Over the past decade, options for prenatal genetic testing have advanced and expanded. Offering screening or diagnostic testing for aneuploidy is recommended for all pregnant women1 and is typically performed at the first obstetric visit. However, counseling regarding the available testing options is complex and requires detailed patient education; time available to perform this education may not be sufficient because many other topics also are addressed at the initial prenatal encounter. Studies have shown that patient knowledge regarding aneuploidy testing, including noninvasive prenatal testing (NIPT), is limited.2–7 In a recent study, only 27% of women understood that a normal NIPT result did not assure a healthy neonate.7 In a survey of 258 obstetricians, 82.6% reported that lack of time was a barrier in counseling patients about NIPT.8
The objectives of our study were to develop and test the effectiveness of a previsit educational video designed to help patients understand available options for prenatal screening and diagnostic testing. We designed the video to provide patients an additional means of receiving and processing information about this complex topic. The video was targeted to a fifth-grade educational level. We hypothesized that the video would improve knowledge of aneuploidy testing options, measured by a change in knowledge between baseline and postappointment tests in women who watched the video compared with those who did not.
MATERIALS AND METHODS
This was a randomized controlled trial at a single university hospital. The protocol was approved by the institutional review board at Beth Israel Deaconess Medical Center. The educational video (Video 1, available online at http://links.lww.com/AOG/B120), developed and narrated by a maternal-fetal medicine physician (K.E.O.) and a genetic counselor (K.F.M.), was 15 minutes in length and provided information on the basics of genetics; common chromosomal abnormalities; and options for prenatal noninvasive and invasive aneuploidy testing. Aneuploidy testing options reviewed in the video were first-trimester combined screening (nuchal translucency and maternal serum analyte screening), cell-free DNA screening (NIPT), and diagnostic testing with chorionic villus sampling and amniocentesis. The video also described the detection rates, risks, and benefits for each of these options.
Women with a singleton pregnancy presenting to our ultrasound unit for nuchal translucency assessment before 14 weeks of gestation, who spoke English, and were 18 years of age or older were eligible for enrollment. There were no additional exclusion criteria. All women received some counseling on aneuploidy testing options by their prenatal care provider at the initial prenatal visit, expressed interest in testing, and were subsequently referred for a nuchal translucency ultrasonogram. Eligible women were approached after checking in for their appointments. All participants provided written informed consent before randomization. Computer-generated block randomization, stratified by maternal age at delivery (younger than 35 years vs 35 years or older), was used to randomize women to either the video (intervention) or no video (control) group. Randomization allocation was placed in sealed sequentially numbered envelopes labeled by stratification group. One coinvestigator (A.M.M.) generated the randomization sequence and performed the randomization allocation. Coinvestigators who enrolled participants (B.M.M., K.E.O.) were blinded to the randomization sequence. The envelopes were opened by the participant after the consent was signed. After randomization, all women completed an initial survey and baseline test to assess knowledge of aneuploidy testing options (Fig. 1). After completion of the survey and test, the intervention group watched the video with headphones in the waiting room before their scheduled ultrasound appointment. All women aged 35 years or older at delivery had an appointment with a genetic counselor before the ultrasonogram; those randomized to the video group attended this appointment after watching the video. Although the study was designed to blind the genetic counselor to randomization allocation, some of the women aged 35 years or older randomized to the video group inadvertently unblinded themselves to the genetic counselor. If this occurred, the genetic counselor did not change the counseling. All ultrasonograms were performed by an ultrasonographer and interpreted by a maternal-fetal medicine physician; the physician, who was blinded to randomization allocation, counseled the patient on the results. Among women choosing first-trimester combined screening, some had serum drawn and analyzed before the appointment and received an instant result after their ultrasonogram; others received a nuchal translucency result only and had serum analytes drawn after the visit. After their ultrasonogram, all participants completed the same 15-question knowledge test. The time between the baseline and postappointment tests was approximately 45 minutes in women aged younger than 35 at delivery and 90 minutes in women aged 35 years or older at delivery.
The survey included questions about demographic characteristics and past and current pregnancies. This information was confirmed using the hospital’s electronic medical record. Gestational age was confirmed at the time of ultrasonography. Surveys were completed on paper, and data were transferred to a secure electronic database. Two coinvestigators (B.M.M. and O.H.C.) reviewed each survey to ensure accuracy of data transfer.
The knowledge test was created by a maternal-fetal medicine physician (K.E.O.) and a genetic counselor (K.F.M.). Each of the 15 questions on the test was answered as either true or false and was worth 1 point. Missing responses on the knowledge survey were scored as incorrect answers. On the postappointment test, all participants also were asked to rate how well they understood the information (“How well do you feel you understand the information? 1=not at all to 5=very well) and their satisfaction (“How satisfied were you with the visit?” 1=not at all satisfied to 5=very satisfied). Participants randomized to the video group also rated how well the video aided their understanding of testing options and those randomized to the no video group indicated how well a video would have helped their understanding (1=not at all to 5=very much).
