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Recruiting

NCT Number: NCT06482450

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

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Healthcare of Atlanta Hughes Spalding Primary Care Clinic

Atlanta, Georgia, 30303, United States

Location status: Recruiting

Location contact

CONTACT

404-785-9850

About this study

The first study objective is to establish the technical feasibility of a scalable, integrated platform to improve patient informed decision-making and increase vaccine uptake. The investigators have established a partnership between vaccine safety and hesitancy experts at the Institute for Vaccine Safety at Johns Hopkins and clinical informatics and implementation experts at Emory University and Children's Healthcare of Atlanta (CHOA). This team will design a technology architecture to accomplish the following goals: (1) provide patients/parents with tailored vaccine messaging videos through the LetsTalkShots (LTS) platform; (2) leverage the same LTS logic that determines which videos are shown in LTS and push associated talking points into the EHR; (3) display patient-specific talking points at the right time in clinical workflows to promote an evidence-based vaccine conversation; (4) centralize maintenance of this messaging with the LTS application; (5) minimize resources required from each healthcare institution to go live with the integrated platform; and (6) establish revenue-generating mechanisms for LTS (e.g. licensing fees) and each healthcare institution (e.g. billing for vaccine counseling).

The second study objective is to evaluate the effectiveness of the integrated platform to improve vaccine uptake. First, providers at the CHOA Hughes Spalding Primary Care clinic will have two opportunities to participate in a 1 hour Continuing Medical Education (CME) session on evidence-based vaccine communication. For intervention visits, parents of undervaccinated patients with upcoming appointments will receive a text message appointment reminder with a link to an EHR-integrated questionnaire on vaccine intent and concerns. This questionnaire will drive the patient/parent to view tailored LTS videos, while pushing the associated talking points back to the clinician at the time of the appointment. For control visits, parents will receive appointment reminders per usual care. Primary outcome: Administration of recommended vaccines at the index appointment. Mixed effects multivariable logistic regression will evaluate the influence of the integrated platform on the primary outcome, adjusted for demographics.

The study hypothesis is that among visits with integrated decision support, vaccination rates will be 10% higher (absolute) than control visits with no such decision support.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • None

Treatment and study plan

LetsTalkShots (patient-facing CDS)

Other

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

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.

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.

Primary outcomes

  1. Vaccination rate

    Time frame: Baseline

    Proportion of vaccines due that are administered at the index appointment

Secondary outcomes

  1. Days undervaccinated

    Time frame: Through 24 months of age

    The sum of all days during which the child was undervaccinated for 1 or more doses of any vaccine(s). Undervaccination begins (per Lumen et al) starting 1 month after the initial due date of a vaccine (e.g. if a patient has not yet received a 2-month vaccine, then days undervaccinated begin accumulating when the child turns 3 months old).

  2. Patient Adoption as assessed by proportion of successful texts sent

    Time frame: Up to one year

    Proportion of successfully sent text messages with links to patient-facing CDS that are clicked on and have questionnaires answered.

  3. Provider Adoption as assessed by proportion of orders opened

    Time frame: Up to one year

    Proportion of provider-facing best practice advisory (BPA) alerts in which the provider opens the order set for all vaccines due.

Study contacts

Contact information is provided by the study sponsor or research team.

Michelle Goryn

CONTACT

[email protected]

919-357-2484

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Children's Healthcare of Atlanta
  • Emory University
  • Merck Sharp & Dohme LLC

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 1, 2024
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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