Using Data to Achieve Surgical Health Equity in the Community (NCT05745077) | Clinical Trial Compass
CompletedNot Applicable
Using Data to Achieve Surgical Health Equity in the Community
United States60 participantsStarted 2023-02-16
Plain-language 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. 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?
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* History of prior cholecystectomy
* Prisoner
* GB cancer
* Advanced cirrhosis
* Untreated coagulopathy
* No indication for surgery
* Unable/unwilling to provide consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.