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Group Intervention on Vaccine Confidence

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05891626
Enrollment
429
Registered
2023-06-07
Start date
2023-08-02
Completion date
2024-12-31
Last updated
2023-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaccination Refusal

Keywords

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

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.

Interventions

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.

Sponsors

Merck Sharp & Dohme LLC
CollaboratorINDUSTRY
MultiCare Health System Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

cluster randomized controlled trial, mixed methods

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Vaccine confidence scale(s)6 months over vaccination attitude for each subpopulationVaccination 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.

Secondary

MeasureTime frameDescription
Missed opportunities for vaccination (MOVs)6 months over vaccination attitude for each subpopulationWell 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.
Vaccination rates6 months over vaccination attitude for each subpopulation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026