MOTIVAC-MATER-Confiance
Condition: Vaccination Promotion
Study type: Interventional

Summary: 
      CONTEXT Vaccination has reduced mortality and morbidity by controlling many
      vaccine-preventable diseases. To prevent recurrence of these diseases, high vaccine coverages
      (VCs) (≥ 95%) are needed. But VCs for infants remain suboptimal, and four out of 10 parents
      doubt the safety and efficacy of vaccines in France. The Ministry of Health therefore decided
      in July 2017 to expand vaccination requirements to 11 valences now required to enter in young
      children collective structures. This measure, which went into effect in January 2018, has
      produced significant effects on VCs, but despite this, vaccine hesitancy (VH) persists in the
      general population at a prevalence level that fluctuates around 20% to 25%.

      Motivational interviewing is a collaborative conversational style that reinforces a person's
      own motivation and commitment to behavior change. It has been successfully tested in multiple
      domains related to health behavior change. It has also been adapted in Quebec in the area of
      vaccination and tested in maternity wards with postpartum mothers (Promovac study). Having
      led to an increase in the VCs of infants by an average of 7 percentage points and a 40%
      decrease in vaccine hesitancy, this approach has been in the process of being generalized to
      all maternity units in Quebec since 2017 (EMMIE program). It is indeed proving to be one of
      the most effective at present in improving confidence in early childhood vaccines.

      OBJECTIVES The main objective of this research is to provide proof of concept that, in the
      French context of mandatory vaccination for infants but also of high rates of VH, an
      educational strategy based on the principles and techniques of motivational interviewing and
      carried out with parents in the maternity ward in the days following delivery can reduce
      vaccine hesitancy (VH).

      The secondary objectives are as follows:

        -  to verify that this reduction in VH is associated with a change in knowledge, attitudes,
           and beliefs regarding vaccines;

        -  to verify that this reduction is sustainable (at 12 months);

        -  to evaluate the acceptability and satisfaction of the interview for the parents

      METHODS This is a pragmatic randomized controlled multicenter study with individual
      randomization unit comparing the impact of motivational interviewing to a standard care with
      a leaflet on vaccination.

      Motivational interviewing will be carried out by trained midwives from the two participating
      maternity units (one in Marseille (Bouches-du-Rhône) and the other in Toulon (Var)), as part
      of the routine care provided to parturients. The midwives will be trained by the founding
      specialist of motivational interviewing in Quebec, during a two and a half day training
      course. This training will include a presentation of the theoretical foundations of this
      approach, its adaptation to the field of vaccination, and interactive games to put it into
      practice. The trained midwives will then be able to put this approach into practice during a
      one-month pilot period with parturients, during which they will be able to benefit from
      support in the form of a debriefing. The actual survey will only start at the end of this
      pilot phase.

      In each group, a questionnaire will be offered to the women (couples) who have agreed to
      participate, both before the motivational interview (or delivery of the leaflet) and after
      the interview (or delivery of the leaflet). The second questionnaire will be completed before
      discharge from the maternity hospital. A third evaluation time is planned at 12 months in
      both groups: it will be carried out by internet or telephone.

      The primary endpoint will be the change in the vaccine hesitancy score, measured by an
      international scale validated in French (Opel scale).

      Secondary endpoints will be changes in knowledge, attitudes and beliefs about vaccination
      between the two groups as well as satisfaction with the ME and the brochure.

      Randomization will be performed in blocks of 8, prior to acceptance for participation in this
      research.

      EXPECTED BENEFITS If the results of this research provide proof of concept that the
      educational strategy based on motivational interviewing adapted to the vaccination of infants
      after delivery, in maternity wards, makes it possible, in the French context, to reduce VH,
      this will be a major advance in public health in France. Indeed, even if the vaccination
      obligations introduced in January 2018 have had a positive impact on infant vaccination
      coverage, VH remains present in parents in a proportion that remains worrying (20 to 25%
      according to surveys). The results of this research will then allow us to study the
      conditions for generalizing motivational interviewing in order to reinforce confidence in
      vaccination, which is lacking in a significant part of the French population.
    


Intervention name(s): Motivational Interviewing; Information flyer
Intervention type(s): Behavioral; Other
Intervention description(s): Mothers randomized in the intervention group will receive an educational session based on the motivational interviewing (MI) approach with a midwife. The midwife will have first received a standardized 3 days 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.; Mothers randomized in the control group will receive a locally information flyer on childhood vaccines without any oral explanation by the midwife.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vaccine hesitancy; Motivational interviewing; Childhood vaccination