Does an Educational Video for Aneuploidy Screening Improve Informed Choice Among Pregnant Women?

Study Overview
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Brief Summary
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Informed decision-making regarding aneuploidy screening has been reported to be low. Poor knowledge and the lack of deliberation have been cited as reasons for uninformed choices, highlighting the need for adequate pre-test counselling. We conducted a study to assess if an educational video improves informed choice in a clinical setting where both the combined first trimester screen and non-invasive prenatal screening are offered routinely to pregnant women.

Detailed Description
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Women attending the antenatal clinic with a viable singleton pregnancy below 14 weeks were randomized to receive routine counselling by their obstetrician or the intervention, where they watched a 16-minute educational video on aneuploidy screening before their consult. The primary outcome, rate of informed choice, was assessed using an adapted multidimensional measure of informed choice (MMIC) questionnaire, where informed choice was defined as good knowledge and value-consistent behaviour. Secondary outcomes included informed choice with deliberation, decisional conflict and anxiety.

Official Title
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Does an Educational Video for Aneuploidy Screening Improve Informed Choice Among Pregnant Women? A Randomized Controlled Trial

Conditions
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Aneuploidy, Down Syndrome, Pregnancy Early

Intervention / Treatment
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* Behavioral: Enhanced (intervention) education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 21 years or older English speaking had a viable singleton pregnancy below 14 weeks gestation Exclusion Criteria: women who had any prior discussion with a clinician regarding aneuploidy screening for their current pregnancy

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The intervention was a 16-minute educational video created by the study investigators which provided information about Down syndrome, diagnostic tests and screening tests. The screening tests covered in the video included the triple test, the combined first trimester screen and non-invasive prenatal screening. Information about how and when each of the tests were performed, their detection rates and possible results and their interpretations were covered in the video. The video was viewed by several healthcare providers and experts in the field of prenatal screening before the commencement of this study to ensure that the content was appropriate and adequate. The intervention was viewed by subjects on a portable tablet in a quiet room in the antenatal clinic. Subjects were then invited to ask their doctor any questions that they may have had about the video during the clinic consult which followed. | Behavioral: Enhanced (intervention) education<br>* See arm description<br>|
| No Intervention: Control<br>Women in the control group were counselled by the referring doctor regarding the aneuploidy screening options of FTS or NIPS, and provided information about the procedures involved for each test, their detection rates, cost, and possible results of testing. The use of a written information leaflet was available to doctors as an adjunct to providing this information. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Informed choice | Outcome will be measured using the modified multidimensional measure of informed choice (MMIC). | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deliberation | Outcome will be measured using 6 questions to measure deliberation on a five-point Likert scale | Day 0 | 
| Knowledge | Outcome will be measured using a 19-item validated true/false knowledge questionnaire. | Day 0 | 
| Value-consistent behaviour | Attitudes towards testing options were assessed using a validated questionnaire and deemed to be value consistent if a participants had a positive attitude towards the test option that they chose, or a negative attitude towards all test options and chose not to test. | Day 0 | 
| anxiety | Anxiety was assessed using the Spielberger State trait anxiety inventory (STAI-6) short form which consisted of 6 items | Day 0 | 
| Decisional Conflict | Decisional conflict was measured using a validated Decisional Conflict Scale (DCS) | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prenatal, Screening, informed choice, randomized controlled trial