Vaccine HesitancyNCT06482450
Improving Vaccine Acceptance Through EHR Integrated Patient- and Provider-Facing Decision Support
A study testing LetsTalkShots (patient-facing CDS), LetsTalkShots (provider-facing CDS) and Appointment Reminder Message in people with Vaccine Hesitancy and Vaccine Refusal, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Vaccine Hesitancy, Vaccine Refusal
- What is being tested?
- LetsTalkShots (patient-facing CDS), LetsTalkShots (provider-facing CDS) and Appointment Reminder Message
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,600 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2025to 24 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta Hughes Spalding Primary Care Clinic
Atlanta, Georgia, 30303
About this study
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.
Read the 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
- Being tested
- LetsTalkShots (patient-facing CDS), LetsTalkShots (provider-facing CDS), Appointment Reminder Message
- Medical subject headings
- Vaccination Hesitancy, Vaccination Refusal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 MessageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. Receives: 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. Receives: Other: Appointment Reminder Message |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccination rate
Proportion of vaccines due that are administered at the index appointment
Measured: Baseline
Secondary outcomes (3)
Days undervaccinated
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).
Measured: Through 24 months of age
Patient Adoption as assessed by proportion of successful texts sent
Proportion of successfully sent text messages with links to patient-facing CDS that are clicked on and have questionnaires answered.
Measured: Up to one year
Provider Adoption as assessed by proportion of orders opened
Proportion of provider-facing best practice advisory (BPA) alerts in which the provider opens the order set for all vaccines due.
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start11 Jun 2025
- Primary completion11 May 2026
- Study completion24 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine HesitancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 3,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Healthcare of Atlanta, Emory University, Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Daniel Salmon, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482450
- Sponsor's protocol ID
- IRB00024984
- Status last verified
- Sep 2026
- First submitted
- 26 Jun 2024
- Last updated
- 4 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Vaccine Acceptance Through EHR Integrated Patient- and Provider-Facing Decision Support
- ClinicalTrials.gov ID
- NCT06482450
- Acronym / sponsor ID
- IRB00024984
- Conditions
- Vaccine Hesitancy, Vaccine Refusal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,600 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Children's Healthcare of Atlanta, Emory University, Merck Sharp & Dohme LLC
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 11 May 2026 (actual)
- Study completion
- 24 Aug 2026 (actual)
- First posted
- 1 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patient- and Provider-Facing CDS | Experimental | Other: LetsTalkShots (patient-facing CDS), Other: LetsTalkShots (provider-facing CDS), Other: Appointment Reminder MessageParents 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 |
| Patient-Facing CDS Only | Experimental | Other: LetsTalkShots (patient-facing CDS), Other: Appointment Reminder MessageAmong 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. |
| Control (MYchart account) | Placebo comparator | Other: Appointment Reminder MessagePatients 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. |
| Control (no MYchart account) | Placebo comparator | Other: Appointment Reminder MessageAs 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Due for a COVID-19 vaccine based on Epic Systems© COVID-19 vaccine health maintenance topic.
- Due for any vaccines based on Epic Systems© implementation using health maintenance topics of the Centers for Disease Control CDS for Immunization (CDSi) specifications.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LetsTalkShots (patient-facing CDS)LetsTalkShots is a website which provides patients/parents with tailored videos addressing vaccine concerns. | Other | Patient- and Provider-Facing CDS, Patient-Facing CDS Only |
| 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 | Patient- and Provider-Facing CDS |
| Appointment Reminder MessageThe 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. | Other | Control (MYchart account), Control (no MYchart account), Patient- and Provider-Facing CDS, Patient-Facing CDS Only |
Primary outcome
Vaccination rate
Time frame: Baseline
Proportion of vaccines due that are administered at the index appointment
3 secondary outcomes
Days undervaccinated
Time frame: Through 24 months of age
Patient Adoption as assessed by proportion of successful texts sent
Time frame: Up to one year
Provider Adoption as assessed by proportion of orders opened
Time frame: Up to one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Salmon, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LetsTalkShots (patient-facing CDS), LetsTalkShots (provider-facing CDS) and Appointment Reminder Message in people with Vaccine Hesitancy and Vaccine Refusal, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccination rate (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.