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

Primary Purpose

Influenza, Tetanus, Diphtheria

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Modified clinical reminders
Sponsored by
Atlanta VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Vaccination, EHR Reminders, Nudge, Electronic Medical Records, Behavioral Economics

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Atlanta VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Percent of patients receiving Tdap/Td or pneumococcal vaccines when due
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
Cost per additional individual vaccinated
Should these data be available, will assess the cost per additional individual vaccinated

Full Information

First Posted
April 25, 2019
Last Updated
January 7, 2020
Sponsor
Atlanta VA Medical Center
Collaborators
General Services Administration (GSA), Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT03950986
Brief Title
Increasing Vaccine Uptake Among Veterans at the Atlanta VA Health Care System
Official Title
Increasing Vaccine Uptake Among Veterans at the Atlanta VA Health Care System Through a Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
May 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Atlanta VA Medical Center
Collaborators
General Services Administration (GSA), Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Tetanus, Diphtheria, Pertussis, Pneumonia
Keywords
Vaccination, EHR Reminders, Nudge, Electronic Medical Records, Behavioral Economics

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Modified clinical reminders
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent of patients receiving one of more vaccines of interest when due for these vaccines
Description
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
Time Frame
6 months
Title
Percent of patients receiving the influenza vaccine when due for the vaccine
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Percent of patients receiving Tdap/Td or pneumococcal vaccines when due
Description
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
Time Frame
6 months
Title
Cost per additional individual vaccinated
Description
Should these data be available, will assess the cost per additional individual vaccinated
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pompa Debroy, MS
Organizational Affiliation
Office of Evaluation Sciences, U.S. General Services Administration
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Russ Burnett, PhD
Organizational Affiliation
Office of Evaluation Sciences, U.S. General Services Administration
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Saad Omer, MBBS, MPH, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joseph M Wallace
Organizational Affiliation
Atlanta VA Health Care System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vincent Marconi, MD
Organizational Affiliation
Atlanta VA Health Care System, Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atlanta VA Medical Center
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36227309
Citation
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.
Results Reference
derived
Links:
URL
https://oes.gsa.gov/projects/increasing-adult-vaccines-atlanta-va/
Description
Project Analysis Plan

Learn more about this trial

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

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