Home Hospital for Bariatric Sleeve Gastrectomy

Acute Care at Home for Adults Undergoing Bariatric Sleeve Gastrectomy: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Bariatric Surgery Candidate; Bariatric Sleeve Gastrectomy; Home Hospital
• Intervention / Treatment: Other: Home hospital

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All existing home hospital criteria apply, with the following taking precedent for this specific condition
• 21-55 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

Exclusion Criteria:

• 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
  • Supplemental oxygen
• Allergy to ketorolac
• Prolonged QTc

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control, Care in the Hospital; After bariatric sleeve gastrectomy, patients receive their care in the hospital, as usual.
Experimental: Intervention, Care in the Home; After bariatric sleeve gastrectomy, patients receive their care in the home.	Other: Home hospital; Acute care provided at home, including nurse/paramedic visits, physician visits, laboratory testing, imaging, continuous monitoring, 24/7 urgent visits, and specialty consultation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Stay	Days spent hospitalized	From day of admission to day of discharge, assessed up to 10 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motion	Percent of the day lying down	From day of admission to day of discharge, assessed up to 10 months
Cost, direct	Presented as a percentage	From day of admission to day of discharge, assessed up to 10 months
Opioid use	Morphine milligram equivalents used	From day of admission to day of discharge, assessed up to 10 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of emergency department presentation	Emergency department presentation without admission	From day of discharge to 30 days later, assessed up to 10 months
Rate of readmission	Readmission to the hospital	From day of discharge to 30 days later, assessed up to 10 months
BodyQ Score	Sum of the following three transformed scales (total of 300 points): Satisfaction with information (100 points) + Satisfaction with doctor/surgeon (100 points) + Satisfaction with medical team (100 points)	From day of admission to day of discharge, assessed up to 10 months
Picker experience questionnaire - 15	0-15 points, more points better	From day of admission to day of discharge, assessed up to 10 months
Global experience score	0-10 points, more points better	From day of admission to day of discharge, assessed up to 10 months
Pain score	Pain score on scale of 0-10, fewer points better	From day of admission to day of discharge, assessed up to 10 months
Number of complications	Sum of the complications included in the metabolic and bariatric surgery accreditation and quality improvement program	From day of admission to day of discharge, assessed up to 10 months
Bed-days saved	Acute care bed days not required due to the intervention	From day of admission to day of discharge, assessed up to 10 months
Stage 2 diet	Time to resumption of stage 2 diet, measured in hours	From day of admission to day of discharge, assessed up to 10 months
400mL intake	Time to intake of 400mL, measured in hours	From day of admission to day of discharge, assessed up to 10 months
6 hours out of bed on post operative day 1	Time to 6 hours out of bed on post operative day 1, measured in hours	From day of admission to day of discharge, assessed up to 10 months

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2022
• Primary Completion (Actual): April 24, 2024
• Study Completion (Actual): May 24, 2024

Study Registration Dates

• First Submitted: February 10, 2022
• First Submitted That Met QC Criteria: February 18, 2022
• First Posted (Actual): February 28, 2022

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2017P002583e

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