Electronic Health Record Strategies to Promote Diverse Participation in Research

Patient Participation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05348603
• Other study ID #: 2000032716
• Secondary ID: 75F40120C00174
• Status: Completed
• Phase: N/A
• Start date: September 13, 2022
• Est. completion date: November 14, 2023

Study information

• Verified date: December 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 726199
• Est. completion date: November 14, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patient Participation

Intervention

Other:
• Traditional Letter
Patients receive a traditional letter.
• Direct to Patient Message
Patients receive a direct to patient message via the portal.
• Chatbot
Patients are contacted by a chatbot via the portal.
• Banner
Patients are exposed to a banner ad via the portal.

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Food and Drug Administration (FDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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