A randomized trial of a prenatal genetic testing interactive computerized information aid.
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ABSTRACT:
SUBMITTER: Yee LM
PROVIDER: S-EPMC4043849 | biostudies-literature | 2014 Jun
REPOSITORIES: biostudies-literature
Publications
A randomized trial of a prenatal genetic testing interactive computerized information aid.
Yee Lynn M LM Wolf Michael M Mullen Rebecca R Bergeron Ashley R AR Cooper Bailey Stacy S Levine Robert R Grobman William A WA
Prenatal diagnosis 20140318 6
<h4>Objective</h4>The aim of this study was to determine whether an interactive computer program could improve patient knowledge regarding genetic screening and diagnostic concepts.<h4>Methods</h4>In this randomized trial, women 6-26 weeks' gestation were assigned to standard care with provider-based counseling or to augmented counseling with an interactive computer program. The computer-based tool conveyed information about genetic testing options. Women were administered a 23-item test of cont ...[more]
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| S-EPMC7821473 | biostudies-literature
Project description:Prenatal genetic testing guidelines recommend providing patients with detailed information to allow informed, preference-based screening and diagnostic testing decisions. The effect of implementing these guidelines is not well understood.To analyze the effect of a decision-support guide and elimination of financial barriers to testing on use of prenatal genetic testing and decision making among pregnant women of varying literacy and numeracy levels.Randomized trial conducted from 2010-2013 at prenatal clinics at 3 county hospitals, 1 community clinic, 1 academic center, and 3 medical centers of an integrated health care delivery system in the San Francisco Bay area. Participants were English- or Spanish-speaking women who had not yet undergone screening or diagnostic testing and remained pregnant at 11 weeks' gestation (n?=?710).A computerized, interactive decision-support guide and access to prenatal testing with no out-of-pocket expense (n?=?357) or usual care as per current guidelines (n?=?353).The primary outcome was invasive diagnostic test use, obtained via medical record review. Secondary outcomes included testing strategy undergone, and knowledge about testing, risk comprehension, and decisional conflict and regret at 24 to 36 weeks' gestation.Women randomized to the intervention group, compared with those randomized to the control group, were less likely to have invasive diagnostic testing (5.9% vs 12.3%; odds ratio [OR], 0.45 [95% CI, 0.25-0.80]) and more likely to forgo testing altogether (25.6% vs 20.4%; OR, 3.30 [95% CI, 1.43-7.64], reference group screening followed by invasive testing). Women randomized to the intervention group also had higher knowledge scores (9.4 vs 8.6 on a 15-point scale; mean group difference, 0.82 [95% CI, 0.34-1.31]) and were more likely to correctly estimate the amniocentesis-related miscarriage risk (73.8% vs 59.0%; OR, 1.95 [95% CI, 1.39-2.75]) and their estimated age-adjusted chance of carrying a fetus with trisomy 21 (58.7% vs 46.1%; OR, 1.66 [95% CI, 1.22-2.28]). Significant differences did not emerge in decisional conflict or regret.Full implementation of prenatal testing guidelines using a computerized, interactive decision-support guide in the absence of financial barriers to testing resulted in less test use and more informed choices. If validated in additional populations, this approach may result in more informed and preference-based prenatal testing decision making and fewer women undergoing testing.clinicaltrials.gov Identifier: NCT00505596.
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| S-EPMC3876764 | biostudies-literature
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| S-EPMC6417985 | biostudies-literature
Project description:ImportanceDevelopmental delays and disabilities are common in children. Research has indicated that intervention during the early years of a child's life has a positive effect on cognitive development, social skills and behavior, and subsequent school performance.ObjectiveTo determine whether a computerized clinical decision support system is an effective approach to improve standardized developmental surveillance and screening (DSS) within primary care practices.Design, setting, and participantsIn this cluster randomized clinical trial performed in 4 pediatric clinics from June 1, 2010, through December 31, 2012, children younger than 66 months seen for primary care were studied.InterventionsWe compared surveillance and screening practices after adding a DSS module to an existing computer decision support system.Main outcomes and measuresThe rates at which children were screened for developmental delay.ResultsMedical records were reviewed for 360 children (180 each in the intervention and control groups) to compare rates of developmental screening at the 9-, 18-, or 30-month well-child care visits. The DSS module led to a significant increase in the percentage of patients screened with a standardized screening tool (85.0% vs 24.4%, P < .001). An additional 120 records (60 each in the intervention and control groups) were reviewed to examine surveillance rates at visits outside the screening windows. The DSS module led to a significant increase in the percentage of patients whose parents were assessed for concerns about their child's development (71.7% vs 41.7%, P = .04).Conclusions and relevanceUsing a computerized clinical decision support system to automate the screening of children for developmental delay significantly increased the numbers of children screened at 9, 18, and 30 months of age. It also significantly improved surveillance at other visits. Moreover, it increased the number of children who ultimately were diagnosed as having developmental delay and who were referred for timely services at an earlier age.Trial registrationclinicaltrials.gov Identifier: NCT01351077.
