Improving decision support about prenatal screening for pregnant women and counselors

Interactive, tailored video decision support about prenatal screening for counselors, pregnant women and their partners

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18016226

Enrollment

1250

Registered

2022-11-04

Start date

2022-10-01

Completion date

Unknown

Last updated

2025-03-17

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

Conditions

Informed decision-making regarding prenatal screening Pregnancy and Childbirth

Interventions

The intervention effects will be tested by means of a pre-post test cluster randomized trial. Participating midwifery practices will be randomly assigned to the control or intervention group by means

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Pregnant women, who have not yet received the prenatal screening (blood test and 13-week and 20-week ultrasound) 2. Midwives in primary care that have been educated and contracted by one of the regions for prenatal screening

Exclusion criteria

Exclusion criteria: 1. Women who are not pregnant 2. Women who have received the prenatal screening (blood test and 13-week and 20-week ultrasound) 3. Counselors who have not been contracted by one of the regional centers for prenatal screening or who are no midwife

Design outcomes

Primary

Measure	Time frame
1. Informed decision making (knowledge and attitude towards prenatal screening and the screening uptake) measured using uptake of screening (or the intention towards participation, instead of the uptake itself, as the screening for the 20-week ultrasound which takes place after the post-test) at pre-test (between 6 and 9 weeks of pregnancy, before counseling about prenatal screening, and before the intervention condition will receive a link to the tailored video-decision support tool) and post-test (between 15 and 18 weeks of pregnancy, after counseling about prenatal screening, and approximately 5 weeks after the intervention condition has received access to the tailored video-decision support tool) 2. Shared decision making (the pregnant women is collaboratively supported by the counselor to make a decision that meets the pregnant women’s values and circumstances, in which trustworthy information is provided accessibly about the decision options and its consequences, and in which the concerns and needs of pregnant women play a major role in the decision) measured using: 2.1. The Shared Decision Making Questionnaire-Physician Version (SDM-Q-Doc) for counselors at pre-test (at the start, after inclusion of the midwifery practice and counselor), and at post-test (6 weeks after baseline, approximately after 4 to 6 counseling conversations; this is also 5 to 6 weeks after the intervention condition has received access to the e-Learning and tailored video-decision support tool) 2.2. The Shared Decision Making Questionnaire (SDM-Q-9) among pregnant women at the post-test (between 15 and 18 weeks of pregnancy)	—

Measure

Time frame

1. Informed decision making (knowledge and attitude towards prenatal screening and the screening uptake) measured using uptake of screening (or the intention towards participation, instead of the uptake itself, as the screening for the 20-week ultrasound which takes place after the post-test) at pre-test (between 6 and 9 weeks of pregnancy, before counseling about prenatal screening, and before the intervention condition will receive a link to the tailored video-decision support tool) and post-test (between 15 and 18 weeks of pregnancy, after counseling about prenatal screening, and approximately 5 weeks after the intervention condition has received access to the tailored video-decision support tool) 2. Shared decision making (the pregnant women is collaboratively supported by the counselor to make a decision that meets the pregnant women’s values and circumstances, in which trustworthy information is provided accessibly about the decision options and its consequences, and in which the concerns and needs of pregnant women play a major role in the decision) measured using: 2.1. The Shared Decision Making Questionnaire-Physician Version (SDM-Q-Doc) for counselors at pre-test (at the start, after inclusion of the midwifery practice and counselor), and at post-test (6 weeks after baseline, approximately after 4 to 6 counseling conversations; this is also 5 to 6 weeks after the intervention condition has received access to the e-Learning and tailored video-decision support tool) 2.2. The Shared Decision Making Questionnaire (SDM-Q-9) among pregnant women at the post-test (between 15 and 18 weeks of pregnancy)

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Secondary

Measure	Time frame
Pregnant women: 1. Determinants of informed decision-making regarding prenatal screening are measured among pregnant individuals: 1.1. Knowledge is measured using items based on Van Agt et al. (2012) at the pre- and post-test 1.2. Attitude is measured using items based on Van Agt et al. (2012) at the pre- and post-test 1.3. Intention is measured using items based on Van Agt et al. (2012) at the pre- and post-test 1.4. Screening uptake is measured using items based on Van den Berg et al. (2006) at the post-test 2. Decisional certainty is measured among pregnant individuals using items based on the certainty subscale of the Decisional Conflict Scales of O’Connor et al., (2002) at the pre- and post-test 3. Shared-decision making is measured among pregnant individuals using items based on the Shared Decision Making Questionnaire (SDM-Q-9), Rodenburg-Vandenbussche et al. (2015), at the post-test 4. Intervention use is measured among pregnant individuals in the intervention group using an item asking whether or not they used the decision aid at the post-test 5. Acceptability of the intervention is measured among pregnant individuals in the intervention group using the following items, based on Pot et al. (2020), at the post-test: 5.1. Their overall satisfaction with the intervention (on a 10-point scale) 5.2. Whether they learned something new of the decision aid (no/don’t know/yes) 5.3. Whether the information in the decision aid was understandable (no/don’t know/yes) 5.4. Whether the decision aid was easy to use (no/don’t know/yes) 5.5. Whether the decision aid was helpful in making an informed decision about prenatal screening (no/don’t know/yes) Counselors: 1. Self-efficacy of counselors regarding prenatal screening counseling with pregnant individuals and their partners, both in general and for those with low literacy skills, is measured using items based on the Shared Decision Making Questionnaire-Physician Version (SDM-Q-Doc), Rodenburg-Vandenbussche et al. (2	—

Measure

Time frame

Pregnant women: 1. Determinants of informed decision-making regarding prenatal screening are measured among pregnant individuals: 1.1. Knowledge is measured using items based on Van Agt et al. (2012) at the pre- and post-test 1.2. Attitude is measured using items based on Van Agt et al. (2012) at the pre- and post-test 1.3. Intention is measured using items based on Van Agt et al. (2012) at the pre- and post-test 1.4. Screening uptake is measured using items based on Van den Berg et al. (2006) at the post-test 2. Decisional certainty is measured among pregnant individuals using items based on the certainty subscale of the Decisional Conflict Scales of O’Connor et al., (2002) at the pre- and post-test 3. Shared-decision making is measured among pregnant individuals using items based on the Shared Decision Making Questionnaire (SDM-Q-9), Rodenburg-Vandenbussche et al. (2015), at the post-test 4. Intervention use is measured among pregnant individuals in the intervention group using an item asking whether or not they used the decision aid at the post-test 5. Acceptability of the intervention is measured among pregnant individuals in the intervention group using the following items, based on Pot et al. (2020), at the post-test: 5.1. Their overall satisfaction with the intervention (on a 10-point scale) 5.2. Whether they learned something new of the decision aid (no/don’t know/yes) 5.3. Whether the information in the decision aid was understandable (no/don’t know/yes) 5.4. Whether the decision aid was easy to use (no/don’t know/yes) 5.5. Whether the decision aid was helpful in making an informed decision about prenatal screening (no/don’t know/yes) Counselors: 1. Self-efficacy of counselors regarding prenatal screening counseling with pregnant individuals and their partners, both in general and for those with low literacy skills, is measured using items based on the Shared Decision Making Questionnaire-Physician Version (SDM-Q-Doc), Rodenburg-Vandenbussche et al. (2

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Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 29, 2026