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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| Vydáno v: | Contemporary clinical trials Ročník 138; s. 107466 |
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| Hlavní autoři: | , , , , , , , , , , , , , , , , , , , , , , , |
| Médium: | Journal Article |
| Jazyk: | angličtina |
| Vydáno: |
United States
Elsevier Inc
01.03.2024
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| Témata: | |
| ISSN: | 1551-7144, 1559-2030, 1559-2030 |
| On-line přístup: | Získat plný text |
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| 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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| Bibliografie: | 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. |
| ISSN: | 1551-7144 1559-2030 1559-2030 |
| DOI: | 10.1016/j.cct.2024.107466 |