A Mixed Methods Vaccine Study Design

Sponsor

MultiCare Health System Research Institute (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05891626

Collaborator

Merck Sharp & Dohme LLC (Industry)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vaccination Refusal	Other: Focus Groups Other: Qualitative Interviews

Study Design

Study Type:

Observational

Anticipated Enrollment :

64 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Aug 31, 2024

Anticipated Study Completion Date :

Nov 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
pediatric patient caregivers Pediatric patient caregivers will be eligible to participate in the focus group if their child(ren) are 10 years old or younger, receive care at MultiCare's South Sound or Eastern Washington locations, and have an incomplete 7-vaccine series immunization record.	Other: Focus Groups Each discussion will last up to 90 minutes and include questions on the following topics: Vaccination uptake and information-seeking behaviors Barriers to vaccine uptake and vaccine confidence Vaccination perceptions and concerns Factors related to confidence, convenience, and cultural sensitivity that shape vaccine hesitancy Other: Qualitative Interviews Each discussion will last up to 90 minutes and include questions investigating: Barriers to vaccine delivery Vaccination perceptions and attitudes Factors related to confidence, convenience, and cultural sensitivity at the provider and systems level that shape MOVs and patient/caregiver decision- making (e.g., confidence in vaccination messaging, electronic systems reminders, provider diversity and cultural empathy)
adult patients Adult patients will be eligible to participate if they are 18 years of age or older, receive care at MultiCare's South Sound or Eastern Washington locations, and have a missed dose of the influenza or pneumonia vaccine, or both, in the previous 12 months.	Other: Focus Groups Each discussion will last up to 90 minutes and include questions on the following topics: Vaccination uptake and information-seeking behaviors Barriers to vaccine uptake and vaccine confidence Vaccination perceptions and concerns Factors related to confidence, convenience, and cultural sensitivity that shape vaccine hesitancy Other: Qualitative Interviews Each discussion will last up to 90 minutes and include questions investigating: Barriers to vaccine delivery Vaccination perceptions and attitudes Factors related to confidence, convenience, and cultural sensitivity at the provider and systems level that shape MOVs and patient/caregiver decision- making (e.g., confidence in vaccination messaging, electronic systems reminders, provider diversity and cultural empathy)

Arm

Intervention/Treatment

pediatric patient caregivers

Pediatric patient caregivers will be eligible to participate in the focus group if their child(ren) are 10 years old or younger, receive care at MultiCare's South Sound or Eastern Washington locations, and have an incomplete 7-vaccine series immunization record.

Other: Focus Groups

Each discussion will last up to 90 minutes and include questions on the following topics: Vaccination uptake and information-seeking behaviors Barriers to vaccine uptake and vaccine confidence Vaccination perceptions and concerns Factors related to confidence, convenience, and cultural sensitivity that shape vaccine hesitancy

Other: Qualitative Interviews

Each discussion will last up to 90 minutes and include questions investigating: Barriers to vaccine delivery Vaccination perceptions and attitudes Factors related to confidence, convenience, and cultural sensitivity at the provider and systems level that shape MOVs and patient/caregiver decision- making (e.g., confidence in vaccination messaging, electronic systems reminders, provider diversity and cultural empathy)

adult patients

Adult patients will be eligible to participate if they are 18 years of age or older, receive care at MultiCare's South Sound or Eastern Washington locations, and have a missed dose of the influenza or pneumonia vaccine, or both, in the previous 12 months.

Other: Focus Groups

Other: Qualitative Interviews

Outcome Measures

Primary Outcome Measures

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. [7 months after the interventional study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

having used MultiCare's services in the past 12 months
current residential location in Washington State
willing to participate

Exclusion Criteria:

terminal disease (to be decided)
cognitive impairment
main immune deficiency conditions

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

MultiCare Health System Research Institute
Merck Sharp & Dohme LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

MultiCare Health System Research Institute

ClinicalTrials.gov Identifier:

NCT05891626

Other Study ID Numbers:

2022/05/26

First Posted:

Jun 7, 2023

Last Update Posted:

Jun 7, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 7, 2023