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临床试验/NCT05348603
NCT05348603已完成不适用

Leveraging Community Engagement and Electronic Health Record Strategies to Promote Diverse Participation in Clinical Research

Yale University1 个研究点 分布在 1 个国家目标入组 726,199 人开始时间: 2022年9月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
726,199
试验地点
1
主要终点
Number of patients who create a research profile

研究概览

简要总结

The purpose of this study is to determine the effectiveness of enhanced features in an online patient portal including banners, a chatbot, and direct to patient message and traditional mailed letters on increasing interest in research among online patient portal users.

详细描述

The primary objective is to examine the effectiveness of enhanced online patient portal features including banners, a chatbot, and direct to patient message and traditional mailed letters on increasing interest in research among online patient portal users, as measured by the user's creation of a research profile.

The secondary objective is to examine the effectiveness of two enhanced online patient portal features including banners, a chatbot and direct-to-patient messages and traditional mailed letters on increasing participation in research among online patient portal users, as measured by the user joining a research study.

This study tests the hypothesis that at one year follow-up, various user engagement tools (e.g. messaging, banners) will increase the proportion of research profiles created by online patient portal users over profiles created by online patient portal users in the absence of those interventions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

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

  • Has an account with the online patient portal
  • Has logged into the online patient portal at least once in the past year
  • Has not set up a research profile

排除标准

  • Currently enrolled in a clinical trial
  • Opted out of research
  • Has received a direct to patient recruitment message within the past year
  • On active cancer treatment
  • Active member of the study team

研究组 & 干预措施

No Intervention

No Intervention

*No intervention.

Traditional Letter Only

Experimental

*A mailed letter will invite the patient to set up a research profile in their patient portal.

干预措施: Traditional Letter (Other)

Direct to Patient Message Only

Experimental

*An e-mail sent to the patient will inform the patient that there is a message pending in their patient portal regarding opportunities to participate in research.

干预措施: Direct to Patient Message (Other)

Chatbot Only

Experimental

*A real-time, interactive chatbot on the patient portal will encourage research participation and direct patients to learn more about research opportunities and trials that match their interests.

干预措施: Chatbot (Other)

Banner Only

Experimental

*Banner-type "advertisements" will appear during routine viewing and use of of the patient's portal for their our medical/clinical care inform patients of research opportunities.

干预措施: Banner (Other)

Traditional Letter + Direct to Patient Message

Experimental
  • A mailed letter will invite the patient to set up a research profile in their patient portal; AND
  • An e-mail sent to the patient will inform the patient that there is a message pending in their patient portal regarding opportunities to participate in research.

干预措施: Traditional Letter (Other)

Traditional Letter + Direct to Patient Message

Experimental
  • A mailed letter will invite the patient to set up a research profile in their patient portal; AND
  • An e-mail sent to the patient will inform the patient that there is a message pending in their patient portal regarding opportunities to participate in research.

干预措施: Direct to Patient Message (Other)

Traditional Letter + Chatbot

Experimental
  • A mailed letter will invite the patient to set up a research profile in their patient portal; AND
  • A real-time, interactive chatbot will encourage research participation and direct patients to learn more about research opportunities and trials that match their interests.

干预措施: Traditional Letter (Other)

Traditional Letter + Chatbot

Experimental
  • A mailed letter will invite the patient to set up a research profile in their patient portal; AND
  • A real-time, interactive chatbot will encourage research participation and direct patients to learn more about research opportunities and trials that match their interests.

干预措施: Chatbot (Other)

Traditional Letter + Banner

Experimental
  • A mailed letter will invite the patient to set up a research profile in their patient portal; AND
  • Banner-type "advertisements" during routine viewing and use of of the patient's portal for their our medical/clinical care inform patients of research opportunities.

干预措施: Traditional Letter (Other)

Traditional Letter + Banner

Experimental
  • A mailed letter will invite the patient to set up a research profile in their patient portal; AND
  • Banner-type "advertisements" during routine viewing and use of of the patient's portal for their our medical/clinical care inform patients of research opportunities.

干预措施: Banner (Other)

Direct to Patient Message + Chatbot

Experimental
  • An e-mail sent to the patient will inform the patient that there is a message pending in their patient portal regarding opportunities to participate in research; AND
  • A real-time, interactive chatbot will encourage research participation and direct patients to learn more about research opportunities and trials that match their interests.

干预措施: Direct to Patient Message (Other)

Direct to Patient Message + Chatbot

Experimental
  • An e-mail sent to the patient will inform the patient that there is a message pending in their patient portal regarding opportunities to participate in research; AND
  • A real-time, interactive chatbot will encourage research participation and direct patients to learn more about research opportunities and trials that match their interests.

