A Multicomponent Clinic-based Intervention to Promote COVID-19 Vaccine Intention and Uptake Among Diverse Youth and Adolescents - Clinical Trial for COVID-19 Vaccination | NCT05722652

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CONFIDENCE

About this trial

This is an interventional prevention trial for COVID-19 Vaccination focused on measuring Vaccination hesitancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

UMass Chan Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Condition

Waitlist Condition

Arm Description

Clinics in this condition will receive the intervention approximately 12 months after the intervention condition.

Outcomes

Primary Outcome Measures

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"

Secondary Outcome Measures

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.

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.

Feasibility: Randomization

Recruitment, data completion and participant characteristics will be compared across the two study conditions to determine if differences emerge.

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.

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?"

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?".

Acceptability: Providers and clinic staff

Will be assessed qualitatively through semi-structured interviews using questions like "How satisfied were you with intervention activities?"

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?"

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."

Full Information

NCT ID

NCT05722652

First Posted

February 8, 2023

Last Updated

May 5, 2023

Sponsor

University of Massachusetts, Worcester

Collaborators

Merck Sharp & Dohme LLC, Baystate Health

1. Study Identification

Unique Protocol Identification Number

NCT05722652

Brief Title

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

Acronym

CONFIDENCE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 27, 2023 (Actual)

Primary Completion Date

August 2024 (Anticipated)

Study Completion Date

August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Massachusetts, Worcester

Collaborators

Merck Sharp & Dohme LLC, Baystate Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19 Vaccination

Keywords

Vaccination hesitancy

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

Participant

Masking Description

Clinics will know if they are assigned to the intervention or control condition. However, individual participants (parents of children ages 5 to 17) will not know if their clinic is in the intervention or control condition.

Allocation

Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention Condition

Arm Type

Experimental

Arm Title

Waitlist Condition

Arm Type

Active Comparator

Arm Description

Clinics in this condition will receive the intervention approximately 12 months after the intervention condition.

Intervention Type

Behavioral

Intervention Name(s)

CONFIDENCE

Intervention Description

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

Primary Outcome Measure Information:

Title

COVID-19 vaccine intention

Description

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 Outcome Measure Information:

Title

Feasibility: Recruitment

Description

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

Title

Feasibility: Data Completeness

Description

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

Title

Feasibility: Randomization

Description

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

Title

Acceptability: Parents

Description

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.

Time Frame