Background: Antipsychotic medications (AP) are inappropriately prescribed to young people. The goal of this pragmatic trial was to test a four-component approach to improved targeting of antipsychotic prescribing to people aged >= 3 and <18 years. Methods: Clinicians in four health systems were cluster randomized by the number of previous AP orders and service line - specialty mental health and all others. Intervention arm clinicians received a best practice alert and child psychiatrist consultation and feedback. Families received system navigation and expedited access to psychotherapy. Primary outcomes were total days' supply of AP medication and proportion of youth with any AP supply at 6 months. We estimated the log-odds of AP use at 6 months and the relative rate of AP over 6 months. The Safer and Targeted Use of Antipsychotics in Youth (SUAY) trial took place between 3/2018 and 12/2020. Results: The trial enrolled 733 patients. The odds ratio (OR) comparing use at 6 months was 0.75 (95% CI: 0.52, 1.09). The mean number of days using AP was 118.5 for intervention patients and 128.2 for control patients (relative risk [RR] = 0.92; 95% CI: 0.81-1.04). Exploratory heterogeneity of treatment effects (HTE) was not detected in groups defined by age, gender, provider specialty, and insurance type. HTE by race/ethnicity was present: among youth of color, mean days' supply was 103.2 for intervention arm and 131.2 for the control arm (RR 0.79, 95% CI: 0.67-0.93). Among secondary outcomes, only new psychotherapy referrals differed with 44.3% (n = 154) of intervention participants having a new order for psychotherapy compared to 33.5% (n = 129) in the control arm (OR 1.47: 95% CI: 1.01-2.14). Conclusions: This intervention did not result in less AP use at 6 months or a reduction in the days' supply of AP medication, although psychotherapy orders increased. The intervention may be effective for some subgroups.

BACKGROUND:Insomnia is a modifiable risk factor for type 2 diabetes. OBJECTIVE:Describe the methodology for the Sleep for Health study, a randomized clinical trial examining the effectiveness of digital cognitive behavioral therapy for insomnia (dCBT-I) in reducing hyperglycemia in 300 people with both insomnia and prediabetes. OUTCOMES:Primary outcome is glucose level 2 h after a 75-g glucose load. Secondary outcomes include fasting glucose, hemoglobin A1c, insulin resistance score, mean glucose from continuous glucose monitoring (CGM), standard deviation of CGM values, and number of CGM values >140 mg/d. METHODS:Participants with a hemoglobin A1c in the prediabetes range (5.7 % to 6.4 %) and clinically significant insomnia are randomized to a dCBT-I program or patient education control program. dCBT-I includes six sessions that focus on changing sleep habits and scheduling factors that affect sleep and addresses misconceptions about sleep and insomnia, utilizing interactive components and goal-setting. Those in the control arm receive access to a sleep-education website, which presents informational content in a simple, static form, without interactive components or active skills training, and all content is provided at once, rather than in modules that unlock over time. At baseline, 11 weeks and 33 weeks after randomization, participants undergo laboratory testing with a 2-h oral glucose tolerance test, hemoglobin A1c, and insulin resistance score. They also undertake 10 days of CGM and actigraphy wear and complete two dietary recalls. SUMMARY:This trial is testing whether a program to improve sleep will positively impact glycemia among those with prediabetes. Registration with clinicaltrials.gov on October 3, 2023: NCT06067139.

