NCT05745077

Brief Summary

The goal of this retrospective cohort and pragmatic pilot trial is to examine the social determinants of health in racial and ethnic minority patients from socially vulnerable backgrounds who have Gallbladder Disease (GBD). The main questions it aims to answer are:

  1. 1.What racial barriers in outcome exist for socially vulnerable patients with gallbladder disease?
  2. 2.How effective is telemedicine consultation in improving surgical outcomes for socially vulnerable patients with gallbladder disease?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

February 16, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2024

Completed
Last Updated

June 6, 2024

Status Verified

June 1, 2024

Enrollment Period

1 year

First QC Date

January 31, 2023

Last Update Submit

June 4, 2024

Conditions

Gallbladder Disease

Keywords

Social Determinants of HealthTelemedicineElective CholecystectomyEmergency Cholecystectomy

Outcome Measures

Primary Outcomes (1)

  • Cholecystectomy Surgical Outcome

    Compare rates of surgical consultation by consultation type.

    6 Months

Secondary Outcomes (5)

  • Time from Referral to Consultation

    6 Months

  • Completion of Consultation

    6 Months

  • Effect of Consultation on Surgical Outcome.

    6 Months

  • Urgency of Operative Treatment

    6 Months

  • Cost

    6 Months

Study Arms (2)

Telemedicine Consultation

EXPERIMENTAL

Patient will schedule a Telemedicine Consultation in place of traditional in-person visit.

Behavioral: Telemedicine Consultation

Traditional In-Person Care

ACTIVE COMPARATOR

Patient will schedule a traditional in-person visit as per usual care.

Behavioral: Traditional Care

Interventions

Telemedicine ConsultationBEHAVIORAL

Patients will be contacted by their surgeon over the phone to discuss surgical treatment.

Telemedicine Consultation
Traditional CareBEHAVIORAL

Patients will proceed with their surgical consultation as per standard practice.

Traditional In-Person Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients age \> 18 in the Primary Care Service Line (PCSL) and Emergency Department (ED) discharges including referral to surgery
  • Member of a racial or ethnic minority, not primary English speaking, from a low-income neighborhood, or underinsured
  • With a new ICD-10 code for symptomatic cholelithiasis or biliary colic seen by a PCSL provider or discharge from an ED between February 1, and June 30, 2023

You may not qualify if:

  • History of prior cholecystectomy
  • Prisoner
  • GB cancer
  • Advanced cirrhosis
  • Untreated coagulopathy
  • No indication for surgery
  • Unable/unwilling to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (33)

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    BACKGROUND

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    PMID: 31177035BACKGROUND

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    PMID: 33914483BACKGROUND

  • Shenoy R, Kirkland P, Maggard-Gibbons M, Russell MM. Symptomatic Cholelithiasis: Do Minority Patients Experience Delays to Surgery? J Surg Res. 2022 Apr;272:88-95. doi: 10.1016/j.jss.2021.11.003. Epub 2021 Dec 22.

    PMID: 34953371BACKGROUND

  • Janeway MG, Sanchez SE, Rosen AK, Patts G, Allee LC, Lasser KE, Dechert TA. Disparities in Utilization of Ambulatory Cholecystectomy: Results From Three States. J Surg Res. 2021 Oct;266:373-382. doi: 10.1016/j.jss.2021.03.052. Epub 2021 Jun 1.

    PMID: 34087621BACKGROUND

  • Saluja S, Hochman M, Dokko R, Morrison JL, Valdez C, Baldwin S, Tandel MD, Cousineau M. Community-Based Health Care Navigation's Impact on Access to Primary Care for Low-Income Latinos. J Am Board Fam Med. 2022 Jan-Feb;35(1):44-54. doi: 10.3122/jabfm.2022.01.210253.

    PMID: 35039411BACKGROUND

  • Han HR, Lee H, Kim MT, Kim KB. Tailored lay health worker intervention improves breast cancer screening outcomes in non-adherent Korean-American women. Health Educ Res. 2009 Apr;24(2):318-29. doi: 10.1093/her/cyn021. Epub 2008 May 7.

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  • Chavarri-Guerra Y, Soto-Perez-de-Celis E, Ramos-Lopez W, San Miguel de Majors SL, Sanchez-Gonzalez J, Ahumada-Tamayo S, Viramontes-Aguilar L, Sanchez-Gutierrez O, Davila-Davila B, Rojo-Castillo P, Perez-Montessoro V, Bukowski A, Goss PE. Patient Navigation to Enhance Access to Care for Underserved Patients with a Suspicion or Diagnosis of Cancer. Oncologist. 2019 Sep;24(9):1195-1200. doi: 10.1634/theoncologist.2018-0133. Epub 2018 Nov 29.

    PMID: 30498134BACKGROUND

  • Berkowitz RL, Phillip N, Berry L, Yen IH. Patient Experiences in a Linguistically Diverse Safety Net Primary Care Setting: Qualitative Study. J Particip Med. 2018 Jan 22;10(1):e4. doi: 10.2196/jopm.9229.

    PMID: 33052110BACKGROUND

  • Gunter RL, Chouinard S, Fernandes-Taylor S, Wiseman JT, Clarkson S, Bennett K, Greenberg CC, Kent KC. Current Use of Telemedicine for Post-Discharge Surgical Care: A Systematic Review. J Am Coll Surg. 2016 May;222(5):915-27. doi: 10.1016/j.jamcollsurg.2016.01.062. Epub 2016 Feb 13. No abstract available.

    PMID: 27016900BACKGROUND

  • Sathiyakumar V, Apfeld JC, Obremskey WT, Thakore RV, Sethi MK. Prospective randomized controlled trial using telemedicine for follow-ups in an orthopedic trauma population: a pilot study. J Orthop Trauma. 2015 Mar;29(3):e139-45. doi: 10.1097/BOT.0000000000000189.

    PMID: 24983434BACKGROUND

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    PMID: 29963556BACKGROUND

  • Hwa K, Wren SM. Telehealth follow-up in lieu of postoperative clinic visit for ambulatory surgery: results of a pilot program. JAMA Surg. 2013 Sep;148(9):823-7. doi: 10.1001/jamasurg.2013.2672.

    PMID: 23842982BACKGROUND

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    PMID: 35974252BACKGROUND

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    PMID: 35213441BACKGROUND

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  • Schmidt M, Sondenaa K, Dumot JA, Rosenblatt S, Hausken T, Ramnefjell M, Njolstad G, Eide GE. Post-cholecystectomy symptoms were caused by persistence of a functional gastrointestinal disorder. World J Gastroenterol. 2012 Mar 28;18(12):1365-72. doi: 10.3748/wjg.v18.i12.1365.

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  • Bakillah E, Harbison S, Rosato FE, Altieri MS, Morris JB, Kaufman E, Schapira M, Peifer M, Kelz RR. Telemedicine and Access to Elective Cholecystectomy for Socially Vulnerable Adults: A Pilot Randomized Clinical Trial. JAMA Netw Open. 2024 Oct 1;7(10):e2438137. doi: 10.1001/jamanetworkopen.2024.38137.

    PMID: 39382898DERIVED

MeSH Terms

Conditions

Gallbladder Diseases

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Study Officials

  • Rachel Kelz, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2023

First Posted

February 27, 2023

Study Start

February 16, 2023

Primary Completion

March 4, 2024

Study Completion

May 21, 2024

Last Updated

June 6, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)