NCT04871776

Brief Summary

This study aims to increase uptake of the COVID booster vaccine through messaging informed by Construal Level Theory. Patients in the Mass General Brigham (MGB) health system aged 18 and older who are eligible for the COVID booster vaccine, but who have not yet received a dose at the time of an upcoming primary care clinic visit, will be randomized to one of three messaging arms: 1) "why" messaging, 2) "how" messaging, or 3) standard of care ("usual care"). Messages will be sent via the electronic patient portal a few days in advance of their office visit. The primary outcome will be the rate of booster vaccination at the targeted visit. The secondary outcome will be the rate of receipt of a COVID booster vaccine within 6 weeks of the targeted visit. Subgroup analyses to assess for any association of patient characteristics with intervention responsiveness will be exploratory.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,671

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Feb 2022

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

April 30, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 4, 2021

Completed
10 months until next milestone

Study Start

First participant enrolled

February 18, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2022

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

January 16, 2024

Completed
Last Updated

January 16, 2024

Status Verified

December 1, 2023

Enrollment Period

3 months

First QC Date

April 30, 2021

Results QC Date

May 5, 2023

Last Update Submit

December 22, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Received a Booster Vaccination Through the Targeted Visit

    Number of participants who received one dose of a COVID booster vaccine between randomization through the date of the scheduled visit, determined through electronic health records.

    2-5 days

Secondary Outcomes (1)

  • Number of Participants Who Received a Booster Vaccination Within 6 Weeks of the Targeted Visit

    6 weeks after the target visit

Study Arms (3)

"Why" messaging

EXPERIMENTAL

In this arm, patients will be sent an electronic patient portal message a few days in advance of their office visit. Messages will focus on reasons to get the COVID booster vaccine, including protecting self and loved ones or the idea of herd immunity.

Behavioral: Messaging informed by construal level theory

"How" messaging

EXPERIMENTAL

In this arm, patients will be sent an electronic patient portal message a few days in advance of their office visit. "How" messages will focus on the details of obtaining a vaccination at MGB, what to expect, and how to prepare for the visit.

Behavioral: Messaging informed by construal level theory

Usual Care

ACTIVE COMPARATOR

In this arm, patients will not receive any additional message about their upcoming visit, beyond what they already receive by the health system.

Behavioral: Usual Care

Interventions

Messages are informed by construal level theory, which suggests that emphasizing "why" elicits more abstract thinking, or high-level construals, and can induce an emotional mindset, which could challenge an individual's sense of identity, autonomy, or political preferences. Conversely, emphasizing "how" is more cognitive and evokes concrete thinking, or low-level construals, and encourages a planning or implementation mindset, which may be better for encouraging vaccine uptake.

"How" messaging"Why" messaging
Usual CareBEHAVIORAL

Usual messaging sent by Mass General Brigham

Usual Care

Eligibility Criteria

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

You may qualify if:

  • Patients in the Mass General Brigham system
  • Aged 18 and older
  • Are eligible for the COVID booster vaccine but have not received a dose at time of upcoming primary care clinic visit

You may not qualify if:

  • Documented allergy to a COVID vaccine or its components
  • Home address outside of Massachusetts
  • Did not receive full set of primary COVID-19 vaccination series

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mass General Brigham

Boston, Massachusetts, 02120, United States

Location

Related Publications (1)

  • Haff N, Choudhry NK, Bhatkhande G, Keller PA, Robertson T, Oran R, Horn D, Crum KL, Oduol T, Hanken K, Lauffenburger JC. "How" Versus "Why" Messaging to Increase Uptake of Booster Vaccination Against COVID-19: Results of a Pragmatic Randomized Trial. J Gen Intern Med. 2024 Mar;39(4):611-618. doi: 10.1007/s11606-023-08492-x. Epub 2023 Nov 6.

MeSH Terms

Conditions

COVID-19Vaccination Refusal

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesTreatment RefusalTreatment Adherence and ComplianceHealth BehaviorBehavior

Results Point of Contact

Title
Nancy Haff, MD, MPH
Organization
Brigham and Women's Hospital

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Epidemiologist, Division of Pharmacoepidemiology

Study Record Dates

First Submitted

April 30, 2021

First Posted

May 4, 2021

Study Start

February 18, 2022

Primary Completion

May 27, 2022

Study Completion

August 17, 2022

Last Updated

January 16, 2024

Results First Posted

January 16, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations