NCT05259111

Brief Summary

Providing acute care at home for medicine patients is a well-studied care model. Providing acute care at home immediately following major surgery is less well understood. The investigators seek to demonstrate the noninferiority of care at home versus the hospital for patients undergoing bariatric sleeve gastrectomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

February 23, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 28, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2024

Completed
Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

2.2 years

First QC Date

February 10, 2022

Last Update Submit

March 16, 2026

Conditions

Bariatric Sleeve GastrectomyBariatric Surgery CandidateHome Hospital

Outcome Measures

Primary Outcomes (1)

  • Length of Stay

    Days spent hospitalized

    From day of admission to day of discharge, assessed up to 10 months

Secondary Outcomes (3)

  • Motion

    From day of admission to day of discharge, assessed up to 10 months

  • Cost, direct

    From day of admission to day of discharge, assessed up to 10 months

  • Opioid use

    From day of admission to day of discharge, assessed up to 10 months

Other Outcomes (11)

  • Rate of emergency department presentation

    From day of discharge to 30 days later, assessed up to 10 months

  • Rate of readmission

    From day of discharge to 30 days later, assessed up to 10 months

  • BodyQ Score

    From day of admission to day of discharge, assessed up to 10 months

  • +8 more other outcomes

Study Arms (2)

Control, Care in the Hospital

NO INTERVENTION

After bariatric sleeve gastrectomy, patients receive their care in the hospital, as usual.

Intervention, Care in the Home

EXPERIMENTAL

After bariatric sleeve gastrectomy, patients receive their care in the home.

Other: Home hospital

Interventions

Home hospitalOTHER

Acute care provided at home, including nurse/paramedic visits, physician visits, laboratory testing, imaging, continuous monitoring, 24/7 urgent visits, and specialty consultation.

Intervention, Care in the Home

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All existing home hospital criteria apply, with the following taking precedent for this specific condition
  • years old
  • Indication for bariatric laparoscopic sleeve gastrectomy per surgeon
  • Caregiver capable of communicating with the home hospital team and able to stay in the same home as the patient the first night the patient is home

You may not qualify if:

  • All existing home hospital criteria apply, with the following taking precedent for this specific condition
  • Comorbidities
  • Body mass index\>55
  • Chronic kidney disease
  • Heart failure
  • History of
  • Chronic pain (with or without opioid use)
  • Substance use disorder
  • Venous thromboembolism
  • Stroke
  • Chronic headache
  • Medications
  • Anticoagulants and anti-platelets: aspirin, clopidogrel, warfarin, and direct oral anticoagulants
  • Beta blockade
  • Immunosuppressive
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brigham and Women's Faulkner Hospital

Boston, Massachusetts, 02130, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02130, United States

Location

Related Publications (3)

  • Leff B, Burton L, Mader SL, Naughton B, Burl J, Inouye SK, Greenough WB 3rd, Guido S, Langston C, Frick KD, Steinwachs D, Burton JR. Hospital at home: feasibility and outcomes of a program to provide hospital-level care at home for acutely ill older patients. Ann Intern Med. 2005 Dec 6;143(11):798-808. doi: 10.7326/0003-4819-143-11-200512060-00008.

    PMID: 16330791BACKGROUND

  • Levine DM, Pian J, Mahendrakumar K, Patel A, Saenz A, Schnipper JL. Hospital-Level Care at Home for Acutely Ill Adults: a Qualitative Evaluation of a Randomized Controlled Trial. J Gen Intern Med. 2021 Jul;36(7):1965-1973. doi: 10.1007/s11606-020-06416-7. Epub 2021 Jan 21.

    PMID: 33479931BACKGROUND

  • Bryan AF, Levine DM, Tsai TC. Home Hospital for Surgery. JAMA Surg. 2021 Jul 1;156(7):679-680. doi: 10.1001/jamasurg.2021.0597. No abstract available.

    PMID: 33909002BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Physician

Study Record Dates

First Submitted

February 10, 2022

First Posted

February 28, 2022

Study Start

February 23, 2022

Primary Completion

April 24, 2024

Study Completion

May 24, 2024

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)