OBJECTIVE:The authors measured implementation of Zero Suicide (ZS) clinical practices that support identification of suicide risk and risk mitigation, including screening, risk assessment, and lethal means counseling, across mental health specialty and primary care settings. METHODS:Six health care systems in California, Colorado, Michigan, Oregon, and Washington participated. The sample included members ages ≥13 years from 2010 to 2019 (N=7,820,524 patients). The proportions of patients with suicidal ideation screening, suicide risk assessment, and lethal means counseling were estimated. RESULTS:In 2019, patients were screened for suicidal ideation in 27.1% (range 5.0%-85.0%) of mental health visits and 2.5% (range 0.1%-35.0%) of primary care visits among a racially and ethnically diverse sample (44.9% White, 27.2% Hispanic, 13.4% Asian, and 7.7% Black). More patients screened positive for suicidal ideation in the mental health setting (10.2%) than in the primary care setting (3.8%). Of the patients screening positive for suicidal ideation in the mental health setting, 76.8% received a risk assessment, and 82.4% of those identified as being at high risk received lethal means counseling, compared with 43.2% and 82.4%, respectively, in primary care. CONCLUSIONS:Six health systems that implemented ZS showed a high level of variation in the proportions of patients receiving suicide screening and risk assessment and lethal means counseling. Two opportunities emerged for further study to increase frequency of these practices: expanding screening beyond patients with regular health care visits and implementing risk assessment with lethal means counseling in the primary care setting directly after a positive suicidal ideation screening.

OBJECTIVEAssess the accuracy of ICD-10-CM coding of self-harm injuries and poisonings to identify self-harm events.MATERIALS AND METHODSIn 7 integrated health systems, records data identified patients reporting frequent suicidal ideation. Records then identified subsequent ICD-10-CM injury and poisoning codes indicating self-harm as well as selected codes in 3 categories where uncoded self-harm events might be found: injuries and poisonings coded as undetermined intent, those coded accidental, and injuries with no coding of intent. For injury and poisoning encounters with diagnoses in those 4 groups, relevant clinical text was extracted from records and assessed by a blinded panel regarding documentation of self-harm intent.RESULTSDiagnostic codes selected for review include all codes for self-harm, 43 codes for undetermined intent, 26 codes for accidental intent, and 46 codes for injuries without coding of intent. Clinical text was available for review for 285 events originally coded as self-harm, 85 coded as undetermined intent, 302 coded as accidents, and 438 injury events with no coding of intent. Blinded review of full-text clinical records found documentation of self-harm intent in 254 (89.1%) of those originally coded as self-harm, 24 (28.2%) of those coded as undetermined, 24 (7.9%) of those coded as accidental, and 48 (11.0%) of those without coding of intent.CONCLUSIONSAmong patients at high risk, nearly 90% of injuries and poisonings with ICD-10-CM coding of self-harm have documentation of self-harm intent. Reliance on ICD-10-CM coding of intent to identify self-harm would fail to include a small proportion of true self-harm events.

INTRODUCTION:The use of data from wearable sensors, smartphones, and apps holds promise as a clinical decision-making tool in health and mental health in primary care medicine. The aim of this study was to determine provider perspectives about the utility of these data for building digitally based decision-making tools.METHODS:This mixed quantitative and qualitative cross-sectional survey of a convenience sample of primary-care clinicians at Kaiser Permanente Northwest was conducted between April and July 2019 online via Institute for Translational Health Sciences' Research Electronic Data Capture. Study outcomes were 1) attitudes toward digital data, 2) willingness to use digital data to support clinical decision making, and 3) concerns and recommendations about implementing a digital tool for clinical decision making.RESULTS:This sample of 131 clinicians was largely white (n = 98) female (n = 91) physicians (n = 86). Although respondents (75.7%, n = 87) had a positive attitude toward using digital tools in their practice, 88 respondents (67.3%) voiced concerns about the possible lack of clinical utility, suspected difficulty in integration with clinical workflows, and worried about the potential burden placed on patients. Participants indicated that the accuracy of the data in detecting the need for treatment adjustments would need to be high and the tool should be clinically tested.CONCLUSIONS:Primary care providers find value in collecting real-world patient data to assist in clinical decision making, provided such information does not interfere with provider workflow or impose undue burden on patients. In addition, digital tools will need to demonstrate high accuracy, be able to integrate into current clinical workflows, and maintain the privacy and security of patients' data.

