Using Data to Achieve Surgical Health Equity in the Community

Study Overview
=================
Brief 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: What racial barriers in outcome exist for socially vulnerable patients with gallbladder disease? 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.

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: 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.

Official Title
-----------------
Using Data to Achieve Surgical Health Equity in the Community

Conditions
-----------------
Gallbladder Disease

Intervention / Treatment
-----------------
* Behavioral: Telemedicine Consultation
* Behavioral: Traditional Care


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Cost | Cost of care including preoperative consultation visit with the surgeon and cholecystectomy visit. Data will be obtained from Horizon Performance Manager. | 6 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Elective Cholecystectomy, Social Determinants of Health, Telemedicine, Emergency Cholecystectomy