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

Primary Purpose

Covid19, Vaccine Refusal

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Messaging informed by construal level theory
Usual Care
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mass General Brigham

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

"Why" messaging

"How" messaging

Usual Care

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

Rate of receipt of booster vaccination at the targeted visit
Receipt of one dose of a COVID booster vaccine on the day of the target visit

Secondary Outcome Measures

Rate of receipt of booster vaccination within 6 weeks of the targeted visit
Receipt of one dose of a COVID booster vaccine within 6 weeks of the targeted visit

Full Information

First Posted
April 30, 2021
Last Updated
April 4, 2023
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04871776
Brief Title
Use of Construal Level Theory to Inform Messaging to Increase Vaccination Against COVID-19
Official Title
Use of Construal Level Theory to Inform Messaging to Increase Vaccination Against COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 18, 2022 (Actual)
Primary Completion Date
May 27, 2022 (Actual)
Study Completion Date
August 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Vaccine Refusal

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
3665 (Actual)

8. Arms, Groups, and Interventions

Arm Title
"Why" messaging
Arm Type
Experimental
Arm Description
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.
Arm Title
"How" messaging
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
In this arm, patients will not receive any additional message about their upcoming visit, beyond what they already receive by the health system.
Intervention Type
Behavioral
Intervention Name(s)
Messaging informed by construal level theory
Intervention Description
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
Intervention Name(s)
Usual Care
Intervention Description
Usual messaging sent by Mass General Brigham
Primary Outcome Measure Information:
Title
Rate of receipt of booster vaccination at the targeted visit
Description
Receipt of one dose of a COVID booster vaccine on the day of the target visit
Time Frame
one day
Secondary Outcome Measure Information:
Title
Rate of receipt of booster vaccination within 6 weeks of the targeted visit
Description
Receipt of one dose of a COVID booster vaccine within 6 weeks of the targeted visit
Time Frame
6 weeks after the target visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Mass General Brigham
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02120
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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