Using Data to Achieve Surgical Health Equity in the Community

Gallbladder Disease Clinical Trial

Official title:

Using Data to Achieve Surgical Health Equity in the Community

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05745077
• Other study ID #: 852524
• Status: Completed
• Phase: N/A
• Start date: February 16, 2023
• Est. completion date: May 21, 2024

Study information

• Verified date: June 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 21, 2024
• Est. primary completion date: March 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gallbladder Disease
• Gallbladder Diseases

Intervention

Behavioral:
• Telemedicine Consultation
Patients will be contacted by their surgeon over the phone to discuss surgical treatment.
• Traditional Care
Patients will proceed with their surgical consultation as per standard practice.

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Leonard Davis Institute of Health Economics

Country where clinical trial is conducted

United States, 

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cholecystectomy Surgical Outcome	Compare rates of surgical consultation by consultation type.	6 Months
Secondary	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.	6 Months
Secondary	Completion of Consultation	Completion of initial pre-operative consultation visit with surgeon for patients referred to surgery. Identified by EMR documentation and encounter visits.	6 Months
Secondary	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).	6 Months
Secondary	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).	6 Months
Secondary	Cost	Cost of care including preoperative consultation visit with the surgeon and cholecystectomy visit. Data will be obtained from Horizon Performance Manager.	6 Months