Objectives: Antipsychotic prescribing in children and adolescents increased sharply beginning in the 1990s, but recent reports among Medicaid enrollees suggest declining trends. However, few studies have included both commercially and publicly insured patients or focused on trends in new antipsychotic medications in children without documented psychotic disorders or other indicated conditions. The objective of the study was to report trends in new antipsychotic prescribing for pediatric patients (age 3-17 years) in a large children's health care system. Methods: Data were abstracted from electronic medical records (January 1, 2013 to December 31, 2017). New antipsychotic medication orders were defined as antipsychotic orders for patients without an order in the 180 days prior. Patients were excluded if the order was initiated in an emergency department or inpatient setting; they were diagnosed with psychotic disorder, mania, autism spectrum disorder, or intellectual disability; or the order was for prochlorperazine. The crude rate of new antipsychotic prescribing is reported quarterly with Poisson 95% confidence intervals in the total sample and by demographic subgroups (child vs. adolescent, female vs. male, public vs. private insurance, and white vs. nonwhite). Results: Antipsychotic orders decreased from 54.9 prescriptions per 10,000 person months in the first quarter of 2013 to 34.1 per 10,000 person months in the last quarter of 2017. Rates of antipsychotic prescribing were significantly higher for adolescents compared with children, patients who were commercially insured compared with Medicaid insured, and at most time points for white compared with non-white patients. However, prescribing rates did not differ significantly based on gender. Conclusions: Antipsychotic prescribing declined for both commercially and Medicaid-insured children in a pediatric hospital-based system, although white and commercially insured patients were more likely to be prescribed antipsychotics. More attention may be needed for reducing potentially avoidable prescribing of antipsychotics in previously understudied subgroups, such as commercially insured patients. Clinical Trial Registration Number: NCT03448575.

This study examined effects of an adolescent depression prevention program on maternal criticisms and positive remarks, whether the extent of adolescents' depression accounted for effects, and whether effects of the program on maternal criticisms and positive remarks differed by adolescents' gender. Participants were 298 adolescent (Mage = 14.79, SD = 1.36; 59% female) offspring of mothers with histories of depression; youth were randomized to either a cognitive-behavioral prevention (CBP) program or usual care (UC). At baseline and 9-month postintervention evaluations, mothers were administered the Five-Minute Speech Sample to measure number of criticisms and positive remarks made during an open-ended description of their child and their relationship. Adolescents' depression from pre- through postintervention was assessed with interviews. A hierarchical generalized linear model showed a significant condition-by-gender interaction, indicating that, controlling for baseline criticism, at postintervention mothers of girls in CBP made significantly more criticisms than did mothers of girls in UC, whereas mothers of boys in CBP made fewer criticisms than did mothers of boys in UC. The extent of adolescents' depression from pre- through postintervention partially mediated the relation between intervention condition and mothers' criticisms, for boys but not for girls. Second, controlling for preintervention positive remarks, at postintervention, mothers of youth in CBP made significantly more positive remarks about their child than did mothers of youth in UC, regardless of gender; this relation was not mediated by adolescent depression from pre- through postintervention. We suggest possible explanations for the observed effects of CBP on mothers' criticisms and positive remarks. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Importance Patients with acute coronary syndrome (ACS) and elevated depressive symptoms are at increased risk for recurrent cardiovascular events and mortality, worse quality of life, and higher health care costs. These observational findings prompted multiple scientific panels to advise universal depression screening in survivors of ACS prior to evidence from randomized screening trials. Objective To determine whether systematically screening for depression in survivors of ACS improves quality of life and depression compared with usual care. Design, Setting, and Participants A 3-group multisite randomized trial enrolled 1500 patients with ACS from 4 health care systems between November 1, 2013, and March 31, 2017, with follow-up ending July 31, 2018. Patients were eligible if they had been hospitalized for ACS in the previous 2 to 12 months and had no prior history of depression. All analyses were performed on an intention-to-treat basis. Interventions Patients with ACS were randomly assigned 1:1:1 to receive (1) systematic depression screening using the 8-item Patient Health Questionnaire, with notification of primary care clinicians and provision of centralized, patient-preference, stepped depression care for those with positive screening results (8-item Patient Health Questionnaire score ≥10; screen, notify, and treat, n = 499); (2) systematic depression screening, with notification of primary care clinicians for those with positive screening results (screen and notify, n = 501); and (3) usual care (no screening, n = 500). Main Outcomes and Measures The primary outcome was change in quality-adjusted life-years. The secondary outcome was depression-free days. Adverse effects and mortality were assessed by patient interview and hospital records. Results A total of 1500 patients (424 women and 1076 men; mean [SD] age, 65.9 [11.5] years) were randomized in the 18-month trial. Only 71 of 1000 eligible survivors of ACS (7.1%) had elevated 8-item Patient Health Questionnaire scores indicating depressive symptoms at screening. There were no differences in mean (SD) change in quality-adjusted life-years (screen, notify and treat, –0.06 [0.20]; screen and notify, −0.06 [0.20]; no screen, −0.06 [0.18];P = .98) or cumulative mean (SD) depression-free days (screen, notify and treat, 343.1 [179.0] days; screen and notify, 351.3 [175.0] days; no screen, 339.0 [176.6] days;P = .63). Harms including death, bleeding, or sleep difficulties did not differ among groups. Conclusions and Relevance In patients with ACS without a history of depression, systematic depression screening with or without providing depression treatment did not alter quality-adjusted life-years, depression-free days, or harms. Trial Registration ClinicalTrials.gov identifier:NCT01993017

