Use of Construal Level Theory to Inform Messaging to Increase Vaccination Against COVID-19

NCT ID: NCT04871776

Last Updated: 2024-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3671 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-18
• Study Completion Date: 2022-08-17

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.

Conditions

Covid19; Vaccine Refusal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

"Why" messaging

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.

Group Type: EXPERIMENTAL

Messaging informed by construal level theory

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Messaging informed by construal level theory

Intervention Type: BEHAVIORAL

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.

Usual Care

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

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: BEHAVIORAL

Usual messaging sent by Mass General Brigham

Interventions

Messaging informed by construal level theory

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.

Intervention Type: BEHAVIORAL

Usual Care

Usual messaging sent by Mass General Brigham

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nancy Haff, MD, MPH

Associate Epidemiologist, Division of Pharmacoepidemiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mass General Brigham

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37932539 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

P30AG064199

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2021P001308

Identifier Type: -

Identifier Source: org_study_id