NCT05989308

Brief Summary

The goal of this randomized controlled trial is to assess the extent to which different modes of contacting parents who have not yet enabled to access to their children's medical records will result in greater proxy access. The main questions the study aims to answer are:

  • will outreach via text or patient portal message result in more parents having access than usual care (which is in-office suggestions to get access).
  • which mode - text or portal - will get more parents access. Participants will get a text message, or a portal message through their own patient portal, or no message. The investigators will check access to see which group has increased more during the study period.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
5,200

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
Oct 2024Sep 2026

First Submitted

Initial submission to the registry

August 2, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
1.2 years until next milestone

Study Start

First participant enrolled

October 15, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

1.9 years

First QC Date

August 2, 2023

Last Update Submit

February 11, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Proportion of participants who activate MyChart Proxy Access

    Proportion of participants who activate access to the patient portal of the child's EHR, also known as MyChart Proxy Access, of all those invited. Proxy MyChart activation is a binary function (yes, has proxy activated; no, does not have proxy activated).

    up to 12 weeks

Secondary Outcomes (1)

  • Proportion of guardians' who activate a personal MyChart account

    up to 12 weeks

Study Arms (3)

Usual Care

NO INTERVENTION

Care as usual

Preferred Modality

EXPERIMENTAL

Text or email message to guardian with proxy information. If the guardian has no personal MyChart access, before sending proxy information to set up access to their child's MyChart, the investigators will message the guardian up to two times with information enabling them to access their personal MyChart.

Behavioral: EmailBehavioral: Text

Patient Portal

EXPERIMENTAL

Patient portal message (MyChart) to guardian with proxy information. If the guardian has no personal MyChart access, before sending proxy information to set up access to their child's MyChart, the investigators will message the guardian up to two times with information enabling them to access their personal MyChart.

Behavioral: Patient Portal Message

Interventions

EmailBEHAVIORAL

Email message sent to guardian with proxy information.

Preferred Modality
TextBEHAVIORAL

Text message sent to guardian with proxy information.

Preferred Modality

Patient portal message (MyChart) to guardian with proxy information.

Patient Portal

Eligibility Criteria

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

You may qualify if:

  • Guardian of a child aged ≤12 years seen in one of the two identified health centers within the last 3 years with guardian status and contact information documented in the child's EHR

You may not qualify if:

  • Preferred method of contact for guardians with no MyChart is telephone or physical letter to home
  • Guardians with EHR proxy access already activated for all children in their care.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Cornell Scott Hill Health Center

New Haven, Connecticut, 06511, United States

RECRUITING

Fair Haven Community Health Center

New Haven, Connecticut, 06513, United States

RECRUITING

Yale New Haven Health

New Haven, Connecticut, 06520, United States

NOT YET RECRUITING

Yale School of Medicine

New Haven, Connecticut, 06520, United States

NOT YET RECRUITING

MeSH Terms

Interventions

Communication Devices for People with Disabilities

Intervention Hierarchy (Ancestors)

Self-Help DevicesEquipment and Supplies

Study Officials

  • Ada Fenick, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ada Fenick, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: JDAT will access EHR visit data for these offices to establish the child patient pool and identify guardians.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2023

First Posted

August 14, 2023

Study Start

October 15, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Deidentified data per the PIs discretion.

Locations