Background: Programs such as the Pediatric Access Line in Washington state have shown decreases in antipsychotic medication use by youth with non-psychotic disorders. Program outcomes have been studied with observational designs. This manuscript describes the protocol for Targeted and Safer Use of Antipsychotics in Youth (SUAY), a randomized controlled trial of psychiatrist review of prescriptions and facilitated access to psychosocial care. The aim of the intervention is to reduce the number of person-days of antipsychotic use among participants. Methods: Recruitment occurs at 4 health systems. Targeted enrollment is 800 youth aged 3-17 years. Clinicians are block randomized to intervention versus usual care prior to the study. Youth are nested within the arm of the prescribing clinician. Clinicians in the intervention group receive an EHR-based best practice alert with options to expedite access to psychosocial care and all medication orders are reviewed by a child and adolescent psychiatrist with feedback provided to the prescriber. The primary outcome is person-days of antipsychotic medication use in the 6 months following the initial order. All randomized individuals contribute data regardless of their level of participation (including declining all services). Discussion: The trial has been approved by the institutional review boards at each of the 4 sites. The intervention has 4 novel design features including automated recruitment using a best practice alert, psychiatrist medication order review and consultation, telephone navigation to psychosocial care, and telemental health visits. Recruitment began in March of 2018 and will be completed in June 2020. Follow-up will be completed December 31, 2020.

ABSTRACTBackgroundPublic health and research assessment of self-harm or suicide attempts must sometimes rely on health system records. Previous research regarding accuracy of encounter or billing diagnoses to identify self-harm or suicide attempt has yielded mixed results.MethodsUsing data from a large pragmatic trial of outreach to prevent suicide attempt, investigators identified ICD-10-CM diagnostic codes in categories where suicide attempt or self-harm might be missed or misclassified: injuries and poisonings coded as having “undetermined intent, injuries and poisonings coded as accidental, and injuries with no coding of intent. For injury and poisoning events with these selected codes, relevant text was extracted from full-text electronic health records and rated by a blinded panel of investigators as indicating or not indicating self-harmResultsDiagnostic codes selected for review include 43 codes for injuries and poisonings with undetermined intent, 26 codes for accidental injuries and poisonings, and 46 codes for injuries without coding of intent. Among injury and poisoning events in this sample, full-text records were available for review for 60 coded as undetermined intent, 173 coded as accidents, and 288 with no coding of intent. After review of text, raters judged 46 (77%), 152 (88%), and 275 (95%) respectively as having adequate text documentation for confident rating of self-harm intent. Among those with adequate text for confident rating, the proportions of events classified as due to self-harm were 19% for injuries and poisonings coded as undetermined intent, 6% for injuries and poisonings coded as accidents, and 15% for injuries without coding of intent.ConclusionsIn this sample of people at high risk for self-harm or suicide attempt, we low rates of misclassified self-harm events among injuries and poisonings coded as having undetermined intent, accidental intent, or no coding of intent. In this sample, inclusion of all misclassified events identified through this search process would increase the total number of self-harm events identified by approximately 10%.

