Promoting vaccination in the province of Québec: the PromoVaQ randomized controlled trial protocol

Arnaud Gagneur, Caroline Quach, François D Boucher, Bruce Tapiero, Philippe De Wals, Anne Farrands, Thomas Lemaitre, Nicole Boulianne, Chantal Sauvageau, Manale Ouakki, Virginie Gosselin, Dominique Gagnon, Geneviève Petit, Marie-Claude Jacques, Ève Dubé, Arnaud Gagneur, Caroline Quach, François D Boucher, Bruce Tapiero, Philippe De Wals, Anne Farrands, Thomas Lemaitre, Nicole Boulianne, Chantal Sauvageau, Manale Ouakki, Virginie Gosselin, Dominique Gagnon, Geneviève Petit, Marie-Claude Jacques, Ève Dubé

Abstract

Background: Vaccination has a huge public health impact. Maintaining vaccine coverage is key to avoid the devastating consequences of resurgence. In the Province of Québec, vaccine coverage in young children are sub-optimal, mostly due to ambivalence toward vaccine safety and efficacy. We previously conducted a regional study in the Québec's Eastern Townships region, the PromoVac Study, to test a new educational intervention, based on motivational interviewing techniques, aimed at promoting infant vaccination. This first study evidenced that the intervention led to a marked increase in mothers' intention to vaccinate, and vaccine coverage in their infants. The current study protocol aims at scaling up these results at a provincial level using a randomized controlled trial design.

Methods: This pragmatic, randomized, controlled, parallel-group clinical trial will compare the effectiveness of the motivational interviewing to an educational intervention, including the distribution of an information flyer as standard of care on vaccination coverage in four maternity wards across the Province of Québec (PromovaQ). Adult mothers of children born in participating maternity wards were recruited between March 2014 and February 2015. Vaccination coverage will be assessed at 3-years of age, thus the trial is expected to be completed in March 2019. Statistical analyses will be conducted under the intention-to-treat principle. Vaccine coverage will be analyzed using Chi-squared distribution testing and logistic regression to identify determinant factors. Secondary outcomes will include vaccine hesitation and intention scores, mother's knowledge, attitudes and beliefs about immunization, and psychosocial determinants of intention to vaccinate.

Discussion: In the case results of this Provincial RCT be confirmed, serious consideration should then be given by Ministry of Health authorities to the possible implementation of MI-based strategies across provincial maternity wards. To ensure adequate input and secure implementation, study design and results will be reviewed with relevant stakeholders, including the children's families, and provincial and regional decision-makers. Results will be adapted and shared with all stakeholders.

Trial registration: ClinicalTrials.gov NCT02666872 (Retrospectively registered as January 28, 2016).

Keywords: Motivational interviewing; Province of Québec; RCT; Vaccination coverage.

Conflict of interest statement

Ethics approval and consent to participate

This trial was approved by the CHUS Research Ethics Board (number 13–074) and was conducted according to applicable laws and regulations. Written informed consent was obtained from each participant prior to starting study participation.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Prochaska’s Stages of Change
Fig. 2
Fig. 2
Intervention composite model

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