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和肺康复（PR）均得到改善 功能，生活质量，并降低再入院率。尽管这两个计划的功效已得到证实，但它们都 严重利用不足，只有不到20%的合格人员参加。心肺患者 生活在农村社区的艾滋病患者的参与率甚至更低。 本提案的目的是检验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 生活在农村的年老体弱的成年人。TAU是指基于中心的康复（CBR）。SC模型 包括最初入组CBR，然后根据预先规定的 无反应标准：1）交通补贴CBR，2）家庭远程康复（TR），和3） 社区卫生工作者-（CHW）支持以家庭为基础的TR。与传统的SC模型不同， 在这个模型中，即CBR，不是最不资源密集的。CBR被选为初始选项，因为它 目前被认为是护理标准。 我们将进行一项平行、2组、随机对照可行性试验。合格受试者将被随机分组 由于迫切需要解决农村地区CR和PR使用不足的问题， 一项拟议的可行性试验将招募CR或PR患者。两组均包括亲自摄入 由康复中心的认证康复护士进行评估，以确定运动 并设计一个量身定制的8周康复计划。随机分配至TAU的患者参加两项 每周在该中心进行一次会议，并鼓励在会议期间在家锻炼。患者 随机分配至SC组的患者也将入组CBR项目。那些满足预先指定的非- 响应标准将提高到交通补贴的社区康复。提供交通可能不是 对于不愿在冬天离开家、不熟悉锻炼的体弱老年人来说， 我不想在一个团体中锻炼。因此，无应答者将被提升到家庭TR。 家庭康复将得到Chanl Health的支持，Chanl Health是一个支持教育和 自我管理、远程监控和康复专家的指导。无应答者将 升级到CHW支持的家庭式TR。CHW将帮助参与者使用移动的应用程序， 教育材料，澄清教育内容，并在每两周一次的亲自访问中进行锻炼。 如果可行性试验成功，我们将进行平行、2组、单盲、多中心 在老年患者中比较SC与TAU（CBR）的有效性和价值（成本-效果）的优效性RCT 生活在乡村的体弱多病的成年人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年老体弱成年人对CR和PR的吸收的证据。