This corrects the article DOI: 10.4088/JCP.09m05885blu.​​.

OBJECTIVE:Youth depression can be prevented, yet few programs are offered. Decision makers lack cost information. This study evaluated the cost-effectiveness of a cognitive-behavioral prevention program (CBP) versus usual care. METHODS:A cost-effectiveness analysis was conducted with data from a randomized controlled trial of 316 youths, ages 13-17, randomly assigned to CBP or usual care. Youths were at risk of depression because of a prior depressive disorder or subthreshold depressive symptoms, or both, and had parents with a prior or current depressive disorder. Outcomes included depression-free days (DFDs), quality-adjusted life years (QALYs), and costs. RESULTS:Nine months after baseline assessment, youths in CBP experienced 12 more DFDs (p=.020) and .018 more QALYs (p=.007), compared with youths in usual care, with an incremental cost-effectiveness ratio (ICER) of $24,558 per QALY. For youths whose parents were not depressed at baseline, CBP youths had 26 more DFDs (p=.001), compared with those in usual care (ICER=$10,498 per QALY). At 33 months postbaseline, youths in CBP had 40 more DFDs (p=.05) (ICER=$12,787 per QALY). At 33 months, CBP youths whose parents were not depressed at baseline had 91 more DFDs (p=.001) (ICER=$13,620 per QALY). For youths with a currently depressed parent at baseline, CBP was not significantly more effective than usual care at either 9 or 33 months, and costs were higher. CONCLUSIONS:CBP produced significantly better outcomes than usual care and was particularly cost-effective for youths whose parents were not depressed at baseline. Depression prevention programs could improve youths' health at a reasonable cost; services to treat depressed parents may also be warranted.

BACKGROUND:Elevated depressive symptoms among survivors of acute coronary syndromes (ACS) confer recurrent cardiovascular events and mortality, worse quality of life, and higher healthcare costs. While multiple scientific groups advise routine depression screening for ACS survivors, no randomized trials exist to inform this screening recommendation. We aimed to assess the effect of screening for depression on change in quality of life over 18 months among ACS patients.METHODS:The Comparison of Depression Identification after Acute Coronary Syndrome on Quality of Life and Cost Outcomes (CODIACS-QoL) trial is a pragmatic, 3-arm trial that randomized ACS patients to 1) systematic depression screening using the 8-item Patient Health Questionnaire (PHQ-8) and if positive screen (PHQ-8 ≥ 10), notification of primary care providers (PCPs) and invitation to participate in centralized, patient-preference, stepped depression care (Screen, Notify, and Treat, N = 499); 2) systematic depression screening and PCP notification only (Screen and Notify, N = 501); and 3) usual care (No Screen, N = 500). Adults hospitalized for ACS in the previous 2-12 months without prior history of depression were eligible for participation. Key outcomes will be quality-adjusted life years (primary), cost of health care utilization, and depression-free days across 18 months.RESULTS:A total of 1500 patients were randomized in the CODIACS-QOL trial (28.3% women; 16.3% Hispanic; mean age 65.9 (11.5) years). Only 7% of ACS survivors had elevated depressive symptoms.CONCLUSIONS:Using a novel randomization schema and pragmatic design principles, the CODIACS-QoL trial achieved its enrollment target. Eventual results of this trial will inform future depression screening recommendations in cardiac patients.TRIAL REGISTRATION:ClinicalTrials.gov (NCT01993017).

