Evaluation of an Intervention PROMOting VAccination in Maternity in Quebec (PROMOVAQ)

April 26, 2021 updated by: Arnaud Gagneur, Université de Sherbrooke

Evaluation of a New Educational Strategy Promoting Vaccination in Maternity in Quebec Based on Motivational Interviewing Techniques: PROMOVAQ Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2719

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H3T 1C5
        • CHU Sainte-Justine
      • Montréal, Quebec, Canada, H3H 1P3
        • McGill University Health Centre (Hôpital de Montréal pour enfants)
      • Québec, Quebec, Canada, G1V 4G2
        • CHU de Québec - CHUL
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre hospitalier universitaire de Sherbrooke

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Motivational interviewing on vaccination
An educational strategy based on motivational interviewing of approximately 15 minutes to promote vaccination, in maternity ward.
Behavioral: Motivational interviewing
No Intervention: Brochure about vaccines for infants
Parents in the control group only received a brochure about vaccines for infants. This brochure is given to all fathers and mothers giving birth to the CHUS, participating or not at our study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaccination status of the child at 7 months of age
Time Frame: 10 months
Data was collected at 10 months of age for all children from regional immunization registries or self-reported by parents over the phone. Vaccination coverage is then defined by the number of infants who received all recommended childhood vaccines at 7 months of age by the total number of children.
10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaccination status of the child at 3 and 5 months of age
Time Frame: 10 months
Data was collected at 10 months of age for all children from regional immunization registries or self-reported by parents over the phone. Early vaccination coverage is then defined by the number of infants who received all recommended childhood vaccines at 3 and 5 months of age by the total number of children.
10 months
Vaccination status of the child at 13, 19 and 24 months of age
Time Frame: 24 months
Data will be collected at 24 months of age for all children from regional immunization registries or self-reported by parents over the phone. Long-term vaccination coverage is then defined by the number of infants who received all recommended childhood vaccines at 13, 19 and 24 months of age by the total number of children.
24 months
Intention's parents to vaccination assessed by a questionnaire based on the Health Belief Model
Time Frame: Within the 20 minutes right before the intervention and within the first 20 minutes right after the intervention
Within the 20 minutes right before the intervention and within the first 20 minutes right after the intervention
Hesitancy 's parents to vaccination by a questionnaire based on the Opel's tool to measure vaccine hesitancy
Time Frame: Within the 20 minutes right before the intervention and within the first 20 minutes right after the intervention
Within the 20 minutes right before the intervention and within the first 20 minutes right after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Collaborators

CHU de Quebec-Universite Laval
McGill University Health Centre/Research Institute of the McGill University Health Centre
St. Justine's Hospital
Fonds de la Recherche en Santé du Québec

Investigators

  • Principal Investigator: Arnaud Gagneur, MD, Ph.D, Sherbrooke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

January 19, 2016

First Submitted That Met QC Criteria

January 25, 2016

First Posted (Estimate)

January 28, 2016

Study Record Updates

Last Update Posted (Actual)

April 27, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 13-074 (French Ministry of Health, PHRC 2013)
  • 27505 (Other Grant/Funding Number: Fonds de recherche du Québec - Santé (FRQS))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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