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OpenTrials
Completed

NCT Number: NCT04871776

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

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.

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Key information

Conditions

Covid19 Behavior COVID-19 Coronaviridae Infections Coronavirus Infections Health Behavior Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Treatment Adherence and Compliance Treatment Refusal Vaccination Refusal Vaccine Refusal Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mass General Brigham

Boston, Massachusetts, 02120, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Messaging informed by construal level theory

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

Behavioral

Usual messaging sent by Mass General Brigham

Primary outcomes

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

    Time frame: 2-5 days

    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.

Secondary outcomes

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

    Time frame: 6 weeks after the target 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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 4, 2021
Registry last updated
Jan 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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