Improving Vaccine Acceptance Through EHR Integrated Patient- and Provider-Facing Decision Support

NCT06482450 | Recruiting

• 1 other identifier: IRB00024984
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this project is to establish the technical feasibility of a scalable, integrated platform to improve patient informed decision-making and increase vaccine uptake and to evaluate the effectiveness of the integrated platform to improve vaccine uptake.

Conditions

Vaccine Hesitancy; Vaccine Refusal

Outcome Measures

Primary Outcomes (1)

• Vaccination rate

  Proportion of vaccines due that are administered at the index appointment

  Baseline

Secondary Outcomes (3)

• Days undervaccinated

  Through 24 months of age

• Patient Adoption as assessed by proportion of successful texts sent

  Up to one year

• Provider Adoption as assessed by proportion of orders opened

  Up to one year

Study Arms (4)

Patient- and Provider-Facing CDS

EXPERIMENTAL

Parents of patients with odd birthdates (e.g. April 13) and vaccines due at the index appointment who also have a MYchart account will receive a text message directing the parent to the LTS server with integration into the provider workflow

Other: LetsTalkShots (patient-facing CDS); Other: LetsTalkShots (provider-facing CDS); Other: Appointment Reminder Message

Patient-Facing CDS Only

EXPERIMENTAL

Among patients without a MYchart account, those with odd birthdates will receive a link to the LTS website (patient-facing CDS) but no integration into the provider workflow.

Other: LetsTalkShots (patient-facing CDS); Other: Appointment Reminder Message

Control (MYchart account)

PLACEBO COMPARATOR

Patients with an even birthdate (e.g. April 14) who have a MYchart account will receive a regular text message and e-mail appointment reminder with a vaccine primer (e.g. "Vaccines are due and reserved for the participant's child"), but no patient- or provider-facing CDS.

Other: Appointment Reminder Message

Control (no MYchart account)

PLACEBO COMPARATOR

As in the other control group, those without a MYchart account and an even birthdate (e.g. April 14) will receive a text message and e-mail appointment reminder with a vaccine primer but no patient- or provider-facing CDS.

Other: Appointment Reminder Message

Interventions

LetsTalkShots (patient-facing CDS) OTHER

LetsTalkShots is a website which provides patients/parents with tailored videos addressing vaccine concerns.

Patient- and Provider-Facing CDS; Patient-Facing CDS Only

LetsTalkShots (provider-facing CDS) OTHER

The provider-facing CDS component will propagate patient concerns obtained from LetsTalkShots (and the appropriate talking points to address the talking points) into the electronic health record (EHR) for the provider at the point of care.

Patient- and Provider-Facing CDS

Appointment Reminder Message OTHER

The regular text message and e-mail appointment reminder includes a vaccine primer (e.g. "Vaccines are due and reserved for the participant's child"), but no patient- or provider-facing CDS.

Control (MYchart account); Control (no MYchart account); Patient- and Provider-Facing CDS; Patient-Facing CDS Only

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has an upcoming appointment in 2 business days at Children's Healthcare of Atlanta Hughes Spalding Primary Care Clinic.
• A valid mobile phone number or e-mail address is available in the EHR as of 2 business days prior to the appointment date.
• Phase 1: COVID-19 Vaccine only:
• Due for a COVID-19 vaccine based on Epic Systems© COVID-19 vaccine health maintenance topic.
• Phase 2: All Vaccines:
• Due for any vaccines based on Epic Systems© implementation using health maintenance topics of the Centers for Disease Control CDS for Immunization (CDSi) specifications.

You may not qualify if:

• None

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Children's Healthcare of Atlanta: collaborator
• Emory University: collaborator
• Merck & Company: collaborator

Study Sites (1)

Children's Healthcare of Atlanta Hughes Spalding Primary Care Clinic

Atlanta, Georgia, 30303, United States

RECRUITING

MeSH Terms

Conditions

Vaccination Hesitancy; Vaccination Refusal

Condition Hierarchy (Ancestors)

Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Daniel Salmon, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Goryn

CONTACT

919-357-2484; mgoryn1@jh.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators will perform a pseudo-randomized controlled trial in which parents of patients with odd birthdates (e.g. April 13) and vaccines due at the index appointment who also have a MYchart account will receive a text message directing the parent to the LTS server with integration into the provider workflow. Patients with an even birthdate (e.g. April 14) who have a MYchart account will receive a regular text message and e-mail appointment reminder with a vaccine primer (e.g. "Vaccines are due and reserved for the participant's child"), but no patient- or provider-facing CDS. Among patients without a MYchart account, those with odd birthdates will receive a link to the LTS website (patient-facing CDS) but no integration into the provider workflow. As in the control group above, those without a MYchart account and an even birthdate (e.g. April 14) will receive a text message and e-mail appointment reminder with a vaccine primer but no patient- or provider-facing CDS.

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 1, 2024
• Study Start: June 11, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)