Skilled Nursing FacilityNCT06547645
Skilled Nursing Facility at Home Trial
A study testing Sub-Acute Rehab at Home in people with Skilled Nursing Facility and Rehabilitation, run by University of Massachusetts, Worcester at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skilled Nursing Facility, Rehabilitation, Home Based Care
- What is being tested?
- Sub-Acute Rehab at Home
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Aug 2024to May 2027
- 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
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Baystate Medical Center
Springfield, Massachusetts, 01199
Peter Lindenauer, MD
Peter Lindenauer, MD
- Recruiting
UMass Memorial Medical Center
Worcester, Massachusetts, 02446
Apurv Soni, MD, PhD
Apurv Soni, MD, PhD
About this study
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.
- Conditions
- Skilled Nursing Facility, Rehabilitation, Home Based Care
- Being tested
- Sub-Acute Rehab at Home
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sub-Acute Rehab at HomeOther
Also called SNF 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.
| Study group | Role | What they receive |
|---|---|---|
| Facility-based | No intervention | Facility based post acute care at a skilled nursing facility, as is the standard care model. |
| Home-based | Active comparator | Home-based Post-Acute Care Receives: Other: Sub-Acute Rehab at Home |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-Day Readmission and Mortality
Hospital readmission rates and mortality rates between the intervention and control groups in the first 30 days after enrollment
Measured: From time of enrollment to 30 days after enrollment
Secondary outcomes (6)
90- and 180- day Readmission and Mortality
Hospital readmission rates and mortality rates between the intervention and control groups in the 90- and 180- days after enrollment
Measured: From time of enrollment, up to 6 months post-enrollment
Days Alive
Starting with the day of randomization, the total number of days alive outside of the hospital during the study period.
Measured: From time of enrollment, up to 6 months post-enrollment
Activities of Daily Living
Compare the improvement in ability to perform activities of daily living between the intervention and control groups from time of enrollment to 30, 90 and 180-days after enrollment.
Measured: From time of enrollment, up to 6 months post-enrollment
Healthcare Costs
Compare healthcare cost incurred and healthcare utilization between the intervention and control group during the PAC episode as well as from time of enrollment to the end of the PAC episode.
Measured: From time of enrollment, up to 6 months post-enrollment
Mortality rate
Compare mortality rates during the study period between the intervention and control groups.
Measured: From time of enrollment to 6 months post-enrollment
Length of stay
Compare length-of-stay (number of days) that study participants receive post-acute, SNF-level care during the index PAC episode between the intervention and control groups
Measured: From time of enrollment, up to 6 months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start26 Aug 2024
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (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.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Baystate Health, UMass Memorial Health, Massachusetts Executive Office of Health and Human Services (EOHHS)
- Responsible party
- Principal investigator, Apurv Soni, University of Massachusetts, Worcester
- Investigators
- Principal Investigator, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547645
- Sponsor's protocol ID
- STUDY00001862
- Status last verified
- Mar 2026
- First submitted
- 7 Aug 2024
- Last updated
- 11 Mar 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 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skilled Nursing Facility at Home Trial
- ClinicalTrials.gov ID
- NCT06547645
- Acronym / sponsor ID
- STUDY00001862
- Conditions
- Skilled Nursing Facility, Rehabilitation, Home Based Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Baystate Health, UMass Memorial Health, Massachusetts Executive Office of Health and Human Services (EOHHS)
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 9 Aug 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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Facility-based | No intervention | –Facility based post acute care at a skilled nursing facility, as is the standard care model. |
| Home-based | Active comparator | Other: Sub-Acute Rehab at HomeHome-based Post-Acute Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| Sub-Acute Rehab at HomeAlso: SNF at HomePatients 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. | Other | Home-based |
Primary outcome
30-Day Readmission and Mortality
Time frame: 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
6 secondary outcomes
90- and 180- day Readmission and Mortality
Time frame: From time of enrollment, up to 6 months post-enrollment
Days Alive
Time frame: From time of enrollment, up to 6 months post-enrollment
Activities of Daily Living
Time frame: From time of enrollment, up to 6 months post-enrollment
Healthcare Costs
Time frame: From time of enrollment, up to 6 months post-enrollment
Mortality rate
Time frame: From time of enrollment to 6 months post-enrollment
Length of stay
Time frame: From time of enrollment, up to 6 months post-enrollment
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 11 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Skilled Nursing Facility
Not yet recruiting
SmartEnLite for Nursing Home Residents With Dementia
Alzheimer's Disease and Related Dementias, Alzheimer Disease and Related Dementias
Recruiting
Pilot Study of a Behavioral Program for Resident Depression in Skilled Nursing Facilities
Nursing Home Resident, Skilled Nursing Facility
Not yet recruiting
Technology Use, Safe Health Information, and Artificial Intelligence Among Older Adults
Older Adults, Nursing Homes
Not yet recruiting
A Virtual Reality Program for Nursing Home Residents With Physical Disabilities
Older Adults Institutionalized in Residential Homes
Enrolling by invitationObservational study
Prescribing Trends and Associated Outcomes of Antiepileptic Drugs in US Nursing Homes Surrounding the COVID-19 Pandemic
Dementia
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.
Principal Investigator principal investigator
University of Massachusetts, Worcester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sub-Acute Rehab at Home in people with Skilled Nursing Facility and Rehabilitation, run by University of Massachusetts, Worcester at 2 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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Contact Study Team (508-523-1284, homerehab@umassmed.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-Day Readmission and Mortality (time frame: From time of enrollment to 30 days after enrollment). 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 11 Mar 2026.