NCT05493787

Brief Summary

The purpose of this study is to test whether messages that make it easy to schedule a flu shot appointment will increase flu shot rates in patients without an upcoming appointment. The study will also test which message versions and message timing are most effective for increasing flu vaccination.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
139,503

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 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 2, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 9, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

November 8, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2023

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

December 2, 2024

Completed
Last Updated

December 30, 2024

Status Verified

December 1, 2024

Enrollment Period

2 months

First QC Date

August 2, 2022

Results QC Date

January 2, 2024

Last Update Submit

December 13, 2024

Conditions

Keywords

VaccinationHealth promotionHealth behaviorEconomics, Behavioral

Outcome Measures

Primary Outcomes (1)

  • Number of Patients Who Self-scheduled a Flu Shot

    Patient self-schedules a flu vaccine appointment through the patient portal. This outcome measures whether the patient schedules an appointment within 4 weeks of the send date, but the appointment can occur more than 4 weeks past the send date.

    Within 4 weeks of message send date

Secondary Outcomes (1)

  • Flu Vaccination

    Within 4 weeks of message send date

Other Outcomes (9)

  • High Confidence Flu Diagnosis

    Up to 7 months

  • "Likely Flu" Diagnosis

    Up to 7 months

  • Flu Complications

    Up to 10 months

  • +6 more other outcomes

Study Arms (6)

Passive control

NO INTERVENTION

No message

Active control message

ACTIVE COMPARATOR

A message that simply states that patients can get a flu shot at Geisinger

Behavioral: Reminder

Ease message

EXPERIMENTAL

A message emphasizing the ease of scheduling a flu shot at Geisinger

Behavioral: Reminder

Waiting for you message

EXPERIMENTAL

A message that states the patient's flu shot is "waiting" for them at Geisinger

Behavioral: Reminder

Protect yourself - rare message

EXPERIMENTAL

A message that emphasizes the rare, dangerous outcomes of getting the flu (e.g., hospitalization, pneumonia), and states that a flu shot can offer protection from those outcomes

Behavioral: Reminder

Protect yourself - frequent message

EXPERIMENTAL

A message that emphasizes the outcomes that frequently occur in people with the flu (e.g., fever, chills, missing important events), and states that a flu shot can offer protection from those outcomes

Behavioral: Reminder

Interventions

ReminderBEHAVIORAL

Patient portal, SMS, email, and/or another modality

Active control messageEase messageProtect yourself - frequent messageProtect yourself - rare messageWaiting for you message

Eligibility Criteria

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

You may qualify if:

  • Included in one or both of the following two base patient lists:
  • Geisinger patient portal flu outreach list for Fall 2022
  • A list of patients obtained from Geisinger's Phenomics and Clinical Data Core (PACDC). This list will include 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 as of October 2022
  • Has had a Geisinger encounter in the last 2 years as of October 2022
  • Either of the following, as of October 2022:
  • Has a Geisinger PCP assigned in the Community Medicine, Pediatrics, or Internal Medicine service line
  • In the last 2 years, has completed an appointment in a Geisinger specialty on a list of specialties approved by system leadership for flu shot communications
  • Has not received a flu-shot during the 2022-23 flu season as of \~1 week prior to the message date (timeline may be slightly different, depending on data pull logistics), according to the Electronic Health Record (EHR)
  • Does not have a scheduled in-person primary care or in-person flu-shot-eligible specialty appointment in the 12 weeks following their assigned message send date, as of \~1 week prior to the message date (timelines may be slightly different, depending on data pull logistics or clinical guidance)
  • As of this writing, the team plans to define a flu-shot-eligible specialty appointments as appointments in departments that have historically documented or administered flu vaccine. However, this approach may change slightly based on changing clinical guidance.

You may not qualify if:

  • The CMSL/Marketing list will include patients in Geisinger's 65Forward or Community Care populations. If necessary due to logistical constraints, we may exclude these 65Forward and/or Community Care patients from our study.
  • 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
  • Has an allergy to flu vaccines according to any EHR allergy table known to the study team
  • Has a health maintenance modifier indicating they are permanently discontinued from receiving a seasonal flu shot
  • Is on a list of dismissed patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geisinger Clinic

Danville, Pennsylvania, 17822, United States

Location

MeSH Terms

Conditions

Influenza, HumanHealth BehaviorBehavior

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Gail Rosenbaum
Organization
Geisinger

Study Officials

  • Christopher F Chabris, PhD

    Geisinger Clinic

    PRINCIPAL INVESTIGATOR
  • Michelle N Meyer, PhD JD

    Geisinger Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

Study Record Dates

First Submitted

August 2, 2022

First Posted

August 9, 2022

Study Start

November 8, 2022

Primary Completion

January 3, 2023

Study Completion

January 3, 2023

Last Updated

December 30, 2024

Results First Posted

December 2, 2024

Record last verified: 2024-12

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.
More information

Locations