Group Intervention on Vaccine Confidence

Vaccination Refusal Clinical Trial

Official title:

Group Intervention to Improve Vaccine Confidence and Vaccination in a Community Healthcare System: A Mixed Methods Study Design

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05891626
• Other study ID #: 2022/05/26
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: MultiCare Health System Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study has one primary objective and two secondary objectives, with an overall goal of understanding barriers to vaccination and vaccination confidence, so that effective interventional strategies can be further developed and tested to improve vaccination outcomes in a community healthcare setting.

Description:

The study will use a mixed methods approach, combining focus group discussion, virtual interviews with healthcare professionals, cross-sectional survey on vaccination attitude, and clinic-based intervention with a cluster randomized controlled trial design for the quantitative stage. They study will also follow up patients with interviews after the quantitative stage completes.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 429
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Qualitative study standards:

Inclusion Criteria:

• having used MultiCare's services in the past 12 months or whose minor child(ren) has/have used MultiCare's services in the past 12 months, and who have been involved in the child(ren)'s immunization decision-making as a caregiver

• current residential location in Washington State

• willing to participate

Exclusion Criteria:

• terminal disease (to be decided)

• cognitive impairment

• main immune deficiency conditions

Quantitative study standards:

We will randomly (and) equally select clinics from 1) Puget Sound and 2) Eastern Washington areas. Since the intervention is on facility level (group intervention), instead of at patient level, blinding will also be impractical. We plan to use stratified random allocation within the pediatric (n1 = 2) or adult stratum (n2 = 4), to decide which sites will get the intervention.

Related Conditions & MeSH terms

• Vaccination Refusal

Intervention

Behavioral:
• Group intervention
An enhanced electronic reminder mechanism specialized on vaccines and actively highlight vaccine standing orders in the system. Set up a data benchmarks, so clinic managers or providers are able to aggregate immunization data, red flag missed opportunities, and facilitate modifying vaccine promotion plans. Other components: missed opportunities and doubts/hesitancy about immunization as a whole; specific questions with regard to specific vaccines; health conditions and socioeconomic/demographic vulnerabilities (insufficient resources in health literacy, linguistic or cultural considerations); and challenges in patient-clinician interactions. These components will be addressed through team training/meetings, pamphlets, physician-led speech in online videos, and group messages via MyChart on the clinic level.

Locations

Country	Name	City	State
United States	Jin	Puyallup	Washington

Sponsors (2)

Lead Sponsor	Collaborator
MultiCare Health System Research Institute	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaccine confidence scale(s)	Vaccination attitude (confidence or hesitancy) measured by the following: For caregivers of 19-35 months children: Parent Attitudes about Childhood Vaccines Survey - Short Form (PACV-SF) and Emory Vaccine Confidence Index (EVCI); For caregivers of pediatric patients 3 years or older: Vaccination Confidence Scale (VCS) and EVCI; For adult patients: Vaccination Attitudes Examination Scale (VAX); For clinical workers/health professionals: VAX.	6 months over vaccination attitude for each subpopulation
Secondary	Missed opportunities for vaccination (MOVs)	Well visit completion in the previous 12 months prior to baseline, and post-pre changes in adult patients; Well-child visit completion rate 12 months prior to baseline, and post-pre changes in 3-18 yo for the pediatric clinics; Total numbers of well clinic visits at baseline and changes over 6 months.	6 months over vaccination attitude for each subpopulation
Secondary	Vaccination rates		6 months over vaccination attitude for each subpopulation