Impact on Patients' Vaccine Hesitancy of a Motivational Interviewing Training in Initial Medical Training Course (MOTI-VAC_IMG)

In France, vaccination coverage of adolescents remains suboptimal, partly because of a loss of confidence, favoring the re-emergence of epidemics. Despite the extension of mandatory vaccination, some vaccines are still recommended.

Motivational Interviewing (MI), which reinforces a person's own motivation and commitment to change, has been shown to be effective in addiction, nutrition, physical activity and vaccination (Promovac study in Quebec). However, it has not been evaluated in the French cultural context (with mandatory vaccination).

The main objective will be to measure the effect of training in MI for general medical interns at the end of their studies on the vaccine hesitancy (VH) of parents of adolescents consulting in primary care, using a validated scale: VCS.

A multicenter study will be conducted in two university departments of general medicine (Marseille and Nice), comparative, clustered exposure/non-exposure type. It will compare the HV of parents of adolescents during consultations by 2 different groups of interns:

• a group of interns trained in MI,
• a group of interns not trained in MI. The randomization will be done by random draw from the 3rd year list of GP interns not in SASPAS training.

After the MI training, each intern in the "exposed" and "unexposed" groups will have 4 months to include at least 3 parents of adolescents seen in consultation.

Descriptive analyses will be performed followed by statistical analysis by modeling the standardized HV score using hierarchical linear regression.

Training of interns in MI applied to vaccination will increase their knowledge, skills and confidence in using this technique.

We can expect a decrease in VH among parents in primary care who consulted a physician trained in MI.

Study Overview

• Status: Recruiting
• Conditions: Vaccination Hesitancy
• Intervention / Treatment: Other: Motivational interview

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eva MITILIAN; Phone Number: 0491000000; Email: eva.MITILIAN@univ-amu.fr
• Study Contact Backup: Name: François CREMIEUX

Study Locations

• France
  • Marseille, France, 13354
    • Recruiting
    • Assistance Publique Hopitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Interns who are not in SASPAS for the semester from early November 2020 to the end of April 2021 and who will complete the SASPAS internship in the following semester (May 2021 to October 2021).

Exclusion Criteria:

• Intern on availability or inter-CHU internship for the semester November 2020 to end of April 2021
• Interns who have already received training at the MI

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Parents of adolescents who had a consultation with a group of IM-trained interns.	Other: Motivational interview; Motivational interview Training
No Intervention: Parents of adolescents who have not had a consultation with a group of IM trained interns.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaccine hesitancy score of parents of adolescents	Score measured using the validated VCS: Vaccination Confidence Scale. This scale is composed of 8 items, each receiving a score ranging from 0 (strongly disagree) to 10 (strongly agree), with the highest score expressing the highest degree of confidence in vaccines and the lowest expressing the highest degree of VH.	through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behaviour, beliefs and knowledge about vaccines	Reponses to Questions about Behaviour, beliefs and knowledge about vaccine	through study completion, an average of 2 years
Parent and medical intern satisfaction with the consultation	Level of parent satisfaction on a scale (not very satisfied to very satisfied)	through study completion, an average of 2 years
MI learning, knowledge and skills for vaccination promotion in interns	Score to the motivational interviewing skills in immunization Questionnaire (MISI)	year 2

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Estimated): August 8, 2023

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: September 30, 2022
• First Posted (Actual): October 4, 2022

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 8, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2020-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No