Home Hospital for Bariatric Sleeve Gastrectomy

Study Overview
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Brief Summary
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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.

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

Conditions
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Bariatric Surgery Candidate, Bariatric Sleeve Gastrectomy, Home Hospital

Intervention / Treatment
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* Other: Home hospital


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |