Skilled Nursing Facility at Home: A Pilot

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04048590
Collaborator
Spire Health, Inc. (Other), Reflexion Health, Inc. (Industry)
10
2
2
4.5
5
1.1

Study Details

Study Description

Brief Summary

We seek to pilot a randomized controlled evaluation of skilled nursing facility care at home. We plan to enroll patients who would normally be sent to a skilled nursing facility following following hospitalization. As a substitute for a skilled nursing facility, we will deploy a technology-enabled team to the home to care for patients.

Condition or Disease Intervention/Treatment Phase
  • Other: Skilled Nursing Facility at Home
N/A

Detailed Description

Post-acute care (PAC) encompasses the wide range of rehabilitative services used to restore a patient's maximal functional status following discharge from an acute hospitalization with the goal of restoring healthful aging. Approximately 40% of all hospitalized Medicare beneficiaries utilize PAC, accounting for 20% of all Medicare expenditures. PAC is a fast-growing segment of Medicare, and for some conditions, Medicare spending on PAC nearly equals that of the initial hospitalization, with skilled nursing facility (SNF) PAC accounting for most of these trends. The quality of SNF PAC is suspect, with substantial regional variation, insufficient physical therapy delivery, high readmission rates, poor attention to whole-person care, and poor patient experience. Given these concerns, some experts have called for national improvement.

The investigators propose a home-based PAC model that substitutes for treatment in a traditional SNF PAC facility. We believe that rehabilitation following hospitalization in one's home has several benefits: support tailored to one's actual living circumstances, an environment that encourages earlier mobilization, support of and interaction with family and caregivers, and psychosocial benefits of being at home. To promote aging in place, the investigators plan to deploy an innovative and tailored set of SNF PAC services delivered in a patient's home that would allow for discharge from the hospital directly to home, despite the need for more intensive rehabilitative care not currently found in the home setting. The investigators plan to combine a high-touch and high-tech approach that combines novel uses of personnel practicing at the very top of their license (certified nursing assistants, nurses, home health aides) with novel uses of technology (virtual physical therapy with three-dimensional camera feedback, continuous monitoring, and video visits).

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Skilled Nursing Facility Care at Home for Adults Discharged From the Hospital: A Pilot Randomized Controlled Evaluation
Actual Study Start Date :
Aug 5, 2019
Actual Primary Completion Date :
Dec 19, 2019
Actual Study Completion Date :
Dec 19, 2019

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control

Control subjects will receive care at a skilled nursing facility.

Active Comparator: Intervention

Intervention subjects will go home from the hospital and receive care from a specialized care team.

Other: Skilled Nursing Facility at Home
We plan to deploy an innovative and tailored set of rehabilitation services delivered in a patient's home that would allow for discharge from the hospital directly to home, despite the need for more intensive rehabilitative care not currently found in the home setting. We plan to combine a high-touch and high-tech approach that combines novel uses of personnel practicing at the very top of their license with novel uses of technology.
Other Names:
  • Rehab at Home
  • Outcome Measures

    Primary Outcome Measures

    1. Cost of care [Enrollment to Discharge, up to 10 weeks]

      Internal cost of providing rehabilitation care in dollars

    Secondary Outcome Measures

    1. Length of stay [Enrollment to Discharge, up to 10 weeks]

      Length of stay in days

    2. Transfer back to the hospital [Enrollment to Discharge, up to 10 weeks]

      Frequency of return to the hospital

    3. Change in activities of daily living [Enrollment to Discharge, up to 10 weeks]

      Change in activities of daily living from admission to discharge. Activities of daily living is a scale 0-6, with 6 representing more activities.

    4. Change in instrumental activities of daily living [Enrollment to Discharge, up to 10 weeks]

      Change in instrumental activities of daily living from admission to discharge. Instrumental activities of daily living is a scale 0-8, with 8 representing more activities.

    5. Modified picker experience questionnaire [Discharge, up to 10 weeks]

      Score on the modified picker experience questionnaire, with scores between 0-15, where 15 represents a higher/better score.

    6. 3 item care transition measure [Discharge, up to 10 weeks]

      Score on the 3 item care transition measure, with scores between 0 and 12, where 12 represents a higher/better score.

    7. Unplanned readmission rate [Enrollment to 30-days after discharge, up to 10 weeks]

      Frequency of unplanned readmissions within 30-days of discharge

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • =18 years old

    • Requires skilled nursing facility care following hospitalization, as determined by inpatient team

    • Lives within 10 miles of Brigham and Women's Hospital (BWH) or Brigham and Women's Faulkner Hospital (BWFH)

    • Has capacity to consent

    • Likely to return to community dwelling status

    • Patient on medical service

    • Pending low volume, we reserve ability to phase in patients on surgical services, including orthopedic trauma

    Exclusion Criteria:
    • Social

    • Undomiciled

    • No working heat (October-April), no working air conditioning if forecast > 80°F (June-September), or no running water

    • In police custody

    • Resides in facility that does not allow advanced on-site medical care

    • Domestic violence screen positive

    • Clinical

    • Requires care of new ostomy or teaching ostomy care associated with complication

    • Requires frequent suctioning, tracheostomy, and/or ventilator needs

    • Requires significant durable medical equipment not already in place at home (e.g., Hoyer lift)

    • Home unable to accommodate patient in current state as determined by the SNF-at-Home Checklist for Home

    • Acute delirium

    • End stage renal disease on hemodialysis

    • On methadone requiring daily pickup of medication

    • Requires administration of intravenous controlled substances

    • Requires administration of specialty medications not already in place at home

    • Requires transfusion of blood products

    • Requires multiple transfers back and forth to hospital for specialty medical care

    • Home SNF census is full

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Brigham and Women's Hospital Boston Massachusetts United States 02115
    2 Brigham and Women's Faulkner Hospital Boston Massachusetts United States 02130

    Sponsors and Collaborators

    • Brigham and Women's Hospital
    • Spire Health, Inc.
    • Reflexion Health, Inc.

    Investigators

    • Principal Investigator: David Levine, MD, MPH, MA, Brigham and Women's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    David Levine, Principal Investigator, Brigham and Women's Hospital
    ClinicalTrials.gov Identifier:
    NCT04048590
    Other Study ID Numbers:
    • 2019P001231
    First Posted:
    Aug 7, 2019
    Last Update Posted:
    Dec 23, 2019
    Last Verified:
    Dec 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by David Levine, Principal Investigator, Brigham and Women's Hospital

    Study Results

    No Results Posted as of Dec 23, 2019