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

Not Applicable

Completed

• Conditions: Patient Participation
• Interventions: Other: Traditional Letter; Other: Direct to Patient Message - Optimized; Other: Optimized Letter; Other: Direct to Patient Message

• Registration Number: NCT06467487
• Lead Sponsor: Yale University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-06-14
• Study First Submitted QC: 2024-06-14
• Study First Posted: 2024-06-21
• Study Start: 2024-09-04
• Status Verified: 2025-01
• Primary Completion: 2025-01-06
• Study Completion: 2025-01-06
• Last Update Submitted: 2025-01-10
• Last Update Posted: 2025-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214526

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Generic Letter	Traditional Letter	Participants receive a 'usual' letter.
Optimized Message	Direct to Patient Message - Optimized	Participants receive an 'optimized' message.
Generic Letter + Generic Message	Traditional Letter	Participants receive both a 'usual' letter and a 'usual' message.
Optimized Letter	Optimized Letter	Participants receive an 'optimized' letter.
Optimized Letter + Optimized Message	Optimized Letter	Participants receive both a 'optimized' letter and a 'optimized' message.
Optimized Letter + Optimized Message	Direct to Patient Message - Optimized	Participants receive both a 'optimized' letter and a 'optimized' message.
Generic Letter + Generic Message	Direct to Patient Message	Participants receive both a 'usual' letter and a 'usual' message.
Generic Message	Direct to Patient Message	Participants receive a 'usual' message.

Primary Outcome Measures

Name	Time	Method
Number of patients who create a research profile	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.

Secondary Outcome Measures

Name	Time	Method
Number of patients who enroll in a research study	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.

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States