Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02984007 |
| Other study ID # |
2017-1578 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 25, 2017 |
| Est. completion date |
April 6, 2021 |
Study information
| Verified date |
April 2021 |
| Source |
Université de Sherbrooke |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
OBJECTIVES
Main objective: To evaluate the impact of the motivational interviewing (MI) intervention on
parents' intention to vaccinate their infant and their vaccine hesitancy (VH) score in a
Pan-Canadian context. In order to explore differences in the intervention's impact according
to cultural and organizational factors, all analysis will also be conducted at the level of
each center.
Specific objectives:
1. To assess parents' intention to vaccinate their infant before the intervention and
immediately after the intervention, globally and at each center level.
2. To assess parents' VH scores before the intervention, immediately after the intervention
and when their infant is 3 months of age, globally and at each center level.
3. To assess parents' knowledge, attitudes and beliefs (KAB) about vaccination before the
intervention, immediately after the intervention and when their infant is 3 months of
age:
- Descriptive analysis according to a composite model inspired from the Health Belief
Model (HBM), the Theory of Planned Behavior, and the VH measures (based on a
validated questionnaire);
- Research of the determinants of vaccination intention.
4. To compare vaccine coverage (VC) at 3 months of age of infants whose parents has
received (intervention group) or not (control group) the intervention in the maternity
ward during the recruitment period.
STUDY DESIGN
This study is a multicentre randomized controlled trial (RCT) with single unit of
randomization that will be conducted in maternity wards of 5 provinces: Quebec (QC), British
Columbia (BC), Ontario (ON), and Nova Scotia (NS)/ Prince Edward Island (PEI). In each
center, parents will be randomized to receive the MI intervention (intervention group) or to
receive an information flyer on childhood vaccines (control group). The flyer that will be
given to mothers of the control group will be the one that is usually given to parents at the
maternity ward or at the first home visit after birth during the first week. Thus, flyers
will be different according to the participating regions in this study. Randomization will be
stratified by center and will be made in blocks of 4, 6 and 8 participants.
STUDY POPULATION
Study participants
The study population will include 1,600 mothers of infants born in the participating
maternity wards during the recruitment period.
Study centers
The study will be conducted in 6 maternity wards located in 4 different centers:
1. Centre hospitalier universitaire de Sherbrooke (CHUS), Sherbrooke, QC;
2. B.C. Women's Hospital & Health Centre, Vancouver, BC and Surrey Memorial Hospital,
Surrey, BC;
3. North York General Hospital, Toronto, ON;
4. IWK Health Centre, Halifax, NS and Queen Elizabeth Hospital, Charlottetown, PE.
The choice of these 6 maternity wards is the best compromise between the study feasibility
and the diversity of the Canadian population. More than 2,500 deliveries per year occur in
each maternity ward (except for Queen Elizabeth Hospital with approximately 1200 annual
births), which ensures the feasibility of the study.
CONDUCT OF STUDY
Enrollment
Each subject must participate in the informed consent process and sign and date the informed
consent form before any procedures specified in this protocol are performed. Mothers
attending the participant maternity wards will be entirely free to participate in the study.
Benefits of the study will be the chance for the parents to discuss childhood immunizations
in a non-confronting and non-judgemental climate and the improvement of their knowledge.
Participation in the study will not involve risk, besides the risk of breach of
confidentiality for which precautions will be taken.
Regulatory considerations
The study will be registered with ClinicalTrials.gov.
Recruitment
Mothers will be approached to participate during the postpartum stay at the maternity ward.
The MI intervention will be delivered by a research assistant (RA) (or a research nurse) that
will have first received a standardized training session on the content and techniques of MI.
Since the postpartum stay may last less than 24 hours in some provinces, RAs will recruit
mothers in a chronological way according to the birth time of the mother to ensure to meet
the highest number of mothers as possible.
The recruitment will be conducted during 4 to 6 months. In the Quebec RCT, 25 participants
were recruited in average each week, so it is feasible to recruit 400 participants within 4
to 6 months.
Study plan
After the mothers agree to participate, they will have to complete an initial questionnaire
(Q1) to assess their intention to vaccinate, their VH scores and their KAB about vaccination,
as well as their socio-demographics characteristics. RAs will collect this questionnaire and
proceed to the randomization of the participating mother to receive the MI intervention or to
receive a flyer on childhood immunizations. Depending on the randomization result, RAs will
perform the MI intervention with the parents or only give the information flyer. RAs will
then distribute a similar questionnaire (Q2) to parents of both groups to assess their
intention to vaccinate, their VH scores and their KAB about vaccination, as well as their
satisfaction of the intervention received (MI or flyer). Before leaving the maternity ward,
parents will have to return their completed questionnaire to the RA or in a designated place.
