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

NCT ID: NCT06467487

Last Updated: 2025-01-13

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

214526 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-04

Study Completion Date

2025-01-06

Brief Summary

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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

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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.

Conditions

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Patient Participation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Optimized Letter

Participants receive an 'optimized' letter.

Group Type EXPERIMENTAL

Optimized Letter

Intervention Type OTHER

Patients receive an optimized letter.

Optimized Message

Participants receive an 'optimized' message.

Group Type EXPERIMENTAL

Direct to Patient Message - Optimized

Intervention Type OTHER

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

Optimized Letter + Optimized Message

Participants receive both a 'optimized' letter and a 'optimized' message.

Group Type EXPERIMENTAL

Optimized Letter

Intervention Type OTHER

Patients receive an optimized letter.

Direct to Patient Message - Optimized

Intervention Type OTHER

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

Generic Letter

Participants receive a 'usual' letter.

Group Type ACTIVE_COMPARATOR

Traditional Letter

Intervention Type OTHER

Patients receive a traditional letter.

Generic Message

Participants receive a 'usual' message.

Group Type ACTIVE_COMPARATOR

Direct to Patient Message

Intervention Type OTHER

Patients receive a direct to patient message via the portal.

Generic Letter + Generic Message

Participants receive both a 'usual' letter and a 'usual' message.

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.

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

Optimized Letter

Patients receive an optimized letter.

Intervention Type OTHER

Direct to Patient Message - Optimized

Patients receive an optimized direct to patient message 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
* 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_a

Identifier Type: -

Identifier Source: org_study_id

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