Clinical trial NCT04048590: Skilled Nursing Facility at Home: A Pilot
Official title: Skilled Nursing Facility Care at Home for Adults Discharged From the Hospital: A Pilot Randomized Controlled Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skilled Nursing Facilities
Rehabilitation
Keywords: Skilled Nursing Facilities
Home-based care
Rehabilitation
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Spire Health, Inc.
name: Reflexion Health, Inc.
First posted: 2019-08-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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).

Eligibility 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

Primary outcomes:
measure: Cost of care
timeFrame: Enrollment to Discharge, up to 10 weeks
Secondary outcomes:
measure: Length of stay
timeFrame: Enrollment to Discharge, up to 10 weeks
measure: Transfer back to the hospital
timeFrame: Enrollment to Discharge, up to 10 weeks
measure: Change in activities of daily living
timeFrame: Enrollment to Discharge, up to 10 weeks
measure: Change in instrumental activities of daily living
timeFrame: Enrollment to Discharge, up to 10 weeks
measure: Modified picker experience questionnaire
timeFrame: Discharge, up to 10 weeks
measure: 3 item care transition measure
timeFrame: Discharge, up to 10 weeks
measure: Unplanned readmission rate
timeFrame: Enrollment to 30-days after discharge, up to 10 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Faulkner Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: David Levine, MD, MPH, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.