Clinical trial NCT06547645: Skilled Nursing Facility at Home Trial
Official title: Skilled Nursing Facility at Home Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Skilled Nursing Facility
Rehabilitation
Home Based Care
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Baystate Health
name: UMass Memorial Health
name: Massachusetts Executive Office of Health and Human Services (EOHHS)
First posted: 2024-08-09
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Primary outcomes:
measure: 30-Day Readmission and Mortality
timeFrame: From time of enrollment to 30 days after enrollment
Secondary outcomes:
measure: 60- and 180- day Readmission and Mortality
timeFrame: From time of enrollment, up to 6 months post-enrollment
measure: Days Alive
timeFrame: From time of enrollment, up to 6 months post-enrollment
measure: Activities of Daily Living
timeFrame: From time of enrollment, up to 6 months post-enrollment
measure: Healthcare Costs
timeFrame: From time of enrollment, up to 6 months post-enrollment
measure: Mortality rate
timeFrame: From time of enrollment to 6 months post-enrollment
measure: Length of stay
timeFrame: From time of enrollment, up to 6 months post-enrollment
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Principal Investigator
role: PRINCIPAL_INVESTIGATOR
References: