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Skilled Nursing Facility at Home: A Pilot

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ClinicalTrials.gov Identifier: NCT04048590
Recruitment Status : Recruiting
First Posted : August 7, 2019
Last Update Posted : August 7, 2019
Sponsor:
Collaborators:
Spire Health, Inc.
Reflexion Health, Inc.
Information provided by (Responsible Party):
David Levine, Brigham and Women's Hospital

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
Skilled Nursing Facilities Rehabilitation Other: Skilled Nursing Facility at Home Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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 : August 5, 2019
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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 Name: Rehab at Home




Primary Outcome Measures :
  1. Cost of care [ Time Frame: Enrollment to Discharge, up to 10 weeks ]
    Internal cost of providing rehabilitation care in dollars


Secondary Outcome Measures :
  1. Length of stay [ Time Frame: Enrollment to Discharge, up to 10 weeks ]
    Length of stay in days

  2. Transfer back to the hospital [ Time Frame: Enrollment to Discharge, up to 10 weeks ]
    Frequency of return to the hospital

  3. Change in activities of daily living [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Enrollment to 30-days after discharge, up to 10 weeks ]
    Frequency of unplanned readmissions within 30-days of discharge



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04048590


Contacts
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Contact: David Levine, MD, MPH, MA 617-732-7063 dmlevine@bwh.harvard.edu
Contact: Mary Cueva, MA 617-732-7063 mcueva@bwh.harvard.edu

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: David M Levine, MD MPH MA    617-732-7063    dmlevine@bwh.harvard.edu   
Principal Investigator: David M Levine, MD MPH MA         
Brigham and Women's Faulkner Hospital Recruiting
Boston, Massachusetts, United States, 02130
Contact: David M Levine, MD MPH MA    617-732-7063    dmlevine@bwh.harvard.edu   
Principal Investigator: David M Levine, MD MPH MA         
Sponsors and Collaborators
Brigham and Women's Hospital
Spire Health, Inc.
Reflexion Health, Inc.
Investigators
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Principal Investigator: David Levine, MD, MPH, MA Brigham and Women's Hospital

Publications:
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Responsible Party: David Levine, Principal Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT04048590     History of Changes
Other Study ID Numbers: 2019P001231
First Posted: August 7, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Levine, Brigham and Women's Hospital:
Skilled Nursing Facilities
Home-based care
Rehabilitation