Group Intervention on Vaccine Confidence

MultiCare Health System Research Institute

Status: Active, not recruiting

Conditions: Vaccination Refusal

Treatments: Behavioral: Group intervention

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05891626

2022/05/26

Details and patient eligibility

About

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.

Full 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.

Enrollment: 429 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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429 participants in 2 patient groups

Group intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Group intervention

Standard care

No Intervention group

Description:

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).