NCT06467487

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214,526

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 21, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

September 4, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2025

Completed
Last Updated

January 13, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

June 14, 2024

Last Update Submit

January 10, 2025

Conditions

Patient Participation

Keywords

Online Patient Portal

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Number of patients who enroll in a research study

    12 months

Study Arms (6)

Optimized Letter

EXPERIMENTAL

Participants receive an 'optimized' letter.

Other: Optimized Letter

Optimized Message

EXPERIMENTAL

Participants receive an 'optimized' message.

Other: Direct to Patient Message - Optimized

Optimized Letter + Optimized Message

EXPERIMENTAL

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

Other: Optimized LetterOther: Direct to Patient Message - Optimized

Generic Letter

ACTIVE COMPARATOR

Participants receive a 'usual' letter.

Other: Traditional Letter

Generic Message

ACTIVE COMPARATOR

Participants receive a 'usual' message.

Other: Direct to Patient Message

Generic Letter + Generic Message

EXPERIMENTAL

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

Other: Traditional LetterOther: Direct to Patient Message

Interventions

Traditional LetterOTHER

Patients receive a traditional letter.

Generic LetterGeneric Letter + Generic Message
Direct to Patient MessageOTHER

Patients receive a direct to patient message via the portal.

Generic Letter + Generic MessageGeneric Message
Optimized LetterOTHER

Patients receive an optimized letter.

Optimized LetterOptimized Letter + Optimized Message
Direct to Patient Message - OptimizedOTHER

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

Optimized Letter + Optimized MessageOptimized Message

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Currently enrolled in a clinical trial
  • Opted out of research
  • On active cancer treatment
  • Active member of the study team

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Brian Smith, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2024

First Posted

June 21, 2024

Study Start

September 4, 2024

Primary Completion

January 6, 2025

Study Completion

January 6, 2025

Last Updated

January 13, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)