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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Vydané v:Contemporary clinical trials Ročník 138; s. 107466
Hlavní autori: 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.
Médium: Journal Article
Jazyk:English
Vydavateľské údaje: United States Elsevier Inc 01.03.2024
Predmet:
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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Popis
Shrnutí: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.
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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.
ISSN:1551-7144
1559-2030
1559-2030
DOI:10.1016/j.cct.2024.107466