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Trial registered on ANZCTR


Registration number
ACTRN12610000332022
Ethics application status
Approved
Date submitted
15/12/2009
Date registered
27/04/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of opt-in versus opt-out parental consent for participation in childhood vaccine safety surveillance using data linkage.
Scientific title
A comparison of opt-in versus opt-out parental consent for participation in childhood vaccine safety surveillance using data linkage: a randomised controlled trial.
Secondary ID [1] 1201 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vaccine safety surveillance using data linkage of administrative datasets 256402 0
Condition category
Condition code
Public Health 256580 256580 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 255698 0
Other interventions
Comparator / control treatment
Opt-out consent vs opt-in consent (to data linkage for vaccine safety surveillance)
Control group
Active

Outcomes
Primary outcome [1] 257470 0
The proportion of parents in each arm participating in data linkage for vaccine safety surveillance (at follow-up).
Timepoint [1] 257470 0
Ten weeks post-partum.
Secondary outcome [1] 262650 0
Attitudes to data linkage elicited from telephone survey at follow-up.
Timepoint [1] 262650 0
Ten weeks post-partum.
Secondary outcome [2] 262651 0
Attitudes to vaccination and baby's vaccination status elicited from telephone survey at follow-up.
Timepoint [2] 262651 0
Ten weeks post-partum.
Secondary outcome [3] 262652 0
Consent preferences for data linkage elicited from telephone survey at follow-up.
Timepoint [3] 262652 0
Ten weeks post-partum.

Eligibility
Key inclusion criteria
Mothers who have had a live and surviving birth at the Women’s and Children’s Hospital.

South Australia residents.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Monthly lists of eligible mothers with a live and surviving birth were extracted from a hospital admissions database and sent to randomisation personnel.

Allocation concealment via central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation, stratified by first or previous live and surviving birth.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
8/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1088
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256179 0
Government body
Name [1] 256179 0
Australian Research Council Linkage Project grant
Country [1] 256179 0
Australia
Primary sponsor type
University
Name
Discipline of Paediatrics, UNIVERSITY OF ADELAIDE
Address
University Department of Paediatrics
Women's and Children's Hospital
72 King William Road
NORTH ADELAIDE SA 5006
Country
Australia
Secondary sponsor category [1] 251519 0
University
Name [1] 251519 0
Discipline of Public Health, UNIVERSITY OF ADELAIDE
Address [1] 251519 0
Discipline of Public Health
Level 9, 10 Pulteney Street
Mail Drop DX650 207
UNIVERSITY OF ADELAIDE SA 5005
Country [1] 251519 0
Australia
Other collaborator category [1] 1001 0
Government body
Name [1] 1001 0
SA Health
Address [1] 1001 0
PO Box 287
Rundle Mall
ADELAIDE SA 5000
Country [1] 1001 0
Australia
Other collaborator category [2] 1002 0
Government body
Name [2] 1002 0
NSW Department of Health
Address [2] 1002 0
LMB 961
NORTH SYDNEY NSW 2059
Country [2] 1002 0
Australia
Other collaborator category [3] 1003 0
Charities/Societies/Foundations
Name [3] 1003 0
Surveillance of Adverse Events Following Vaccination In the Community (SAEFVIC)
Address [3] 1003 0
Royal Children's Hospital
Flemington Road
PARKVILLE VIC 3052
Country [3] 1003 0
Australia
Other collaborator category [4] 1004 0
Charities/Societies/Foundations
Name [4] 1004 0
Australian Paediatric Surveillance Unit (APSU)
Address [4] 1004 0
Children's Hospital Westmead
Locked Bag 4001
WESTMEAD NSW 2145
Country [4] 1004 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258284 0
Children, Youth & Women's Health Service Human Research Ethics Committee
Ethics committee address [1] 258284 0
Children, Youth and Women's Health Service (CYWHS)
Human Research Ethics Committee
Women's and Children's Hospital
72 King William Rd
NORTH ADELAIDE SA 5006
Ethics committee country [1] 258284 0
Australia
Date submitted for ethics approval [1] 258284 0
Approval date [1] 258284 0
31/08/2009
Ethics approval number [1] 258284 0
REC 2087/7/11

Summary
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.
Trial website
http://health.adelaide.edu.au/paediatrics/research/valid/
Trial related presentations / publications
Pending
Public notes

Contacts
Principal investigator
Name 30618 0
Address 30618 0
Country 30618 0
Phone 30618 0
Fax 30618 0
Email 30618 0
Contact person for public queries
Name 13865 0
Katherine Duszynski
Address 13865 0
University Department of Paediatrics
Women's and Children's Hospital
72 King William Road
NORTH ADELAIDE SA 5006
Country 13865 0
Australia
Phone 13865 0
+61 8 8161 7304
Fax 13865 0
+61 8 8161 7031
Email 13865 0
katherine.duszynski@adelaide.edu.au
Contact person for scientific queries
Name 4793 0
Dr Michael Gold
Address 4793 0
University Department of Paediatrics
Women's and Children's Hospital
72 King William Road
NORTH ADELAIDE SA 5006
Country 4793 0
Australia
Phone 4793 0
+61 8 8161 7266
Fax 4793 0
+61 8 8161 7031
Email 4793 0
michael.gold@adelaide.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIA randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage: study protocol2011https://doi.org/10.1186/1745-6215-12-1
N.B. These documents automatically identified may not have been verified by the study sponsor.