Ignite Creation Date:
2024-07-17 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06482450
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-26
Brief Title:
Improving Vaccine Acceptance Through EHR Integrated Patient- and Provider-Facing Decision Support
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Johns Hopkins Bloomberg School of Public Health
Study Overview
Official Title:
Improving Vaccine Acceptance Through EHR Integrated Patient- and Provider-Facing Decision Support
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Childrens Healthcare of Atlanta CHOA This team will design a technology architecture to accomplish the following goals 1 provide patientsparents 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 eg licensing fees and each healthcare institution eg 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 patientparent 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
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 patientparent 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None