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Using Data to Achieve Surgical Health Equity in the Community

Primary Purpose

Gallbladder Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telemedicine Consultation
Traditional Care
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gallbladder Disease focused on measuring Social Determinants of Health, Telemedicine, Elective Cholecystectomy, Emergency Cholecystectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital of the University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telemedicine Consultation

Traditional In-Person Care

Arm Description

Patient will schedule a Telemedicine Consultation in place of traditional in-person visit.

Patient will schedule a traditional in-person visit as per usual care.

Outcomes

Primary Outcome Measures

Cholecystectomy Surgical Outcome
Compare rates of surgical consultation by consultation type.

Secondary Outcome Measures

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.
Completion of Consultation
Completion of initial pre-operative consultation visit with surgeon for patients referred to surgery. Identified by EMR documentation and encounter visits.
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).
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).
Cost
Cost of care including preoperative consultation visit with the surgeon and cholecystectomy visit. Data will be obtained from Horizon Performance Manager.

Full Information

First Posted
January 31, 2023
Last Updated
September 5, 2023
Sponsor
University of Pennsylvania
Collaborators
Leonard Davis Institute of Health Economics
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1. Study Identification

Unique Protocol Identification Number
NCT05745077
Brief Title
Using Data to Achieve Surgical Health Equity in the Community
Official Title
Using Data to Achieve Surgical Health Equity in the Community
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 16, 2023 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Leonard Davis Institute of Health Economics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallbladder Disease
Keywords
Social Determinants of Health, Telemedicine, Elective Cholecystectomy, Emergency Cholecystectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telemedicine Consultation
Arm Type
Experimental
Arm Description
Patient will schedule a Telemedicine Consultation in place of traditional in-person visit.
Arm Title
Traditional In-Person Care
Arm Type
Active Comparator
Arm Description
Patient will schedule a traditional in-person visit as per usual care.
Intervention Type
Behavioral
Intervention Name(s)
Telemedicine Consultation
Intervention Description
Patients will be contacted by their surgeon over the phone to discuss surgical treatment.
Intervention Type
Behavioral
Intervention Name(s)
Traditional Care
Intervention Description
Patients will proceed with their surgical consultation as per standard practice.
Primary Outcome Measure Information:
Title
Cholecystectomy Surgical Outcome
Description
Compare rates of surgical consultation by consultation type.
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Time from Referral to Consultation
Description
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.
Time Frame
6 Months
Title
Completion of Consultation
Description
Completion of initial pre-operative consultation visit with surgeon for patients referred to surgery. Identified by EMR documentation and encounter visits.
Time Frame
6 Months
Title
Effect of Consultation on Surgical Outcome.
Description
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).
Time Frame
6 Months
Title
Urgency of Operative Treatment
Description
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).
Time Frame
6 Months
Title
Cost
Description
Cost of care including preoperative consultation visit with the surgeon and cholecystectomy visit. Data will be obtained from Horizon Performance Manager.
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emna Bakillah, MD
Phone
267-624-3566
Email
Emna.bakillah@pennmedicine.upenn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Kelz, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emna Bakillah, MD
Phone
267-624-3566
Email
emna.bakillah@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Rachel Kelz, MD

12. IPD Sharing Statement

Plan to Share IPD
No
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Using Data to Achieve Surgical Health Equity in the Community

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