Cisco G. Espinosa , Sasha Vergez , Margaret V. McDonald , Monika M. Safford , Jacklyn Cho , Jonathan N. Tobin , Omar Mourad , Rosa Marcus , Joanna Joanna Bryan Ringel , Samprit Banerjee , Nicola Dell , Penny Feldman , Madeline R. Sterling
{"title":"Leveraging home health aides to improve outcomes in heart failure: A pilot study protocol","authors":"Cisco G. Espinosa , Sasha Vergez , Margaret V. McDonald , Monika M. Safford , Jacklyn Cho , Jonathan N. Tobin , Omar Mourad , Rosa Marcus , Joanna Joanna Bryan Ringel , Samprit Banerjee , Nicola Dell , Penny Feldman , Madeline R. Sterling","doi":"10.1016/j.cct.2024.107570","DOIUrl":null,"url":null,"abstract":"<div><p>Heart failure (HF) affects six million people in the U.S., is associated with high morbidity, mortality, and healthcare utilization.<sup>(1, 2)</sup> Despite a decade of innovation, the majority of interventions aimed at reducing hospitalization and readmissions in HF have not been successful.<sup>(3–7)</sup> One reason may be that most have overlooked the role of home health aides and attendants (HHAs), who are often highly involved in HF care.<sup>(8–13)</sup> Despite their contributions, studies have found that HHAs lack specific HF training and have difficulty reaching their nursing supervisors when they need urgent help with their patients. Here we describe the protocol for a pilot randomized control trial (pRCT) assessing a novel stakeholder-engaged intervention that provides HHAs with a) HF training (enhanced usual care arm) and b) HF training plus a mobile health application that allows them to chat with a nurse in real-time (intervention arm). In collaboration with the VNS Health of New York, NY, we will conduct a single-site parallel arm pRCT with 104 participants (HHAs) to evaluate the feasibility, acceptability, and effectiveness (primary outcomes: HF knowledge; HF caregiving self-efficacy) of the intervention among HHAs caring for HF patients. We hypothesize that educating and better integrating HHAs into the care team can improve their ability to provide support for patients and outcomes for HF patients as well (exploratory outcomes include hospitalization, emergency department visits, and readmission). This study offers a novel and potentially scalable way to leverage the HHA workforce and improve the outcomes of the patients for whom they care.</p><p>Clinical <span>trial.gov</span><svg><path></path></svg> registration: <span>NCT04239911</span><svg><path></path></svg></p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.0000,"publicationDate":"2024-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary clinical trials","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1551714424001538","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
引用次数: 0
Abstract
Heart failure (HF) affects six million people in the U.S., is associated with high morbidity, mortality, and healthcare utilization.(1, 2) Despite a decade of innovation, the majority of interventions aimed at reducing hospitalization and readmissions in HF have not been successful.(3–7) One reason may be that most have overlooked the role of home health aides and attendants (HHAs), who are often highly involved in HF care.(8–13) Despite their contributions, studies have found that HHAs lack specific HF training and have difficulty reaching their nursing supervisors when they need urgent help with their patients. Here we describe the protocol for a pilot randomized control trial (pRCT) assessing a novel stakeholder-engaged intervention that provides HHAs with a) HF training (enhanced usual care arm) and b) HF training plus a mobile health application that allows them to chat with a nurse in real-time (intervention arm). In collaboration with the VNS Health of New York, NY, we will conduct a single-site parallel arm pRCT with 104 participants (HHAs) to evaluate the feasibility, acceptability, and effectiveness (primary outcomes: HF knowledge; HF caregiving self-efficacy) of the intervention among HHAs caring for HF patients. We hypothesize that educating and better integrating HHAs into the care team can improve their ability to provide support for patients and outcomes for HF patients as well (exploratory outcomes include hospitalization, emergency department visits, and readmission). This study offers a novel and potentially scalable way to leverage the HHA workforce and improve the outcomes of the patients for whom they care.
期刊介绍:
Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.