The primary outcome was change in knowledge score between the baseline and postappointment tests. The secondary outcomes were participant self-reported understanding of aneuploidy testing options and patient satisfaction. We compared categorical data with a χ2 or Fisher exact test based on data distribution. Wilcoxon rank-sum tests for two independent samples were used to compare continuous variables between the intervention groups and Wilcoxon signed-rank tests for paired samples were used to compare preintervention and postintervention continuous variables in the same participants. Data were analyzed with SAS 9.4. All tests were two-sided and P values <.05 were considered statistically significant.
A prior study at our institution found a mean knowledge score of 70% (±17) after consent among participants planning to undergo sacrocolpopexy.9 Thus, we assumed that the intervention group in this study would have a mean postappointment knowledge score of 10.5 (±3). We also assumed that a 20% absolute increase in the mean knowledge score would be clinically meaningful; this translated to a mean baseline knowledge score of 7.5 (±3) for both groups. Thus, we assumed that the mean knowledge score would increase by 3 points in the intervention group and 0 points in the control group. Assuming a two-sided α of 0.05, we needed 17 participants per group to have 80% power to detect the specified difference. Accounting for a possible nonnormal distribution and the potential for 10% loss to follow-up, we aimed to enroll 23 participants per group for a total of 46 participants younger than 35 years of age and 46 participants 35 years or older.
A total of 104 potentially eligible women were approached from September 2016 to March 2017; 92 women (88%) consented and were randomized, including 46 women aged younger than 35 years at delivery and 46 women aged 35 years or older at delivery. We excluded 11 participants after randomization; two inadvertently watched the video before completing the baseline test, two were determined to have pregnancies conceived from donor oocyte after randomization, three had pregnancy losses identified on ultrasonography, and four did not complete both the baseline and postappointment tests. Participants who conceived using a donor oocyte were excluded because the genetic counselors tailor counseling based on the age of the donor oocyte, and the use of infertility treatment was not known at the time of randomization. Thus, 81 women were analyzed, including 40 women aged younger than 35 years at delivery and 41 women aged 35 years or older at delivery (Fig. 2). There were no cases of thickened nuchal translucency, which was defined as 3 mm or greater.
Among participants in the younger than 35 years groups, baseline characteristics were similar in the video and no video groups (Table 1). The majority of women were nulliparous, college-educated, and had not had genetic counseling in the current pregnancy or in a prior pregnancy.
The median baseline knowledge score was 6.0 (4.0–8.0) in the video group and 6.0 (5.0–8.0) in the no video group. The video group had a significant improvement in the primary outcome, knowledge score (+2.0 [1.0–5.0]), compared with the control group (0 [−1.0 to 1.0]; P=.01) (Table 2).
We then assessed several secondary outcomes. When asked how well they felt they understood the information, the video group reported a better understanding of the information with a median score of 4.0 (interquartile range 3.0–5.0) compared with the control group (median score 3.0 [interquartile range 2.0–3.0], P<.001). Patient satisfaction scores were similar between the intervention (median score 5.0 [interquartile range 4.0–5.0]) and control groups (median score 4.0 [interquartile range 4.0–5.0], P=.25) (Table 3). Women randomized to the video group felt that watching the video helped their understanding with a median score of 4.0 (interquartile range 4.0–5.0). The control group felt that watching a video would have improved their understanding with a median score of 4.5 (interquartile range 2.5–5.0).
The majority of women aged younger than 35 years at delivery (78.9% in the video group and 76.2% in the no video group) knew that Down syndrome does not occur only in women 35 years or older. In contrast, at baseline, few women younger than 35 years (10.5% in the video group and 4.8% in the control group) understood that trisomy 18 is more severe than trisomy 21. The video appeared to improve knowledge of this question with 68.4% in the video group correctly responding on the postappointment test compared with 19.0% in the control group. In addition, at baseline, few women (21.1% in the video group and 14.3% in the control group) knew that ultrasonography cannot be used to diagnose Down syndrome. Although both groups demonstrated better knowledge regarding this question on the postappointment survey, the proportions remained relatively low (36.8% and 38.1% in the video and control groups, respectively).
In women 35 years or older at delivery, baseline characteristics were similar between the video and no video groups. In contrast to women younger than 35 years at delivery, the majority of these women were multiparous. However, similar to the women younger than 35 years at delivery, most women were college-educated and had not had genetic counseling in the current pregnancy or in a prior pregnancy.
The median baseline score was 7.0 (5.0–8.0) in the video group and 8.0 (6.5–10.0) in the no video group. Both groups had higher scores on the postappointment knowledge test, although there was no difference in the median change in score, our primary outcome, between the video group (+3.0 [0.0–4.0]) and the control group (+2.5 [0.0–4.5]; P=.98) (Table 2).
