Clinical trial NCT02666872: Evaluation of an Intervention PROMOting VAccination in Maternity in Quebec
Official title: Evaluation of a New Educational Strategy Promoting Vaccination in Maternity in Quebec Based on Motivational Interviewing Techniques: PROMOVAQ Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motivational Interviewing
Keywords: Vaccination
Infant
Parents
Intention
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: CHU de Quebec-Universite Laval
name: St. Justine's Hospital
name: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Fonds de la Recherche en Santé du Québec
First posted: 2016-01-28
Enrollment: 2719
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Vaccination greatly reduced mortality and morbidity from many preventable diseases. However, to avoid the resurgence of these diseases and the human drama associated, high vaccine coverage should be maintained in the population. Yet in Quebec, vaccine coverage (VC) in young children remains suboptimal, especially caused by a proportion of parents who are ambivalent about the safety and effectiveness of vaccines. In this context, the Provincial Immunization Committee developed in 2010 a Quebec's immunization promotion plan.

Therefore, our research team tested and validated across the Eastern Townships, a vaccination promotion concept by means of an educational intervention within maternities, based on motivational interviewing techniques. This intervention has not only significantly increased the intention of vaccination (+15%) within parents who had received the intervention but also increased their child vaccination coverage (+7.5% at 7 months). This is the purpose of the PROMOVAQ study (PROmotion of VAccination in Quebec) This research project evaluated the impact of an educational strategy based on motivational interviewing techniques within maternity ward on infants' VC. This strategy has been tested through a provincial study (Montreal, Quebec, Sherbrooke) including more than 2500 families.

At term, this research program will offer the Quebec's Health Ministry an optimal strategy for immunization awareness so that Quebec's children may grow healthy and thrive.


Eligibility criteria: Inclusion Criteria:

* Parents of all infants born in each participating maternity hospitals
* In Sherbrooke, inclusion limited to parents residing in the region of the Eastern Townships
* In Québec, inclusion limited to parents residing in the National Capital region.

Exclusion Criteria:

* Minor parents
* Parents who do not speak English or French
* Any health condition of the child or the mother needing acute care. That is to say, if the child must be hospitalized in neonatology, or if the mother has an incompatible condition with an interview.

Primary outcomes:
measure: Vaccination status of the child at 7 months of age
timeFrame: 10 months
Secondary outcomes:
measure: Vaccination status of the child at 3 and 5 months of age
timeFrame: 10 months
measure: Vaccination status of the child at 13, 19 and 24 months of age
timeFrame: 24 months
measure: Intention's parents to vaccination assessed by a questionnaire based on the Health Belief Model
timeFrame: Within the 20 minutes right before the intervention and within the first 20 minutes right after the intervention
measure: Hesitancy 's parents to vaccination by a questionnaire based on the Opel's tool to measure vaccine hesitancy
timeFrame: Within the 20 minutes right before the intervention and within the first 20 minutes right after the intervention
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: McGill University Health Centre (Hôpital de Montréal pour enfants)
state: Quebec
city: Montréal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
city: Québec
country: Canada
facility: CHU de Québec - CHUL
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre hospitalier universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Sherbrooke University
name: Arnaud Gagneur, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Prochaska JO, DiClemente CC. Stages and processes of self-change of smoking: toward an integrative model of change. J Consult Clin Psychol. 1983 Jun;51(3):390-5. doi: 10.1037//0022-006x.51.3.390. No abstract available.
citation: Gagneur A, Quach C, Boucher FD, Tapiero B, De Wals P, Farrands A, Lemaitre T, Boulianne N, Sauvageau C, Ouakki M, Gosselin V, Gagnon D, Petit G, Jacques MC, Dube E. Promoting vaccination in the province of Quebec: the PromoVaQ randomized controlled trial protocol. BMC Public Health. 2019 Feb 6;19(1):160. doi: 10.1186/s12889-019-6468-z.