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

University of Massachusetts, Worcester667 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

667

Conditions

COVID-19 Vaccination

Interventions

This clinic-based, multicomponent intervention consists of 3 parts: 1. Webinar training for clinicians and clinic staff about how to communicate with vaccine-hesitant parents 2. Parent-facing educational materials about COVID-19 vaccination 3. Support in creating a personalized poster campaign featuring providers and clinic staff sharing personal stories about COVID-19 vaccination

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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"

Time frame: Data collection will occur in the four weeks following implementation

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.