Skip to main content
OpenTrials
Completed

NCT Number: NCT05745077

Using Data to Achieve Surgical Health Equity in the Community

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gallbladder Disease Biliary Tract Diseases Digestive System Diseases Gallbladder Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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:

  • 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)
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telemedicine Consultation

Behavioral

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

Traditional Care

Behavioral

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

Primary outcomes

  1. Cholecystectomy Surgical Outcome

    Time frame: 6 Months

    Compare rates of surgical consultation by consultation type.

Secondary outcomes

  1. Time from Referral to Consultation

    Time frame: 6 Months

    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.

  2. Completion of Consultation

    Time frame: 6 Months

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

  3. Effect of Consultation on Surgical Outcome.

    Time frame: 6 Months

    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).

  4. Urgency of Operative Treatment

    Time frame: 6 Months

    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).

  5. Cost

    Time frame: 6 Months

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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 27, 2023
Registry last updated
Jun 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.