Skilled Nursing Facility at Home Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 650
- 试验地点
- 4
- 主要终点
- 30-Day Readmission and Mortality
研究概览
简要总结
Skilled Nursing Facility at Home is a multicenter randomized control trial that aims to evaluate a home-based model of providing post-acute care (PAC). We will enroll 650 hospitalized patients who require rehabilitation and/or skilled-nursing support upon discharge and randomly assign them to an intervention (home-based PAC) or control arm (facility-based PAC). Our design includes two different health systems in Massachusetts: Baystate Health and UMass Memorial Health. We will perform 1:1 randomization between the intervention and control arm using a permuted block design, with stratification by clinical site and payor group. The primary outcome of the trial will be the difference in hospital readmission and mortality rates from the time of enrollment to 30 days after enrollment. Secondary clinical, functional, and cost outcomes include length of stay in PAC, difference in health-related quality of life (HRQoL), and healthcare cost and utilization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •Admitted to an inpatient unit OR receiving home health and requiring an escalation to skilled-nursing facility care
- •Require post-acute care in a skilled nursing facility based on the clinical inpatient team's assessment (or, if the participant is coming from home, based on the home health team's assessment)
- •Pass the home readiness assessment
- •Reside within Greater Worcester or Greater Springfield
排除标准
- •Inability to return to a home residence where care can be provided
- •Inability for patient or their proxy to provide informed consent for the study
- •Requires long-term care
- •Requires palliative or hospice care
- •On active chemotherapy
- •Post-transplant surgery
- •Requires hemodialysis
- •Requires radiation therapy
- •Requires two-person assist or mechanical lift
- •Expresses unwillingness to be randomized to SNF OR SNF at Home care
- •Considered clinically inappropriate by SNF at Home clinical team
研究组 & 干预措施
Facility-based
Facility based post acute care at a skilled nursing facility, as is the standard care model.
Home-based
Home-based Post-Acute Care
干预措施: Sub-Acute Rehab at Home (Other)
结局指标
主要结局
30-Day Readmission and Mortality
时间窗: From time of enrollment to 30 days after enrollment
Hospital readmission rates and mortality rates between the intervention and control groups in the first 30 days after enrollment
次要结局
- 90- and 180- day Readmission and Mortality(From time of enrollment, up to 6 months post-enrollment)
- Mortality rate(From time of enrollment to 6 months post-enrollment)
- Days Alive(From time of enrollment, up to 6 months post-enrollment)
- Activities of Daily Living(From time of enrollment, up to 6 months post-enrollment)
- Healthcare Costs(From time of enrollment, up to 6 months post-enrollment)
- Length of stay(From time of enrollment, up to 6 months post-enrollment)
研究者
Apurv Soni
Assistant Professor
University of Massachusetts, Worcester