An interventional study of iPad-based decision aid and Genetic counseling appointment in Aneuploidy and Pregnancy Complications, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-22.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Supportive care
The investigators aim to assess whether use of a novel, tablet-based computerized decision aid for aneuploidy screening is similar to routine care with a brief genetic counseling visit in improving patient knowledge and decreasing decisional conflict.
184 women will be randomized in a 1:1 fashion to use of a novel computerized iPad-based decision aid in addition to routine counseling or routine counseling only during a single study visit. This decision aid was developed at a 10th grade literacy level using input from Maternal Fetal Medicine physicians and certified genetic counselors, and piloted by 20 English and Spanish speaking women of varying education levels. Following completion of genetic counseling, participants will complete several surveys assessing knowledge and decision conflict. Data will be abstracted regarding demographics, screening and diagnostic testing uptake, and testing results.
73 studies on the registry are indexed under Aneuploidy; 10 are open to participants now.
This study's enrollment of 197 is close to the median of 200 across 34 interventional studies indexed under Aneuploidy.
Browse Aneuploidy studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.
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Exclusion Criteria:
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.
Other: Genetic counseling appointment
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.
Other: iPad-based decision aid · Other: Genetic counseling appointment
This is a novel decision aid 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.
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.
Knowledge Score
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.
Time frame: 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
Decisional Conflict Score
A 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.
Time frame: At completion of decision aid (Experimental group) and completion of genetic counseling (all participants), approximately 10-60 minutes
Test Chosen
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.
Time frame: At completion of decision aid and at completion genetic counseling, approximately 10-60 minutes
Supplementary Tests Performed
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.
Time frame: 22 weeks gestation
| Milestone | Routine Care | Experimental |
|---|---|---|
| Started | 105 | 92 |
| Completed | 105 | 92 |
| Not completed | 0 | 0 |
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.
| score on a scale | Routine Care | Experimental |
|---|---|---|
| Knowledge Score | 10.6 ± 1.9 | 10.2 ± 2.4 |
A 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.
| score on a scale | Routine Care | Experimental |
|---|---|---|
| Pre-genetic counseling/post-decision aid | NA ± NA | 1.6 ± 3.5 |
| Post-Genetic Counseling | 1.7 ± 4.8 | 0.2 ± 3.5 |
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.
| Participants | Experimental: Pre-genetic Counseling | Experimental: Post-genetic Counseling |
|---|---|---|
| None/US only | 17 | 11 |
| First trimester screen | 35 | 28 |
| Cell free DNA | 27 | 25 |
| Quadruple analyte screen | 3 | 2 |
| Chorionic villus sampling | 0 | 1 |
| Amniocentesis | 1 | 0 |
| Don't know | 2 | 0 |
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.
| Participants | Routine Care | Experimental |
|---|---|---|
| Invasive testing for high-risk results | 2 | 1 |
| No invasive testing for high-risk results | 2 | 1 |
Collected over Over the course of the study visit, approximately 1 hour. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Routine Care | 0/105 (0%) | 0/105 (0%) | 0/105 (0%) |
| Experimental | 0/92 (0%) | 0/92 (0%) | 0/92 (0%) |
Knowledge score (on 12 point scale) for each participant will be analyzed by group.
| Age, Continuous(years) | Routine Care | Experimental | Total |
|---|---|---|---|
| Mean | 32.4 ± 5.7 | 32.7 ± 5.6 | 32.6 ± 5.6 |
| Sex: Female, Male(Participants) | Routine Care | Experimental | Total |
|---|---|---|---|
| Female | 105 | 92 | 197 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Routine Care | Experimental | Total |
|---|---|---|---|
| White | 63 | 47 | 110 |
| Black | 19 | 10 | 29 |
| Hispanic/Latino | 15 | 24 | 39 |
| Asian | 5 | 9 | 14 |
| Unspecified/other | 3 | 2 | 5 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Individual participant data will not be shared with other researchers.
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University of North Carolina, Chapel Hill →