NCT03950986

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 15, 2019

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

January 10, 2020

Status Verified

January 1, 2020

Enrollment Period

8 months

First QC Date

April 25, 2019

Last Update Submit

January 7, 2020

Conditions

Keywords

VaccinationEHR RemindersNudgeElectronic Medical RecordsBehavioral Economics

Outcome Measures

Primary Outcomes (2)

  • Percent of patients receiving one of more vaccines of interest when due for these vaccines

    Percent of patients receiving of one or more of the influenza, pneumococcal (PCV13 or PPSV23) or Tdap/Td vaccines during the observation period, conditional on the patient being due for at least one of these vaccines at any appointment during the observation period

    6 months

  • Percent of patients receiving the influenza vaccine when due for the vaccine

    Percent of patients receiving the influenza vaccine during the observation period, conditional on the patient being due for the influenza vaccine at any appointment during the observation period

    6 months

Secondary Outcomes (2)

  • Percent of patients receiving Tdap/Td or pneumococcal vaccines when due

    6 months

  • Cost per additional individual vaccinated

    6 months

Study Arms (2)

Control

NO INTERVENTION

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.

Treatment

EXPERIMENTAL

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.

Other: Modified clinical reminders

Interventions

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.

Treatment

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlanta VA Medical Center

Decatur, Georgia, 30033, United States

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Influenza, HumanTetanusDiphtheriaWhooping CoughPneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesClostridium InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesCorynebacterium InfectionsActinomycetales InfectionsBordetella InfectionsGram-Negative Bacterial InfectionsLung Diseases

Study Officials

  • Pompa Debroy, MS

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

    PRINCIPAL INVESTIGATOR
  • Russ Burnett, PhD

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

    PRINCIPAL INVESTIGATOR
  • Saad Omer, MBBS, MPH, PhD

    Emory University

    PRINCIPAL INVESTIGATOR
  • Joseph M Wallace

    Atlanta VA Health Care System

    PRINCIPAL INVESTIGATOR
  • Vincent Marconi, MD

    Atlanta VA Health Care System, Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Infectious Diseases Research

Study Record Dates

First Submitted

April 25, 2019

First Posted

May 15, 2019

Study Start

October 15, 2018

Primary Completion

May 30, 2019

Study Completion

June 30, 2019

Last Updated

January 10, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations