Increasing Vaccine Uptake Among Veterans at the Atlanta VA Health Care System

NCT ID: NCT03950986

Last Updated: 2020-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-15

Study Completion Date

2019-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The Office of Evaluation Sciences is collaborating with Emory University and the Atlanta VA Health Care System to increase adult immunizations uptake among veterans. The intervention targets patients of primary care providers (physicians, physician assistants and nurse practitioners) through a modification of the existing reminders in the VA electronic health record system. The team will evaluate the intervention using a randomized controlled trial.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The Office of Evaluation Sciences is collaborating with Emory University and the Atlanta VA Health Care System to increase adult immunizations uptake among veterans. The intervention targets patients of primary care providers (physicians, physician assistants and nurse practitioners) through a modification of the existing reminders in the VA electronic health record system.

The intervention includes a bundled vaccination reminder for influenza, pneumococcal and TDap vaccines, an immunization dashboard that relays a patient's vaccination status and history, and talking points for providers to use in their dialogues with patients. This intervention was designed to mitigate potential bottlenecks to vaccination, based on conversations and observations with facility clinicians.

The team will evaluate the intervention using a randomized controlled trial.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Influenza Tetanus Diphtheria Pertussis Pneumonia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intervention is designed to target patients of primary care providers (physicians, physician assistants and nurse practitioners) in the Atlanta VA Medical System. Primary care providers will be assigned to a provider-side treatment (modified vaccine reminders in the electronic health record (EHR) system) or to control (existing vaccine reminders). Outcomes will be tracked for patients who have appointments with these providers.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Providers assigned to the control group will receive unmodified vaccine reminders (as they already appear in the VA EHR system). Separate reminders will appear for the different vaccines of interest.

Group Type NO_INTERVENTION

No interventions assigned to this group

Treatment

Providers in the treatment group will receive modified clinical reminders for the vaccines of interest. Reminders for the different vaccines of interest will be bundled into a single reminder, and other changes made to streamline the design and reduce provider burden. Other changes include an immunization dashboard that relays a patient's vaccination status and talking points for providers to use in their dialogues with patients.

Group Type EXPERIMENTAL

Modified clinical reminders

Intervention Type OTHER

Clinical reminders for the vaccines of interest will be bundled into a single reminder, and other changes made to streamline the design and reduce provider burden. Other changes include an immunization dashboard that relays a patient's vaccination status and talking points for providers to use in their dialogues with patients.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Modified clinical reminders

Clinical reminders for the vaccines of interest will be bundled into a single reminder, and other changes made to streamline the design and reduce provider burden. Other changes include an immunization dashboard that relays a patient's vaccination status and talking points for providers to use in their dialogues with patients.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All patients must have appointments with active primary care providers (physicians, physician assistants and nurse practitioners) in the Atlanta VA Health Care System
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

General Services Administration (GSA)

FED

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role collaborator

Atlanta VA Medical Center

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Vincent Marconi

Director of Infectious Diseases Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pompa Debroy, MS

Role: PRINCIPAL_INVESTIGATOR

Office of Evaluation Sciences, U.S. General Services Administration

Russ Burnett, PhD

Role: PRINCIPAL_INVESTIGATOR

Office of Evaluation Sciences, U.S. General Services Administration

Saad Omer, MBBS, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Joseph M Wallace

Role: PRINCIPAL_INVESTIGATOR

Atlanta VA Health Care System

Vincent Marconi, MD

Role: PRINCIPAL_INVESTIGATOR

Atlanta VA Health Care System, Emory University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Atlanta VA Medical Center

Decatur, Georgia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Debroy P, Balu R, Burnett R, Johnson RA, Kappes HB, Wallace JM, Marconi VC. A cluster randomized controlled trial of a modified vaccination clinical reminder for primary care providers. Health Psychol. 2023 Mar;42(3):195-204. doi: 10.1037/hea0001218. Epub 2022 Oct 13.

Reference Type DERIVED
PMID: 36227309 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Statistical Analysis Plan

View Document

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AtlantaVAMC

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Views on COVID-19 and Vaccination
NCT04706403 COMPLETED NA
Effect of Reminders on Adherence
NCT02411006 COMPLETED NA
Genius PillBox Study
NCT06901258 ENROLLING_BY_INVITATION NA