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Skilled Nursing FacilitiesNCT04048590

Skilled Nursing Facility at Home: A Pilot

A study testing Skilled Nursing Facility at Home in people with Skilled Nursing Facilities and Rehabilitation, run by Brigham and Women's Hospital at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Skilled Nursing Facilities, Rehabilitation
What is being tested?
Skilled Nursing Facility at Home
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesUnited States
Study dates
5 Aug 2019to 19 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • >=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

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Brigham and Women's Faulkner Hospital

    Boston, Massachusetts, 02130

Other trials in United States

About this study

Official title: 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.

Read the 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).

Being tested
Skilled Nursing Facility at Home
Keywords
Skilled Nursing Facilities, Home-based care, Rehabilitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Skilled Nursing Facility at HomeOther

    Also called Rehab 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.

Study groups in NCT04048590
Study groupRoleWhat they receive
ControlNo interventionControl subjects will receive care at a skilled nursing facility.
InterventionActive comparatorIntervention subjects will go home from the hospital and receive care from a specialized care team.
Receives: Other: Skilled Nursing Facility at Home

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cost of care

    Internal cost of providing rehabilitation care in dollars

    Measured: Enrollment to Discharge, up to 10 weeks

Secondary outcomes (7)

  1. Length of stay

    Length of stay in days

    Measured: Enrollment to Discharge, up to 10 weeks

  2. Transfer back to the hospital

    Frequency of return to the hospital

    Measured: Enrollment to Discharge, up to 10 weeks

  3. 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.

    Measured: Enrollment to Discharge, up to 10 weeks

  4. 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.

    Measured: Enrollment to Discharge, up to 10 weeks

  5. Modified picker experience questionnaire

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

    Measured: Discharge, up to 10 weeks

  6. 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.

    Measured: Discharge, up to 10 weeks

  7. Unplanned readmission rate

    Frequency of unplanned readmissions within 30-days of discharge

    Measured: Enrollment to 30-days after discharge, up to 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2019
  2. Study start5 Aug 2019
  3. Primary completion19 Dec 2019
  4. Study completion19 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04048590
Sponsor's protocol ID
2019P001231
Status last verified
Dec 2019
First submitted
5 Jun 2019
Last updated
23 Dec 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 16239239

  • 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.

    PubMed 27346649

  • 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.

    PubMed 24552315

  • 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.

    PubMed 23650319

  • 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.

    PubMed 35266835

Questions about this trial

What is this clinical trial studying?

A study testing Skilled Nursing Facility at Home in people with Skilled Nursing Facilities and Rehabilitation, run by Brigham and Women's Hospital at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cost of care (time frame: Enrollment to Discharge, up to 10 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04048590, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2019.

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