NCT06238726

Brief Summary

The purpose of this study is to test whether messages encouraging patients to ask about a Shingrix vaccine at an upcoming appointment will increase Shingrix vaccination rates. The study will also test which of several message versions is most effective.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50,786

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2024

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

First Submitted

Initial submission to the registry

January 25, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 2, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

March 25, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

1.3 years

First QC Date

January 25, 2024

Last Update Submit

July 9, 2025

Conditions

ShinglesVaccination BehaviorBehavior, Health

Outcome Measures

Primary Outcomes (1)

  • First Shingrix vaccination

    Received a first Shingrix vaccination on the appointment date (y/n)

    3 days after enrollment

Other Outcomes (7)

  • First Shingrix vaccination

    In the 10 days following enrollment

  • Attended scheduled appointment

    3 days after enrollment

  • First Shingrix vaccination

    In the 14 months following enrollment

  • +4 more other outcomes

Study Arms (5)

Passive control

NO INTERVENTION

Patients in this arm will not be sent any messages.

Active control

ACTIVE COMPARATOR

Patients in this arm will be sent messages encouraging them to ask about Shingrix at their upcoming appointment.

Behavioral: Reminder

High risk

EXPERIMENTAL

Patients in this arm will be sent messages informing them that they are at high risk for shingles because they are ages 50+, and encouraging them to ask about Shingrix at their upcoming appointment.

Behavioral: Reminder

Multi-fact

EXPERIMENTAL

Patients in this arm will be sent messages with facts about shingles and Shingrix, and encouraging them to ask about Shingrix at their upcoming appointment.

Behavioral: Reminder

High risk + multi-fact

EXPERIMENTAL

Patients in this arm will be sent messages informing them that they are at high risk for shingles because they are ages 50+, with additional facts about shingles and Shingrix, and encouraging them to ask about Shingrix at their upcoming appointment.

Behavioral: Reminder

Interventions

ReminderBEHAVIORAL

Shingrix messages via SMS, patient portal, email, and/or another modality

Active controlHigh riskHigh risk + multi-factMulti-fact

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 50+
  • Has not received any doses of the Shingrix vaccine according to the Geisinger EHR
  • Has a non-acute in-person Geisinger primary care appointment in a department that stocks Shingrix scheduled with enough time to be randomized

You may not qualify if:

  • Cannot be contacted via the communication modality being used in the study (e.g., patient portal, SMS), e.g., due to insufficient/missing contact information in the EHR or because they opted out
  • Patient does not have an approved insurance on file for Shingrix outreach for their appointment type or department
  • Appointment type or department not approved for outreach by Geisinger leadership at the time of outreach

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geisinger Clinic

Danville, Pennsylvania, 17822, United States

Location

Related Links

MeSH Terms

Conditions

Herpes ZosterHealth Behavior

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsBehavior

Study Officials

  • Christopher F Chabris, PhD

    Geisinger Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Although patients will not be explicitly informed of which arm they were randomized to, they will be aware of the messages they receive.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor & Director of Decision Sciences

Study Record Dates

First Submitted

January 25, 2024

First Posted

February 2, 2024

Study Start

March 25, 2024

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

July 14, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

Data with no personally identifiable information will be made available to other researchers on the Open Science Framework for transparency. This will include the essential data and code needed to replicate the analysis that yielded reported findings.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
By the paper's online publication date. Data will remain available for as long as the Open Science Framework hosts it.
Access Criteria
The data on the Open Science Framework will be open to anyone requesting that information.

Locations

US(1)