Trial Outcomes & Findings for Use of Construal Level Theory to Inform Messaging to Increase Vaccination Against COVID-19 (NCT NCT04871776)
NCT ID: NCT04871776
Last Updated: 2024-01-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
3671 participants
Primary outcome timeframe
2-5 days
Results posted on
2024-01-16
Participant Flow
The three patient deaths reported here occurred after randomization but before the study intervention could be administered, and so are excluded from primary analyses. In addition, 3 patients were excluded from the primary analysis for not meeting eligibility criteria. Thus the primary analysis consisted of 3665 patients.
Participant milestones
| Measure |
"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.
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.
|
"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.
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
In this arm, patients will not receive any additional message about their upcoming visit, beyond what they already receive by the health system.
Usual Care: Usual messaging sent by Mass General Brigham
|
|---|---|---|---|
|
Overall Study
STARTED
|
1200
|
1252
|
1219
|
|
Overall Study
COMPLETED
|
1199
|
1249
|
1217
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
2
|
Reasons for withdrawal
| Measure |
"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.
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.
|
"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.
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
In this arm, patients will not receive any additional message about their upcoming visit, beyond what they already receive by the health system.
Usual Care: Usual messaging sent by Mass General Brigham
|
|---|---|---|---|
|
Overall Study
Death after randomization but before intervention could have been administered
|
0
|
2
|
1
|
|
Overall Study
Did not meet eligibility criteria
|
1
|
1
|
1
|
Baseline Characteristics
Pneumonia vaccines and zoster vaccines were analyzed only among the populations who would be eligible for those vaccines based on age. Ever received pneumonia vaccine was analyzed among the population age \>65 (N = 973). Ever received a zoster vaccine was analyzed among the population age \>50) (N = 2101).
Baseline characteristics by cohort
| Measure |
"Why" Messaging
n=1199 Participants
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.
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.
|
"How" Messaging
n=1249 Participants
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.
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
n=1217 Participants
In this arm, patients will not receive any additional message about their upcoming visit, beyond what they already receive by the health system.
Usual Care: Usual messaging sent by Mass General Brigham
|
Total
n=3665 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.23 years
STANDARD_DEVIATION 17.46 • n=1199 Participants
|
53.80 years
STANDARD_DEVIATION 17.36 • n=1249 Participants
|
53.40 years
STANDARD_DEVIATION 16.96 • n=1217 Participants
|
53.5 years
STANDARD_DEVIATION 17.3 • n=3665 Participants
|
|
Sex: Female, Male
Female
|
697 Participants
n=1199 Participants
|
733 Participants
n=1249 Participants
|
736 Participants
n=1217 Participants
|
2166 Participants
n=3665 Participants
|
|
Sex: Female, Male
Male
|
502 Participants
n=1199 Participants
|
516 Participants
n=1249 Participants
|
481 Participants
n=1217 Participants
|
1499 Participants
n=3665 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
324 Participants
n=1199 Participants
|
322 Participants
n=1249 Participants
|
329 Participants
n=1217 Participants
|
975 Participants
n=3665 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
769 Participants
n=1199 Participants
|
830 Participants
n=1249 Participants
|
768 Participants
n=1217 Participants
|
2367 Participants
n=3665 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
106 Participants
n=1199 Participants
|
97 Participants
n=1249 Participants
|
120 Participants
n=1217 Participants
|
323 Participants
n=3665 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=1199 Participants
|
2 Participants
n=1249 Participants
|
0 Participants
n=1217 Participants
|
3 Participants
n=3665 Participants
|
|
Race (NIH/OMB)
Asian
|
49 Participants
n=1199 Participants
|
48 Participants
n=1249 Participants
|
51 Participants
n=1217 Participants
|
148 Participants
n=3665 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1199 Participants
|
0 Participants
n=1249 Participants
|
0 Participants
n=1217 Participants
|
0 Participants
n=3665 Participants
|
|
Race (NIH/OMB)
Black or African American
|
74 Participants
n=1199 Participants
|
91 Participants
n=1249 Participants
|
99 Participants
n=1217 Participants
|
264 Participants
n=3665 Participants
|
|
Race (NIH/OMB)
White
|
724 Participants
n=1199 Participants
|
766 Participants
n=1249 Participants
|
718 Participants
n=1217 Participants
|
2208 Participants
n=3665 Participants
|
|
Race (NIH/OMB)
More than one race
|
15 Participants
n=1199 Participants
|
17 Participants
n=1249 Participants
|
17 Participants
n=1217 Participants
|
49 Participants
n=3665 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
336 Participants
n=1199 Participants
|
325 Participants
n=1249 Participants
|
332 Participants
n=1217 Participants
|
993 Participants
n=3665 Participants
|
|
Baseline vaccinations, N(%)
Flu shot in the past year
|
542 participants
n=1199 Participants • Pneumonia vaccines and zoster vaccines were analyzed only among the populations who would be eligible for those vaccines based on age. Ever received pneumonia vaccine was analyzed among the population age \>65 (N = 973). Ever received a zoster vaccine was analyzed among the population age \>50) (N = 2101).
|
582 participants
n=1249 Participants • Pneumonia vaccines and zoster vaccines were analyzed only among the populations who would be eligible for those vaccines based on age. Ever received pneumonia vaccine was analyzed among the population age \>65 (N = 973). Ever received a zoster vaccine was analyzed among the population age \>50) (N = 2101).
|
537 participants
n=1217 Participants • Pneumonia vaccines and zoster vaccines were analyzed only among the populations who would be eligible for those vaccines based on age. Ever received pneumonia vaccine was analyzed among the population age \>65 (N = 973). Ever received a zoster vaccine was analyzed among the population age \>50) (N = 2101).
