Skilled Nursing Facility at Home: A Pilot

Skilled Nursing Facility Care at Home for Adults Discharged From the Hospital: A Pilot Randomized Controlled Evaluation

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.

Study Overview

• Status: Completed
• Conditions: Rehabilitation; Skilled Nursing Facilities
• Intervention / Treatment: Other: Skilled Nursing Facility at Home

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02130
      • Brigham and Women's Faulkner Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost of care	Internal cost of providing rehabilitation care in dollars	Enrollment to Discharge, up to 10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay	Length of stay in days	Enrollment to Discharge, up to 10 weeks
Transfer back to the hospital	Frequency of return to the hospital	Enrollment to Discharge, up to 10 weeks
Change in activities of daily living	Change in activities of daily living from admission to discharge. Activities of daily living is a scale 0-6, with 6 representing more activities.	Enrollment to Discharge, up to 10 weeks
Change in instrumental activities of daily living	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.	Enrollment to Discharge, up to 10 weeks
Modified picker experience questionnaire	Score on the modified picker experience questionnaire, with scores between 0-15, where 15 represents a higher/better score.	Discharge, up to 10 weeks
3 item care transition measure	Score on the 3 item care transition measure, with scores between 0 and 12, where 12 represents a higher/better score.	Discharge, up to 10 weeks
Unplanned readmission rate	Frequency of unplanned readmissions within 30-days of discharge	Enrollment to 30-days after discharge, up to 10 weeks

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Spire Health, Inc.; Reflexion Health, Inc.
• Investigators: Principal Investigator: David Levine, MD, MPH, MA, Brigham and Women's Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 5, 2019
• Primary Completion (ACTUAL): December 19, 2019
• Study Completion (ACTUAL): December 19, 2019

Study Registration Dates

• First Submitted: June 5, 2019
• First Submitted That Met QC Criteria: August 5, 2019
• First Posted (ACTUAL): August 7, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 23, 2019
• Last Update Submitted That Met QC Criteria: December 19, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Rehabilitation; Skilled Nursing Facilities; Home-based care
• Other Study ID Numbers: 2019P001231

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No