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.

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000234516

Acronym

ADEPT

Enrollment

664

Registered

2004-02-23

Start date

2004-08-13

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Educational / counselling / training

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

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

Outcome results