NCT04728594

Brief Summary

In this evaluation, two versions of emails will be sent to Geisinger employees who have not been vaccinated against COVID-19. A delayed-contact control group will be emailed after a delay of at least two days. The researchers hypothesize that either of the emails - which use content informed by behavioral nudge theory - will lead to more COVID-19 vaccinations than the delayed-contact control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9,566

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

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

Study Start

First participant enrolled

January 15, 2021

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2021

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 28, 2021

Completed
6 months until next milestone

Results Posted

Study results publicly available

July 26, 2021

Completed
Last Updated

July 26, 2021

Status Verified

July 1, 2021

Enrollment Period

2 days

First QC Date

January 26, 2021

Results QC Date

July 16, 2021

Last Update Submit

July 22, 2021

Conditions

Keywords

ImmunizationPersuasive CommunicationElectronic MailEconomics, BehavioralPsychology

Outcome Measures

Primary Outcomes (1)

  • Number of Employees Who Scheduled Vaccination Appointments After 3 Days

    Binary variable of a scheduled vaccination appointment 3 days after the emails were sent

    3 days

Secondary Outcomes (2)

  • Number of Employees Who Opened Emails After 3 Days

    3 days

  • Number of Employees Who Clicked Scheduling Links After 3 Days

    3 days

Other Outcomes (3)

  • Number of Employees Who Scheduled Vaccination Appointments Until Policy Change (4 Days)

    4 days

  • Number of Employees Who Opened Emails Until Policy Change (4 Days)

    4 days

  • Number of Employees Who Clicked the Scheduling Link Until Policy Change (4 Days)

    4 days

Study Arms (3)

Delayed Contact

NO INTERVENTION

This group will not receive an email for at least two days.

Social Proof

EXPERIMENTAL

This group will receive an email that points out that vaccine availability for employees will soon be limited. It also emphasizes how many fellow health care workers have been vaccinated. Seeing the behaviors of other people might encourage recipients to copy that behavior.

Behavioral: Social ProofBehavioral: Scarcity Message

Reframing Side Effects and Adverse Reactions

EXPERIMENTAL

This group will receive an email that points out that vaccine availability for employees will soon be limited. It also addresses concerns about the side effects and adverse reactions of the vaccine. Due to potentially overblown concerns about the vaccine caused by the salience of side effects in the (social) media, the email attempts to reframe the risks by explicitly noting the small possibility of being affected by serious side effects and by contrasting that to the more severe effects of COVID-19. As a result of this reframing, recipients might recalibrate their perception of risks and benefits and opt for vaccination.

Behavioral: ReframingBehavioral: Scarcity Message

Interventions

Social ProofBEHAVIORAL

Email

Social Proof
ReframingBEHAVIORAL

Email

Reframing Side Effects and Adverse Reactions

Email

Reframing Side Effects and Adverse ReactionsSocial Proof

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Employees at Geisinger Health System who have not gotten a COVID-19 vaccination

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geisinger

Danville, Pennsylvania, 17822, United States

Location

Related Publications (1)

  • Santos HC, Goren A, Chabris CF, Meyer MN. Effect of Targeted Behavioral Science Messages on COVID-19 Vaccination Registration Among Employees of a Large Health System: A Randomized Trial. JAMA Netw Open. 2021 Jul 1;4(7):e2118702. doi: 10.1001/jamanetworkopen.2021.18702.

MeSH Terms

Conditions

Vaccination RefusalCommunicationBehavior

Interventions

Cognitive Restructuring

Condition Hierarchy (Ancestors)

Treatment RefusalTreatment Adherence and ComplianceHealth Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Limitations and Caveats

In the original ClinicalTrials record, the researchers preregistered that the study would examine primary and secondary outcomes after two days. This was extended to about three days, which was the time when the delayed control group was emailed. This altered timing was dictated by when the organization's marketing department was ready to send emails to the delayed control group.

Results Point of Contact

Title
Amir Goren, PhD
Organization
Geisinger Clinic

Study Officials

  • Michelle M Meyer, PhD

    Geisinger Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Participants will not know what group they are in. The relevant care provider (either their primary care provider or provider administering the vaccine) will not know about this study or assignment into groups.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 1 x 3 design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty Co-Director, Behavioral Insights Team

Study Record Dates

First Submitted

January 26, 2021

First Posted

January 28, 2021

Study Start

January 15, 2021

Primary Completion

January 17, 2021

Study Completion

January 20, 2021

Last Updated

July 26, 2021

Results First Posted

July 26, 2021

Record last verified: 2021-07

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, ANALYTIC CODE
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.
More information

Locations