Electronic Health Record Strategies to Promote Diverse Participation in Research

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Patient Participation

Intervention / Treatment
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* Other: Traditional Letter
* Other: Direct to Patient Message
* Other: Chatbot
* Other: Banner


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: To examine the effectiveness of enhanced online patient portal features in increasing interest and participation in clinical trials, a randomized trial that will employ a full 2X2X2X2 factorial design.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Intervention<br>*No intervention. | |
| Experimental: Traditional Letter Only<br>*A mailed letter will invite the patient to set up a research profile in their patient portal. | Other: Traditional Letter<br>* Patients receive a traditional letter.<br>|
| Experimental: Direct to Patient Message Only<br>*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. | Other: Direct to Patient Message<br>* Patients receive a direct to patient message via the portal.<br>|
| Experimental: Chatbot Only<br>*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. | Other: Chatbot<br>* Patients are contacted by a chatbot via the portal.<br>|
| Experimental: Banner Only<br>*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. | Other: Banner<br>* Patients are exposed to a banner ad via the portal.<br>|
| Experimental: Traditional Letter + Direct to Patient Message<br>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. | Other: Traditional Letter<br>* Patients receive a traditional letter.<br>Other: Direct to Patient Message<br>* Patients receive a direct to patient message via the portal.<br>|
| Experimental: Traditional Letter + Chatbot<br>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. | Other: Traditional Letter<br>* Patients receive a traditional letter.<br>Other: Chatbot<br>* Patients are contacted by a chatbot via the portal.<br>|
| Experimental: Traditional Letter + Banner<br>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. | Other: Traditional Letter<br>* Patients receive a traditional letter.<br>Other: Banner<br>* Patients are exposed to a banner ad via the portal.<br>|
| Experimental: Direct to Patient Message + Chatbot<br>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. | Other: Direct to Patient Message<br>* Patients receive a direct to patient message via the portal.<br>Other: Chatbot<br>* Patients are contacted by a chatbot via the portal.<br>|
| Experimental: Direct to Patient Message + Banner<br>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. | Other: Direct to Patient Message<br>* Patients receive a direct to patient message via the portal.<br>Other: Banner<br>* Patients are exposed to a banner ad via the portal.<br>|
| Experimental: Chatbot + Banner<br>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. | Other: Chatbot<br>* Patients are contacted by a chatbot via the portal.<br>Other: Banner<br>* Patients are exposed to a banner ad via the portal.<br>|
| Experimental: Traditional Letter + Direct to Patient Message + Chatbot<br>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. | Other: Traditional Letter<br>* Patients receive a traditional letter.<br>Other: Direct to Patient Message<br>* Patients receive a direct to patient message via the portal.<br>Other: Chatbot<br>* Patients are contacted by a chatbot via the portal.<br>|
| Experimental: Traditional Letter + Direct to Patient Message + Banner<br>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. | Other: Traditional Letter<br>* Patients receive a traditional letter.<br>Other: Direct to Patient Message<br>* Patients receive a direct to patient message via the portal.<br>Other: Banner<br>* Patients are exposed to a banner ad via the portal.<br>|
| Experimental: Traditional Letter + Chatbot + Banner<br>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. | Other: Traditional Letter<br>* Patients receive a traditional letter.<br>Other: Chatbot<br>* Patients are contacted by a chatbot via the portal.<br>Other: Banner<br>* Patients are exposed to a banner ad via the portal.<br>|
| Experimental: Direct to Patient Message + Chatbot + Banner<br>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. | Other: Direct to Patient Message<br>* Patients receive a direct to patient message via the portal.<br>Other: Chatbot<br>* Patients are contacted by a chatbot via the portal.<br>Other: Banner<br>* Patients are exposed to a banner ad via the portal.<br>|
| Experimental: Traditional Letter + Direct to Patient Message + Chatbot + Banner<br>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. | Other: Traditional Letter<br>* Patients receive a traditional letter.<br>Other: Direct to Patient Message<br>* Patients receive a direct to patient message via the portal.<br>Other: Chatbot<br>* Patients are contacted by a chatbot via the portal.<br>Other: Banner<br>* Patients are exposed to a banner ad via the portal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who create a research profile | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who enroll in a research study | 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Online Patient Portal