干预措施: Chatbot (Other)

Direct to Patient Message + Banner

Experimental
  • An e-mail sent to the patient will inform the patient that there is a message pending in their patient portal regarding opportunities to participate in research AND
  • Banner-type "advertisements" during routine viewing and use of of the patient's portal for their our medical/clinical care inform patients of research opportunities.

干预措施: Direct to Patient Message (Other)

Direct to Patient Message + Banner

Experimental
  • An e-mail sent to the patient will inform the patient that there is a message pending in their patient portal regarding opportunities to participate in research AND
  • Banner-type "advertisements" during routine viewing and use of of the patient's portal for their our medical/clinical care inform patients of research opportunities.

干预措施: Banner (Other)

Chatbot + Banner

Experimental
  • A real-time, interactive chatbot will encourage research participation and direct patients to learn more about clinical trial opportunities and trials that match their interests; AND
  • Banner-type "advertisements" during routine viewing and use of of the patient's portal for their our medical/clinical care will inform patients of research opportunities.

干预措施: Chatbot (Other)

Chatbot + Banner

Experimental
  • A real-time, interactive chatbot will encourage research participation and direct patients to learn more about clinical trial opportunities and trials that match their interests; AND
  • Banner-type "advertisements" during routine viewing and use of of the patient's portal for their our medical/clinical care will inform patients of research opportunities.

干预措施: Banner (Other)

Traditional Letter + Direct to Patient Message + Chatbot

Experimental
  • A mailed letter will invite the patient to set up a research profile in their patient portal; AND
  • An e-mail sent to the patient will inform the patient that there is a message pending in their patient portal regarding opportunities to participate in research; AND
  • A real-time, interactive chatbot will encourage research participation and direct patients to learn more about research opportunities and trials that match their interests.

干预措施: Traditional Letter (Other)

Traditional Letter + Direct to Patient Message + Chatbot

Experimental
  • A mailed letter will invite the patient to set up a research profile in their patient portal; AND
  • An e-mail sent to the patient will inform the patient that there is a message pending in their patient portal regarding opportunities to participate in research; AND
  • A real-time, interactive chatbot will encourage research participation and direct patients to learn more about research opportunities and trials that match their interests.

干预措施: Direct to Patient Message (Other)

Traditional Letter + Direct to Patient Message + Chatbot

Experimental
  • A mailed letter will invite the patient to set up a research profile in their patient portal; AND
  • An e-mail sent to the patient will inform the patient that there is a message pending in their patient portal regarding opportunities to participate in research; AND
  • A real-time, interactive chatbot will encourage research participation and direct patients to learn more about research opportunities and trials that match their interests.

干预措施: Chatbot (Other)

Traditional Letter + Direct to Patient Message + Banner

Experimental
  • A mailed letter will invite the patient to set up a research profile in their patient portal; AND
  • An e-mail sent to the patient will inform the patient that there is a message pending in their patient portal regarding opportunities to participate in research; AND
  • Banner-type "advertisements" during routine viewing and use of of the patient's portal for their our medical/clinical care inform patients of research opportunities.

干预措施: Traditional Letter (Other)

Traditional Letter + Direct to Patient Message + Banner

Experimental
  • A mailed letter will invite the patient to set up a research profile in their patient portal; AND
  • An e-mail sent to the patient will inform the patient that there is a message pending in their patient portal regarding opportunities to participate in research; AND
  • Banner-type "advertisements" during routine viewing and use of of the patient's portal for their our medical/clinical care inform patients of research opportunities.

干预措施: Direct to Patient Message (Other)

Traditional Letter + Direct to Patient Message + Banner

Experimental
  • A mailed letter will invite the patient to set up a research profile in their patient portal; AND
  • An e-mail sent to the patient will inform the patient that there is a message pending in their patient portal regarding opportunities to participate in research; AND
  • Banner-type "advertisements" during routine viewing and use of of the patient's portal for their our medical/clinical care inform patients of research opportunities.

干预措施: Banner (Other)

Traditional Letter + Chatbot + Banner

Experimental
  • A mailed letter will invite the patient to set up a research profile in their patient portal; AND
  • A real-time, interactive chatbot will encourage research participation and direct patients to learn more about research opportunities and trials that match their interests.

AND

*Banner-type "advertisements" during routine viewing and use of of the patient's portal for their our medical/clinical care inform patients of research opportunities.

干预措施: Traditional Letter (Other)

Traditional Letter + Chatbot + Banner

Experimental
  • A mailed letter will invite the patient to set up a research profile in their patient portal; AND
  • A real-time, interactive chatbot will encourage research participation and direct patients to learn more about research opportunities and trials that match their interests.

