Skilled Nursing Facility at Home Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Massachusetts, Worcester
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Sub-Acute Rehab at Home
Other interventionPatients 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.
Treatment groups
650 Participants
are divided into 2 treatment groupsGroup A: Facility-basedNo intervention 0 interventions
Group B: Home-basedActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
30-Day Readmission and Mortality
Hospital readmission rates and mortality rates between the intervention and control groups in the first 30 days after enrollment
Time frame
From time of enrollment to 30 days after enrollmentSecondary outcomes
1
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
Time frame
From time of enrollment, up to 6 months post-enrollment2
Days Alive
Starting with the day of randomization, the total number of days alive outside of the hospital during the study period.
Time frame
From time of enrollment, up to 6 months post-enrollment3
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.
Time frame
From time of enrollment, up to 6 months post-enrollment4
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.
Time frame
From time of enrollment, up to 6 months post-enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Massachusetts, Worcester
Lead sponsor
Baystate Health
Collaborator
UMass Memorial Health
Collaborator
Massachusetts Executive Office of Health and Human Services (EOHHS)
Collaborator
Source ClinicalTrials.gov