Home Hospital for Bariatric Sleeve Gastrectomy

NCT ID: NCT05259111

Last Updated: 2022-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-23

Study Completion Date

2023-03-23

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.

Detailed Description

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Conditions

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Bariatric Surgery Candidate Bariatric Sleeve Gastrectomy Home Hospital

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control, Care in the Hospital

After bariatric sleeve gastrectomy, patients receive their care in the hospital, as usual.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention, Care in the Home

After bariatric sleeve gastrectomy, patients receive their care in the home.

Group Type EXPERIMENTAL

Home hospital

Intervention Type OTHER

Acute care provided at home, including nurse/paramedic visits, physician visits, laboratory testing, imaging, continuous monitoring, 24/7 urgent visits, and specialty consultation.

Interventions

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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.

Intervention Type OTHER

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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David Levine

Associate Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Brigham and Women's Faulkner Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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David Levine, MD

Role: CONTACT

6177327063

Facility Contacts

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David Levine

Role: primary

617-732-7063

David Levine

Role: primary

617-732-7063

References

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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.

Reference Type BACKGROUND
PMID: 16330791 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33479931 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33909002 (View on PubMed)

Other Identifiers

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2017P002583e

Identifier Type: -

Identifier Source: org_study_id

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