Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000234516
Ethics application status
Approved
Date submitted
23/02/2004
Date registered
23/02/2004
Date last updated
23/02/2004
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a decision aid for prenatal testing of fetal abnormalities compared to a pamphlet on improving women’s informed choice and decreasing decisional conflict: a randomised controlled trial.
Scientific title
Evaluation of a decision aid for prenatal testing of fetal abnormalities compared to a pamphlet on improving women’s informed choice and decreasing decision al conflict: a cluster randomised controlled trial.
Secondary ID [1] 52 0
Perinatal Trials Registry: PTR513
Secondary ID [2] 53 0
International Standard Randomized Controlled Trial Number (ISRCTN): ISRCTN22532458
Universal Trial Number (UTN)
Trial acronym
ADEPT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Women's decision-making regarding prenatal genetic tests. 49 0
Condition category
Condition code
Reproductive Health and Childbirth 55 55 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention:
A decision aid provided to women for use during the time they are making decisions about prenatal test options.
Both resources are provided to the participating woman by her GP at the time of her first visit in pregnancy (varies from 5 –12 weeks gestation) and are to be used during the time she is making decisions about test options (dependant on test). The duration of use varies from 1 -9 weeks depending on presenting gestation and choice of test.
Intervention code [1] 1097 0
Other interventions
Comparator / control treatment
Control:
A pamphlet provided to women for use during the time they are making decisions about prenatal test options.
Control group
Active

Outcomes
Primary outcome [1] 87 0
Informed choice and decisional conflict
Timepoint [1] 87 0
Measured at 14 weeks gestation
Secondary outcome [1] 173 0
Acceptability of the decision aid/pamphlet to women and GPs.
Timepoint [1] 173 0
Measured at 14 weeks
Secondary outcome [2] 174 0
Anxiety, Depression, attitudes to the pregnancy/fetus.
Timepoint [2] 174 0
Measured at 14 weeks, 24 weeks and 3 months post partum.
Secondary outcome [3] 175 0
Satisfaction with the decision, and decisional regret.
Timepoint [3] 175 0
Measured at 24 weeks and 3 months post partum.
Secondary outcome [4] 176 0
Changes in informed choice and decisional conflict.
Timepoint [4] 176 0
Measured at 24 weeks and 3 months post partum.

Eligibility
Key inclusion criteria
Victorian GPs will be eligible for participation provided they consult with least 30 women meeting the selection criteria in a 12-month period. Pregnant attending a participating GP will be eligible if they are: less than 12 weeks gestation.
Minimum age
18 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. are non-english speaking2. are unable to give written informed consent3. require genetic counselling due to a familiy history of an inherited disorder4. have not undertaken any testing to date for fetal abnormality in this pregnancy5. are currently experiencing vaginal bleeding6. have a known multiple pregnancy

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)
All GPs provided verbal consent to be randomised prior to randomisation and were therefore unaware of the group to which they would be allocated. A statistician independent of the project conducted all randomisation. The allocation schedule was “off site”.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated random list
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
13/08/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
664
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 79 0
Government body
Name [1] 79 0
National Health & Medical Research Council project grant (ID 237124) 2002-2004.
Country [1] 79 0
Australia
Primary sponsor type
Individual
Name
Jane Halliday, Murdoch Childrens Research Institute
Address
Country
Australia
Secondary sponsor category [1] 65 0
None
Name [1] 65 0
Nil
Address [1] 65 0
Country [1] 65 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 584 0
the ethics committee of Royal Australian College of General Practices
Ethics committee address [1] 584 0
Ethics committee country [1] 584 0
Australia
Date submitted for ethics approval [1] 584 0
Approval date [1] 584 0
20/12/2004
Ethics approval number [1] 584 0
NREE03-16

Summary
Brief summary
In recent years new prenatal tests have been developed and these are available earlier in pregnancy. There has also been a dramatic increase in the uptake of screening tests for women in all age groups. Peak obstetric and genetic bodies in Britain, Canada and Australia now recommend that:
1. all women pregnant be informed of, and offered screening tests for fetal abnormality and
2. women who are at an increased risk of chromosomal abnormality on the basis of their age or previously affected pregnancy should be informed of, and offerred the choice of screening or diagnostic tests.

This means that an ever-increasing number of women are confronted with information that is complex and women are required to make decisions that are often difficult and confusing. To date, technological developments have not resulted in commensurate improvements in the resources available to support women faced with important decisions regarding prenatal testing.

Studies from a variety of health settings such as cancer treatments and hormone replacement therapy, have demonstrated that decision support strategies such as decision aids have facilitated an increase in the capacity of individuals to make an informed choice and have decreased levels of uncertainty and conflict. However, the role of decision aids in prenatal testing is not established.

This trial aims to evaluate a decision aid for prenatal testing of fetal abnormalities in the Victorian primary health cre setting using a cluster randomised controlled trial. Fifty GPs will be randomly allocated to either the intervention or the control arm of the trial. GPs will recruit 10 consecutive women using pre-specified selection criteria.
The primary outcomes will be the difference in the rate of informed choice and decisional conflict between the two groups assessed at 14 weeks gestation
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36018 0
Address 36018 0
Country 36018 0
Phone 36018 0
Fax 36018 0
Email 36018 0
Contact person for public queries
Name 10286 0
Cate Nagle
Address 10286 0
Public Health Genetics
Murdoch Childrens Research Institute
Flemington Road
Parkville VIC 3052
Country 10286 0
Australia
Phone 10286 0
+61 3 83416370
Fax 10286 0
+61 3 83416212
Email 10286 0
[email protected]
Contact person for scientific queries
Name 1214 0
Cate Nagle
Address 1214 0
Public Health Genetics
Murdoch Childrens Research Institute
Flemington Road
Parkville VIC 3052
Country 1214 0
Australia
Phone 1214 0
+61 3 83416370
Fax 1214 0
+61 3 83416212
Email 1214 0
[email protected]

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
No additional documents have been identified.