Electronic Health Record Strategies to Promote Diverse Participation in Research

NCT ID: NCT05348603

Last Updated: 2023-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

726199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-13

Study Completion Date

2023-11-14

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.

Conditions

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Patient Participation

Keywords

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Online Patient Portal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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No Intervention

\*No intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Traditional Letter Only

\*A mailed letter will invite the patient to set up a research profile in their patient portal.

Group Type EXPERIMENTAL

Traditional Letter

Intervention Type OTHER

Patients receive a traditional letter.

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.

Group Type EXPERIMENTAL

Direct to Patient Message

Intervention Type OTHER

Patients receive a direct to patient message via the portal.

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.

Group Type EXPERIMENTAL

Chatbot

Intervention Type OTHER

Patients are contacted by a chatbot via the portal.

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.

Group Type EXPERIMENTAL

Banner

Intervention Type OTHER

Patients are exposed to a banner ad via the portal.

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.

Group Type EXPERIMENTAL

Traditional Letter

Intervention Type OTHER

Patients receive a traditional letter.

Direct to Patient Message

Intervention Type OTHER

Patients receive a direct to patient message via the portal.

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.

Group Type EXPERIMENTAL

Traditional Letter

Intervention Type OTHER

Patients receive a traditional letter.

Chatbot

Intervention Type OTHER

Patients are contacted by a chatbot via the portal.

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.

Group Type EXPERIMENTAL

Traditional Letter

Intervention Type OTHER

Patients receive a traditional letter.

Banner

Intervention Type OTHER

Patients are exposed to a banner ad via the portal.

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.

Group Type EXPERIMENTAL

Direct to Patient Message

Intervention Type OTHER

Patients receive a direct to patient message via the portal.

Chatbot

Intervention Type OTHER

Patients are contacted by a chatbot via the portal.

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.

Group Type EXPERIMENTAL

Direct to Patient Message

Intervention Type OTHER

Patients receive a direct to patient message via the portal.

Banner

Intervention Type OTHER

Patients are exposed to a banner ad via the portal.

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.

Group Type EXPERIMENTAL

Chatbot

Intervention Type OTHER

Patients are contacted by a chatbot via the portal.

Banner

Intervention Type OTHER

Patients are exposed to a banner ad via the portal.

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.

Group Type EXPERIMENTAL

Traditional Letter

Intervention Type OTHER

Patients receive a traditional letter.

Direct to Patient Message

Intervention Type OTHER

Patients receive a direct to patient message via the portal.

Chatbot

Intervention Type OTHER

Patients are contacted by a chatbot via the portal.

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.

Group Type EXPERIMENTAL

Traditional Letter

Intervention Type OTHER

Patients receive a traditional letter.

Direct to Patient Message

Intervention Type OTHER

Patients receive a direct to patient message via the portal.

Banner

Intervention Type OTHER

Patients are exposed to a banner ad via the portal.

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.

Group Type EXPERIMENTAL

Traditional Letter

Intervention Type OTHER

Patients receive a traditional letter.

Chatbot

Intervention Type OTHER

Patients are contacted by a chatbot via the portal.

Banner

Intervention Type OTHER

Patients are exposed to a banner ad via the portal.

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.

Group Type EXPERIMENTAL

Direct to Patient Message

Intervention Type OTHER

Patients receive a direct to patient message via the portal.

Chatbot

Intervention Type OTHER

Patients are contacted by a chatbot via the portal.

Banner

Intervention Type OTHER

Patients are exposed to a banner ad via the portal.

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.

Group Type EXPERIMENTAL

Traditional Letter

Intervention Type OTHER

Patients receive a traditional letter.

Direct to Patient Message

Intervention Type OTHER

Patients receive a direct to patient message via the portal.

Chatbot

Intervention Type OTHER

Patients are contacted by a chatbot via the portal.

Banner

Intervention Type OTHER

Patients are exposed to a banner ad via the portal.

Interventions

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Traditional Letter

Patients receive a traditional letter.

Intervention Type OTHER

Direct to Patient Message

Patients receive a direct to patient message via the portal.

Intervention Type OTHER

Chatbot

Patients are contacted by a chatbot via the portal.

Intervention Type OTHER

Banner

Patients are exposed to a banner ad via the portal.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Food and Drug Administration (FDA)

FED

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian Smith, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale University

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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75F40120C00174

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2000032716

Identifier Type: -

Identifier Source: org_study_id