Abstract
Objectives
Decisional conflict and regret about prenatal genetic screening and diagnostic tests may have important consequences in the current pregnancy and for future reproductive decisions. Identifying mechanisms that reduce conflict associated with the decision to use or decline these options is necessary for optimal patient counseling.
Methods
We conducted a cluster-randomized controlled trial of a shared decision-making tool (NEST) at the beginning of prenatal care. Enrolled patients completed follow-up surveys at the time of testing (QTT) and in the second–third trimester (QFF), including the Decision Conflict Scale (DCS). Total DCS scores were analyzed using a multivariate linear mixed-effect model.
Results
Of the total number of participants (n=502) enrolled, 449 completed the QTT and QFF surveys. The mean age of participants was 31.6±3.8, with most parous at the time of study participation (n=321; 71.7 %). Both the NEST (the intervention) and control groups had lower median total DCS scores at QFF (NEST 13.3 [1.7, 25.0] vs. control 16.7 [1.7, 25.0]; p=0.24) compared to QTT (NEST 20.8 [5.0, 25.0] vs. control 18.3 [3.3, 26.7]; p=0.89). Participants exposed to NEST had lower decisional conflict at QFF compared to control (β −3.889; [CI −7.341, −0.437]; p=0.027).
Conclusions
Using a shared decision-making tool at the start of prenatal care decreased decisional conflict regarding prenatal genetic testing. Such interventions have the potential to provide an important form of decision-making support for patients facing the unique type of complex and preference-based choices about the use of prenatal genetic tests.
Funding source: National Human Genome Research Institute
Award Identifier / Grant number: R01HG010092
Acknowledgements
We would like to thank Patricia Agatisa, PhD, and Uma Perni, MD, for their contributions to this project.
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Research ethics: This study has complied with all relevant national regulations and institutional policies of the Cleveland Clinic. It has been approved by the authors’ Institutional Review Board. The study has been conducted in accordance with the Declaration of Helsinki (as revised in 2013).
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Informed consent: Informed consent was obtained from all individuals included in this study, or their legal guardians or wards.
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Author contributions: The authors have accepted responsibility for the entire content of this manuscript and approved its submission. All authors met the following criteria: (1) substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; (2) drafting the work or revising it critically for important intellectual content; (3) final approval of the version to be published; (4) agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
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Competing interests: Dr. Rose is a consulting ethicist for Blue Cross Blue Shield Association (national nonprofit). The remaining authors state no conflict of interest.
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Research funding: This study was funded by a grant from the National Human Genome Research Institute (R01HG010092).
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Data availability: The raw data can be obtained on request from the corresponding author.
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Trial registration: The trial was registered in clinicaltrials.gov.
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