None listed
Conditions
Brief summary
The study compares the feasibility of two different consent mechanisms for parental participation in data linkage of their infants’ vaccination and health records to evaluate vaccine safety. When their infant is 6 weeks of age (prior to their 2 month vaccinations) parents will be sent an information sheet about the study. In the opt-in arm, parents will be asked to signal willingness to participate in data linkage by returning a signed reply form (or can phone or email). In the opt-out arm, all parents will be included unless they indicate an unwillingness to participate by returning a signed reply form (or can phone or email). When their infant is 10 weeks of age (after their 2 month vaccinations), every household will be called and a parent will be asked to participate in a 20 minute telephone interview, in order to elicit attitudes, and knowledge about, data linkage, consent preferences, and their baby’s vaccination status. This study will examine the following null hypotheses: Primary hypothesis That an opt-in or opt-out method of consent will result in an equal proportion of parents consenting to participate in a study of vaccine safety data linkage. Secondary hypotheses Neither consent option will result in parental participation >90%. That there are no differences in parental demographics between those who choose to participate in data linkage and those who do not.
Interventions
When their baby is 6 weeks of age (prior to their 2 month vaccinations), parent(s) will be sent an information sheet detailing information about data linkage for vaccine safety surveillance. In the opt-in arm, parents(s) will be asked to signal willingness to participate in data linkage by returning a signed reply form (or by phone or email). Non-return of the form indicates passive dissent to data linkage for vaccine safety surveillance. In the opt-out arm, parents will be included unless they
When their baby is 6 weeks of age (prior to their 2 month vaccinations), parent(s) will be sent an information sheet detailing information about data linkage for vaccine safety surveillance. In the opt-in arm, parents(s) will be asked to signal willingness to participate in data linkage by returning a signed reply form (or by phone or email). Non-return of the form indicates passive dissent to data linkage for vaccine safety surveillance. In the opt-out arm, parents will be included unless they indicate an unwillingness to participate by returning a signed reply form (or can phone or email). Non-return of form in the opt-out arm will indicate passive consent to participation in data linkage for vaccine safety surveillance. No follow-up to initial mailing will be conducted. When their child is 10 weeks of age (after their 2 month vaccinations), every household regardless of return/non-return of form will be called and a parent will be asked to participate in a 20 minute telephone interview, in order to elicit attitudes, and knowledge about, data linkage, consent preferences, and their baby’s vaccination status. Duration of intervention is concluded following interview participation or non-contact up to 14-weeks post-partum.
Sponsors
Discipline of Paediatrics, UNIVERSITY OF ADELAIDE
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Mothers who have had a live and surviving birth at the Women’s and Children’s Hospital. South Australia residents.
Exclusion criteria
Mothers having had a stillbirth or neonatal death. Mothers having had a home-birth or birth as an inward transfer from another hospital. Births where the infant stayed in the Neonatal Intensive Care Unit (NICU) for 2 weeks or longer.
Outcome results
None listed