Vaccine Refusal
Conditions
Keywords
altruism, vaccine acceptance, flu vaccine
Brief summary
Subjects enrolled in this study are eligible for the seasonal influenza vaccine. The purpose of this research study is to figure out if increasing individuals' awareness of the benefits of herd immunity, specifically to the local pediatric oncology community, can improve vaccination uptake rates.
Detailed description
The purpose of this study is to identify associations with influenza vaccine hesitancy, including parental demographics and altruism score, in families with healthy children attending two pediatric practices. Also, in the cohort of families with baseline vaccine hesitancy, to assess the effectiveness of a pilot educational intervention focusing on the development of herd immunity for pediatric oncology patients by measuring: 1. The change in vaccine hesitancy scores pre- and post-intervention. 2. The rate of influenza vaccine uptake compared to historic controls from previous influenza seasons. Another aim is to explore the relationship between baseline influenza vaccine hesitancy rates and baseline altruism scores. Effectiveness of this intervention is dependent on parental altruism levels; therefore, the study team also seeks to determine if there is an association between parental altruism and vaccine hesitancy for their children. This is a single-arm prospective cohort study. The study will enroll legal guardians of children who are influenza vaccine-eligible to measure their vaccine hesitancy scores, altruism scores, and the impact of an educational intervention focused on herd immunity on the guardians' vaccine hesitancy score.
Interventions
BEHAVIORALeducational intervention
If the guardian screens positive for vaccine hesitancy (i.e., vaccine hesitancy score average \> 3), they will be given the informational handout along with a brief script.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* All legal guardians of children aged 6 months and up who are influenza vaccine-eligible and present to the pediatric clinic.
Exclusion criteria
* Legal guardians of children who are not influenza vaccine-eligible including children less than 6 months of age, children on immunosuppressive medications, and children with underlying medical conditions resulting in an immunocompromised state.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Vaccine Hesitancy Scores Pre- and Post-Intervention. | Baseline (Pre-intervention) and Post-Intervention, up to 4 hours | 8-item Vaccine Hesitancy Scale. Subjects identified as vaccine-hesitant based on a Vaccine Hesitancy Score \>/= 3. Score range is 1-5 and \> or = 3 is considered vaccine hesitant. |
| Pre-Intervention Vaccine Hesitancy Score | baseline | 8-item Vaccine Hesitancy Scale. Subjects identified as vaccine-hesitant based on a Vaccine Hesitancy Score \>/= 3. Score range is 1-5 and \> or = 3 is considered vaccine hesitant. |
| Post-Intervention Vaccine Hesitancy Score | Post-Intervention up to 4 Hours | 8-item Vaccine Hesitancy Scale. Subjects identified as vaccine-hesitant based on a Vaccine Hesitancy Score \>/= 3. Score range is 1-5 and \> or = 3 is considered vaccine hesitant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Influenza Vaccine Uptake | baseline | The subject's child's electronic health record will be accessed to document whether that patient received the seasonal influenza vaccine during the baseline visit. |
| Pre-Intervention Altruism Scale | baseline | Scale ranges from 20-100 with a higher score denoting higher altruism. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Complex Interaction Interviews | Month 9 | Motivational interviews will be conducted with 20 vaccine-hesitant participants, and with four study volunteers. Each motivational interview will be conducted by the same person. Data from these interviews will be entered directly into a Research Electronic Data Capture database and analyzed using Statistical Analysis Software (SAS v9.4). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vaccine Hesitant Subjects who consent to this study and deemed vaccine hesitant, they will receive an educational intervention.
educational intervention: If the guardian screens positive for vaccine hesitancy (i.e., vaccine hesitancy score average \> 3), they will be given the informational handout along with a brief script. | 73 |
| Total | 73 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Subjects were not Vaccine-hesitant | 437 |
Baseline characteristics
| Characteristic | — | Vaccine Hesitant |
|---|---|---|
| Age, Continuous | — years | — |
| Race (NIH/OMB) American Indian or Alaska Native | — | 0 Participants |
| Race (NIH/OMB) Asian | — | 2 Participants |
| Race (NIH/OMB) Black or African American | — | 23 Participants |
| Race (NIH/OMB) More than one race | — | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | — | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | — | 7 Participants |
| Race (NIH/OMB) White | — | 41 Participants |
| Region of Enrollment United States | — | 73 participants |
| Sex: Female, Male Female | — | 0 Participants |
| Sex: Female, Male Male | — | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 510 |
| other Total, other adverse events | 0 / 510 |
| serious Total, serious adverse events | 0 / 510 |
Outcome results
Primary
Change in Vaccine Hesitancy Scores Pre- and Post-Intervention.
8-item Vaccine Hesitancy Scale. Subjects identified as vaccine-hesitant based on a Vaccine Hesitancy Score \>/= 3. Score range is 1-5 and \> or = 3 is considered vaccine hesitant.
Time frame: Baseline (Pre-intervention) and Post-Intervention, up to 4 hours
Population: Population who scored as vaccine hesitant initially who completed both the pre-intervention (N=73) and post-intervention (N=68) aVHS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vaccine Hesitant | Change in Vaccine Hesitancy Scores Pre- and Post-Intervention. | -0.4 units on a scale | Standard Deviation 0.63 |
Primary
Post-Intervention Vaccine Hesitancy Score
8-item Vaccine Hesitancy Scale. Subjects identified as vaccine-hesitant based on a Vaccine Hesitancy Score \>/= 3. Score range is 1-5 and \> or = 3 is considered vaccine hesitant.
Time frame: Post-Intervention up to 4 Hours
Population: Of our vaccine-hesitant cohort (N=73), only 68 completed the post-intervention aVHS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vaccine Hesitant | Post-Intervention Vaccine Hesitancy Score | 3.42 units on a scale | Standard Deviation 0.87 |
Primary
Pre-Intervention Vaccine Hesitancy Score
8-item Vaccine Hesitancy Scale. Subjects identified as vaccine-hesitant based on a Vaccine Hesitancy Score \>/= 3. Score range is 1-5 and \> or = 3 is considered vaccine hesitant.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vaccine Hesitant | Pre-Intervention Vaccine Hesitancy Score | 3.81 units on a scale | Standard Deviation 0.61 |
Secondary
Pre-Intervention Altruism Scale
Scale ranges from 20-100 with a higher score denoting higher altruism.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vaccine Hesitant | Pre-Intervention Altruism Scale | 60.4 score on a scale | Standard Deviation 13.3 |
Secondary
Rate of Influenza Vaccine Uptake
The subject's child's electronic health record will be accessed to document whether that patient received the seasonal influenza vaccine during the baseline visit.
Time frame: baseline
Population: We examined this outcome for subjects who completed both the pre-intervention (N=73) and post-intervention (N=68) aVHS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vaccine Hesitant | Rate of Influenza Vaccine Uptake | 8 Participants |
Other Pre-specified
Complex Interaction Interviews
Motivational interviews will be conducted with 20 vaccine-hesitant participants, and with four study volunteers. Each motivational interview will be conducted by the same person. Data from these interviews will be entered directly into a Research Electronic Data Capture database and analyzed using Statistical Analysis Software (SAS v9.4).
Time frame: Month 9