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临床试验/NCT05721326
NCT05721326
已完成
不适用

Sequential EHR Based Interventions to Increase Genetic Testing for Breast and Ovarian Cancer Predisposition Across Diverse Patient Populations in Gynecology Practices at Penn Medicine

Abramson Cancer Center at Penn Medicine2 个研究点 分布在 1 个国家目标入组 1,330 人2023年5月1日

概览

阶段
不适用
干预措施
Sequential EHR Communications
疾病 / 适应症
Genetic Predisposition to Disease
发起方
Abramson Cancer Center at Penn Medicine
入组人数
1330
试验地点
2
主要终点
Number of Genetic Counseling Appointments Completed Following Provider Nudge
状态
已完成
最后更新
3个月前

概览

简要总结

The goal of this sequential study design is to increase genetic testing in those meeting national clinical guidelines. The main question it aims to answer is: which intervention is most effective in uptake of genetic testing for the target population? Participants will receive genetic testing and counseling that may initiate life-saving screenings.

详细描述

Germline genetic testing is recommended by the National Cancer Center Network (NCCN) for individuals with a personal history of ovarian cancer, young-onset (\<50 years) breast cancer, and a family history of ovarian cancer or male breast cancer, among others. Recent publications demonstrate that the uptake of genetic testing is under-utilized, overall, and rates are consistently lower in minority populations. EHR-based algorithms will be used to identify patients of two Penn Medicine Ob/Gyn practices for whom genetic testing is recommended based on NCCN guidelines and to test pragmatic methods using messages delivered to patients or clinicians to encourage testing. The ACC Electronic Phenotyping Core developed the algorithms based on cancer registry data along with family history fields and this study will develop and test messages directed at patients and clinicians to encourage testing. The aims are: 1. Identification of at-risk populations through electronic health record (EHR) searches followed by patient nudges (MPM and then Way To Health) to increase the uptake of genetic counseling referral and testing in patients at gynecology practices at Dickens Center and Penn Medicine Radnor. 2. In patients who have not responded to patient nudges (Aim 1), test a provider nudge to increase the uptake of genetic counseling referral and testing in gynecology practices at Dickens Center and Penn Medicine Radnor (Aim 2).

注册库
clinicaltrials.gov
开始日期
2023年5月1日
结束日期
2025年12月31日
最后更新
3个月前
研究类型
Interventional
研究设计
Sequential
性别
Female

研究者

入排标准

入选标准

  • Patients with serous ovarian cancer diagnosed more than two years prior to study contact
  • Patients with breast cancer diagnosed at \<50 years of age more than two years prior to study contact
  • Patients with triple negative breast cancer diagnosed more than two years prior to study contact
  • Unaffected individuals reporting a family history of ovarian cancer
  • Unaffected individuals reporting a family history of male breast cancer
  • Unaffected individuals reporting a family history of breast cancer \<50 years

排除标准

  • 1\. Patients who have previously received genetic counseling and/or testing

研究组 & 干预措施

Sequential Communications

This sequential arm contains three types of communication to be employed following non-response to the previous type. The initial communication will be a direct message to the patient via the MyPennMedicine. The subsequent message will be sent as a text via the Way To Health app(lication). The final communication will be a nudge to the patient's physician which will send upon opening the patient's chart and will remain as a flag thereafter.

干预措施: Sequential EHR Communications

结局指标

主要结局

Number of Genetic Counseling Appointments Completed Following Provider Nudge

时间窗: Within six months of provider nudge

Scheduling and completion of genetic counseling appointments will be monitored through EHR. The provider nudge will be delivered as a Best Practice Alert (BPA) upon opening the patient's chart.

Number of Genetic Counseling Appointments Completed Following MPM Delivery

时间窗: Within six months of MPM delivery

Scheduling and completion of genetic counseling appointments will be monitored through EHR. MPM stands for MyPennMedicine message which will be sent directly to the patient through the medical record.

次要结局

  • Response Rate of Way To Health text(Within one month of receiving text)
  • Open Rate of MPM(Within one month of receiving MPM)

研究点 (2)

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