PromoVac update. From PromoVac to EMMIE program

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PromoVac update From PromoVac to EMMIE program Pr Arnaud Gagneur Département de Pédiatrie, Centre de Recherche clinique CHUS Université de Sherbrooke, Québec, Canada

Plan PromoVac concept Motivational Interviewing of Miller and Rollnick PromoVac studies Future prospects EMMIE program 2

The PROMOVAC concept Need for an early strategy of promoting vaccination to avoid delays in first vaccines First vaccines at 2 months of age Delays in first vaccines were associated with delayed or incomplete vaccination schedule in childhood Nurseries should be a place for a early strategy of promoting vaccination Failure of traditional educational or information's strategies Motivational Interviewing of Miller and Rollnick and trans-theoretical model of Prochaska should be adapted to vaccination promotion

Motivational interviewing is a collaborative, goal-oriented style of communication with particular attention to the language of change. It is designed to strengthen personal motivation for and commitment to a specific goal by eliciting and exploring the person s own reasons for change (solving their own ambivalence) within an atmosphere of acceptance and compassion. has been described as a promising tool for the health promotion strategy Motivational Interviewing- Helping People Change. William R Miller, Stephen Rollnick, 3rd edition Appiah-Brempong E. Am J Health Promot 2014;29:e32 4 4

5

Five-point standardized information plan on vaccination Elaboration of a Five-point standardized information plan on vaccination easily understandable for parents STEP 1 STEP 2 Presentation of the vaccine preventable Diseases Vaccines and vaccines efficacy STEP 3 Importance of the immunization schedule +++ STEP 4 STEP 5 Fears and reluctance about vaccination Logistic organization of the vaccination

Educational information session PROCHASKA STAGES PRE-COMTEMPLATION CONTEMPLATION PREPARATION ACTION NOT READY GETTING READY READY CONGRATULATE Fears? Fears? Could there be barriers to vaccination? CONGRATULATE Could there be barriers to vaccination? Step 4 +++ Step 4 +++ Step 4 if needed Step 4 if needed Could you see some advantages to vaccination? Could you see some advantages to vaccination? INFORMATION INFORMATION ORGANISATION ORGANISATION Step 1 et 2 ++ Step 1 et 2 ++ Step 5 +++ Step 5 +++ Step 3 + Step 3 + INFORMATION INFORMATION If you take decisions towards vaccination If you take decisions towards vaccination Step 1 ++ and 3 +++ Step 1 ++ and 3 +++ Step 5 ± Step 5 ± Step 2 + Step 2 +

PromoVac studies PromoVac Assess the effectiveness of an information session targeting immunization based on motivational interviewing techniques in nurseries on vaccination intention and vaccination coverage on infants

Impact on parents vaccination intention Pre and post intervention parents vaccination intention P<0,001 Governmental report. A Gagneur et al. Should an innovative promotion of immunization in maternity improve the immunization coverage of infants. The Promovac study. Bibliothèque et archives nationales du Canada 2013. ISBN :978-2-9813830-0-6, 112p

Impact on infants vaccination coverage Vaccination coverage (VC) Expérimental Group Control Group n = 1140 n = 1249 n (%) n (%) Increase of VC (%) p RR (95% CI) 3 m 1041 (91,3) 1101 (88,1) +3,2 0,01 1,04 (1,01-1,06) 5 m 948 (83,2) 978 (78,3) +4,9 < 0,01 1.06 (1,02-1,10) 7 m 865 (75,9) 857 (68,6) +7,3 < 0,001 1,11 (1,05-1,16) 13 m 755 (66,2) 743 (59,5) +6,7 < 0,001 1,11 (1,05-1,18) 19 m 646 (56,7) 576 (46,1) +10,6 < 0,0001 1,23 (1,14-1,33) 24 m 905 (79,4) 928 (74,3) +5,1 < 0,01 1,07 (1,02-1,12) Gagneur A et al. Vaccinology Research Symposium 2015, Vancouver 5-8 nov.

Impact on 0-2 years infants vaccination coverage RR (95% CI) 1.09 (1.05-1.13) <0.001 p Univariate logistic regressions with repeated measures according to the Generalized estimating equations (GEE) procedure with Poisson distribution : To estimate the chance for a child to have a complete vaccine status during early childhood Gagneur A et al. European Society for Pediatric infectious disease 2016, Brighton 10-14 may 11

