IMPORTANCE Emergency department (ED) visits present opportunities to identify and refer suicidal youth for outpatient mental health care, although this practice is not routine.OBJECTIVE To examine whether a motivational interviewing-based intervention increases linkage of adolescents to outpatient mental health services and reduces depression symptoms and suicidal ideation in adolescents seeking emergency care for non-mental health-related concerns who screen positive for suicide risk. DESIGN, SETTING, AND PARTICIPANTSIn this randomized clinical trial, adolescents aged 12 to 17 years who screened positive on the Ask Suicide Screening Questions (ASQ) during a nonpsychiatric ED visit at 2 academic pediatric EDs in Ohio were recruited from INTERVENTIONS The Suicidal Teens Accessing Treatment After an Emergency Department Visit (STAT-ED) intervention included motivational interviewing to target family engagement, problem solving, referral assistance, and limited case management. The enhanced usual care (EUC) intervention consisted of brief mental health care consultation and referral. MAIN OUTCOMES AND MEASURES Primary outcomes were mental health treatment initiation and attendance within 2 months of ED discharge and suicidal ideation (assessed by the Suicidal Ideation Questionnaire JR) and depression symptoms (assessed by the Center for Epidemiologic Studies-Depression scale) at 2 and 6 months. Exploratory outcomes included treatment initiation and attendance and suicide attempts at 6 months. RESULTS A total of 168 participants were randomized and 159 included in the intention-to-treatanalyses (mean [SD] age, 15.0 [1.5] years; 126 [79.2%] female; and 80 [50.3%] white). Seventy-nine participants were randomized to receive the STAT-ED intervention and 80 to receive EUC. At 2 months, youth in the STAT-ED group had similar rates of mental health treatment initiation compared with youth in the EUC group as assessed by parent report (29 [50.9%] vs 22 [34.9%]; adjusted odds ratio [OR], 2.08; 95% CI, 0.97-4.45) and administrative data from mental health care agencies (19 [29.7%] vs 11 [19.3%]; adjusted OR, 1.77; 95% CI, 0.76-4.15). At 2 months, youth in the STAT-ED group and the EUC group had similar rates of treatment attendance (1 appointment: 6 [9.7%] vs 2 [3.6%]; adjusted OR, 2.97; 95% CI, 0.56-15.73; Ն2 appointments: 10 [16.1%] vs 7 [12.7%]; adjusted OR, 1.43;95% CI, 0.50-4.11). There were no significant group × time differences in suicidal ideation (F = 0.28; P = .72) and depression symptoms (F = 0.49; P = .60) during the 6-month follow-up period. In (continued)
IMPORTANCE Childhood lead exposure is associated with neurobehavioral deficits. The effect of a residential lead hazard intervention on blood lead concentrations and neurobehavioral development remains unknown. OBJECTIVE To determine whether a comprehensive residential lead-exposure reduction intervention completed during pregnancy could decrease residential dust lead loadings, prevent elevated blood lead concentrations, and improve childhood neurobehavioral outcomes. DESIGN, SETTING, AND PARTICIPANTS This longitudinal, community-based randomized clinical trial of pregnant women and their children, the Health Outcomes and Measures of the Environment (HOME) Study, was conducted between March 1, 2003, and January 31, 2006. Pregnant women attending 1 of 9 prenatal care clinics affiliated with 3 hospitals in the Cincinnati, Ohio, metropolitan area were recruited. Of the 1263 eligible women, 468 (37.0%) agreed to participate and 355 women (75.8%) were randomized in this intention-to-treat analysis. Participants were randomly assigned to receive 1 of 2 interventions designed to reduce residential lead or injury hazards. Follow-up on children took place at 1, 2, 3, 4, 5, and 8 years of age. Data analysis was performed from September 2, 2017, to May 6, 2018. MAIN OUTCOMES AND MEASURES Residential dust lead loadings were measured at baseline and when children were 1 and 2 years of age. At 1, 2, 3, 4, 5, and 8 years of age, the children's blood lead concentrations as well as behavior, cognition, and executive functions were assessed. RESULTS Of the 355 women randomized, 174 (49.0%) were assigned to the intervention group (mean [SD] age at delivery, 30.1 (5.5) years; 119 [68.3%] self-identified as non-Hispanic white) and 181 (50.9%) to the control group (mean [SD] age at delivery, 29.2 [5.7] years; 123 [67.9%] self-identified as non-Hispanic white). The intervention reduced the dust lead loadings for the floor (24%; 95% CI,-43% to 1%), windowsill (40%; 95% CI,-60% to-11%), and window trough (47%; 95% CI,-68% to-10%) surfaces. The intervention did not statistically significantly reduce childhood blood lead concentrations (-6%; 95% CI,-17% to 6%; P = .29). Neurobehavioral test scores were not statistically different between children in the intervention group than those in the control group except for a reduction in anxiety scores in the intervention group (β =-1.6; 95% CI,-3.2 to-0.1; P = .04). CONCLUSIONS AND RELEVANCE Residential lead exposures, as well as blood lead concentrations in non-Hispanic black children, were reduced through a comprehensive lead-hazard intervention without elevating the lead body burden. However, this decrease did not result in substantive neurobehavioral improvements in children. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT00129324
Background One critical hurdle for clinical trial recruitment is the lack of an efficient method for identifying subjects who meet the eligibility criteria. Given the large volume of data documented in electronic health records (EHRs), it is labor-intensive for the staff to screen relevant information, particularly within the time frame needed. To facilitate subject identification, we developed a natural language processing (NLP) and machine learning–based system, Automated Clinical Trial Eligibility Screener (ACTES), which analyzes structured data and unstructured narratives automatically to determine patients’ suitability for clinical trial enrollment. In this study, we integrated the ACTES into clinical practice to support real-time patient screening. Objective This study aimed to evaluate ACTES’s impact on the institutional workflow, prospectively and comprehensively. We hypothesized that compared with the manual screening process, using EHR-based automated screening would improve efficiency of patient identification, streamline patient recruitment workflow, and increase enrollment in clinical trials. Methods The ACTES was fully integrated into the clinical research coordinators’ (CRC) workflow in the pediatric emergency department (ED) at Cincinnati Children’s Hospital Medical Center. The system continuously analyzed EHR information for current ED patients and recommended potential candidates for clinical trials. Relevant patient eligibility information was presented in real time on a dashboard available to CRCs to facilitate their recruitment. To assess the system’s effectiveness, we performed a multidimensional, prospective evaluation for a 12-month period, including a time-and-motion study, quantitative assessments of enrollment, and postevaluation usability surveys collected from the CRCs. Results Compared with manual screening, the use of ACTES reduced the patient screening time by 34% ( P <.001). The saved time was redirected to other activities such as study-related administrative tasks ( P =.03) and work-related conversations ( P =.006) that streamlined teamwork among the CRCs. The quantitative assessments showed that automated screening improved the numbers of subjects screened, approached, and enrolled by 14.7%, 11.1%, and 11.1%, respectively, suggesting the potential of ACTES in streamlining recruitment workflow. Finally, the ACTES achieved a system usability scale of 80.0 in the postevaluation surveys, suggesting that it was a good computerized solution. Conclusions By leveraging NLP and machine learning technologies, the ACTES demonstrated good capacity for improving efficiency of patient identification. The quantitative assessments demonstrated the potential of ACTES in streamlining recruitment workflow and improving patient enrollment. The postevaluation surveys suggested that the sy...
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