A Multicomponent Clinic-based Intervention to Promote COVID-19 Vaccine Intention and Uptake Among Diverse Youth and Adolescents

Study Overview
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Brief Summary
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The goal of this study is to refine and test CONFIDENCE, a multi-component clinic-based intervention in pediatric or family practice clinical settings. Using a randomized control trial design, the investigators will assess preliminary effectiveness of the intervention to increase COVID-19 vaccine intention among parents of under-vaccinated children ages 5 to 17. Participating clinics will receive a brief intervention consisting of: (1) webinar training focused on communication with vaccine-hesitant parents, (2) parent-facing educational materials about COVID-19 vaccination, (3) support to create a personalized, poster campaign featuring providers. Clinics in the control condition will receive the intervention approximately 12 months after the clinics in the intervention condition.

Official Title
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CONFIDENCE: A Pilot Randomized Control Trial With Waitlist Condition to Test a Multicomponent Clinic-based Intervention to Promote COVID-19 Vaccine Intention and Uptake Among Diverse Youth and Adolescents

Conditions
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COVID-19 Vaccination

Intervention / Treatment
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* Behavioral: CONFIDENCE


Participation Criteria
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Eligibility Criteria
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Practice site inclusion criteria Pediatric or family practice clinic that serves pediatric population (ages 5 to 17) Affiliated with UMass Memorial Health Care and/or Baystate Health Serve a patient population that is at least 30% racial/ethnic minority group members. Inclusion Criteria for Parents: The following inclusion criteria will be applied to parents (on behalf of their children): Parent/guardian (referred to as parents in this proposal) of child between ages 5 and 17 Able to read and write in English, Spanish, Portuguese or Vietnamese, which are the predominant languages in the target communities Parent of patient at participating clinical site/child received non-urgent care visit during study period Child not up-to-date for COVID-19 per current CDC guidelines at the time of enrollment. Exclusion Criteria for Parents: °Parent under age of 18

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The investigators will be using a cluster, randomized control trial design, in which clinics are assigned to either the intervention or control group. Clinics in the control group or waitlist condition, will receive the intervention approximately 12 months later.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Condition<br> | Behavioral: CONFIDENCE<br>* This clinic-based, multicomponent intervention consists of 3 parts: Webinar training for clinicians and clinic staff about how to communicate with vaccine-hesitant parents Parent-facing educational materials about COVID-19 vaccination Support in creating a personalized poster campaign featuring providers and clinic staff sharing personal stories about COVID-19 vaccination<br>|
| Active Comparator: Waitlist Condition<br>Clinics in this condition will receive the intervention approximately 12 months after the intervention condition. | Behavioral: CONFIDENCE<br>* This clinic-based, multicomponent intervention consists of 3 parts: Webinar training for clinicians and clinic staff about how to communicate with vaccine-hesitant parents Parent-facing educational materials about COVID-19 vaccination Support in creating a personalized poster campaign featuring providers and clinic staff sharing personal stories about COVID-19 vaccination<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 vaccine intention | Parent exit survey in clinics: Parents will report their intention to vaccinate their children for COVID-19. See survey question below: Did you decide to vaccinate your child against COVID-19 today? Yes/No | Data collection will occur in the four weeks following implementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility: Recruitment | Completion of the parent exit surveys will be documented and used to calculate the percentage of eligible parents (those who received a form) who completed the survey. | End of study; approximately 15 months | 
| Feasibility: Data Completeness | Data completeness/missing data for all participant-level measures from the parent exit survey at the item-level will be examined. An exploratory analysis will be conducted to further decipher the quality of COVID-19 vaccination data in electronic medical records to determine its potential utility in a future trial. | End of study; approximately 15 months | 
| Feasibility: Randomization | Recruitment, data completion and participant characteristics will be compared across the two study conditions to determine if differences emerge. | End of study; approximately 15 months | 
| Acceptability: Parents | Perceived acceptability will be assessed via the survey question How satisfied were you with the conversations about COVID-19 vaccination for your child at your visit today, which will have a 3-point Likert response scale, ranging from not at all to very satisfied. | Four to eight weeks post implementation | 
| Perceived appropriateness: Parents | Perceived appropriateness will be assessed via the survey question How appropriate were the conversations about COVID-19 vaccination for your child at your visit today? | Four to eight weeks post implementation | 
| Implementation Fidelity | Implementation fidelity will be assessed by three questions that ask about provider's behavior regarding the intervention: Did you and the provider discuss COVID-19 vaccination for your child today?; Did the provider share their own COVID-19 experience with you?; and Did the doctor give you any materials about the COVID-19 vaccination today?. | Four to eight weeks post implementation | 
| Acceptability: Providers and clinic staff | Will be assessed qualitatively through semi-structured interviews using questions like How satisfied were you with intervention activities? | Four to eight weeks post implementation | 
| Perceived Appropriateness: Providers and clinic staff | Will be assessed qualitatively through semi-structured interviews using questions like How relevant were intervention components and how compatible was the intervention with values and the workflow of the practice? | Four to eight weeks post implementation | 
| Perceived feasibility: Providers and clinic staff | Will be assessed qualitative through semi-structured interviews using questions like What is the likelihood of sustaining the implementation of the intervention component in practice after the research study concludes. | Four to eight weeks post implementation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccination hesitancy