Electronic Health Record Strategies to Promote Diverse Participation in Research
Leveraging Community Engagement and Electronic Health Record Strategies to Promote Diverse Participation in Clinical Research
2 other identifiers
interventional
726,199
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2022
CompletedFirst Posted
Study publicly available on registry
April 27, 2022
CompletedStudy Start
First participant enrolled
September 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 14, 2023
CompletedDecember 11, 2023
December 1, 2023
8 months
April 19, 2022
December 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Number of patients who enroll in a research study
12 months
Study Arms (16)
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Interventions
Patients receive a traditional letter.
Patients receive a direct to patient message via the portal.
Patients are contacted by a chatbot via the portal.
Patients are exposed to a banner ad via the portal.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- Food and Drug Administration (FDA)collaborator
Study Sites (1)
Yale University
New Haven, Connecticut, 06511, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian Smith, MD
Yale University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2022
First Posted
April 27, 2022
Study Start
September 13, 2022
Primary Completion
May 15, 2023
Study Completion
November 14, 2023
Last Updated
December 11, 2023
Record last verified: 2023-12