|
1661 participants
n=3665 Participants • Pneumonia vaccines and zoster vaccines were analyzed only among the populations who would be eligible for those vaccines based on age. Ever received pneumonia vaccine was analyzed among the population age \>65 (N = 973). Ever received a zoster vaccine was analyzed among the population age \>50) (N = 2101).
|
|
Baseline vaccinations, N(%)
Ever received pneumonia vaccine (if age >65)
|
287 participants
n=324 Participants • Pneumonia vaccines and zoster vaccines were analyzed only among the populations who would be eligible for those vaccines based on age. Ever received pneumonia vaccine was analyzed among the population age \>65 (N = 973). Ever received a zoster vaccine was analyzed among the population age \>50) (N = 2101).
|
306 participants
n=334 Participants • Pneumonia vaccines and zoster vaccines were analyzed only among the populations who would be eligible for those vaccines based on age. Ever received pneumonia vaccine was analyzed among the population age \>65 (N = 973). Ever received a zoster vaccine was analyzed among the population age \>50) (N = 2101).
|
285 participants
n=315 Participants • Pneumonia vaccines and zoster vaccines were analyzed only among the populations who would be eligible for those vaccines based on age. Ever received pneumonia vaccine was analyzed among the population age \>65 (N = 973). Ever received a zoster vaccine was analyzed among the population age \>50) (N = 2101).
|
878 participants
n=973 Participants • Pneumonia vaccines and zoster vaccines were analyzed only among the populations who would be eligible for those vaccines based on age. Ever received pneumonia vaccine was analyzed among the population age \>65 (N = 973). Ever received a zoster vaccine was analyzed among the population age \>50) (N = 2101).
|
|
Baseline vaccinations, N(%)
Ever received a zoster vaccine *if age >50)
|
329 participants
n=682 Participants • Pneumonia vaccines and zoster vaccines were analyzed only among the populations who would be eligible for those vaccines based on age. Ever received pneumonia vaccine was analyzed among the population age \>65 (N = 973). Ever received a zoster vaccine was analyzed among the population age \>50) (N = 2101).
|
374 participants
n=726 Participants • Pneumonia vaccines and zoster vaccines were analyzed only among the populations who would be eligible for those vaccines based on age. Ever received pneumonia vaccine was analyzed among the population age \>65 (N = 973). Ever received a zoster vaccine was analyzed among the population age \>50) (N = 2101).
|
322 participants
n=693 Participants • Pneumonia vaccines and zoster vaccines were analyzed only among the populations who would be eligible for those vaccines based on age. Ever received pneumonia vaccine was analyzed among the population age \>65 (N = 973). Ever received a zoster vaccine was analyzed among the population age \>50) (N = 2101).
|
1025 participants
n=2101 Participants • Pneumonia vaccines and zoster vaccines were analyzed only among the populations who would be eligible for those vaccines based on age. Ever received pneumonia vaccine was analyzed among the population age \>65 (N = 973). Ever received a zoster vaccine was analyzed among the population age \>50) (N = 2101).
|
|
Baseline vaccinations, N(%)
Tetanus vaccine in last 10 years
|
962 participants
n=1199 Participants • Pneumonia vaccines and zoster vaccines were analyzed only among the populations who would be eligible for those vaccines based on age. Ever received pneumonia vaccine was analyzed among the population age \>65 (N = 973). Ever received a zoster vaccine was analyzed among the population age \>50) (N = 2101).
|
997 participants
n=1249 Participants • Pneumonia vaccines and zoster vaccines were analyzed only among the populations who would be eligible for those vaccines based on age. Ever received pneumonia vaccine was analyzed among the population age \>65 (N = 973). Ever received a zoster vaccine was analyzed among the population age \>50) (N = 2101).
|
985 participants
n=1217 Participants • Pneumonia vaccines and zoster vaccines were analyzed only among the populations who would be eligible for those vaccines based on age. Ever received pneumonia vaccine was analyzed among the population age \>65 (N = 973). Ever received a zoster vaccine was analyzed among the population age \>50) (N = 2101).
|
2944 participants
n=3665 Participants • Pneumonia vaccines and zoster vaccines were analyzed only among the populations who would be eligible for those vaccines based on age. Ever received pneumonia vaccine was analyzed among the population age \>65 (N = 973). Ever received a zoster vaccine was analyzed among the population age \>50) (N = 2101).
|
PRIMARY outcome
Timeframe: 2-5 daysNumber 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.
Outcome measures
| Measure |
"Why" Messaging
n=1199 Participants
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.
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.
|
"How" Messaging
n=1249 Participants
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.
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
n=1217 Participants
In this arm, patients will not receive any additional message about their upcoming visit, beyond what they already receive by the health system.
Usual Care: Usual messaging sent by Mass General Brigham
|
|---|---|---|---|
|
Number of Participants Who Received a Booster Vaccination Through the Targeted Visit
|
164 Participants
|
146 Participants
|
166 Participants
|
SECONDARY outcome
Timeframe: 6 weeks after the target visitNumber 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.
Outcome measures
| Measure |
"Why" Messaging
n=1199 Participants
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.
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.
|
"How" Messaging
n=1249 Participants
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.
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
n=1217 Participants
In this arm, patients will not receive any additional message about their upcoming visit, beyond what they already receive by the health system.
Usual Care: Usual messaging sent by Mass General Brigham
|
|---|---|---|---|
|
Number of Participants Who Received a Booster Vaccination Within 6 Weeks of the Targeted Visit
|
264 Participants
|
231 Participants
|
265 Participants
|
Adverse Events
"Why" Messaging
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
"How" Messaging
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place