Vaccination RefusalNCT05891626
Group Intervention on Vaccine Confidence
A study testing Group intervention in people with Vaccination Refusal, run by MultiCare Health System Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccination Refusal
- What is being tested?
- Group intervention
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 429 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Group Intervention to Improve Vaccine Confidence and Vaccination in a Community Healthcare System: A Mixed Methods Study Design
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.
Read the 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
- Being tested
- Group intervention
- Keywords
- Vaccine confidence, Adult patient, Caregiver of pediatric patients, Missed opportunities for vaccination (MoV), Vaccination rates, Vaccine hesitancy
- Medical subject headings
- Vaccination Refusal, Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group interventionBehavioural
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:
- missed opportunities and doubts/hesitancy about immunization as a whole;
- specific questions with regard to specific vaccines;
- health conditions and socioeconomic/demographic vulnerabilities (insufficient resources in health literacy, linguistic or cultural considerations); and
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months over vaccination attitude for each subpopulation
Secondary outcomes (2)
Missed opportunities for vaccination (MOVs)
Well 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.
Measured: 6 months over vaccination attitude for each subpopulation
Vaccination rates
Measured: 6 months over vaccination attitude for each subpopulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start2 Aug 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccination RefusalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- cluster randomized controlled trial, mixed methods
- Masking
- None (open label)
- Enrolment
- 429 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MultiCare Health System Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891626
- Sponsor's protocol ID
- 2022/05/26
- Status last verified
- Oct 2023
- First submitted
- 26 May 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Intervention to Improve Vaccine Confidence and Vaccination in a Community Healthcare System: A Mixed Methods Study Design
- ClinicalTrials.gov ID
- NCT05891626
- Acronym / sponsor ID
- 2022/05/26
- Conditions
- Vaccination Refusal
- Keywords
- Vaccine confidence, Adult patient, Caregiver of pediatric patients, Missed opportunities for vaccination (MoV), Vaccination rates, Vaccine hesitancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 429 participants (estimated)
- Lead sponsor
- MultiCare Health System Research InstituteUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- cluster randomized controlled trial, mixed methods
| Arm | Type | Receives |
|---|---|---|
| Group intervention | Experimental | Behavioral: Group interventionSix 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. |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- terminal disease (to be decided)
- cognitive impairment
- main immune deficiency conditions
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group interventionAn 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. | Behavioural | Group intervention |
Primary outcome
Vaccine confidence scale(s)
Time frame: 6 months over vaccination attitude for each subpopulation
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.
2 secondary outcomes
Missed opportunities for vaccination (MOVs)
Time frame: 6 months over vaccination attitude for each subpopulation
Vaccination rates
Time frame: 6 months over vaccination attitude for each subpopulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group intervention in people with Vaccination Refusal, run by MultiCare Health System Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccine confidence scale(s) (time frame: 6 months over vaccination attitude for each subpopulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023; AzTrials last refreshed its copy on 29 Oct 2026.