Mark A. Supiano: Critically reviewed the protocol and manuscript. Kate Young and Jonathan Mahnken: Drafted the statistical analysis sections of the manuscript. Author contributions Aditi Gupta: Secured funding and drafted the protocol and manuscript. Shellie D Ellis: Drafted implementation sections and critically reviewed the manuscript.
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Snippet	Hypertension control remains poor. Multiple barriers at the level of patients, providers, and health systems interfere with implementation of hypertension... AbstractHypertension control remains poor. Multiple barriers at the level of patients, providers, and health systems interfere with implementation of...
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SubjectTerms	Aged Alzheimer's disease Blood Pressure Blood Pressure Determination Cardiovascular Delivery of Health Care Hematology, Oncology, and Palliative Medicine Humans Hypertension Hypertension - diagnosis Hypertension - therapy Implementation Medicare Remote patient monitoring SMBP United States
Title	Design of a pragmatic randomized implementation effectiveness trial testing a health system wide hypertension program for older adults
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