Impact on 0-2 years infants vaccination coverage Unadjusted RR Adjusted RR p (95% CI) (95% CI) p Intervention 1.09 (1.05-1.13) <0.001 1.05 (1.02-1.07) <0.001 Complete vaccine status at 3 months of age 2.72 (2.20-3.37) <0.001 6.81 (5.58-8.30) <0.001 Time 0.99 (0.99-0.99) <0.001 0.99 (0.99-0.99) <0.001 Mother s age 1.00 (1.00-1.00) 1.00 (1.00-1.01) <0.01 More than one child 0.90 (0.88-0.93) <0.001 0.91 (0.88-0.93) <0.001 Caesarean delivery 0.97 (0.93-1.01) <0.001 0.99 (0.96-1.02) Neonatology hospitalization 0.90 (0.83-0.95) <0.001 0.96 (0.92-1.01) Multivariate GEE models with repeated measures with Poisson distribution : To estimate the chance for a child to have a complete immunization status to 24 months depending on whether or not parents have received the intervention adjusting for immunization status at three months, time, age of the mother, the number of children of the mother, caesarean delivery and hospitalization in neonatology Gagneur A et al. European Society for Pediatric infectious disease 2016, Brighton 10-14 may 12

PromoVac studies PromoVaQ

Impact on parents vaccination intention A significant increase in vaccination intention was observed in each center after the intervention, with a global increase of 12% (p<0.0001). Gagneur A et al. European Society for Pediatric infectious disease 2016, Brighton 10-14 may 14

Impact on parental vaccination hesitancy score 35 30 28,2 28,7 27,3 27,1 25 24 20 15 16,1 20,7 16,5 12,5 16,4 before after 10 5 0 Sherbrooke McGill Ste justine Quebec Total A significant decrease in Opel s vaccine hesitancy score was also observed in each maternity ward after the intervention, with a global decrease of 40% (p<0.0001). Gagneur A et al. European Society for Pediatric infectious disease 2016, Brighton 10-14 may 15

Impact on parental vaccination hesitancy score 100 90 80 70 60 54 79 55 71 52 76 62 88 56 79 50 40 30 20 10 0 28 25 35 28 26 21 16 19 16 18 20 13 8 16 5 8 11 5 4 5 before after before after before after before after before after Sherbrooke Mc Gill Ste Justine Quebec Total 51 et plus 30-50 0-<30 < 30 Low level of VH 30-50 Intermediate level > 50 High level Gagneur A et al. European Society for Pediatric infectious disease 2016, Brighton 10-14 may 16

Impact on vaccination coverage (2/4 nurseries) Vaccination coverage (VC) intervention Group Control Group n = 629 n = 627 n (%) n (%) Increase of VC (%) p 3 m 558 (88.7) 525 (83.7) + 5.0 0,01 5 m 526 (83.6) 510 (81.3) + 2.3 0.29 7 m 503 (80.0) 463 (73.8) + 6.2 0,01 17

Discussion-reflexions : What works? No conflict of interest with the counselor 2 months before the first vaccine (time to take decision) Infant s vaccination induce stress to parents? Novelty Tailored informations Unpredictability Threat to the ego Motivational interviewing Sense of control Intervention tailored to the needs Informations Educational methods 18

Decisional process Vaccination? CONTROVERSIES Distrust in public Health authorities Vaccines risk Perceived severity or vulnerability to diseases AMBIVALENCE Perceived necessity of vaccines Subjectives norms Insufficient knowledge Vaccines benefits YES NO? 19

PromoVac to PromoVaQ to PromoVaC PROMOtion Vaccination in Canada (2017-2020) RCT in 5 provincies (BC, NS, PEI, ON, QC) CIRN and CRCHUS fundings, INSPQ partnership Validation in differents cultural and logistical contexts 1600 families will be enrolled International RCT? France, Austria, Italy, USA, Australia. Universal validation of the concept And now in Québec? 20

From PromoVac to EMMIE program Deadly gap between research and real life 17 years to 1 year

From PromoVac to EMMIE : Challenges PromoVac High fidelity As intended To ensure effect and causal attribution Intervention components (training of research nurses) Parents in University maternity wards Research funds Intervention implementation EMMIE Adapted to the need As applicable To ensure sustainability Adaptation of the intervention (training of vaccination counselors) Parents in Quebec Service delivery funds Powell el al. Implementation Science 2015 Thanks to Nick Sevladis!

Implementation outcomes Implementation outcome Acceptability Adoption Feasability Fidelity Implementation costs Coverage Sustainability Definition Perception among stakeholders new intervention is agreeable Intention of application of a new intervention Extent to which an intervention can be applied Extent to which an intervention gets applied as originally designed Costs of the delivery strategy Extent to which eligible population actually receive the intervention Extent to which a new intervention is maintained postintroduction Nick Sevladis. Vaccine hesitancy meeting, fondation Mérieux 2016

EMMIE program Immunization Partnership Fund (IPF) : Subvention grants of 2-3M$/year for projects aimed at improving vaccination coverage in Canada. Application of the Quebec Ministry of health to implement the PromoVac strategy in maternity wards in Quebec. EMMIE program phase 1: Funds (IPF 0.5 M$ and MSSS 2 M$) Period 2017-2019 Maternity wards 2500 annual births 55% of Quebec annual births (45 000 neonates) 13 maternity wards in 6 administrative regions.

