Trial Outcomes & Findings for Use of a Novel Computerized Decision Aid for Prenatal Aneuploidy Screening (NCT NCT02991729)
NCT ID: NCT02991729
Last Updated: 2020-10-22
Results Overview
All patients in the intervention arm will complete a knowledge questionnaire following completion of the decision and and again immediately following genetic counseling. The investigators will assess noninferiority of the decision aid on participant knowledge, with primary outcome comparing knowledge after completion of the decision aid in the intervention arm, to knowledge following genetic counseling only in the routine care arm. The questionnaire is a modification of the validated Maternal Serum Screening Knowledge Questionnaire. This is on a 12-point scale (values 0-12), with higher score indicating greater knowledge.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
197 participants
Primary outcome timeframe
At completion of genetic counseling for the Routine Care Group and at completion of decision aid and genetic counseling for Experimental Group, approximately 10-60 minutes
Results posted on
2020-10-22
Participant Flow
Participant milestones
| Measure |
Routine Care
These patients will receive routine care at our institution for counseling on aneuploidy screening; they will be counseled by a genetic counselor on options, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey immediately following genetic counseling.
Genetic counseling appointment: All participants will undergo an approximately 15 minute educational genetic counseling appointment regarding aneuploidy screening options. Should family history concerns be identified on intake, this visit may be extended to include a discussion of additional issues.
|
Experimental
These patients will use an iPad-based decision aid explaining options for aneuploidy screening and testing. They will then immediately be counseled by a genetic counselor on their options as is routine at our institution, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey following use of the decision aid, and again immediately following genetic counseling.
iPad-based decision aid: This novel decision aid was developed by genetic counselors and Maternal Fetal Medicine physicians. It is used via an iPad and is interactive. It is available in English and Spanish has been piloted by 20 English and Spanish speaking women. It takes approximately 15 minutes to complete.
Genetic counseling appointment: All participants will undergo an approximately 15-min educational genetic counseling appointment
|
|---|---|---|
|
Overall Study
STARTED
|
105
|
92
|
|
Overall Study
COMPLETED
|
105
|
92
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of a Novel Computerized Decision Aid for Prenatal Aneuploidy Screening
Baseline characteristics by cohort
| Measure |
Routine Care
n=105 Participants
These patients will receive routine care at our institution for counseling on aneuploidy screening; they will be counseled by a genetic counselor on options, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey immediately following genetic counseling.
Genetic counseling appointment: All participants will undergo an approximately 15 minute educational genetic counseling appointment regarding aneuploidy screening options. Should family history concerns be identified on intake, this visit may be extended to include a discussion of additional issues.
|
Experimental
n=92 Participants
These patients will use an iPad-based decision aid explaining options for aneuploidy screening and testing. They will then immediately be counseled by a genetic counselor on their options as is routine at our institution, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey following use of the decision aid, and again immediately following genetic counseling.
iPad-based decision aid: This novel decision aid was developed by genetic counselors and Maternal Fetal Medicine physicians. It is used via an iPad and is interactive. It is available in English and Spanish has been piloted by 20 English and Spanish speaking women. It takes approximately 15 minutes to complete.
Genetic counseling appointment: All participants will undergo an approximately 15-min educational genetic counseling appointment
|
Total
n=197 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.4 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
32.7 years
STANDARD_DEVIATION 5.6 • n=7 Participants
|
32.6 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
197 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
63 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
19 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
15 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unspecified/other
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At completion of genetic counseling for the Routine Care Group and at completion of decision aid and genetic counseling for Experimental Group, approximately 10-60 minutesAll patients in the intervention arm will complete a knowledge questionnaire following completion of the decision and and again immediately following genetic counseling. The investigators will assess noninferiority of the decision aid on participant knowledge, with primary outcome comparing knowledge after completion of the decision aid in the intervention arm, to knowledge following genetic counseling only in the routine care arm. The questionnaire is a modification of the validated Maternal Serum Screening Knowledge Questionnaire. This is on a 12-point scale (values 0-12), with higher score indicating greater knowledge.
Outcome measures
| Measure |
Routine Care
n=105 Participants
These patients will receive routine care at our institution for counseling on aneuploidy screening; they will be counseled by a genetic counselor on options, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey immediately following genetic counseling.
Genetic counseling appointment: All participants will undergo an approximately 15 minute educational genetic counseling appointment regarding aneuploidy screening options. Should family history concerns be identified on intake, this visit may be extended to include a discussion of additional issues.
|
Experimental
n=92 Participants
These patients will use an iPad-based decision aid explaining options for aneuploidy screening and testing. They will then immediately be counseled by a genetic counselor on their options as is routine at our institution, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey following use of the decision aid, and again immediately following genetic counseling.
iPad-based decision aid: This novel decision aid was developed by genetic counselors and Maternal Fetal Medicine physicians. It is used via an iPad and is interactive. It is available in English and Spanish has been piloted by 20 English and Spanish speaking women. It takes approximately 15 minutes to complete.
Genetic counseling appointment: All participants will undergo an approximately 15-min educational genetic counseling appointment
|
|---|---|---|
|
Knowledge Score
|
10.6 score on a scale
Standard Deviation 1.9
|
10.2 score on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: At completion of decision aid (Experimental group) and completion of genetic counseling (all participants), approximately 10-60 minutesA low-literacy decisional conflict questionnaire will be used. This will be completed by patients in the intervention arm following use of the decision and and again following genetic counseling. It will be completed by patients in the routine care arm following genetic counseling. Decisional conflict at all time points will be compared - specifically, decisional conflict following decision aid completion in the Experimental Group will be compared to decisional conflict following genetic counseling in the Routine Care Group, and decisional conflict following both decision aid completion and genetic counseling in the Experimental Group will be compared to decisional conflict following genetic counseling in the Routine Care Group. This questionnaire is on a 40 point scale (values 0-40), with higher score indicating higher level of decisional conflict.