AND

*Banner-type "advertisements" during routine viewing and use of of the patient's portal for their our medical/clinical care inform patients of research opportunities.

干预措施: Chatbot (Other)

Traditional Letter + Chatbot + Banner

Experimental
  • A mailed letter will invite the patient to set up a research profile in their patient portal; AND
  • A real-time, interactive chatbot will encourage research participation and direct patients to learn more about research opportunities and trials that match their interests.

AND

*Banner-type "advertisements" during routine viewing and use of of the patient's portal for their our medical/clinical care inform patients of research opportunities.

干预措施: Banner (Other)

Direct to Patient Message + Chatbot + Banner

Experimental
  • An e-mail sent to the patient will inform the patient that there is a message pending in their patient portal regarding opportunities to participate in research; AND
  • A real-time, interactive chatbot will encourage research participation and direct patients to learn more about research opportunities and trials that match their interests; AND
  • Banner-type "advertisements" during routine viewing and use of of the patient's portal for their our medical/clinical care inform patients of research opportunities.

干预措施: Direct to Patient Message (Other)

Direct to Patient Message + Chatbot + Banner

Experimental
  • An e-mail sent to the patient will inform the patient that there is a message pending in their patient portal regarding opportunities to participate in research; AND
  • A real-time, interactive chatbot will encourage research participation and direct patients to learn more about research opportunities and trials that match their interests; AND
  • Banner-type "advertisements" during routine viewing and use of of the patient's portal for their our medical/clinical care inform patients of research opportunities.

干预措施: Chatbot (Other)

Direct to Patient Message + Chatbot + Banner

Experimental
  • An e-mail sent to the patient will inform the patient that there is a message pending in their patient portal regarding opportunities to participate in research; AND
  • A real-time, interactive chatbot will encourage research participation and direct patients to learn more about research opportunities and trials that match their interests; AND
  • Banner-type "advertisements" during routine viewing and use of of the patient's portal for their our medical/clinical care inform patients of research opportunities.

干预措施: Banner (Other)

Traditional Letter + Direct to Patient Message + Chatbot + Banner

Experimental
  • A mailed letter will invite the patient to set up a research profile in their patient portal; AND
  • An e-mail sent to the patient will inform the patient that there is a message pending in their patient portal regarding opportunities to participate in research; AND
  • A real-time, interactive chatbot will encourage research participation and direct patients to learn more about research opportunities and trials that match their interests; AND
  • Banner-type "advertisements" during routine viewing and use of of the patient's portal for their our medical/clinical care inform patients of research opportunities.

干预措施: Traditional Letter (Other)

Traditional Letter + Direct to Patient Message + Chatbot + Banner

Experimental
  • A mailed letter will invite the patient to set up a research profile in their patient portal; AND
  • An e-mail sent to the patient will inform the patient that there is a message pending in their patient portal regarding opportunities to participate in research; AND
  • A real-time, interactive chatbot will encourage research participation and direct patients to learn more about research opportunities and trials that match their interests; AND
  • Banner-type "advertisements" during routine viewing and use of of the patient's portal for their our medical/clinical care inform patients of research opportunities.

干预措施: Direct to Patient Message (Other)

Traditional Letter + Direct to Patient Message + Chatbot + Banner

Experimental
  • A mailed letter will invite the patient to set up a research profile in their patient portal; AND
  • An e-mail sent to the patient will inform the patient that there is a message pending in their patient portal regarding opportunities to participate in research; AND
  • A real-time, interactive chatbot will encourage research participation and direct patients to learn more about research opportunities and trials that match their interests; AND
  • Banner-type "advertisements" during routine viewing and use of of the patient's portal for their our medical/clinical care inform patients of research opportunities.

干预措施: Chatbot (Other)

Traditional Letter + Direct to Patient Message + Chatbot + Banner

Experimental
  • A mailed letter will invite the patient to set up a research profile in their patient portal; AND
  • An e-mail sent to the patient will inform the patient that there is a message pending in their patient portal regarding opportunities to participate in research; AND
  • A real-time, interactive chatbot will encourage research participation and direct patients to learn more about research opportunities and trials that match their interests; AND
  • Banner-type "advertisements" during routine viewing and use of of the patient's portal for their our medical/clinical care inform patients of research opportunities.

干预措施: Banner (Other)

结局指标

主要结局

Number of patients who create a research profile

时间窗: 12 months

The outcome will be assessed by querying the patient's electronic medical record to determine whether the patient has registered in the Yale University Volunteer Database. This database is comprised of patients who agree to be contacted if there is a study at Yale that meets their interests.

次要结局

  • Number of patients who enroll in a research study(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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