Group Intervention on Vaccine Confidence

NCT05891626 | Unknown

• 1 other identifier: 2022/05/26
• Study Type: interventional
• Target: 429
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vaccination Refusal

Keywords

Vaccine confidence; Adult patient; Caregiver of pediatric patients; Missed opportunities for vaccination (MoV); Vaccination rates; Vaccine hesitancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Missed opportunities for vaccination (MOVs)

  6 months over vaccination attitude for each subpopulation

• Vaccination rates

  6 months over vaccination attitude for each subpopulation

Study Arms (2)

Group intervention

EXPERIMENTAL

Six comparable general clinics (2 for pediatric care and 4 for adult primary care) from all MultiCare facilities will be selected to participate in the study. Half of the clinics will be in the Puget Sound Region and others in the Eastern Washington Areas. Allocation to the intervention will be based on randomization: one pediatric and two adult (Internal Medicine or Family Medicine) clinics will get the comprehensive intervention.

Behavioral: Group intervention

Standard care

NO INTERVENTION

The other three facilities will stay as the control under routine care. The three control group sites will have no additional interventional activities regarding vaccination, except for MultiCare's usual vaccine promotion practices (which the interventional clinics will have also).

Interventions

Group intervention BEHAVIORAL

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: 1. missed opportunities and doubts/hesitancy about immunization as a whole; 2. specific questions with regard to specific vaccines; 3. health conditions and socioeconomic/demographic vulnerabilities (insufficient resources in health literacy, linguistic or cultural considerations); and 4. 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.

Group intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• MultiCare Health System Research Institute: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Jin

Puyallup, Washington, 98372, United States

Location

MeSH Terms

Conditions

Vaccination Refusal; Vaccination Hesitancy

Condition Hierarchy (Ancestors)

Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: cluster randomized controlled trial, mixed methods

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 7, 2023
• Study Start: August 2, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)