Clinical trial NCT05259111: Home Hospital for Bariatric Sleeve Gastrectomy
Official title: Acute Care at Home for Adults Undergoing Bariatric Sleeve Gastrectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bariatric Surgery Candidate
Bariatric Sleeve Gastrectomy
Home Hospital
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2022-02-28
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Length of Stay
timeFrame: From day of admission to day of discharge, assessed up to 10 months
Secondary outcomes:
measure: Motion
timeFrame: From day of admission to day of discharge, assessed up to 10 months
measure: Cost, direct
timeFrame: From day of admission to day of discharge, assessed up to 10 months
measure: Opioid use
timeFrame: From day of admission to day of discharge, assessed up to 10 months
Other outcomes:
measure: Rate of emergency department presentation
timeFrame: From day of discharge to 30 days later, assessed up to 10 months
measure: Rate of readmission
timeFrame: From day of discharge to 30 days later, assessed up to 10 months
measure: BodyQ Score
timeFrame: From day of admission to day of discharge, assessed up to 10 months
measure: Picker experience questionnaire - 15
timeFrame: From day of admission to day of discharge, assessed up to 10 months
measure: Global experience score
timeFrame: From day of admission to day of discharge, assessed up to 10 months
measure: Pain score
timeFrame: From day of admission to day of discharge, assessed up to 10 months
measure: Number of complications
timeFrame: From day of admission to day of discharge, assessed up to 10 months
measure: Bed-days saved
timeFrame: From day of admission to day of discharge, assessed up to 10 months
measure: Stage 2 diet
timeFrame: From day of admission to day of discharge, assessed up to 10 months
measure: 400mL intake
timeFrame: From day of admission to day of discharge, assessed up to 10 months
measure: 6 hours out of bed on post operative day 1
timeFrame: From day of admission to day of discharge, assessed up to 10 months
Locations:
city: Boston
country: United States
facility: Brigham and Women's Faulkner Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.