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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:
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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemedicine Consultation | Experimental | Patient will schedule a Telemedicine Consultation in place of traditional in-person visit. |
|
| Traditional In-Person Care | Active Comparator | Patient will schedule a traditional in-person visit as per usual care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemedicine Consultation | Behavioral | Patients will be contacted by their surgeon over the phone to discuss surgical treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cholecystectomy Surgical Outcome | Compare rates of surgical consultation by consultation type. | 6 Months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Kelz, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Cox, M.R., G.D. Eslick, and R. Padbury, The management of gallstone disease: a practical and evidence-based approach. 2018: Springer. | ||
| 29063306 | Background | Altieri MS, Yang J, Zhu C, Sbayi S, Spaniolas K, Talamini M, Pryor A. What happens to biliary colic patients in New York State? 10-year follow-up from emergency department visits. Surg Endosc. 2018 Apr;32(4):2058-2066. doi: 10.1007/s00464-017-5902-5. Epub 2017 Oct 23. | |
| Background | Prevention, C.f.D.C.a. Adult Obesity Facts. Division of Nutrition, Physical Activity, and Obesity, National Center for Chronic Disease Prevention and Health Promotion 2022 May 17, 2022 [cited 2022 September 19, 2022]; Available from: https://www.cdc.gov/obesity/data/adult.html#:~:text=Obesity%20affects%20some%20groups%20more%20than%20others&text=Non%2DHispanic%20Black%20adults%20(49.9,Hispanic%20Asian%20adults%20(16.1%25).%20Accessed%2009/18/2022. | ||
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 22, 2022 | Feb 10, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005705 | Gallbladder Diseases |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| Traditional Care | Behavioral | Patients will proceed with their surgical consultation as per standard practice. |
|
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 |
| Background |
| Overby DW, Apelgren KN, Richardson W, Fanelli R; Society of American Gastrointestinal and Endoscopic Surgeons. SAGES guidelines for the clinical application of laparoscopic biliary tract surgery. Surg Endosc. 2010 Oct;24(10):2368-86. doi: 10.1007/s00464-010-1268-7. Epub 2010 Aug 13. No abstract available. |
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| 39382898 | Derived | Bakillah E, Harbison S, Rosato FE, Altieri MS, Morris JB, Kaufman E, Schapira M, Peifer M, Kelz RR. Telemedicine and Access to Elective Cholecystectomy for Socially Vulnerable Adults: A Pilot Randomized Clinical Trial. JAMA Netw Open. 2024 Oct 1;7(10):e2438137. doi: 10.1001/jamanetworkopen.2024.38137. |