Electronic Health Record Strategies to Promote Diverse Participation in Research

December 7, 2023 updated by: Yale University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

726199

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Yale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

Food and Drug Administration (FDA)

Investigators

  • Principal Investigator: Brian Smith, MD, Yale School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2022

Primary Completion (Actual)

May 15, 2023

Study Completion (Actual)

November 14, 2023

Study Registration Dates

First Submitted

April 19, 2022

First Submitted That Met QC Criteria

April 25, 2022

First Posted (Actual)

April 27, 2022

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2000032716
  • 75F40120C00174 (Other Grant/Funding Number: FDA)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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