Improving Shingrix Vaccination Among US Veterans Receiving Immunosuppression

VA Quality Improvement Research and Training Initiative

The goal of this wait-list control trial is to learn if having access to a new dashboard displaying information about immunosuppressed Veterans missing vaccinations for Shingrix can improve Shingrix vaccination rates at VA facilities.

The main question[s] it aims to answer is: Will vaccination rates improve more rapidly for facilities with access to the dashboard compare to facilities without access? VA facility personnel will be granted access to the dashboard and outcomes (vaccination rates) will be measured using electronic health record data.

Study Overview

• Status: Enrolling by invitation
• Conditions: Immunosuppresion
• Intervention / Treatment: Other: Access to Shingrix dashboard

Detailed Description

Assignment of the intervention will occur at the facility level. Outcomes (vaccination) will be assessed for patients cared for at each facility.

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94121
      • San Francisco VA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• In order to be included in the study, clinicians need to work at a VHA facility and have access to the electronic health record.

Exclusion Criteria:

• None.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early dashboard access; The early dashboard access arm will receive access to the Shingrix dashboard as soon as the study begins.	Other: Access to Shingrix dashboard; The investigators will build and grant access to a clinical dashboard that exists behind the VA firewall. The dashboard will identify Veterans from each VA facility who are receiving immunosuppressants (prescribed via the VA). The dashboard will also provide information about the number of Shingrix vaccines each patient has received (which have been documented within the VA electronic health record). VA clinicians will have access to view information about patients based on their VA electronic health record permissions.
Other: Wait list control arm; The wait list control arm will receive no intervention for 6-9 months; after this period, this arm will also receive access to the Shingrix dashboard.	Other: Access to Shingrix dashboard; The investigators will build and grant access to a clinical dashboard that exists behind the VA firewall. The dashboard will identify Veterans from each VA facility who are receiving immunosuppressants (prescribed via the VA). The dashboard will also provide information about the number of Shingrix vaccines each patient has received (which have been documented within the VA electronic health record). VA clinicians will have access to view information about patients based on their VA electronic health record permissions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with at least 1 Shingrix vaccine documented, by facility	Percentage of patients with at least 1 Shingrix vaccinations documented, by facility	From enrollment until end of follow up at 18 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with at least 2 Shingrix vaccinations documented, by facility	Percentage of patients with at least 2 Shingrix vaccinations documented, by facility	From enrollment until end of follow up at 18 months.

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: San Francisco Veterans Affairs Medical Center
• Investigators: Principal Investigator: Gabriela Schmajuk, MD MS, San Francisco VA Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: September 9, 2024
• First Submitted That Met QC Criteria: September 12, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Wait-list control randomized trial
• Other Study ID Numbers: 15-18358- SHINGRIX; I50HX003266 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: VA data is only available to VA investigators with specific permission under DUA.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No