Addressing Vaccine Hesitancy: Pan-Canadian Validation of an Effective Strategy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Université de Sherbrooke
- Enrollment
- 667
- Locations
- 6
- Primary Endpoint
- Vaccination status of the child at 3 months of age
Study Overview
Brief Summary
Synopsis: In most countries, there is an increase in the number of parents who refuse some, most or all vaccines or who adopt delayed vaccination schedule. Vaccine hesitancy (VH) is a global phenomenon that needs to be measured and addressed. However, to this date, no effective strategy has been identified. Dr Gagneur have developed and validated a new approach to educate parents of newborns about vaccination, based on motivational interviewing (MI) techniques. MI is a method to elicit and strengthen motivation for change based on the person's own arguments for change that has been shown effective for the adoption of many preventive health behaviors. This approach has been validated for vaccination during a pilot study as well as in a provincial RCT in Quebec. Now that a proof of concept has been made in Quebec, the investigators will validate the approach in other contexts (e.g. English-speaking provinces and settings with different ways to deliver maternity care and childhood vaccines).
Hypothesis: An educational strategy, based on MI techniques, delivered in the maternity ward increases parents' intention to vaccinate their infant, reduces VH scores and increases infants' vaccine uptake in Quebec. This approach may be applicable across the country in order to tackle VH and thus improve infants' vaccine coverage (VC).
Objective: To evaluate the impact of the MI intervention on parents' intention to vaccinate their child and their VH score and on infants' VC at 3 months of age, in a pan-Canadian context.
Methods: Multicentre RCT in maternity wards of 5 provinces (QC, BC, ON, NS/PE). Parents will be randomized to receive the MI intervention (intervention group) or to receive an information flyer on vaccines (control group). MI intervention will be delivered by research assistant that will have first received a standardized training session on the content and techniques of MI. Parents will complete a self-administered questionnaire to measure knowledge and vaccination intention as well as VH before and after the intervention. Immunization data will be collected through an online questionnaire sent when the child will reach 3 months of age.
Expected benefits: The strategy will be validated across different immunization programs from 5 Canadian provinces to take account of the differences in logistics and cultural contexts. Results from this study will provide to the provincial and national public health authorities an effective strategy to tackle VH.
Detailed Description
OBJECTIVES
Main objective: To evaluate the impact of the motivational interviewing (MI) intervention on parents' intention to vaccinate their infant and their vaccine hesitancy (VH) score in a Pan-Canadian context. In order to explore differences in the intervention's impact according to cultural and organizational factors, all analysis will also be conducted at the level of each center.
Specific objectives:
- To assess parents' intention to vaccinate their infant before the intervention and immediately after the intervention, globally and at each center level.
- To assess parents' VH scores before the intervention, immediately after the intervention and when their infant is 3 months of age, globally and at each center level.
- To assess parents' knowledge, attitudes and beliefs (KAB) about vaccination before the intervention, immediately after the intervention and when their infant is 3 months of age:
- Descriptive analysis according to a composite model inspired from the Health Belief Model (HBM), the Theory of Planned Behavior, and the VH measures (based on a validated questionnaire);
- Research of the determinants of vaccination intention.
- To compare vaccine coverage (VC) at 3 months of age of infants whose parents has received (intervention group) or not (control group) the intervention in the maternity ward during the recruitment period.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •All mothers of infants born in 1 of the 6 participating maternity wards.
Exclusion Criteria
- •Mothers aged <18 years;
- •Mothers who do not speak English or French;
- •Any health situation of the newborn or the mother requiring acute care (i.e. if the newborn needs to be hospitalized in the neonatology unit or if the mother has an incompatible condition for an interview);
- •Mothers who have participated in one of the two studies evaluating the impact of the MI intervention in the Eastern Townships in 2009-2010 and in the province of Quebec in 2014-2015.
Arms & Interventions
Motivational Interviewing
Educational session based on the motivational interviewing
Intervention: Motivational Interviewing (Behavioral)
Information flyer
Information flyer on childhood vaccines
Intervention: Information flyer (Other)
Outcomes
Primary Outcomes
Vaccination status of the child at 3 months of age
Time Frame: 3 months after the intervention at the maternity ward
Information on the first vaccines that the child might have received assessed at 3 months of age by an online questionnaire sent to parents by email.
Secondary Outcomes
- Intention to vaccinate(During the 24-hour postpartum stay at the maternity ward)
- Vaccine hesitancy(During the 24-hour postpartum stay at the maternity ward and 3 months later at home)
Investigators
Arnaud Gagneur
Principal Investigator
Université de Sherbrooke