Background Anxiety disorders are the most common mental health problem among youth, contribute to reduced quality of daily life, and are associated with high rates of comorbidity. However, treatment rates for anxiety are very low, causing a sizeable treatment gap. There is an immediate need to identify treatment interventions that are effective, affordable, and can be delivered easily to the youth population. Cognitive Bias Modification (CBM) is one potentially effective intervention that could reach youth on a large scale, especially when self-administered at home. Thus, we aim to assess the benefit of CBM to treat youth anxiety. Further, we aim to test whether adding an adherence promotion (AP) component to the CBM intervention can improve outcomes, and whether CBM delivered both with and without the AP component is cost effective. Methods This is a 12-month randomized controlled trial (RCT) conducted within an existing healthcare system. Potentially eligible youth (ages 12 to 17) will be identified by reviewing the electronic health record (EHR) for clinical anxiety diagnoses, which are then confirmed via research interview. We aim to enroll 498 participants and randomize them 1:1:1 to one of three arms: Arm 1 is a Low-Ratio version of the CBM program (nearly identical to the other CBM versions, but minimally effective); Arm 2 is a High-Ratio “active” CBM program; and Arm 3 is the High-Ratio CBM program with an added AP component. Participants will complete assessments at baseline, 1-, 3-, 6- and 12-months post-baseline. Youth in all three arms will self-administer the CBM program at home and will be asked to complete twelve intervention sessions over a four-week period. Arm 3 participants (High-Ratio CBM + AP) will also receive up to four telephone calls from phone coaches during the intervention period to provide technical assistance, encouragement, and motivational enhancement to increase adherence. The primary clinical outcome will be anxiety remission at 6-month follow-up. Discussion This study protocol describes the method and design for an RCT to test whether self-administered CBM both with and without adherence promotion can be an effective at-home treatment for anxious youth. Trial registration ClinicalTrials.gov : NCT02156531, First Posted June 5, 2014.

Depression is a debilitating and difficult-to-treat condition that affects interpersonal, school, and work functioning. Furthermore, the age of onset for first depressive episode appears to be decreasing. Thus, there has been increased interest in determining predictors of depression course in at-risk youth.

Aims: Determine association between insomnia and risk of type 2 diabetes (T2DM). Methods: We conducted a retrospective panel cohort study to examine risk of developing T2DM among prediabetes patients with and without insomnia (physician identified or insomnia medication dispense). Participants with prediabetes (physician identified or by 2 laboratory tests) between 1/1/2007 and 12/31/2015 were followed until 12/31/2016. Patients were determined to have T2DM when two of the following occurred within 2 years: physician-entered outpatient T2DM diagnosis, dispensing of an anti-hyperglycemia agent, A1C ≥6.5%, or fasting plasma glucose >125 mg/dl. One hospital inpatient stay with an associated T2DM diagnosis was also sufficient for T2DM classification. Results: Our cohort comprised 79,608 persons with prediabetes. Almost 30% (23,370) were classified as having insomnia during the observation period. After adjustment for traditional risk factors, those with insomnia were 28% more likely to develop T2DM than those without. This estimate was essentially unchanged after adjusting for baseline A1C level (Table). Conclusions: The association of insomnia with increased T2DM risk is similar to that of traditional risk factors such as overweight and nonwhite race. This finding has the potential to be of great value as a modifiable factor in diabetes prevention efforts. Disclosure E. LeBlanc: None. N. Smith: None. M. Allison: None. G. Nichols: Research Support; Self; Boehringer Ingelheim GmbH, Amarin Corporation, Janssen Pharmaceuticals, Inc., Sanofi. G. Clarke: None.