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

Patient Participation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06467487
• Other study ID #: 2000032716_a
• Secondary ID: 75F40120C00174
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: November 2027

Study information

• Verified date: June 2024
• Source: Yale University
• Contact: Helen Seow, PhD
• Phone: (203) 737-4512
• Email: helen.seow[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 210000
• Est. completion date: November 2027
• Est. primary completion date: May 2027
• 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
• 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.
• Optimized Letter
Patients receive an optimized letter.
• Direct to Patient Message - Optimized
Patients receive an optimized direct to patient message 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