EMMIE program : Aims To assess implementation and impact of the program in real life Specific aims Description of the implementation of the program (Implementation guide) Identification of barriers and facilitators of implementation Assess the impact of the program on Vaccine intention and vaccine hesitancy score in parents Vaccine coverage in children in Quebec EMMIE program phase 2 (2019-2021) Implementation in all maternity wards in Quebec Adoption as a new public health policy

EMMIE : ORGANIZATIONAL FRAMEWORK

Vaccination counselors Nurses or not? Immunization training Based on the website PIQ program Specific immunization training (EMMIE immunization guide) Trainers in each region Specifically adapted to the intervention for parents MI training in 5 steps +++ 1) 2 days session by 2 certified trainers 2) Training period (3 weeks in maternity wards, audio recording with trainers feedback) 3) Feed-back one day session 4) Validation period (2 weeks in maternity wards, audio recording, trainers visit on site) 5) Implementation (annual audio recording, annual visit, community of practice)

EMMIE outcomes (Implementation) Population Outcomes Data source- instruments Vaccination counselors Maternity wards HCP MI knowledge and competences MI training satisfaction % of parents meet during post-partum stay (characteristics of non-met parents) % refusal (characteristics of parents) Duration of interventions % parents acceptation of registry access Acceptation in maternity wards team Satisfaction about the program Suggestions to improve the program Program s impact on activity Satisfaction about the program Barriers and facilitators Suggestions to improve the program Self administered questionnaire before and after training MITI 4.2 Admistrative data of maternity wards Field diary of counsellors Individual meeting Focus group Self administered questionnaire Individual meeting Focus group Managers, administrators Satisfaction about the program Barriers and facilitators Suggestions to improve the program Individual meeting Focus group

EMMIE outcomes (Implementation) Population Outcomes Data source- instruments Parents Program acceptability Satisfaction about the program Self administered questionnaire before and after intervention Research team Number and % of HCP and administrators met during the program presentation Fidelity and difference between anticipated and real timeline for recruitment and training of counselors Numbers of recruited and trained counselors Annual counselors renewal rate Duration of training period Directs costs of the program Costs/additional vaccinated child Dashboard of counselors recruitment and training process. Hospital administrative data

EMMIE outcomes (Impact) Population Outcomes Data source- instruments Parents Socio-demographics data Vaccination intention score Vaccination hesitancy score Knowledge about vaccination Fidelity and differences between PromoVac studies results Self administered questionnaire before and after intervention Children recruited in the program VC at 3,5,7,13,19 and 24 months Long-term VC (3,6,12 years) Age at vaccination Number of days underimmunized Vaccination place Address Socio-demographics data Fidelity and differences between PromoVac studies results Quebec provincial registry of vaccination

EMMIE Timeline Protocol redaction May-July 2017 Informations about the program to : April-August 2017 - Public health regional directions - Hospitals directions - Ministry of health - Maternity wards administration Recrutment of counsellors September-October 2017 Training of counsellors November 2017 to January 2018 Data collection November 2017 to February 2019 Data analysis implementation March 2018- March 2019 Data analysis impact Questionnaire January-April 2019 VC (3,5,7 months) August 2019-October 2019 VC (13,19,24 months) January-march 2021 VC (3 years) 2022 VC (6 years) 2025 VC (12 years) 2031 Preliminary results diffusion November 2018 - March 2019

Future directions EMMIE phase 2 New practice of care in maternity wards in Quebec Perennial funds by the MSSS Improve VC of 5-10% in children Change of vaccination perception in the population? 90 000 annual births 180 000 parents = 2% of Quebec population The program could be reached 20% of the Quebec population in 10 years Sufficient critical mass population to change the vaccination perception in Quebec? Herd immunity about vaccination perception?

Acknowledgements Research team: Thomas Lemaitre, Anne Farrands, Marie-Laure Specq, Virginie Gosselin Parents involved in the studies EMMIE collaboration team : Danielle Auger, Infectious disease coordinator MSSS Carole Albert, Johanne Sanson, EMMIE managers Virginie Gosselin, EMMIE coordinator Julie Bergeron, post-doc student Anne Farrands, Danielle Pinsenault, MI trainers Members of EMMIE comitees : Eve Dubé, Monique Landry, Maryse Guay, Nadine Sicard, Evelyne Toth, Nicole Boulianne,

The art of persuasion is as much about agreeing as it is about convincing. Blaise Pascal (1623-1662)