- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03950986
Increasing Vaccine Uptake Among Veterans at the Atlanta VA Health Care System
Increasing Vaccine Uptake Among Veterans at the Atlanta VA Health Care System Through a Randomized Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Georgia
-
Decatur, Georgia, United States, 30033
- Atlanta VA Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: 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.
|
|
|
Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent of patients receiving one of more vaccines of interest when due for these vaccines
Time Frame: 6 months
|
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
Time Frame: 6 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent of patients receiving Tdap/Td or pneumococcal vaccines when due
Time Frame: 6 months
|
Percent of patients receiving Tdap/Td or pneumococcal 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
|
|
Cost per additional individual vaccinated
Time Frame: 6 months
|
Should these data be available, will assess the cost per additional individual vaccinated
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: 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
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AtlantaVAMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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