PROMOtion of VAccination in Canada (PromovaC Study)

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.

Conditions

• Vaccination Promotion

Interventions

BEHAVIORAL

Motivational Interviewing

Mothers randomized in the intervention group will receive an educational session based on the motivational interviewing (MI) approach with a research assistant (RA). The RA will have first received a standardized training session on the content and techniques of MI. The MI intervention will be carried out in simple and understandable language in order to allow discussion and questions from parents rather than provide prescriptive and direct information. The intervention will last approximatively 15 to 20 minutes.

OTHER

Information flyer

Mothers randomized in the control group will receive a locally information flyer on childhood vaccines without any oral explanation by the research assistant.

Sponsors & Collaborators

• University of British Columbia

  collaborator OTHER

• University of Toronto

  collaborator OTHER

• Dalhousie University

  collaborator OTHER

• Université de Sherbrooke

  lead OTHER

Principal Investigators

• Arnaud Gagneur, MD, PhD · Université de Sherbrooke

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-03-25

Primary Completion

2019-03-31

Completion

2021-04-06

Countries

• Canada

Study Locations