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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Down Syndrome; Aneuploidy; Pregnancy Early
• Intervention / Treatment: Behavioral: Enhanced (intervention) education

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 286
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 119074
    • National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; See arm description
No Intervention: Control; 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?

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

Collaborators and Investigators

• Sponsor: National University Hospital, Singapore

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2021
• Primary Completion (Actual): February 24, 2022
• Study Completion (Anticipated): July 30, 2022

Study Registration Dates

• First Submitted: July 31, 2022
• First Submitted That Met QC Criteria: August 5, 2022
• First Posted (Actual): August 9, 2022

Study Record Updates

• Last Update Posted (Actual): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 5, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: randomized controlled trial; Screening; prenatal; informed choice
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Congenital Abnormalities; Genetic Diseases, Inborn; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Chromosome Aberrations; Down Syndrome; Aneuploidy
• Other Study ID Numbers: 2020/01123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No