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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05348603
Enrollment
726199
Registered
2022-04-27
Start date
2022-09-13
Completion date
2023-11-14
Last updated
2023-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Participation

Keywords

Online Patient Portal

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.

Interventions

Patients receive a traditional letter.

Patients receive a direct to patient message via the portal.

OTHERChatbot

Patients are contacted by a chatbot via the portal.

OTHERBanner

Patients are exposed to a banner ad via the portal.

Sponsors

Food and Drug Administration (FDA)
CollaboratorFED
Yale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients who create a research profile12 monthsThe 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

MeasureTime frameDescription
Number of patients who enroll in a research study12 monthsThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026