PROMOtion of VAccination in Canada (PromovaC Study)

NCT02984007 | Completed DMC

• 1 other identifier: 2017-1578
• Study Type: interventional
• Target: 667
• Locations: 1 country
• Sites: 6

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.

Conditions

Vaccination Promotion

Outcome Measures

Primary Outcomes (1)

• Vaccination status of the child at 3 months of age

  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.

  3 months after the intervention at the maternity ward

Secondary Outcomes (2)

• 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

Study Arms (2)

Motivational Interviewing

EXPERIMENTAL

Educational session based on the motivational interviewing

Behavioral: Motivational Interviewing

Information flyer

OTHER

Information flyer on childhood vaccines

Other: Information flyer

Interventions

Motivational Interviewing BEHAVIORAL

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.

Motivational Interviewing

Information flyer OTHER

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

Information flyer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All mothers of infants born in 1 of the 6 participating maternity wards.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université de Sherbrooke: lead
• University of British Columbia: collaborator
• University of Toronto: collaborator
• Dalhousie University: collaborator

Study Sites (6)

Surrey Memorial Hospital

Surrey, British Columbia, V3V 1Z2, Canada

Location

B.C. Women's Hospital & Health Centre

Vancouver, British Columbia, V6H 3N1, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

North York General Hospital

Toronto, Ontario, M2K 1E1, Canada

Location

Queen Elizabeth Hospital

Charlottetown, Prince Edward Island, C1A 8T5, Canada

Location

Centre hospitalier universitaire de Sherbrooke (CHUS)

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Arnaud Gagneur, MD, PhD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2016
• First Posted: December 6, 2016
• Study Start: March 25, 2017
• Primary Completion: March 31, 2019
• Study Completion: April 6, 2021
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6)