Contact information
Type
Scientific
Primary contact
Dr Jane Halliday
ORCID ID
Contact details
Public Health Genetics Unit
10th floor Murdoch Childrens Research Institute
Flemington Road
Parkville
3052
Australia
+61 (0)3 8341 6260
jane.halliday@mcri.edu.au
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
237124; ACTRN12606000234516
Study information
Scientific title
A randomised controlled trial of a decision aid for prenatal screening and diagnosis
Acronym
ADEPT
Study hypothesis
Compared with pregnant women receiving a pamphlet, pregnant women who receive a decision aid on prenatal testing for foetal abnormality will have:
1. A higher rate of informed choice
2. Less decisional conflict
Ethics approval
Ethics Committee of Royal Australian College of General Practitioners gave approval on the 20th December 2004 (ref: NREEC 03-16)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Condition
Prenatal testing of foetal abnormalities
Intervention
Decision aid versus pamphlet:
1. The decision aid for prenatal testing of foetal abnormalities has been developed using the three steps of the Ottawa Decision Support framework:
1.1. Identifying needs
1.2. Providing decision support
1.3. Evaluating decision support
2. The pamphlet has been developed by Genetic Health Services Victoria (GHSV). The pamphlet contains information on maternal age related risk, screening and diagnostic tests, a table summarising the tests available and what conditions they detect.
Data will be collected from women using questionnaires at 14 weeks and 24 weeks gestation.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Informed choice, measured by the percentage of women in each arm of the trial identified as making an informed choice using the multi-dimensional measure of informed choice (MMIC) scale
2. Decisional conflict, measured by the difference in mean scores of the Decisional Conflict Scale between women in each arm
Secondary outcome measures
1. Anxiety
2. Depression
3. Attachment to the pregnancy/foetus
4. Acceptability of the decision aid to both woman and GP
Overall trial start date
01/08/2004
Overall trial end date
30/04/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Pregnant women attending a participating general practice (GP) were eligible to participate provided they were:
1. Aged 18 years or older
2. Equal to or less than 12 weeks gestation
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
500
Participant exclusion criteria
1. Non-English speaking
2. Were unable to give written informed consent
3. Required genetic counselling due to a family history of an inherited condition or recurrent risk for foetal abnormality
4. Having already undertaken testing for foetal abnormality in this pregnancy
5. Experiencing vaginal bleeding
6. Currently having a known multiple pregnancy
Recruitment start date
01/08/2004
Recruitment end date
30/04/2006
Locations
Countries of recruitment
Australia
Trial participating centre
Public Health Genetics Unit
Parkville
3052
Australia
Sponsor information
Organisation
Murdoch Childrens Research Institute (MCRI) (Australia)
Sponsor details
Royal Childrens Hospital
Flemington Road
Parkville
3052
Australia
+61 (0)3 8341 6200
jane.halliday@mcri.edu.au
Sponsor type
Research organisation
Website
Funders
Funder type
Research council
Funder name
National Health and Medical Research Council (NHMRC) (Australia)
Alternative name(s)
NHMRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Australia
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. Study protocol in http://www.ncbi.nlm.nih.gov/pubmed/16611368
2. Results in http://www.ncbi.nlm.nih.gov/pubmed/18190370
Publication citations
-
Study protocol
Nagle C, Lewis S, Meiser B, Metcalfe S, Carlin JB, Bell R, Gunn J, Halliday J, Evaluation of a decision aid for prenatal testing of fetal abnormalities: a cluster randomised trial [ISRCTN22532458]., BMC Public Health, 2006, 6, 96, doi: 10.1186/1471-2458-6-96.
-
Results
Nagle C, Gunn J, Bell R, Lewis S, Meiser B, Metcalfe S, Ukoumunne OC, Halliday J, Use of a decision aid for prenatal testing of fetal abnormalities to improve women's informed decision making: a cluster randomised controlled trial [ISRCTN22532458]., BJOG, 2008, 115, 3, 339-347, doi: 10.1111/j.1471-0528.2007.01576.x.