Skilled Nursing Facility at Home: A Pilot

NCT04048590 | Completed DMC

• 1 other identifier: 2019P001231
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Skilled Nursing Facilities; Rehabilitation

Keywords

Skilled Nursing Facilities; Home-based care; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Cost of care

  Internal cost of providing rehabilitation care in dollars

  Enrollment to Discharge, up to 10 weeks

Secondary Outcomes (7)

• Length of stay

  Enrollment to Discharge, up to 10 weeks

• Transfer back to the hospital

  Enrollment to Discharge, up to 10 weeks

• Change in activities of daily living

  Enrollment to Discharge, up to 10 weeks

• Change in instrumental activities of daily living

  Enrollment to Discharge, up to 10 weeks

• Modified picker experience questionnaire

  Discharge, up to 10 weeks

Study Arms (2)

Control

NO INTERVENTION

Control subjects will receive care at a skilled nursing facility.

Intervention

ACTIVE COMPARATOR

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

Other: Skilled Nursing Facility at Home

Interventions

Skilled Nursing Facility at Home OTHER

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.

Also known as: Rehab at Home

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>=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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Brigham and Women's Faulkner Hospital

Boston, Massachusetts, 02130, United States

Location

Related Publications (5)

• Caplan GA, Coconis J, Board N, Sayers A, Woods J. Does home treatment affect delirium? A randomised controlled trial of rehabilitation of elderly and care at home or usual treatment (The REACH-OUT trial). Age Ageing. 2006 Jan;35(1):53-60. doi: 10.1093/ageing/afi206. Epub 2005 Oct 20.

  PMID: 16239239 BACKGROUND

• David S, Sheikh F, Mahajan D, Greenough W, Bellantoni M. Whom Do We Serve? Describing the Target Population for Post-acute and Long-term Care, Focusing on Nursing Facility Settings, in the Era of Population Health in the United States. J Am Med Dir Assoc. 2016 Jul 1;17(7):574-80. doi: 10.1016/j.jamda.2016.05.004. No abstract available.

  PMID: 27346649 BACKGROUND

• Mechanic R. Post-acute care--the next frontier for controlling Medicare spending. N Engl J Med. 2014 Feb 20;370(8):692-4. doi: 10.1056/NEJMp1315607. No abstract available.

  PMID: 24552315 BACKGROUND

• Chandra A, Dalton MA, Holmes J. Large increases in spending on postacute care in Medicare point to the potential for cost savings in these settings. Health Aff (Millwood). 2013 May;32(5):864-72. doi: 10.1377/hlthaff.2012.1262.

  PMID: 23650319 BACKGROUND

• Levine DM, Cueva MA, Shi S, Limaj I, Wambolt B, Grabowski DC, Schnipper JL, Pu CT. Skilled Nursing Facility Care at Home for Adults Discharged From the Hospital: A Pilot Randomized Controlled Trial. J Appl Gerontol. 2022 Jun;41(6):1585-1594. doi: 10.1177/07334648221077092. Epub 2022 Mar 10.

  PMID: 35266835 DERIVED

Study Officials

• David Levine, MD, MPH, MA

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: August 7, 2019
• Study Start: August 5, 2019
• Primary Completion: December 19, 2019
• Study Completion: December 19, 2019
• Last Updated: December 23, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)