Skilled Nursing Facility at Home Trial

Обзор

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.

Вмешательства

• Другое Sub-Acute Rehab at Home
  Patients randomized to the intervention group will receive skilled nursing and rehabilitative care at home upon discharge from the hospital, or when eligible for skilled-nursing facility care when requiring a step up in services at home. Home care will be delivered and overseen by a multidisciplinary clinical team, which will develop individualized care plans based on diagnosis, specific rehabilitation objectives, and broader goals of care.

Первичные конечные точки

• 30-Day Readmission and Mortality [Срок оценки: From time of enrollment to 30 days after enrollment]

Вторичные конечные точки (6)

• 90- and 180- day Readmission and Mortality [Срок оценки: From time of enrollment, up to 6 months post-enrollment]
• Days Alive [Срок оценки: From time of enrollment, up to 6 months post-enrollment]
• Activities of Daily Living [Срок оценки: From time of enrollment, up to 6 months post-enrollment]
• Healthcare Costs [Срок оценки: From time of enrollment, up to 6 months post-enrollment]
• Mortality rate [Срок оценки: From time of enrollment to 6 months post-enrollment]
• Length of stay [Срок оценки: From time of enrollment, up to 6 months post-enrollment]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

США · 2 центра

• Baystate Medical Center — Springfield
• UMass Memorial Medical Center — Worcester

Идентификаторы

NCT: NCT06547645 · STUDY00001862

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