NCT06482450

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,200 (estimated)
• Sponsor: Johns Hopkins Bloomberg School of Public Health · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Vaccine Hesitancy
• Vaccine Refusal

Interventions

Type	Name	Description
OTHER	LetsTalkShots (patient-facing CDS)	LetsTalkShots is a website which provides patients/parents with tailored videos addressing vaccine concerns.
OTHER	LetsTalkShots (provider-facing CDS)	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.
OTHER	Appointment Reminder Message	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.

Timeline

• Start date: 2025-06-11
• Primary completion: 2026-05-01
• Completion: 2026-06-01
• First posted: 2024-07-01
• Last updated: 2025-07-20

Locations

1 site across 1 country: United States