Skilled Nursing FacilityNCT06416670
Skilled Nursing Facility Care at Home
A study testing Skilled nursing facility care at home in people with Skilled Nursing Facility and Rehabilitation, run by Brigham and Women's Hospital at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skilled Nursing Facility, Rehabilitation
- What is being tested?
- Skilled nursing facility care at home
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 5 sitesUnited States
- Study dates
- 3 Jun 2024to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >=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)
Who cannot join
- 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
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- 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
- Clinical
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston Medical Center
Boston, Massachusetts, 02118
Brigham and Women's Hospital
Boston, Massachusetts, 02120
Brigham and Women's Faulkner Hospital
Boston, Massachusetts, 02130
Cambridge Health Alliance
Cambridge, Massachusetts, 02139
About this study
Official title: Skilled Nursing Facility Care at Home: A Randomized Controlled Trial
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.
- Conditions
- Skilled Nursing Facility, Rehabilitation
- Being tested
- Skilled nursing facility care at home
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skilled nursing facility care at homeOther
Skilled nursing facility care at home delivers a range of advanced rehabilitation services in patients' homes, enabling care at home despite requiring intensive rehabilitative care. Our approach blends personalized, high-level professional care with innovative technology applications to ensure adequate rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Skilled nursing facility care at home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in activities of daily living between admission to rehab and discharge from rehab
Subtract the patient's activities of daily living at discharge from rehab from the patient's activities of daily living on admission to rehab.
Measured: Admission to rehab until discharge from rehab, no more than 6 months
Secondary outcomes (4)
Percent time supine per day
The percentage of time a patient is supine per day, as measured by their wrist-worn accelerometer.
Measured: Admission to rehab until discharge from rehab, no more than 6 months
Total direct medical expenditure
The percent difference in direct cost of care to deliver rehab care.
Measured: Admission to rehab until discharge from rehab, no more than 6 months
Patient experience with care
The Picker patient experience questionaire-15
Measured: Admission to rehab until discharge from rehab, no more than 6 months
30-day readmission or 30-day mortality
The percentage of patients who are readmitted or deceased within 30-days of discharge from rehab.
Measured: Discharge from rehab until 30-days later, no more than 30-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start3 Jun 2024
- Primary completion22 Oct 2025
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skilled Nursing FacilityStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Medical Center, Cambridge Health Alliance
- Responsible party
- Principal investigator, David Levine, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416670
- Sponsor's protocol ID
- 2024P000266
- Status last verified
- Oct 2025
- First submitted
- 11 May 2024
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skilled Nursing Facility Care at Home: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06416670
- Acronym / sponsor ID
- 2024P000266
- Conditions
- Skilled Nursing Facility, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Boston Medical Center, Cambridge Health Alliance
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 22 Oct 2025 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Skilled nursing facility care at homeIntervention subjects will receive care in their home from a specialized care team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- >=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)
Key exclusion criteria (37 listed)
- Environmental
- Clinical
- Neurology patients
- RAH census is full
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skilled nursing facility care at homeSkilled nursing facility care at home delivers a range of advanced rehabilitation services in patients' homes, enabling care at home despite requiring intensive rehabilitative care. Our approach blends personalized, high-level professional care with innovative technology applications to ensure adequate rehabilitation. | Other | Rehab at home |
Primary outcome
Change in activities of daily living between admission to rehab and discharge from rehab
Time frame: 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.
4 secondary outcomes
Percent time supine per day
Time frame: Admission to rehab until discharge from rehab, no more than 6 months
Total direct medical expenditure
Time frame: Admission to rehab until discharge from rehab, no more than 6 months
Patient experience with care
Time frame: Admission to rehab until discharge from rehab, no more than 6 months
30-day readmission or 30-day mortality
Time frame: Discharge from rehab until 30-days later, no more than 30-days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skilled nursing facility care at home in people with Skilled Nursing Facility and Rehabilitation, run by Brigham and Women's Hospital at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in activities of daily living between admission to rehab and discharge from rehab (time frame: Admission to rehab until discharge from rehab, no more than 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.