Electronic Health Record Strategies to Promote Diverse Participation in Research

Not Applicable

Completed

• Conditions: Patient Participation
• Interventions: Other: Traditional Letter; Other: Banner; Other: Direct to Patient Message; Other: Chatbot

• Registration Number: NCT05348603
• Lead Sponsor: Yale University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-04-19
• Study First Submitted QC: 2022-04-25
• Study First Posted: 2022-04-27
• Study Start: 2022-09-13
• Primary Completion: 2023-05-15
• Study Completion: 2023-11-14
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 726199

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Traditional Letter + Banner	Banner	* 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.
Traditional Letter + Direct to Patient Message + Chatbot	Direct to Patient Message	* 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.
Direct to Patient Message + Chatbot	Chatbot	* 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.
Traditional Letter + Direct to Patient Message + Banner	Direct to Patient Message	* 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.
Traditional Letter + Direct to Patient Message + Banner	Banner	* 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.
Traditional Letter Only	Traditional Letter	\*A mailed letter will invite the patient to set up a research profile in their patient portal.
Banner Only	Banner	\*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.
Traditional Letter + Banner	Traditional Letter	* 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.
Chatbot + Banner	Chatbot	* 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.
Traditional Letter + Direct to Patient Message + Chatbot	Traditional Letter	* 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.
Traditional Letter + Direct to Patient Message + Chatbot	Chatbot	* 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.
Direct to Patient Message + Chatbot + Banner	Banner	* 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.
Traditional Letter + Direct to Patient Message + Chatbot + Banner	Direct to Patient Message	* 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.
Direct to Patient Message + Banner	Direct to Patient Message	* 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.
Traditional Letter + Direct to Patient Message + Banner	Traditional Letter	* 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.
Traditional Letter + Direct to Patient Message	Traditional Letter	* 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.
Direct to Patient Message Only	Direct to Patient Message	\*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.
Chatbot Only	Chatbot	\*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.
Traditional Letter + Direct to Patient Message	Direct to Patient Message	* 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.
Traditional Letter + Chatbot	Traditional Letter	* 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.
Traditional Letter + Chatbot	Chatbot	* 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.
Direct to Patient Message + Chatbot	Direct to Patient Message	* 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.
Chatbot + Banner	Banner	* 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.
Traditional Letter + Chatbot + Banner	Banner	* 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.
Direct to Patient Message + Banner	Banner	* 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.
Traditional Letter + Chatbot + Banner	Traditional Letter	* 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.
Direct to Patient Message + Chatbot + Banner	Direct to Patient Message	* 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.
Traditional Letter + Direct to Patient Message + Chatbot + Banner	Chatbot	* 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.
Traditional Letter + Chatbot + Banner	Chatbot	* 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.
Direct to Patient Message + Chatbot + Banner	Chatbot	* 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.
Traditional Letter + Direct to Patient Message + Chatbot + Banner	Traditional Letter	* 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.
Traditional Letter + Direct to Patient Message + Chatbot + Banner	Banner	* 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.

Primary Outcome Measures

Name	Time	Method
Number of patients who create a research profile	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.

Secondary Outcome Measures

Name	Time	Method
Number of patients who enroll in a research study	12 months	The outcome will be assessed by querying our clinical trials management system or electronic health record system to determine if the patient has consented to participate in a research study.

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States