Use of a Novel Decision Aid for Prenatal Aneuploidy Screening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 197
- 试验地点
- 1
- 主要终点
- Knowledge Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnancy at less than 22 weeks gestation
- •English or Spanish speaking
- •Undergoing genetic counseling at North Carolina Women's Hospital for aneuploidy screening
排除标准
- •Known fetal anomalies
- •Known multiple gestations
- •Prior genetic counseling or aneuploidy screening in current pregnancy
研究组 & 干预措施
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.
干预措施: Genetic counseling appointment (Other)
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.
干预措施: iPad-based decision aid (Other)
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.
干预措施: Genetic counseling appointment (Other)
结局指标
主要结局
Knowledge Score
时间窗: 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
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.
次要结局
- Decisional Conflict Score(At completion of decision aid (Experimental group) and completion of genetic counseling (all participants), approximately 10-60 minutes)
- Test Chosen(At completion of decision aid and at completion genetic counseling, approximately 10-60 minutes)
- Supplementary Tests Performed(22 weeks gestation)