Using Data to Achieve Surgical Health Equity in the Community

June 4, 2024 updated by: University of Pennsylvania

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telemedicine Consultation
Patient will schedule a Telemedicine Consultation in place of traditional in-person visit.
Behavioral: Telemedicine Consultation
Patients will be contacted by their surgeon over the phone to discuss surgical treatment.
Active Comparator: Traditional In-Person Care
Patient will schedule a traditional in-person visit as per usual care.
Behavioral: Traditional Care
Patients will proceed with their surgical consultation as per standard practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cholecystectomy Surgical Outcome
Time Frame: 6 Months
Compare rates of surgical consultation by consultation type.
6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 Months
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.
6 Months
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).
6 Months
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).
6 Months
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.
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

Leonard Davis Institute of Health Economics

Investigators

  • Principal Investigator: Rachel Kelz, MD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2023

Primary Completion (Actual)

March 4, 2024

Study Completion (Actual)

May 21, 2024

Study Registration Dates

First Submitted

January 31, 2023

First Submitted That Met QC Criteria

February 22, 2023

First Posted (Actual)

February 27, 2023

Study Record Updates

Last Update Posted (Actual)

June 6, 2024

Last Update Submitted That Met QC Criteria

June 4, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 852524

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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