A Randomized Controlled Trial on the Effect of Standardized Video Education on Prenatal Genetic Testing Choices: Uptake of Genetic Testing.

OBJECTIVE: This study aimed to assess the use of a standardized prenatal genetic testing educational video and its effects on patient uptake of prenatal testing, patient knowledge, decisional conflict, and decisional regret. STUDY DESIGN: This was an Institutional Review Board-approved randomized controlled trial. Patients were randomized to intervention (standardized video education) or control (no video education). The video education group viewed a 5-minute educational video on genetic testing options, and the control group did not review the video. Both groups answered validated questionnaires to assess maternal knowledge (Maternal Serum Screening Knowledge Questionnaire [MSSK]), conflict (Decisional Conflict Scale [DCS]), and regret (Decisional Regret Scale [DRS]). The primary outcome was genetic testing uptake; secondary outcomes were knowledge-based test score, and level of decisional conflict and regret. RESULTS: We enrolled 210 patients between 2016 and 2020, with 208 patients randomized, 103 patients in the video education group and 105 patients in the control group. Four patients were excluded from the video education group for missing data. Video education was associated with a 39% lower chance of prenatal testing compared with patients who did not receive video education, (odds ratio 0.39, 95% confidence interval 0.16-0.92). Patients in the video education group had higher mean MSSKQ scores by 2.9 points (8.5 vs. 5.7, p < 0.001), lower Decisional Conflict Scores by 7.3 points (31.5 vs. 38.8, p < 0.001), lower Decisional Regret Scores by 5.4 points (23.8 vs. 29.2, p < 0.001). CONCLUSION: We found that video education on prenatal genetic testing improved patients' knowledge, decreased testing and decisional conflict and regret regarding testing. This may indicate improved understanding of testing options and more informed decisions that align with their personal values and beliefs. This standardized video can be easily implemented in clinical practice to increase patient understanding and support decisions that align with patient's values. KEY POINTS: · A standardized educational video improves patient knowledge about prenatal testing options in pregnancy.. · Video education decreases testing and decisional conflict and decisional regret in pregnancy.. · A standardized educational video may be used in the clinical setting to educate patients on testing options and help them make informed decisions about testing..

What guidance does HIPAA offer to providers considering familial risk notification and cascade genetic testing?

BACKGROUND: It is unclear how the Health Insurance Portability and Accountability Act (HIPAA) should be interpreted in the context of sharing of genomic information between family members. METHODS: The authors analyzed the HIPAA Privacy Rule, reviewed the literature and constructed a clinical scenario to inform how HIPAA can be interpreted for multiple forms of patient- and provider-mediated genetic risk notification. RESULTS: Under HIPAA, healthcare providers can lawfully notify relatives to recommend genetic risk assessment using multiple approaches, including supporting the patient telling their own relatives, contacting relatives directly with the patient's authorization, or contacting a relative's provider directly. CONCLUSIONS: Multiple forms of patient- or provider-mediated contact of relatives are already legally permissible under HIPAA, are consistent with ethical obligations of care to patients and their families, and could result in improved population health through identification of clinically actionable disease risk. Unanswered questions remain about implementation and impacts of provider-mediated programs.