Group Intervention on Vaccine Confidence

NCT ID: NCT05891626

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 429 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-02
• Study Completion Date: 2024-12-31

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.

Detailed 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.

Conditions

Vaccination Refusal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Group intervention

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.

Group Type: EXPERIMENTAL

Group intervention

Intervention Type: 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.

Standard care

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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:

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

MultiCare Health System Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jin

Puyallup, Washington, United States

Countries

United States

Other Identifiers

2022/05/26

Identifier Type: -

Identifier Source: org_study_id