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.

项目概要 心脏康复 (CR) 降低死亡率，CR 和肺康复 (PR) 均改善 功能、生活质量并降低再入院率。尽管这两个计划已被证明有效，但 严重未充分利用，符合资格的人员参与人数不足 20%。心肺患者 农村社区的疾病参与率甚至更低。 该提案的目的是测试进行全面随机对照试验的可行性 （RCT）比较分级护理（SC）模式与常规治疗（TAU）的有效性和价值 居住在农村县的年老体弱的成年人。 TAU 是指以中心为基础的康复（CBR）。 SC模型 包括最初加入 CBR，然后根据预先指定的情况逐步增加至三项干预措施 无答复标准：1) 交通补贴 CBR，2) 家庭远程康复 (TR)，以及 3) 社区卫生工作者 (CHW) 支持家庭 TR。与传统的 SC 模型不同，初始治疗 在这个模型中，即 CBR，并不是资源密集程度最低的。选择 CBR 作为初始选项是因为它 目前被认为是护理标准。 我们将进行一项平行、双臂、随机对照的可行性试验。符合资格的参与者将被随机分配 至 TAU (CBR) 或 SC。由于迫切需要解决农村地区 CR 和 PR 未充分利用的问题， 拟议的可行性试验将招募转至 CR 或 PR 的患者。两只手臂都包括亲自摄入 由康复中心的认证康复护士进行评估以确定运动量 耐受并设计量身定制的8周康复计划。随机接受 TAU 的患者参加两项 每周在该中心进行一次课程，并鼓励在课程间隙在家锻炼。患者 随机分配到 SC 组的患者也将参加 CBR 计划。那些符合预先指定的非 响应标准将升级为交通补贴 CBR。提供交通可能不 对于冬天不愿出门、不熟悉锻炼的体弱老年人，或 不想在集体环境中锻炼。因此，无应答者将被升级至家庭 TR。 Chanl Health 将支持家庭康复，Chanl Health 是一个支持教育和康复的虚拟平台。 自我管理、远程监控和康复专家的指导。无响应者将被 加强 CHW 支持的家庭 TR。 CHW 将帮助参与者使用移动应用程序、访问 教育材料，澄清教育内容，并在每两周一次的亲自访问期间进行练习。 如果可行性试验成功，我们将继续进行并行、2臂、单盲、多站点 优越性随机对照试验，比较 SC 与 TAU (CBR) 在老年人中的有效性和价值（成本效益） 居住在农村县的体弱成年人。我们的长期目标是为医院系统提供高质量 关于如何最好地优化农村社区老年体弱成年人对 CR 和 PR 的吸收的证据。