Skilled Nursing Facility at Home Trial

NCT ID: NCT06547645

Last Updated: 2026-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

650 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-26

Study Completion Date

2026-06-26

Brief Summary

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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.

Detailed Description

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Conditions

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Skilled Nursing Facility Rehabilitation Home Based Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Facility-based

Facility based post acute care at a skilled nursing facility, as is the standard care model.

Group Type NO_INTERVENTION

No interventions assigned to this group

Home-based

Home-based Post-Acute Care

Group Type ACTIVE_COMPARATOR

Sub-Acute Rehab at Home

Intervention Type OTHER

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.

Interventions

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Sub-Acute Rehab 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.

Intervention Type OTHER

Other Intervention Names

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SNF at Home

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baystate Health

OTHER

Sponsor Role collaborator

UMass Memorial Health

OTHER

Sponsor Role collaborator

Massachusetts Executive Office of Health and Human Services (EOHHS)

UNKNOWN

Sponsor Role collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role lead

Responsible Party

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Apurv Soni

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Principal Investigator

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts, Worcester

Locations

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Baystate Medical Center

Springfield, Massachusetts, United States

Site Status RECRUITING

UMass Memorial Medical Center

Worcester, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Study Team

Role: CONTACT

508-523-1284

Facility Contacts

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Peter Lindenauer, MD

Role: primary

Apurv Soni, MD, PhD

Role: primary

Other Identifiers

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STUDY00001862

Identifier Type: -

Identifier Source: org_study_id

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