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.

摘要：心力衰竭 (HF) 影响着美国 620 万人，每年造成 300 亿美元的损失，并且 每年导致 25% 的 Medicare 中有 100 万人在 30 天内再次入院。 受益人因心力衰竭住院，之前为减少再入院而采取的干预措施收效有限。 减少心力衰竭再入院和改善预后的最有前途的策略之一是通过家庭治疗 医疗保健 (HHC)，由 Medicare 认证的 HHC 机构提供，并提供熟练的护士之家 每年，34% 的医疗保险受益人都会在急性期后进行探访以监测和管理患者。 因心衰住院的患者接受 HHC 之前的 AHRQ 资助的国家观察性比较有效性。 研究（R01HS020257）发现心力衰竭患者的 30 天再入院率降低 8%（相对 40%） 当他们接受两种基于证据的做法时： a) 早期和密集的 HHC 护士就诊（定义 出院 2 天内首次 HHC 护理就诊，并且在出院后 2 天内总共进行了 3 次或以上护理就诊 与出院第一周内的门诊医疗就诊者相比 然而，在全国范围内，只有 12% 的 Medicare 受益人能够及早得到这种跟进。 访问协议，代表着重大差距的实施。 我们将测试一项名为“改善家庭心力衰竭患者的转变和结果”的干预措施 Health CaRe (I-TRANSFER-HF)，包括早期和密集的 HHC 护士就诊和门诊就诊 出院后 7 天内，我们将使用混合 1 型阶梯楔形随机试验设计进行测试。 I-TRANSFER-HF 与 4 个不同地域的伙伴合作的有效性和实施 美国各地的医院和 HHC 机构（“医院-HHC 机构”二元组）将测试目标 1 的有效性。 I-TRANSFER-HF 可减少 30 天再入院（主要结果）和急诊就诊（次要结果）以及 与接受及时随访的心力衰竭患者相比，在家中的天数增加（次要结果） 医院-HHC 机构二人组将随机从无基线期跨越。 每个二元组的医疗保险索赔数据将用于不同时间点的干预。 确定结果；这些数据将补充国家索赔数据，以用于外部控制 试验，加权以产生协变量平衡，将使用广义混合模型进行测试。 将使用多种方法和指导来评估 I-TRANSFER-HF 实施的决定因素 将根据实施研究综合框架（CFIR）进行定性访谈。 与医院-HHC 机构的主要利益相关者一起评估可接受性、障碍和促进因素 首先将使用医疗保险索赔数据来评估实施的可行性和流程措施。 HHC 治疗心力衰竭的实用试验，这项研究有可能显着改善心力衰竭的护理和结果 患者并为 HHC 在全国范围内的传播和实施提供新颖的见解。