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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04871776
• Other study ID #: 2021P001308
• Secondary ID: P30AG064199
• Status: Completed
• Phase: N/A
• Start date: February 18, 2022
• Est. completion date: August 17, 2022

Study information

• Verified date: December 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3671
• Est. completion date: August 17, 2022
• Est. primary completion date: May 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Vaccine Refusal

Intervention

Behavioral:
• 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.
• Usual Care
Usual messaging sent by Mass General Brigham

Locations

Country	Name	City	State
United States	Mass General Brigham	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants Who Received a Booster Vaccination Within 6 Weeks of the Targeted Visit	Number of participants who received one dose of a COVID booster vaccine between randomization through 6 weeks after the targeted visit, determined through electronic health records.	6 weeks after the target visit