Outcome measures
| Measure |
Routine Care
n=105 Participants
These patients will receive routine care at our institution for counseling on aneuploidy screening; they will be counseled by a genetic counselor on options, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey immediately following genetic counseling.
Genetic counseling appointment: All participants will undergo an approximately 15 minute educational genetic counseling appointment regarding aneuploidy screening options. Should family history concerns be identified on intake, this visit may be extended to include a discussion of additional issues.
|
Experimental
n=92 Participants
These patients will use an iPad-based decision aid explaining options for aneuploidy screening and testing. They will then immediately be counseled by a genetic counselor on their options as is routine at our institution, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey following use of the decision aid, and again immediately following genetic counseling.
iPad-based decision aid: This novel decision aid was developed by genetic counselors and Maternal Fetal Medicine physicians. It is used via an iPad and is interactive. It is available in English and Spanish has been piloted by 20 English and Spanish speaking women. It takes approximately 15 minutes to complete.
Genetic counseling appointment: All participants will undergo an approximately 15-min educational genetic counseling appointment
|
|---|---|---|
|
Decisional Conflict Score
Pre-genetic counseling/post-decision aid
|
NA score on a scale
Standard Deviation NA
This group did not complete a decisional conflict score prior to genetic counseling.
|
1.6 score on a scale
Standard Deviation 3.5
|
|
Decisional Conflict Score
Post-Genetic Counseling
|
1.7 score on a scale
Standard Deviation 4.8
|
0.2 score on a scale
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: At completion of decision aid and at completion genetic counseling, approximately 10-60 minutesPopulation: Some participants chose not to answer this question and so the numbers above reflect the number of participants for whom we have data.
For participants in the intervention arm, initial choice of aneuploidy screening following use of the decision aid will be compared to final test chosen following genetic counseling.
Outcome measures
| Measure |
Routine Care
n=85 Participants
These patients will receive routine care at our institution for counseling on aneuploidy screening; they will be counseled by a genetic counselor on options, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey immediately following genetic counseling.
Genetic counseling appointment: All participants will undergo an approximately 15 minute educational genetic counseling appointment regarding aneuploidy screening options. Should family history concerns be identified on intake, this visit may be extended to include a discussion of additional issues.
|
Experimental
n=67 Participants
These patients will use an iPad-based decision aid explaining options for aneuploidy screening and testing. They will then immediately be counseled by a genetic counselor on their options as is routine at our institution, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey following use of the decision aid, and again immediately following genetic counseling.
iPad-based decision aid: This novel decision aid was developed by genetic counselors and Maternal Fetal Medicine physicians. It is used via an iPad and is interactive. It is available in English and Spanish has been piloted by 20 English and Spanish speaking women. It takes approximately 15 minutes to complete.
Genetic counseling appointment: All participants will undergo an approximately 15-min educational genetic counseling appointment
|
|---|---|---|
|
Test Chosen
None/US only
|
17 Participants
|
11 Participants
|
|
Test Chosen
First trimester screen
|
35 Participants
|
28 Participants
|
|
Test Chosen
Cell free DNA
|
27 Participants
|
25 Participants
|
|
Test Chosen
Quadruple analyte screen
|
3 Participants
|
2 Participants
|
|
Test Chosen
Chorionic villus sampling
|
0 Participants
|
1 Participants
|
|
Test Chosen
Amniocentesis
|
1 Participants
|
0 Participants
|
|
Test Chosen
Don't know
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 22 weeks gestationPopulation: This analysis was updated to include only invasive testing - these numbers represent those women undergoing chorionic villus sampling or amniocentesis for high risk screening results.
Use of additional aneuploidy screening or testing modalities (cell-free DNA, chorionic villus sampling, or amniocentesis in addition to initial screening test) in the current pregnancy will be assessed up to 22 weeks gestation.
Outcome measures
| Measure |
Routine Care
n=4 Participants
These patients will receive routine care at our institution for counseling on aneuploidy screening; they will be counseled by a genetic counselor on options, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey immediately following genetic counseling.
Genetic counseling appointment: All participants will undergo an approximately 15 minute educational genetic counseling appointment regarding aneuploidy screening options. Should family history concerns be identified on intake, this visit may be extended to include a discussion of additional issues.
|
Experimental
n=2 Participants
These patients will use an iPad-based decision aid explaining options for aneuploidy screening and testing. They will then immediately be counseled by a genetic counselor on their options as is routine at our institution, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey following use of the decision aid, and again immediately following genetic counseling.
iPad-based decision aid: This novel decision aid was developed by genetic counselors and Maternal Fetal Medicine physicians. It is used via an iPad and is interactive. It is available in English and Spanish has been piloted by 20 English and Spanish speaking women. It takes approximately 15 minutes to complete.
Genetic counseling appointment: All participants will undergo an approximately 15-min educational genetic counseling appointment
|
|---|---|---|
|
Supplementary Tests Performed
Invasive testing for high-risk results
|
2 Participants
|
1 Participants
|
|
Supplementary Tests Performed
No invasive testing for high-risk results
|
2 Participants
|
1 Participants
|
Adverse Events
Routine Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Laura Carlson, MD
UNC School of Medicine Maternal Fetal Medicine
Phone: 8643503140
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place