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Gallbladder DiseaseNCT05745077

Using Data to Achieve Surgical Health Equity in the Community

A study testing Telemedicine Consultation and Traditional Care in people with Gallbladder Disease, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gallbladder Disease
What is being tested?
Telemedicine Consultation and Traditional Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
16 Feb 2023to 21 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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

Study participants will be asked to undergo telemedicine consultation in place of regular consultation with their doctor before undergoing treatment.

Researchers will compare the telemedicine consultation groups with traditional care patients to see if telemedicine consultation is effective at reducing surgical disparity outcomes.

Read the detailed description

This study seeks to identify differences in the care paradigms to find and test solutions to racial disparities in emergent cholecystectomy, as well as develop and test a pilot study to compare the effectiveness of telemedicine consultation. To address surgical health equity in patients with gallbladder disease, this study aims to:

  1. Examine racial disparities in outcomes of Primary Care Service Line (PCSL) patients with symptomatic GB disease with attention to conditional effects of social vulnerabilities (SV)
  2. Compare the effectiveness study of telemedicine consultation for symptomatic GB disease in patients with social vulnerabilities

This study will be divided into two phases to address each aim. The first aim will be conducted as a retrospective cohort study and examine the outcomes of PCSL patients diagnosed with symptomatic GB disease between Jan. 1, 2020 and Sept. 30, 2022 using PennMedicine data to build regression models with interaction terms to examine racial disparities in surgical consultation and the conditional effects of SV factors on this relationship. The second aim will be performed as a pragmatic pilot trial of Penn PCSL patients with SV. For this aim, the investigators will pragmatically assign two groups to traditional care and telemedicine consultation and study the resultant outcomes from patients with diagnosed with symptomatic cholelithiasis or biliary colic as seen by a PCSL provider between April 1, and June 30, 2023. These results will provide data to develop evidence-based solutions to racial disparities within Penn Medicine and to serve as preliminary data for subsequent studies to promote health equity in patients with symptomatic GBD.

Being tested
Telemedicine Consultation, Traditional Care
Keywords
Social Determinants of Health, Telemedicine, Elective Cholecystectomy, Emergency Cholecystectomy
Medical subject headings
Gallbladder Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telemedicine ConsultationBehavioural

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

  • Traditional CareBehavioural

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

Study groups in NCT05745077
Study groupRoleWhat they receive
Telemedicine ConsultationExperimentalPatient will schedule a Telemedicine Consultation in place of traditional in-person visit.
Receives: Behavioral: Telemedicine Consultation
Traditional In-Person CareActive comparatorPatient will schedule a traditional in-person visit as per usual care.
Receives: Behavioral: Traditional Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cholecystectomy Surgical Outcome

    Compare rates of surgical consultation by consultation type.

    Measured: 6 Months

Secondary outcomes (5)

  1. Time from Referral to Consultation

    Number of days between initial documentation of referral to surgery by provider and initial pre-operative consultation with surgeon by consultation type. Identified by EMR documentation and encounter visits.

    Measured: 6 Months

  2. Completion of Consultation

    Completion of initial pre-operative consultation visit with surgeon for patients referred to surgery. Identified by EMR documentation and encounter visits.

    Measured: 6 Months

  3. Effect of Consultation on Surgical Outcome.

    Operative treatment outcomes received by patients who received pre-operative consultation with the surgeon. Operative treatment will be determined using CPT and ICD-10-PCS codes for cholecystectomy as listed in HPM (CPT 47562, CPT 47563, CPT 47600, CPT 47605, CPT 56340, CPT 56341, ICD10 0FB40ZX, ICD10 OFB40ZZ, ICD10 OFT40ZZ).

    Measured: 6 Months

  4. Urgency of Operative Treatment

    Urgency for operative treatment for whether cholecystectomy was performed in the emergent or elective setting as determined by admission source for the associated operative encounter and CPT and ICD-10-PCS codes for cholecystectomy as listed in HPM (CPT 47562, CPT 47563, CPT 47600, CPT 47605, CPT 56340, CPT 56341, ICD10 0FB40ZX, ICD10 OFB40ZZ, ICD10 OFT40ZZ).

    Measured: 6 Months

  5. Cost

    Cost of care including preoperative consultation visit with the surgeon and cholecystectomy visit. Data will be obtained from Horizon Performance Manager.

    Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2023
  2. Study start16 Feb 2023
  3. Primary completion4 Mar 2024
  4. Study completion21 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05745077
Sponsor's protocol ID
852524
Status last verified
Jun 2024
First submitted
31 Jan 2023
Last updated
6 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cox, M.R., G.D. Eslick, and R. Padbury, The management of gallstone disease: a practical and evidence-based approach. 2018: Springer.

  • Altieri MS, Yang J, Zhu C, Sbayi S, Spaniolas K, Talamini M, Pryor A. What happens to biliary colic patients in New York State? 10-year follow-up from emergency department visits. Surg Endosc. 2018 Apr;32(4):2058-2066. doi: 10.1007/s00464-017-5902-5. Epub 2017 Oct 23.

    PubMed 29063306

  • Prevention, C.f.D.C.a. Adult Obesity Facts. Division of Nutrition, Physical Activity, and Obesity, National Center for Chronic Disease Prevention and Health Promotion 2022 May 17, 2022 [cited 2022 September 19, 2022]; Available from: https://www.cdc.gov/obesity/data/adult.html#:~:text=Obesity%20affects%20some%20groups%20more%20than%20others&text=Non%2DHispanic%20Black%20adults%20(49.9,Hispanic%20Asian%20adults%20(16.1%25).%20Accessed%2009/18/2022.

  • Overby DW, Apelgren KN, Richardson W, Fanelli R; Society of American Gastrointestinal and Endoscopic Surgeons. SAGES guidelines for the clinical application of laparoscopic biliary tract surgery. Surg Endosc. 2010 Oct;24(10):2368-86. doi: 10.1007/s00464-010-1268-7. Epub 2010 Aug 13. No abstract available.

    PubMed 20706739

  • Radunovic M, Lazovic R, Popovic N, Magdelinic M, Bulajic M, Radunovic L, Vukovic M, Radunovic M. Complications of Laparoscopic Cholecystectomy: Our Experience from a Retrospective Analysis. Open Access Maced J Med Sci. 2016 Dec 15;4(4):641-646. doi: 10.3889/oamjms.2016.128. Epub 2016 Nov 9.

    PubMed 28028405

  • Cheruvu CV, Eyre-Brook IA. Consequences of prolonged wait before gallbladder surgery. Ann R Coll Surg Engl. 2002 Jan;84(1):20-2.

    PubMed 11892728

  • Sobolev B, Mercer D, Brown P, FitzGerald M, Jalink D, Shaw R. Risk of emergency admission while awaiting elective cholecystectomy. CMAJ. 2003 Sep 30;169(7):662-5.

    PubMed 14517123

  • To KB, Cherry-Bukowiec JR, Englesbe MJ, Terjimanian MN, Shijie C, Campbell DA Jr, Napolitano LM. Emergent versus elective cholecystectomy: conversion rates and outcomes. Surg Infect (Larchmt). 2013 Dec;14(6):512-9. doi: 10.1089/sur.2012.160. Epub 2013 Nov 25.

    PubMed 24274058

  • Rutledge D, Jones D, Rege R. Consequences of delay in surgical treatment of biliary disease. Am J Surg. 2000 Dec;180(6):466-9. doi: 10.1016/s0002-9610(00)00520-1.

    PubMed 11182399

  • Munoz E, Tinker MA, Margolis I, Wise L. Surgonomics: the cost of cholecystectomy. Surgery. 1984 Oct;96(4):642-7.

    PubMed 6435271

  • Carmichael H, Moore A, Steward L, Velopulos CG. Using the Social Vulnerability Index to Examine Local Disparities in Emergent and Elective Cholecystectomy. J Surg Res. 2019 Nov;243:160-164. doi: 10.1016/j.jss.2019.05.022. Epub 2019 Jun 6.

    PubMed 31177035

  • Lin JA, Braun HJ, Schwab ME, Pierce L, Sosa JA, Wick EC. Pandemic Recovery: Persistent Disparities in Access to Elective Surgical Procedures. Ann Surg. 2023 Jan 1;277(1):57-65. doi: 10.1097/SLA.0000000000004848. Epub 2021 Mar 3.

    PubMed 33914483

  • 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.

    PubMed 34953371

  • 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.

    PubMed 34087621

  • 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.

    PubMed 35039411

Questions about this trial

What is this clinical trial studying?

A study testing Telemedicine Consultation and Traditional Care in people with Gallbladder Disease, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cholecystectomy Surgical Outcome (time frame: 6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05745077, which also lists 33 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.

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