Home Hospital for Bariatric Sleeve Gastrectomy

Bariatric Surgery Candidate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05259111
• Other study ID #: 2017P002583e
• Status: Recruiting
• Phase: N/A
• Start date: February 23, 2022
• Est. completion date: March 23, 2023

Study information

• Verified date: February 2022
• Source: Brigham and Women's Hospital
• Contact: David Levine, MD
• Phone: 6177327063
• Email: dmlevine[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 23, 2023
• Est. primary completion date: February 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate

Intervention

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.

Locations

Country	Name	City	State
United States	Brigham and Women's Faulkner Hospital	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of emergency department presentation	Emergency department presentation without admission	From day of discharge to 30 days later, assessed up to 10 months
Other	Rate of readmission	Readmission to the hospital	From day of discharge to 30 days later, assessed up to 10 months
Other	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
Other	Picker experience questionnaire - 15	0-15 points, more points better	From day of admission to day of discharge, assessed up to 10 months
Other	Global experience score	0-10 points, more points better	From day of admission to day of discharge, assessed up to 10 months
Other	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
Other	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
Other	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
Other	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
Other	400mL intake	Time to intake of 400mL, measured in hours	From day of admission to day of discharge, assessed up to 10 months
Other	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
Primary	Length of Stay	Days spent hospitalized	From day of admission to day of discharge, assessed up to 10 months
Secondary	Motion	Percent of the day lying down	From day of admission to day of discharge, assessed up to 10 months
Secondary	Cost, direct	Presented as a percentage	From day of admission to day of discharge, assessed up to 10 months
Secondary	Opioid use	Morphine milligram equivalents used	From day of admission to day of discharge, assessed up to 10 months