Feasibility, Acceptability, and Preliminary Effectiveness of a Combined Digital Platform and Community Health Worker Intervention for Patients With Heart Failure: Pilot Randomized Controlled Trial.

Q2 Medicine
JMIR Cardio Pub Date : 2024-08-08 DOI:10.2196/59948
Jocelyn A Carter Carter, Natalia Swack, Eric Isselbacher, Karen Donelan, Anne Thorndike
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引用次数: 0

Abstract

Background: Heart failure (HF) is a burdensome condition and a leading cause of 30-day hospital readmissions in the United States. Clinical and social factors are key drivers of hospitalization. These 2 strategies, digital platforms and home-based social needs care, have shown preliminary effectiveness in improving adherence to clinical care plans and reducing acute care use in HF. Few studies, if any, have tested combining these 2 strategies in a single intervention.

Objective: This study aims to perform a pilot randomized controlled trial assessing the acceptability, feasibility, and preliminary effectiveness of a 30-day digitally-enabled community health worker (CHW) intervention in HF.

Methods: Adults hospitalized with a diagnosis of HF at an academic hospital were randomly assigned to receive digitally-enabled CHW care (intervention; digital platform +CHW) or CHW-enhanced usual care (control; CHW only) for 30 days after hospital discharge. Primary outcomes were feasibility (use of the platform) and acceptability (willingness to use the platform in the future). Secondary outcomes assessed preliminary effectiveness (30-day readmissions, emergency department visits, and missed clinic appointments).

Results: A total of 56 participants were randomized (control: n=31; intervention: n=25) and 47 participants (control: n=28; intervention: n=19) completed all trial activities. Intervention participants who completed trial activities wore the digital sensor on 78% of study days with mean use of 11.4 (SD 4.6) hours/day, completed symptom questionnaires on 75% of study days, used the blood pressure monitor 1.1 (SD 0.19) times/day, and used the digital weight scale 1 (SD 0.13) time/day. Of intervention participants, 100% responded very or somewhat true to the statement "If I have access to the [platform] moving forward, I will use it." Some (n=9, 47%) intervention participants indicated they required support to use the digital platform. A total of 19 (100%) intervention participants and 25 (89%) control participants had ≥5 CHW interactions during the 30-day study period. All intervention (n=19, 100%) and control (n=26, 93%) participants who completed trial activities indicated their CHW interactions were "very satisfying." In the full sample (N=56), fewer participants in the intervention group were readmitted 30 days after hospital discharge compared to the control group (n=3, 12% vs n=8, 26%; P=.12). Both arms had similar rates of missed clinic appointments and emergency department visits.

Conclusions: This pilot trial of a digitally-enabled CHW intervention for HF demonstrated feasibility, acceptability, and a clinically relevant reduction in 30-day readmissions among participants who received the intervention. Additional investigation is needed in a larger trial to determine the effect of this intervention on HF home management and clinical outcomes.

Trial registration: Clinicaltrials.gov NCT05130008; https://clinicaltrials.gov/study/NCT05130008.

International registered report identifier (irrid): RR2-10.2196/55687.

针对心力衰竭患者的数字平台与社区卫生工作人员联合干预措施的可行性、可接受性和初步效果:随机对照试验。
背景:在美国,心力衰竭(HF)是一种负担沉重的疾病,也是导致 30 天内再次入院的主要原因。临床和社会因素是导致患者住院的主要原因。数字平台和基于家庭的社会需求护理这两种策略在改善心力衰竭患者对临床护理计划的依从性和减少急症护理使用方面已显示出初步效果。很少有研究(如果有的话)对这两种策略在单一干预中的结合进行测试:进行一项试验性 RCT,评估对高血压进行为期 30 天的数字化 CHW 干预的可接受性、可行性和初步有效性:方法:在一家学术医院住院并诊断为高血压的成人被随机分配至出院后接受为期 30 天的数字化 CHW 护理(干预;数字化平台 + CHW)或 CHW 加强型常规护理(对照;仅 CHW)。主要结果是可行性(平台的使用)和可接受性(未来使用平台的意愿)。次要结果评估初步效果(30 天再入院率、急诊室就诊率和错过门诊时间):共有 56 名参与者被随机分配(31 名对照组;25 名干预组),47 名参与者(28 名对照组;19 名干预组)完成了所有试验活动。完成试验活动的干预参与者在 78.0% 的研究日佩戴了数字传感器,平均使用时间为 11.4 小时/天(SD=4.6),在 75% 的研究日填写了症状问卷,使用血压计 1.1 次/天(SD=0.19),使用数字体重秤 1 次/天(SD=0.13)。在干预参与者中,89.5% 的人对 "如果今后有机会使用[平台],我会使用 "这句话的回答为 "非常正确 "或 "比较正确"。九名(47.4%)干预参与者表示他们需要支持才能使用数字平台。在 30 天的研究期间,19 名干预参与者(100%)和 25 名对照参与者(89.3%)与保健工作者的互动次数≥5 次。所有完成试验活动的干预参与者(19 人 [100%])和对照参与者(26 人 [92.9%])都表示,他们与 CHW 的互动 "非常令人满意"。在全部样本(N=56)中,干预组与对照组相比,出院 30 天后再次入院的人数较少(3 [12%] vs 8 [25.8%];P= 0.12)。两组的错过门诊预约和急诊室就诊率相似:这项针对高血压的数字化社区保健员干预试点试验证明了其可行性和可接受性,并在接受干预的参与者中减少了 30 天再入院的临床相关性。需要在更大规模的试验中进行进一步调查,以确定该干预措施对高血压家庭管理和临床结果的影响:临床试验:Clinicaltrials.gov NCT05130008.国际注册报告:RR2-10.2196/55687。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
JMIR Cardio
JMIR Cardio Computer Science-Computer Science Applications
CiteScore
3.50
自引率
0.00%
发文量
25
审稿时长
12 weeks
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