We also assessed several secondary outcomes. The video group had no change in self-reported understanding of the information (median score 4.0 [interquartile range 3.0–5.0]) compared with the control group (median score 4.0 [3.5–4.0], P=.49). Similar to the younger than 35 years age group, patient satisfaction scores were similar between the video and control groups in women 35 years or older at delivery (median score 5.0 [interquartile range 4.0–5.0] for both groups, P=.30) (Table 3). Women randomized to the video group felt that watching the video helped their understanding with a median score of 4.0 (interquartile range 4.0–5.0). The control group felt that watching a video would have improved their understanding with a median score of 4.0 (interquartile range 3.0–4.0).
Most women aged 35 years or older at delivery (81.0% and 95.0% in the video and control groups, respectively) understood that the chance of a chromosomal abnormality increases with maternal age. As with the women younger than 35 years, few women aged 35 years or older at delivery (14.3% in the video group and 15.0% in the control group) knew that trisomy 18 is more severe than trisomy 21. Both groups demonstrated improvement on the postappointment survey with 66.7% in the video group and 75.0% in the control group correctly responding. At baseline, 28.6% of the video group and 50.0% of the control group understood that ultrasonography cannot be used to diagnose Down syndrome. These proportions were similar on the postappointment test with no improvement in the video group (28.6%) and minimal improvement in the control group (60.0%).
We report that in women aged younger than 35 years at delivery, a preappointment educational audiovisual presentation improved understanding of aneuploidy and available aneuploidy testing options at our tertiary care center. This was measured both objectively, by change in knowledge score on a test taken before and after the appointment, and also subjectively, by participant self-report. In contrast, women aged 35 years or older at delivery had no change in knowledge score or self-reported understanding. This likely occurred because genetic counseling was provided to all women in the 35 years or older age group. Women who watched the video found it helpful, and those who did not watch the video felt that a video would have helped them understand aneuploidy testing options.
Educational videos have been shown to improve patient knowledge and understanding. Among intensive care unit patients and surrogate decision-makers, a video demonstrating cardiopulmonary resuscitation and preferences for resuscitation improved knowledge of inpatient cardiopulmonary resuscitation terminology and options among those randomized to a video plus usual care compared with usual care alone.10 In another study, women with a new diagnosis of advanced-stage ovarian cancer who were randomized to an educational video discussing cancer information and experiences had improved knowledge compared with a placebo video; however, these women also had an increase in negative learning attitudes and intrusive thoughts consistent with increased distress.11
Educational materials to supplement in-person counseling for aneuploidy testing have been examined in prior studies. Interactive prenatal genetic testing decision aids, designed to assist women with decision-making on aneuploidy testing, have been shown to improve patient knowledge12,13 and satisfaction.12 Yee et al14 showed that pregnant women randomized to an interactive computer program had improved test scores compared with those receiving standard counseling. However, this program did not include NIPT because it was designed before its availability.
In the United States, there is a shortage of clinical genetic counselors, which is anticipated to continue to grow with increased demand for genetic testing.15 The results of our study support the potential use of audiovisual counseling aids to educate average-risk women regarding their aneuploidy testing options. Further studies are needed to determine whether video-based genetic counseling alone is as effective as in-person genetic counseling.
Our study has several limitations. First, we excluded women in both age groups with early pregnancy loss diagnosed on ultrasonography; this was done so that women could leave immediately after the appointment. Second, the knowledge test we developed and tested was not a validated assessment tool; however, it specifically addressed the topics reviewed in the video. Third, baseline knowledge scores were different than what we assumed for the power calculation. We only included women who had already decided to have nuchal translucency ultrasonography; therefore, women who declined screening and diagnostic testing may have had different baseline knowledge of these testing options. Additionally, most participants were white and had at least a college education and all of them spoke English, which may limit generalizability to other populations. Lastly, the study was not designed to assess a difference in participant decisions regarding specific aneuploidy testing options; rather, our goal was to develop and test a video that patients would be able to watch before coming to the hospital, which would educate them on their options before their visit and save time in health care provider counseling.
Despite these limitations, our study has several strengths. The randomized design allowed us to minimize confounding, and we stratified by age 35 years to account for women who received genetic counseling. Our study adds to the literature by specifically addressing whether an educational video improves knowledge of aneuploidy testing options in obstetric patients. In addition, we had a very high rate of study participation with 88% of women approached agreeing to participate.
We found that a patient-centered educational video, which we developed to explain the concept of aneuploidy and aneuploidy testing options, improved knowledge and subjective understanding of the information in women aged younger than 35 years at delivery with no change in patient satisfaction. We did not observe a difference in women aged 35 years or older at delivery, likely as a result of genetic counseling provided to these women.
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