NCT05509270

Brief Summary

The purpose of this study is to test which modalities (mailed letter, short message service \[SMS\] text, or patient portal messages) are most effective for encouraging flu shots in high-risk patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43,225

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

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

First Submitted

Initial submission to the registry

August 18, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
15 days until next milestone

Study Start

First participant enrolled

September 6, 2022

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2022

Completed
Last Updated

October 12, 2022

Status Verified

October 1, 2022

Enrollment Period

28 days

First QC Date

August 18, 2022

Last Update Submit

October 6, 2022

Conditions

Keywords

Flu VaccineChoice ArchitectureMachine LearningPerceived Credibility

Outcome Measures

Primary Outcomes (1)

  • Flu vaccination

    Flu vaccination within 4 weeks of the first message send date

    4 weeks after the first messages are sent in the study

Other Outcomes (6)

  • High confidence flu diagnosis

    Up to 8 months

  • "Likely flu" diagnosis

    Up to 8 months

  • Flu complications

    Up to 11 months

  • +3 more other outcomes

Study Arms (6)

Control

NO INTERVENTION

No additional pro-vaccination intervention - some patients are currently targeted for flu vaccination messages due to a non-machine learning-based assessment that they are at high risk for complications, but are not told that they are at high risk or that they have been targeted

Letter only

EXPERIMENTAL

This group will receive a letter telling them they are at high risk for flu and complications

Behavioral: Letter

Patient portal only

EXPERIMENTAL

This group will receive a patient portal message telling them they are at high risk for flu and complications

Behavioral: Patient portal

SMS only

EXPERIMENTAL

This group will receive an SMS telling them they are at high risk for flu and complications

Behavioral: SMS

Patient portal + SMS

EXPERIMENTAL

This group will receive a patient portal message and an SMS telling them they are at high risk for flu and complications

Behavioral: Patient portalBehavioral: SMS

Letter + Patient portal + SMS

EXPERIMENTAL

This group will receive a letter, a patient portal message, and an SMS telling them they are at high risk for flu and complications

Behavioral: LetterBehavioral: Patient portalBehavioral: SMS

Interventions

LetterBEHAVIORAL

Mailed letter about flu vaccination

Letter + Patient portal + SMSLetter only
Patient portalBEHAVIORAL

Patient portal message about flu vaccination

Letter + Patient portal + SMSPatient portal + SMSPatient portal only
SMSBEHAVIORAL

SMS about flu vaccination

Letter + Patient portal + SMSPatient portal + SMSSMS only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Included on a list of active Geisinger patients (all patients on this list attended at least one primary care appointment at Geisinger between 10/1/2008 and 4/13/2022, and either had a Geisinger primary care provider assigned as of April 2022, or were in the Electronic Health Record \[EHR\] since at least September 2021 and had at least one encounter in 2020-2022)
  • Aged 18 or older
  • In the top 10% of risk for flu and flu complications, according to Medial's flu complications machine learning algorithm (which operates on coded EHR data)
  • Has a Geisinger PCP assigned as of August 2022
  • Has had an encounter in the last 2 years as of August 2022

You may not qualify if:

  • \- Cannot be contacted via any of the communication modalities (e.g., letter, patient portal, SMS) being used in the study, either due to insufficient/missing contact information in the EHR or because they opted out of all modalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geisinger

Danville, Pennsylvania, 17822, United States

Location

MeSH Terms

Conditions

Influenza, HumanHealth BehaviorRisk Reduction Behavior

Interventions

College Fraternities and SororitiesPatient Portals

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesBehavior

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and OrganizationsHealth Records, PersonalMedical RecordsRecordsData CollectionEpidemiologic MethodsInvestigative Techniques

Study Officials

  • Christopher Chabris, PhD

    Geisinger Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
Providers who prescribe vaccination and diagnose conditions will not be randomized to study arms or informed of patient assignment. Although patients will not be explicitly informed which arm they have been 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

Study Record Dates

First Submitted

August 18, 2022

First Posted

August 22, 2022

Study Start

September 6, 2022

Primary Completion

October 4, 2022

Study Completion

October 4, 2022

Last Updated

October 12, 2022

Record last verified: 2022-10

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
Time Frame
The data will become available after publication of study results in a scientific journal and will be available as long as the Open Science Framework hosts the data.
Access Criteria
The data on the Open Science Framework will be open to anyone requesting that information.

Locations