跳至主要内容
临床试验/NCT06422455
NCT06422455招募中不适用

Increasing Access to Genetic Testing in Underserved Patients Using a Multilingual Conversational Agent

University of Southern California2 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2023年10月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
800
试验地点
2
主要终点
Proportion of participants who receive genetic testing

研究概览

简要总结

This study compares the experiences of people who receive information about genetic testing from a computer-generated character to patients who receive information from a human genetics healthcare provider. Patients with cancer are increasingly recommended for genetic testing as standard of care. Multiple factors contribute to low usage of genetic testing but for many patients the lack of access to genetic counseling and testing is an important and flexible factor. Lack of access is especially relevant to racial/ethnic minority patients and those living in non-metropolitan rural settings who are frequently cared for at safety-net hospitals with limited genetics services. Alternative delivery models are necessary to improve rates of access to genetic testing in patients with cancer. Health information technology is under used by genetics providers. A patient-facing relational agent (PERLA) will provide pre-test genetics education in both English and Spanish across two clinical settings to facilitate more timely access to genetic testing. Using the PERLA intervention may help researchers learn different ways to provide education about genetic testing to patients with cancer compared to usual care.

详细描述

PRIMARY OBJECTIVES:

I. To obtain patient and provider input on the optimal content and format of a new relational agent (RA) intervention ("PERLA") for automated pre-test genetics education.

II. To obtain patient feedback on the usability of the English- and Spanish-language PERLAs.

III. To determine the acceptability of the newly designed English- and Spanish-language PERLAs among patients with cancer.

IV. To evaluate the impact of the English- and Spanish-language PERLAs on the proportion of patients who meet cancer-based genetic testing guidelines who receive genetic test results within 3 months of initiating cancer care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
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

入选标准

  • Age > 18 years old
  • Diagnosed with least one of the following:
  • Epithelial ovarian cancer
  • Exocrine pancreatic cancer
  • Metastatic or high or very high-risk prostate cancer
  • Breast cancer at or before age 50
  • Bilateral breast cancer
  • Triple negative breast cancer
  • Male breast cancer OR
  • Healthcare provider who treats patients with any of the above types of cancer
  • Able to read and write in English or Spanish
  • Able to provide informed consent

排除标准

  • Patients who cannot provide informed consent
  • Patients who cannot see, read, or write
  • Patients who have the cancer and clinical characteristics defined in the inclusion criteria, but who do not speak English or Spanish
  • Patients with none of the listed cancer diagnoses and clinical characteristics
  • Healthcare provider who do not treats cancer patients

研究组 & 干预措施

Intervention Phase Arm A (PERLA)

Experimental

Patients receive access to PERLA comprising pre-test genetics education and standard post-test provider-based genetic counseling over 20-60 minutes. .

干预措施: Electronic Health Record Review (Other)

Intervention Phase Arm A (PERLA)

Experimental

Patients receive access to PERLA comprising pre-test genetics education and standard post-test provider-based genetic counseling over 20-60 minutes. .

干预措施: Interview (Other)

Intervention Phase Arm A (PERLA)

Experimental

Patients receive access to PERLA comprising pre-test genetics education and standard post-test provider-based genetic counseling over 20-60 minutes. .

干预措施: Genetic Counseling (Other)

Intervention Phase Arm A (PERLA)

Experimental

Patients receive access to PERLA comprising pre-test genetics education and standard post-test provider-based genetic counseling over 20-60 minutes. .

干预措施: Educational Intervention (Other)

Intervention Phase Arm A (PERLA)

Experimental

Patients receive access to PERLA comprising pre-test genetics education and standard post-test provider-based genetic counseling over 20-60 minutes. .

干预措施: Survey Administration (Other)

Intervention Phase Arm B (usual care)

Active Comparator

Patients receive access to usual care pre- and post-test provider-based genetic counseling.

干预措施: Best Practice (Other)

Intervention Phase Arm B (usual care)

Active Comparator

Patients receive access to usual care pre- and post-test provider-based genetic counseling.

干预措施: Electronic Health Record Review (Other)

Intervention Phase Arm B (usual care)

Active Comparator

Patients receive access to usual care pre- and post-test provider-based genetic counseling.

干预措施: Survey Administration (Other)

结局指标

主要结局

Proportion of participants who receive genetic testing

时间窗: Up to 3 months

The proportion of participants who receive genetic testing will be reported.

次要结局

  • Patient-reported outcomes(Up to 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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