Decision Support for Vaccine Hesitancy

Overseen By Michelle Goryn

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins Bloomberg School of Public Health

Compensation: Varies

Number of Visits: Unknown

1200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool called LetsTalkShots, designed to help parents make informed decisions about vaccinating their children. The researchers aim to determine if this tool can increase vaccine uptake by providing information directly to parents and integrating it into the healthcare provider's workflow. Participants will be divided into groups, with some receiving regular vaccine reminders and others accessing the LetsTalkShots platform. Parents of children who have a vaccine due soon and have an appointment at the Children's Healthcare of Atlanta Hughes Spalding Primary Care Clinic are eligible to join. As an unphased trial, this study offers a unique opportunity for parents to contribute to innovative healthcare solutions that could improve vaccine uptake.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this platform is safe for improving vaccine uptake?

Research has shown that LetsTalkShots helps people make decisions about vaccines. User feedback indicates that the information is clear and reliable. Most people found it both interesting and helpful. While LetsTalkShots aims to improve understanding of vaccines, it involves no medication or physical treatment. Consequently, there are no reports of side effects or safety issues for users. It serves solely as a tool to help people make informed vaccine choices. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring new ways to address vaccine hesitancy using digital tools. Unlike traditional approaches that may involve direct conversations with healthcare providers, this trial tests a digital decision support system called LetsTalkShots (LTS). This system integrates into existing workflows, providing tailored reminders and information to parents based on their child’s birthdate and MYchart account status. By leveraging technology to deliver targeted, personalized information, researchers hope to improve vaccination rates and better understand how digital interventions can influence health decisions.

What evidence suggests that this trial's treatments could be effective for improving vaccine uptake?

Research shows that LetsTalkShots, evaluated in this trial, helps people make informed vaccine choices. One study found that 85.5% of users considered the information interesting, and 87% found it helpful. The system provides personalized content to address specific vaccine concerns. This customized approach has been well-received, even by those initially unsure. Engaging animations and clear communication enhance its effectiveness by building trust and understanding about vaccine risks and benefits. Overall, LetsTalkShots aims to improve vaccine uptake by making information easy to access and relate to. ^{1 2 3 4 6}

Who Is on the Research Team?

Daniel Salmon, PhD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Are You a Good Fit for This Trial?

This trial is for individuals who are hesitant or refuse vaccines. It aims to improve vaccine acceptance by using a platform that reminds patients of appointments and provides decision support tools for both patients and providers.

Inclusion Criteria

Patient has an upcoming appointment in 2 business days at Children's Healthcare of Atlanta Hughes Spalding Primary Care Clinic

My contact information is up-to-date in my health records.

I am due for a COVID-19 vaccine according to my health records.

Exclusion Criteria

N/A

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Providers participate in CME sessions and parents receive tailored vaccine messaging through the LTS platform

Up to one year

Multiple visits as per appointment schedule

Follow-up

Participants are monitored for vaccine uptake and provider adoption of the integrated platform

Up to one year

What Are the Treatments Tested in This Trial?

Interventions

• LetsTalkShots

Trial Overview The study tests an integrated platform with two main features: 'LetsTalkShots', which offers decision support to patients and healthcare providers, and an appointment reminder system, all within the electronic health record (EHR) system.

How Is the Trial Designed?

Group I: Patient-Facing CDS Only Experimental Treatment 2 Interventions

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.

Group II: Patient- and Provider-Facing CDS Experimental Treatment 3 Interventions

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

Group III: Control (MYchart account) Placebo Group 1 Intervention

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.

Group IV: Control (no MYchart account) Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Johns Hopkins Bloomberg School of Public Health

Lead Sponsor

Trials

441

Recruited

2,157,000+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Children's Healthcare of Atlanta

Collaborator

Trials

172

Recruited

108,000+

Merck & Company

Collaborator

Published Research Related to This Trial

Vaccine hesitancy remains a significant issue globally, affecting 15-35% of parents even among those with well-vaccinated children, despite strong evidence supporting vaccine safety and effectiveness.

Health care provider recommendations are crucial for increasing vaccine uptake, with stronger, more assertive language (like presumptive announcements) leading to higher vaccination rates compared to softer, conversational approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How health care providers should address vaccine hesitancy in the clinical setting: Evidence for presumptive language in making a strong recommendation. Jacobson, RM., St Sauver, JL., Griffin, JM., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10348877/

LetsTalkShots: personalized vaccine risk communication Our group has focused on addressing vaccine hesitancy and supporting vaccination decision-making, often resulting in increased vaccine ...

2. researchgate.net researchgate.net/publication/372038539_LetsTalkShots_personalized_vaccine_risk_communication

LetsTalkShots: personalized vaccine risk communication Most respondents indicated that the information presented was interesting (85.5%), clear (96.0%), helpful (87.0%), and trustworthy (82.2%).

3. letstalkshots.com letstalkshots.com/main/about/

Let's Talk Shots LetsTalkShots is designed to support vaccine decision-making. It shares engaging animated content based on a person's questions or concerns.

4. files.comminit.com files.comminit.com/content/letstalkshots-personalized-vaccine-risk-communication

LetsTalkShots: Personalized Vaccine Risk Communication The animations were well received even among subpopulations with lower reported usability. For example, 46% of persons who were not confident in ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37457264/

LetsTalkShots: personalized vaccine risk communication Tailored vaccine risk communication can assist decision makers as they consider vaccination for themselves, their families, ...

6. health.comminit.com health.comminit.com/content/letstalkshots-personalized-vaccine-risk-communication

LetsTalkShots: Personalized Vaccine Risk Communication "While not a panacea for the global challenge of vaccine hesitancy, tailored vaccine risk communication can assist decision makers as they ...