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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06467487
Enrollment
214526
Registered
2024-06-21
Start date
2024-09-04
Completion date
2025-01-06
Last updated
2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Participation

Keywords

Online Patient Portal

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.

Interventions

OTHERDirect to Patient Message - Optimized

Patients receive an optimized direct to patient message via the portal.

OTHEROptimized Letter

Patients receive an optimized letter.

Patients receive a traditional letter.

Patients receive a direct to patient message via the portal.

Sponsors

Food and Drug Administration (FDA)
CollaboratorFED
Yale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients who create a research profile12 monthsThe 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

MeasureTime frameDescription
Number of patients who enroll in a research study12 monthsThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026