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| ID | Type | Description | Link |
|---|---|---|---|
| P30AG064199 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Why" messaging | Experimental | 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. |
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| "How" messaging | Experimental | 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. |
|
| Usual Care | Active Comparator | In this arm, patients will not receive any additional message about their upcoming visit, beyond what they already receive by the health system. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mass General Brigham | Boston | Massachusetts | 02120 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37932539 | Derived | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | "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. |
| FG001 | "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. |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Six patients were excluded after randomization. The three patients died after randomization but before the study intervention could be administered and three patients were excluded from the primary analysis for not meeting eligibility criteria. Thus the primary analysis consisted of 3665 patients.
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| ID | Title | Description |
|---|---|---|
| BG000 | "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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 2-5 days |
|
Adverse event data were collected between randomization and 6-week follow up for each study participant.
Note that deaths are reported for the randomized sample of 3671. Three deaths occurred after randomization but before intervention could be delivered. These participants were excluded from the primary analytic sample, as indicated in the patient flow section, but the deaths are included here. Two deaths occurred during the 6-week follow up period after primary outcome assessment was complete, also included here. Adverse event data is otherwise presented for the analytic sample of 3665.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | "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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nancy Haff, MD, MPH | Brigham and Women's Hospital | 857-307-3826 | nhaff@partners.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 10, 2022 | Apr 5, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D000072758 | Vaccination Refusal |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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|
| Usual Care | Behavioral | Usual messaging sent by Mass General Brigham |
|
| BG001 | "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. |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Baseline vaccinations, N(%) | 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). | Number | participants |
|
| OG001 | "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. |
| OG002 | 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 |
|
|
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| 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. | Posted | Count of Participants | Participants | 6 weeks after the target visit |
|
|
|
|
| 2 |
| 1,200 |
| 0 |
| 1,199 |
| 0 |
| 1,199 |
| EG001 | "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. | 2 | 1,252 | 0 | 1,249 | 0 | 1,249 |
| EG002 | 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 | 1 | 1,219 | 0 | 1,217 | 0 | 1,217 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D016312 | Treatment Refusal |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| Male |
|
| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
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| Unknown or Not Reported |
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We used generalized estimating equations with a logit link function and binary-distributed errors, adjusting for clinic-day clustering and including clinic as an adjustment variable for all models. This analysis is otherwise unadjusted.
| Odds Ratio (OR) |
| 1.03 |
| 2-Sided |
| 95 |
| 0.87 |
| 1.23 |
| Superiority |
| We used generalized estimating equations with a logit link function and binary-distributed errors, adjusting for clinic-day clustering and including clinic as an adjustment variable for all models. This analysis is otherwise unadjusted. | Odds Ratio (OR) | 1.26 | 2-Sided | 95 | 1.06 | 1.49 | Superiority |