Home Hospital for Bariatric Sleeve Gastrectomy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Length of Stay [From day of admission to day of discharge, assessed up to 10 months]
Days spent hospitalized
Secondary Outcome Measures
- Motion [From day of admission to day of discharge, assessed up to 10 months]
Percent of the day lying down
- Cost, direct [From day of admission to day of discharge, assessed up to 10 months]
Presented as a percentage
- Opioid use [From day of admission to day of discharge, assessed up to 10 months]
Morphine milligram equivalents used
Other Outcome Measures
- Rate of emergency department presentation [From day of discharge to 30 days later, assessed up to 10 months]
Emergency department presentation without admission
- Rate of readmission [From day of discharge to 30 days later, assessed up to 10 months]
Readmission to the hospital
- BodyQ Score [From day of admission to day of discharge, assessed up to 10 months]
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)
- Picker experience questionnaire - 15 [From day of admission to day of discharge, assessed up to 10 months]
0-15 points, more points better
- Global experience score [From day of admission to day of discharge, assessed up to 10 months]
0-10 points, more points better
- Pain score [From day of admission to day of discharge, assessed up to 10 months]
Pain score on scale of 0-10, fewer points better
- Number of complications [From day of admission to day of discharge, assessed up to 10 months]
Sum of the complications included in the metabolic and bariatric surgery accreditation and quality improvement program
- Bed-days saved [From day of admission to day of discharge, assessed up to 10 months]
Acute care bed days not required due to the intervention
- Stage 2 diet [From day of admission to day of discharge, assessed up to 10 months]
Time to resumption of stage 2 diet, measured in hours
- 400mL intake [From day of admission to day of discharge, assessed up to 10 months]
Time to intake of 400mL, measured in hours
- 6 hours out of bed on post operative day 1 [From day of admission to day of discharge, assessed up to 10 months]
Time to 6 hours out of bed on post operative day 1, measured in hours
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Brigham and Women's Faulkner Hospital | Boston | Massachusetts | United States | 02130 |
| 2 | Brigham and Women's Hospital | Boston | Massachusetts | United States | 02130 |
Sponsors and Collaborators
- Brigham and Women's Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 2017P002583e