Stepped care versus center-based cardiopulmonary rehabilitation for older frail adults living in rural MA

针对生活在马萨诸塞州农村地区的老年体弱患者的分级护理与中心心肺康复

• 批准号: 10370454
• 负责人: Liana Fraenkel
• 金额: $ 16.27万
• 依托单位: BAYSTATE MEDICAL CENTER, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-15 至 2025-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10370454
• 关键词: Address; Adherence; Cardiac rehabilitation; Cardiopulmonary rehabilitation; Caring; Community Health Aides; County; Education; Educational Materials; Enrollment; Evaluation; Event; Exercise; Exercise Tolerance; Frail Elderly; Goals; Health; Heart Diseases; Home; Hospitals; Intake; Intervention; Lung diseases; Massachusetts; Measures; Modeling; Outcome; Participant; Patients; Persons; Process; Quality of life; Randomized; Randomized Controlled Trials; Rehabilitation Centers; Rehabilitation Nursing; Rehabilitation therapy; Research; Resource-limited setting; Resources; Rural; Rural Community; Self Management; Single-Blind Study; Site; Specialist; System; Technology; Training; Transportation; Visit; Work; arm; base; compare effectiveness; cost effectiveness; design; eligible participant; feasibility testing; feasibility trial; improved; improved functioning; individual patient; mobile application; mortality; patient oriented; programs; pulmonary rehabilitation; readmission rates; remote monitoring; rural area; rural counties; standard of care; telerehabilitation; treatment as usual; trial comparing; uptake; virtual platform

Project Summary Cardiac rehabilitation (CR) decreases mortality and both CR and pulmonary rehabilitation (PR) improve function, quality of life, and decrease readmission rates. Despite their proven efficacy, both programs are grossly underutilized, with fewer than 20% of eligible persons participating. Patients with heart and lung disease living in rural communities have even lower rates of participation. The objective of this proposal is to test the feasibility of performing a full-scale randomized controlled trial (RCT) to compare the effectiveness and value of a stepped care (SC) model versus treatment as usual (TAU) in older frail adults living rural counties. TAU refers to center-based rehabilitation (CBR). The SC model includes initial enrollment into CBR followed by possible step up to three interventions based on prespecified non-response criteria: 1) Transportation-subsidized CBR, 2) Home-based telerehabilitation (TR), and 3) Community health worker-(CHW) supported home-based TR. Unlike traditional SC models, the initial treatment in this model, i.e. CBR, is not the least resource intensive. CBR was chosen as the initial option because it is currently considered the standard of care. We will conduct a parallel, 2-arm, randomized controlled feasibility trial. Eligible participants will be randomized to TAU (CBR) or SC. Because of the urgent need to address underuse of both CR and PR in rural regions, the proposed feasibility trial will enroll patients referred to either CR or PR. Both arms include an in-person intake evaluation conducted by a certified rehabilitation nurse in the rehabilitation center to determine exercise tolerance and design a tailored 8-week rehabilitation program. Patients randomized to TAU participate in two weekly sessions at the center and are encouraged to exercise at home in between sessions. Patients randomized to the SC arm will also be enrolled in the CBR program. Those who meet prespecified non- response criteria will be stepped up to transportation-subsidized CBR. Providing transportation may not be sufficient for frail older adults who are reluctant to leave their homes in the winter, unfamiliar with exercising, or do not want to exercise in a group setting. Thus, non-responders, will be stepped up to home-based TR. Home-based rehabilitation will be supported by Chanl Health, a virtual platform that supports education and self-management, remote monitoring, and coaching by rehabilitation specialists. Non-responders will be stepped up to CHW-supported home-based TR. The CHW will be help participants use the mobile app, access educational materials, clarify educational content, and exercise during biweekly in-person visits. If the feasibility trial is successful, we will proceed to conduct a parallel, 2-arm, single blind, multi-site superiority RCT to compare the effectiveness and value (cost-effectiveness) of SC versus TAU (CBR) in older frail adults living rural counties. Our long-term objective is to provide hospital systems with high quality evidence on how best to optimize uptake of CR and PR for older frail adults living in rural communities.

项目摘要 心脏康复（CR）降低了死亡率，CR和肺部康复（PR）改善 功能，生活质量和降低再入院率。尽管它们有证实的功效，但两个程序都是 严重未充分利用，只有不到20％的合格人员参加。心脏和肺的患者 生活在农村社区的疾病甚至更低。 该建议的目的是测试执行全尺度随机对照试验的可行性 （RCT）比较阶梯护理（SC）模型与往常治疗的有效性和价值（TAU） 在年龄较大的脆弱的成年人中，居住在农村县。 TAU指的是基于中心的康复（CBR）。 SC模型 包括初始入学到CBR，然后根据预先指定的最多三分干预措施进行三项干预措施 无响应标准：1）运输补贴的CBR，2）基于家庭的远离居民（TR）和3） 社区卫生工作者（CHW）支持基于家庭的TR。与传统的SC模型不同，初始处理 在此模型中，即CBR并不是最少的资源密集型。选择CBR作为初始选项，因为它是 目前被认为是护理标准。 我们将进行一项平行的2臂，随机对照的可行性试验。合格的参与者将被随机分配 到tau（CBR）或sc。由于迫切需要解决农村地区CR和PR的不足，所以 拟议的可行性试验将招募参考CR或PR的患者。两臂都包括面对面的摄入量 由康复中心认证的康复护士进行的评估以确定锻炼 容忍和设计量身定制的8周康复计划。随机tau参与两个患者 中心每周会议，并鼓励在会议之间在家中锻炼身体。患者 随机分配到SC臂也将参加CBR计划。那些遇到预先指定的非 - 响应标准将加强到运输补贴的CBR。提供运输可能不是 足以让冬季不愿离开家的脆弱的老年人，不熟悉锻炼或 不想在小组环境中锻炼。因此，非反应者将加入基于家庭的TR。 基于家庭的康复将得到Chanl Health的支持，Chanl Health是一个支持教育和的虚拟平台 自我管理，远程监控和康复专家指导。非响应者将是 加入了CHW支持的家庭TR。 CHW将帮助参与者使用移动应用程序，访问 每两周面对面的访问期间，教育材料，澄清教育内容和运动。 如果可行性试验成功，我们将继续进行平行的2臂，单个盲，多站点 优势RCT比较旧的SC与TAU（CBR）的有效性和价值（成本效益） 脆弱的成年人居住农村县。我们的长期目标是提供高质量的医院系统 关于如何最好地优化居住在农村社区的老年人成年人的CR和PR的摄取的证据。