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

抽象的。心力衰竭在美国影响着620万人，每年造成300亿美元的损失， 结果每年有100万人住院。25%的医疗保险患者在30天内再次入院 受益人因心力衰竭住院，以前减少再入院的干预措施收效甚微。 减少再入院和改善心衰预后的最有希望的策略之一是通过家庭 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 在急性后时期进行探视，以监测和管理病人。每年，34%的医疗保险受益人 因心衰住院接受HHC治疗。我们先前由AHRQ资助的国家、观察性、相对有效性 研究(R01HS020257)发现，心力衰竭患者30天再住院率降低8%(相对为40% 减少)，当他们接受两种循证做法时：a)早期和密集的HHC护士就诊(定义 在出院后2天内首次到医院护理中心就诊，共就诊3次或以上 第一周)和b)出院第一周内的门诊就诊，与那些这样做的人相比 没有得到这一及时的跟进。然而，在全国范围内，只有12%的医疗保险受益人提前领取了 访问协议，这是一个重大的实施差距。为了推动科学进步，改善心力衰竭的治疗结果， 我们将测试一种名为改善家庭心力衰竭患者的过渡和结果的干预措施 卫生保健(I-Transfer-HF)，包括早期和密集的HHC护士就诊和门诊就诊 在出院后7天内。使用混合类型1，阶梯楔形随机试验设计，我们将测试 I-Transfer-HF与4个地理位置不同的联手的有效性和实施 美国各地的医院和HHC机构(“医院-HHC机构”)。目标1将测试以下各项的有效性 I-Transfer-HF减少30天再入院(主要结果)和急诊室就诊(次要结果)和 与接受及时随访的心力衰竭患者相比，他们在家中的天数增加(次要结果) 照常照看。医院-HHC机构DYAD将被随机从无基线时期交叉 干预要在不同的时间点进行干预。每个DYAD的Medicare索赔数据将用于 确定结果；这些数据将得到国家索赔数据的补充，这些数据不在 试验，加权以产生协变量平衡。假设将用广义混合模型进行检验。目标2 将使用多方法方法和指导来评估I-Transfer-HF实施的决定因素 执行研究综合框架(CFIR)。将进行定性访谈 与整个医院的关键利益相关者-HHC机构DYAD一起评估可接受性、障碍和促进者 实施情况；将使用医疗保险索赔数据评估可行性和流程措施。作为第一个 HHC在心力衰竭中的实用试验，这项研究有可能极大地改善心力衰竭的护理和预后 并为HHC在全国的传播和实施提供新的见解。

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.