Improving Vaccine Acceptance Through EHR Integrated Patient- and Provider-Facing Decision Support
NCT ID: NCT06482450
Last Updated: 2025-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1200 participants
INTERVENTIONAL
2025-06-11
2026-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
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.
OTHER
NONE
Study Groups
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Patient- and Provider-Facing CDS
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
LetsTalkShots (patient-facing CDS)
LetsTalkShots is a website which provides patients/parents with tailored videos addressing vaccine concerns.
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.
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.
Patient-Facing CDS Only
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.
LetsTalkShots (patient-facing CDS)
LetsTalkShots is a website which provides patients/parents with tailored videos addressing vaccine concerns.
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.
Control (MYchart account)
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.
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.
Control (no MYchart account)
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.
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.
Interventions
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LetsTalkShots (patient-facing CDS)
LetsTalkShots is a website which provides patients/parents with tailored videos addressing vaccine concerns.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
ALL
Yes
Sponsors
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Children's Healthcare of Atlanta
OTHER
Emory University
OTHER
Merck & Company
UNKNOWN
Johns Hopkins Bloomberg School of Public Health
OTHER
Responsible Party
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Principal Investigators
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Daniel Salmon, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins Bloomberg School of Public Health
Locations
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Children's Healthcare of Atlanta Hughes Spalding Primary Care Clinic
Atlanta, Georgia, United States
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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IRB00024984
Identifier Type: -
Identifier Source: org_study_id
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