NCT06416670进行中（未招募）不适用
Skilled Nursing Facility Care at Home: A Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 10
- 主要终点
- Change in activities of daily living between admission to rehab and discharge from rehab
研究概览
简要总结
We will perform a parallel-group multicenter patient-level randomized controlled evaluation of skilled nursing facility care at home. Patients typically referred to a skilled nursing facility following hospitalization will be eligible for enrollment. Instead of admission to a skilled nursing facility, participants will receive care from a technology-enabled team in their own homes or will be allocated to receive care in a traditional skilled nursing facility setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, 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
- •>=18 years old
- •Requires SNF PAC care following hospitalization, as determined by the inpatient team (requires documented rehabilitative therapy recommendation)
- •Community-dwelling before hospitalization
- •Likely to return to community-dwelling status following short-term rehabilitation as determined by RAH liaison
- •Lives within 10 miles of any study site hospital (or per specified catchment)
- •Surgical trauma and elective patients (weight bearing as tolerated and transfer with no more than one-person assist)
- •Neurology patients - Stroke (needs acute rehabilitation, but insurance will not cover, so bound for SNF. Does not meet acute rehabilitation criteria and does not need long-term placement)
排除标准
- •Environmental
- •Undomiciled
- •No working heat (October-April), no working air conditioning if forecast > 80°F, or no running water
- •In police custody
- •Resides in a facility that does not allow advanced on-site care
- •Domestic violence screen positive
- •Weapons that cannot be appropriately secured
- •Difficulty accessing the bathroom (unless there is space for a bedside commode where the patient sleeps or if the patient is entirely dependent on toileting)
- •Home has insufficient accessible space to sleep, eat, and perform rehabilitative therapy
- •Home lacks sufficient kitchen facilities to either cook or heat meals
- •Patient, or patient's family caregiver, unable to communicate via telephone
- •Patient, or patient's family caregiver, lacks consistent access to a telephone
- •Requires more than one assist (unless the family can provide additional 24/7 assistance)
- •Requires care of new ostomy or teaching ostomy care
- •Requires frequent suctioning, tracheostomy, and ventilator needs
- •Requires total parenteral nutrition
- •Requires nasogastric tube feeds
- •Requires durable medical equipment not already in place at home and excluded below
- •Requires daily subcutaneous injection unless patient or family caregiver is teachable and able to administer daily
- •Acute delirium noted by RAH liaison requiring more than one caregiver
- •Active psychiatric diagnosis without an adequate treatment plan
- •On methadone requiring daily pickup of medication
- •Requires administration of intravenous controlled substances
- •Requires administration of specialty medications not already in place at home
- •Requires transfusion of blood products
- •Requires three times weekly or more transfers back and forth to obtain specialty medical care
- •Requires hemodialysis
- •Orthopedic trauma and elective patients
- •Traumatic brain injury
- •Wound or appliance care that requires daily nursing care
- •For spine trauma: neurologic deficits requiring more than one assist
- •Neurology patients
- •PRESS score (for ischemic stroke; use PRESS app): no return to pre-stroke diet > 50%
- •FUNC score (for primary intracerebral hemorrhage only): <75% probability of functional independence at 90 days
- •ASTRAL score (for ischemic stroke only and patients with pre-stroke independence [Modified Rankin Scale 0-2]): <75% probability of a 90-day poor functional outcome (Modified Rankin Scale result of 3-6)
- •RAH census is full
研究组 & 干预措施
Usual skilled nursing facility care
No Intervention
Control subjects will receive care at a skilled nursing facility as per usual.
Rehab at home
Active Comparator
Intervention subjects will receive care in their home from a specialized care team.
干预措施: Skilled nursing facility care at home (Other)
结局指标
主要结局
Change in activities of daily living between admission to rehab and discharge from rehab
时间窗: Admission to rehab until discharge from rehab, no more than 6 months
Subtract the patient's activities of daily living at discharge from rehab from the patient's activities of daily living on admission to rehab.
次要结局
- Percent time supine per day(Admission to rehab until discharge from rehab, no more than 6 months)
- Total direct medical expenditure(Admission to rehab until discharge from rehab, no more than 6 months)
- Patient experience with care(Admission to rehab until discharge from rehab, no more than 6 months)
- 30-day readmission or 30-day mortality(Discharge from rehab until 30-days later, no more than 30-days)
研究者
David Levine
Associate Physician
Brigham and Women's Hospital
研究点 (10)
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