When the child is 3 months of age, an online survey (Q3) will be sent to participants by
email to assess their VH score and their KAB as well as the child's vaccine status.
Standardization of the intervention
To ensure that the content of the information sessions will be standardized and similar for
each center or RA, a reference document on the primary vaccination (vaccines administered
before the age of 1 year) will be made according to the provincial recommendations for each
center and will be used for the training of RAs. This training will be conducted over 3 days
including supervision via audio recordings (2 days + 1 day). First, RAs will participate in a
2-day centralized training seminar in Montreal on the MI techniques given by a certified
trainer before the beginning of the study. Subsequently, RAs will practice their MI skills
during a 4 to 6-week trial period in their respective maternity ward. During this time, RAs
will send an online audio recording of their MI intervention with a mother in the maternity
ward (a separate informed consent form will be signed by these mothers to authorize the
record and the sending of the MI intervention). The audio recordings will be securely
transferred to the certified MI trainer through a web-based application named REDCap
(Research Electronic Data Capture). Based on this recording, the certified MI trainer will
assess their MI skills and offer them support and feedback to improve their practice. After 6
weeks of trial, the study coordinator and the certified MI trainer will visit each center to
give individual feedback and coaching to each RA. They will observe and validate the MI
intervention performed by the RAs and identify possible barriers to the implementation of the
study according to each maternity ward. This training framework is consistent with the
literature since MI training indeed requires training in 2 steps with feedback training and
coaching in real situations after the initial training. Data collected during the 6-week
trial period will be discarded since the RAs will be practising conducting the study. Data
will only be used to monitor good clinical practices (GCPs) in each center during the audit
by the study coordinator. After this training, RAs will officially start the recruitment in
the maternity wards. The MI trainer will be available to answer questions and offer support
to the RAs regarding their MI techniques throughout the study.
Confidentiality protection
Source documents containing names, addresses and other contact information of participants
will be stored at each local site in individual folders, identified by the assigned
participant identification number (PID) number. These documents are stored in locked filing
cabinets in a secure research facility, with controlled access, limited to authorized staff
and investigators. No personal identifiers will appear in any summary or report of the study
data and will not be sent to the coordinating center.
STATISTICAL CONSIDERATIONS
Sample size
In order to identify a statistically significant amelioration of 8% in parents' intention to
vaccinate, and taking account of a basic intention to vaccinate of 78%, a risk of alpha error
of 0.05 and a power of 80%, a total of 400 parents by center will be included. This sample
size will also allow detect a minimum of 5% reduction in VH scores in each center. The total
sample of 1,600 families will allow detecting a significant amelioration of 6% in infants'
VC.
Data analysis
A descriptive analysis of responses from Q1, Q2 and Q3 will be conducted. Q1 and Q2 responses
as well as Q1 and Q3 responses (KAB, vaccination intention and VH scores) will be compared
for mothers belonging to the intervention group in order to assess intervention's
effectiveness, globally and for each participating center. Q1, Q2 and Q3 responses (KAB,
vaccination intention and VH scores) will be also compared between intervention and control
groups in order to demonstrate the MI intervention's effectiveness compared to the
information flyer. Parents' intention to vaccinate their infant measured before the
intervention will be dichotomized as "certainly" vs. "probably"; "probably not" and
"certainly not" and compared to all covariates measured before the intervention. Multivariate
logistic regression analysis will be conducted to identify independent determinants
influencing vaccination intention. Regarding VC, it will be defined as the proportion of
children having a complete vaccine status on the total of participating children. A child is
considered having a complete vaccine status if he has received all vaccines and antigens
recommended by his respective provincial immunization schedule at 3 months of age.
Q1 and Q2 responses (KAB, vaccination intention and VH scores) will be first compared using
McNemar's test and Wilcoxon's signed rank test for paired data for mothers belonging to the
intervention group. Thereafter, Q1, Q2 and Q3 responses (KAB, vaccination intention and VH
scores) will be compared between intervention and control groups using the Chi-square test or
the Fisher's exact test as appropriate while continuous variables will be compared using the
Student's t-test or the Mann-Whitney U test as appropriate. Moreover, covariates will be
compared with vaccination intention using the appropriate tests mentioned. In multivariate
analysis, collinearity of the variables included in the model will be checked and the model
adequacy will be assessed by the Hosmer-Lemeshow test and the deviance test. Finally, VC will
be analyzed globally, comparing proportion of properly vaccinated children between
intervention and control groups using the Chi-square test. The SAS software (version 9.4, SAS
Institute, Inc., Cary, NC) will be used for all statistical analysis.
