I-TRANSFER-HF: Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe: A Type 1 Hybrid Effectiveness Implementation Trial

I-TRANSFER-HF：改善家庭医疗保健中心力衰竭患者的过渡和结果：1 型混合有效性实施试验

• 批准号: 10714524
• 负责人: Madeline R Sterling
• 金额: $ 77.77万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-10 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10714524
• 关键词: Accountability; Acute; Adult; Affect; Ambulatory Care; Area; COVID-19; Care given by nurses; Caring; Certification; Chronic; Clinical; Cluster randomized trial; Complex; Consolidated Framework for Implementation Research; Data; Discipline of Nursing; Dissemination and Implementation; Effectiveness of Interventions; Elderly; Emergency department visit; Equilibrium; Evidence based intervention; Evidence based practice; Funding; Geography; Goals; Guidelines; Health; Health Care Costs; Healthcare Systems; Heart failure; Home; Home Care Services; Home Health Agency; Home Health Care Agencies; Home visitation; Hospitalization; Hospitals; Hybrids; Intervention; Interview; Length of Stay; Medical; Medicare; Medicare claim; Methods; Modeling; Monitor; Morbidity - disease rate; National Heart, Lung, and Blood Institute; Observational Study; Outcome; Outpatients; Patients; Persons; Phase; Pragmatic clinical trial; Process; Process Measure; Protocols documentation; Randomized; Research Priority; Role; Sampling; Science; Symptoms; Telemedicine; Testing; Time; United States Agency for Healthcare Research and Quality; United States Centers for Medicare and Medicaid Services; Visit; Visiting Nurse; beneficiary; comparative effectiveness study; cost; effectiveness testing; effectiveness/implementation hybrid; effectiveness/implementation trial; evidence base; follow-up; high risk; hospital readmission; hybrid type 1 design; implementation facilitators; implementation science; improved; improved outcome; innovation; insight; mortality; novel; nursing skill; patient population; payment; pragmatic trial; primary outcome; programs; randomized trial; readmission rates; response; secondary outcome; success; treatment as usual; trial design; virtual

ABSTRACT. Heart failure (HF) affects 6.2 million people in the US, costs $30 billion dollars per year, and results in 1 million hospitalizations per year. Readmission within 30 days occurs in 25% of Medicare beneficiaries hospitalized for HF, and previous interventions to reduce readmissions have had limited success. One of the most promising strategies to reduce readmissions and improve outcomes in HF is through home health care (HHC), which is delivered by Medicare certified HHC agencies, and provides skilled nurse home visits to monitor and manage patients during the post-acute period. Annually, 34% of Medicare beneficiaries hospitalized for HF receive HHC. Our prior AHRQ-funded national, observational, comparative effectiveness study (R01HS020257) found that HF patients had an 8% lower 30-day readmission rate (40% relative reduction) when they received two evidence-based practices: a) early and intensive HHC nurse visits (defined as a first HHC nursing visit within 2 days of hospital discharge with a total of three or more nursing visits within the first week) and b) an outpatient medical visit within the first week of discharge, compared to those who did not receive this timely follow-up. However, nationwide, only 12% of Medicare beneficiaries receive this early visit protocol, representing a major implementation gap. To advance the science and improve outcomes in HF, we will test an intervention called Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF), comprised of early and intensive HHC nurse visits and an outpatient visit within 7 days of discharge. Using a Hybrid Type 1, stepped wedge randomized trial design, we will test the effectiveness and implementation of I-TRANSFER-HF in partnership with 4 geographically diverse dyads of hospitals and HHC agencies (“hospital-HHC agency” dyads) across the US. Aim 1 will test the effectiveness of I-TRANSFER-HF to reduce 30-day readmissions (primary outcome) and ED visits (secondary outcome) and increase days at home (secondary outcome) among HF patients who receive timely follow-up compared to usual care. Hospital-HHC agency dyads will be randomized to cross over from a baseline period of no intervention to the intervention at different points in time. Medicare claims data from each dyad will be used to ascertain outcomes; these data will be supplemented with national claims data for external controls not in the trial, weighted to produce covariate balance. Hypotheses will be tested with generalized mixed models. Aim 2 will assess the determinants of I-TRANSFER-HF’s implementation using a multi-method approach and guided by the Consolidated Framework for Implementation Research (CFIR). Qualitative interviews will be conducted with key stakeholders across the hospital-HHC agency dyads to assess acceptability, barriers, and facilitators of implementation; feasibility and process measures will be assessed with Medicare claims data. As the first pragmatic trial of HHC in HF, this study has the potential to dramatically improve care and outcomes for HF patients and produce novel insights for the dissemination and implementation of HHC nationally.

抽象的。心力衰竭（HF）在美国影响620万人，每年耗资300亿美元，并且 每年导致100万个住院。 30天内的再入院发生在Medicare的25％ 受益人住院的HF，以前减少再入院的干预措施的成功有限。 减少再入院并改善HF的最有前途的策略之一是通过家 由Medicare认证的HHC机构提供的医疗保健（HHC），并提供熟练的护士家庭 在急性后访问以监测和管理患者。每年34％的医疗保险受益人 住院HF接受HHC。我们以前由AHRQ资助的国家，观察性，比较效力 研究（R01HS020257）发现，HF患者的30天再入院率降低了8％（相对40％ 减少）当他们获得两种基于证据的做法时：a）早期而密集的HHC护士访问（定义 作为HHC护士在出院后的2天内访问，总共三个或更多的护士访问 第一个星期）和b）在出院第一周内进行门诊医疗访问，与那些这样做的人相比 没有收到这种及时的后续行动。但是，在全国范围内，只有12％的医疗保险受益人早早接受 访问协议，代表一个主要的实施差距。为了推进科学并改善HF的成果， 我们将测试一项称为改善家庭心力衰竭患者的改善过渡和结果的干预措施 医疗保健（I-Transfer-HF），由早期和密集的HHC护士访问和门诊就诊 在出院后的7天内。使用1型混合动力车，阶梯楔随机试验设计，我们将测试 I-Transfer-HF的有效性和实施与4个地理上不同的二元组合作 整个美国的医院和HHC机构（“医院HHC机构”二元组）。 AIM 1将测试 I-Transfer-HF减少30天的再入院（主要结果）和ED访问（次要结果）和 与接受及时随访的HF患者相比 通常的护理。医院HHC机构二元组将随机从基准期开始越过 干预不同时间点的干预措施。 Medicare索赔的数据将用于 确定结果；这些数据将补充国家索赔数据的外部控制数据 试验，加权以产生协变量平衡。假设将通过广义混合模型进行测试。目标2 将使用多方法方法评估I-Transfer-HF实施的确定因素，并指导 由合并实施研究框架（CFIR）。定性访谈将进行 在医院HHC代理机构中，主要利益相关者二元组评估可接受性，障碍和促进者 实施；可行性和过程措施将通过Medicare索赔数据进行评估。作为第一个 HHC在HF中的务实试验，这项研究有可能显着改善HF的护理和结果 患者并产生新的见解，以全国HHC的传播和实施。