| NCT ID | NCT06547645 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Massachusetts, Worcester |
| Condition | Skilled Nursing Facility |
| Study Type | INTERVENTIONAL |
| Enrollment | 650 participants |
| Start Date | 2024-08-26 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 650 participants in total. It began in 2024-08-26 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 (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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Principal Investigator
PRINCIPAL INVESTIGATOR
University of Massachusetts, Worcester
Frequently Asked Questions
Who can join the NCT06547645 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Skilled Nursing Facility. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06547645 currently recruiting?
Yes, NCT06547645 is actively recruiting participants. Contact the research team at homerehab@umassmed.edu for enrollment information.
Where is the NCT06547645 trial being conducted?
This trial is being conducted at Springfield, United States, Worcester, United States.
Who is sponsoring the NCT06547645 clinical trial?
NCT06547645 is sponsored by University of Massachusetts, Worcester. The principal investigator is Principal Investigator at University of Massachusetts, Worcester. The trial plans to enroll 650 participants.