Using Data to Achieve Surgical Health Equity in the Community
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Cholecystectomy Surgical Outcome
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •History of prior cholecystectomy
- •GB cancer
- •Advanced cirrhosis
- •Untreated coagulopathy
- •No indication for surgery
- •Unable/unwilling to provide consent
结局指标
主要结局
Cholecystectomy Surgical Outcome
时间窗: 6 Months
Compare rates of surgical consultation by consultation type.
次要结局
- Completion of Consultation(6 Months)
- Urgency of Operative Treatment(6 Months)
- Effect of Consultation on Surgical Outcome.(6 Months)
- Cost(6 Months)
- Time from Referral to Consultation(6 Months)