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Project description:BackgroundBy providing information on the relative merits and potential harms of the options available and a framework to clarify preferences, decision aids can improve knowledge and realistic expectations and decrease decisional conflict in individuals facing decisions between alternative forms of action. Decision-making about prenatal testing for fetal abnormalities is often confusing and difficult for women and the effectiveness of decision aids in this field has not been established. This study aims to test whether a decision aid for prenatal testing of fetal abnormalities, when compared to a pamphlet, improves women's informed decision-making and decreases decisional conflict.Methods/designA cluster designed randomised controlled trial is being conducted in Victoria, Australia. Fifty General Practitioners (GPs) have been randomised to one of two arms: providing women with either a decision aid or a pamphlet. The two primary outcomes will be measured by comparing the difference in percentages of women identified as making an informed choice and the difference in mean decisional conflict scores between the two groups. Data will be collected from women using questionnaires at 14 weeks and 24 weeks gestation. The sample size of 159 women in both arms of the trial has been calculated to detect a difference of 18% (50 to 68%) in informed choice between the two groups. The required numbers have been adjusted to accommodate the cluster design, miscarriage and participant lost--to--follow up. Baseline characteristics of women will be summarised for both arms of the trial. Similarly, characteristics of GPs will be compared between arms. Differences in the primary outcomes will be analysed using 'intention-to-treat' principles. Appropriate regression techniques will adjust for the effects of clustering and include covariates to adjust for the stratifying variable and major potential confounding factors.DiscussionThe findings from this trial will make a significant contribution to improving women's experience of prenatal testing and will have application to a variety of maternity care settings. The evaluation of a tailored decision aid will also have implications for pregnancy care providers by identifying whether or not such a resource will support their role in providing prenatal testing information.
| S-EPMC1479329 | biostudies-literature
Project description:BackgroundPrenatal genetic testing is an essential part of routine prenatal care. Yet, obstetricians often lack the time to provide comprehensive prenatal genetic testing education to their patients. Pregnant women lack prenatal genetic testing knowledge, which may hinder informed decision-making during their pregnancies. Due to the rapid growth of technology, mobile apps are a potentially valuable educational tool through which pregnant women can learn about prenatal genetic testing and improve the quality of their communication with obstetricians. The characteristics, quality, and number of available apps containing prenatal genetic testing information are, however, unknown.ObjectiveThis study aims to conduct a firstreview to identify, evaluate, and summarize currently available mobile apps that contain prenatal genetic testing information using a systematic approach.MethodsWe searched both the Apple App Store and Google Play for mobile apps containing prenatal genetic testing information. The quality of apps was assessed based on the criteria adopted from two commonly used and validated mobile app scoring systems, including the Mobile Application Rating Scale (MARS) and the APPLICATIONS evaluation criteria.ResultsA total of 64 mobile apps were identified. Of these, only 2 apps were developed for a specific prenatal genetic test. All others were either pregnancy-related (61/64, 95%) or genetics-related (1/64, 2%) apps that provided prenatal genetic testing information. The majority of the apps (49/64, 77%) were developed by commercial companies. The mean quality assessment score of the included apps was 13.5 (SD 2.9), which was equal to the average of possible theoretical score. Overall, the main weaknesses of mobile apps in this review included the limited number of prenatal genetic tests mentioned; incomprehensiveness of testing information; unreliable and missing information sources; absence of developmental testing with users (not evidence based); high level of readability; and the lack of visual information, customization, and a text search field.ConclusionsOur findings suggest that the quality of mobile apps with prenatal genetic testing information must be improved and that pregnant women should be cautious when using these apps for prenatal genetic testing information. Obstetricians should carefully examine mobile apps before referring any of them to their patients for use as an educational tool. Both improving the quality of existing mobile apps, and developing new, evidence-based, high-quality mobile apps targeting all prenatal genetic tests should be the focus of mobile app developers going forward.
| S-EPMC8554671 | biostudies-literature
Project description:BackgroundCounseling to reduce access to lethal means such as firearms and medications is recommended for suicidal adults but does not routinely occur. We developed the Web-based Lock to Live (L2L) decision aid to help suicidal adults and their families choose options for safer home storage.ObjectiveThis study aimed to test the feasibility and acceptability of L2L among suicidal adults in emergency departments (EDs).MethodsAt 4 EDs, we enrolled participants (English-speaking, community-dwelling, suicidal adults) in a pilot randomized controlled trial. Participants were randomized in a 13:7 ratio to L2L or control (website with general suicide prevention information) groups and received a 1-week follow-up telephone call.ResultsBaseline characteristics were similar between the intervention (n=33) and control (n=16) groups. At baseline, many participants reported having access to firearms (33/49, 67%), medications (46/49, 94%), or both (29/49, 59%). Participants viewed L2L for a median of 6 min (IQR 4-10 min). L2L also had very high acceptability; almost all participants reported that they would recommend it to someone in the same situation, that the options felt realistic, and that L2L was respectful of values about firearms. In an exploratory analysis of this pilot trial, more participants in the L2L group reported reduced firearm access at follow-up, although the differences were not statistically significant.ConclusionsThe L2L decision aid appears feasible and acceptable for use among adults with suicide risk and may be a useful adjunct to lethal means counseling and other suicide prevention interventions. Future large-scale studies are needed to determine the effect on home access to lethal means.Trial registrationClinicalTrials.gov NCT03478501; https://clinicaltrials.gov/ct2/show/NCT03478501.
| S-EPMC7016618 | biostudies-literature
Project description:Intervention group:Education + Decision Aid;Control group:Routine Education + Educational Manual
Primary outcome(s): Informed desicion
Study Design: Parallel
| 2716370 | ecrin-mdr-crc