Electronic Health Record Strategies to Promote Diverse Participation in Research AIM 2

January 10, 2025 updated by: Yale University

Leveraging Community Engagement and Electronic Health Record Strategies to Promote Diverse Participation in COVID-19 Clinical Trials -2

Based on the outcomes of the initial study (NCT05348603), this optimization study will employ the most effective interventions (letters and messages) and distribute these communications to underrepresented minorities to further promote interest in research. Optimized language will be distributed in English, Spanish, Portuguese, Chinese, Arabic, or Haitian Creole, based on preferred language identified in the patient profile in an electronic medical records system.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective of the optimization study is to examine the effectiveness on increasing interest in research of an optimized letter versus a generic letter; an optimized message versus a generic message; and an optimized letter and an optimized message versus a generic letter and a generic message.

The secondary objective of the optimization study is to examine the effectiveness on increasing participation in research of an optimized letter versus a generic letter, an optimized message versus a generic message, an optimized letter and an optimized message versus a generic letter and a generic message.

Study Type

Interventional

Enrollment (Actual)

214526

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 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

  • 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
  • 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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Optimized Letter
Participants receive an 'optimized' letter.
Other: Optimized Letter
Patients receive an optimized letter.
Experimental: Optimized Message
Participants receive an 'optimized' message.
Other: Direct to Patient Message - Optimized
Patients receive an optimized direct to patient message via the portal.
Experimental: Optimized Letter + Optimized Message
Participants receive both a 'optimized' letter and a 'optimized' message.
Other: Optimized Letter
Patients receive an optimized letter.
Other: Direct to Patient Message - Optimized
Patients receive an optimized direct to patient message via the portal.
Active Comparator: Generic Letter
Participants receive a 'usual' letter.
Other: Traditional Letter
Patients receive a traditional letter.
Active Comparator: Generic Message
Participants receive a 'usual' message.
Other: Direct to Patient Message
Patients receive a direct to patient message via the portal.
Experimental: Generic Letter + Generic Message
Participants receive both a 'usual' letter and a 'usual' message.
Other: Traditional Letter
Patients receive a traditional letter.
Other: Direct to Patient Message
Patients receive a direct to patient message 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 University

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 4, 2024

Primary Completion (Actual)

January 6, 2025

Study Completion (Actual)

January 6, 2025

Study Registration Dates

First Submitted

June 14, 2024

First Submitted That Met QC Criteria

June 14, 2024

First Posted (Actual)

June 21, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 10, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

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

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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