Safety planning intervention and follow-up: A telehealth service model for suicidal individuals in emergency department settings: Study design and protocol.

BACKGROUND: The Safety Planning Intervention with follow-up services (SPI+) is a promising suicide prevention intervention, yet many Emergency Departments (EDs) lack the resources for adequate implementation. Comprehensive strategies addressing structural and organizational barriers are needed to optimize SPI+ implementation and scale-up. This protocol describes a test of one strategy in which ED staff connect at-risk patients to expert clinicians from a Suicide Prevention Consultation Center (SPCC) via telehealth. METHOD: This stepped wedge, cluster-randomized trial compares the effectiveness, implementation, cost, and cost offsets of SPI+ delivered by SPCC clinicians versus ED-based clinicians (enhanced usual care; EUC). Eight EDs will start with EUC and cross over to the SPCC phase. Blocks of two EDs will be randomly assigned to start dates 3 months apart. Approximately 13,320 adults discharged following a suicide-related ED visit will be included; EUC and SPCC samples will comprise patients from before and after SPCC crossover, respectively. Effectiveness data sources are electronic health records, administrative claims, and the National Death Index. Primary effectiveness outcomes are presence of suicidal behavior and number/type of mental healthcare visits and secondary outcomes include number/type of suicide-related acute services 6-months post-discharge. We will use the same data sources to assess cost offsets to gauge SPCC scalability and sustainability. We will examine preliminary implementation outcomes (reach, adoption, fidelity, acceptability, and feasibility) through patient, clinician, and health-system leader interviews and surveys. CONCLUSION: If the SPCC demonstrates clinical effectiveness and health system cost reduction, it may be a scalable model for evidence-based suicide prevention in the ED.

An exposure-based implementation strategy to decrease clinician anxiety about implementing suicide prevention evidence-based practices: protocol for development and pilot testing (Project CALMER).

BACKGROUND: Clinicians often report that their own anxiety and low self-efficacy inhibit their use of evidence-based suicide prevention practices, including gold-standard screening and brief interventions. Exposure therapy to reduce clinician maladaptive anxiety and bolster self-efficacy use is a compelling but untested approach to improving the implementation of suicide prevention evidence-based practices (EBPs). This project brings together an interdisciplinary team to leverage decades of research on behavior change from exposure theory to design and pilot test an exposure-based implementation strategy (EBIS) to target clinician anxiety to improve suicide prevention EBP implementation. METHODS: We will develop, iteratively refine, and pilot test an EBIS paired with implementation as usual (IAU; didactic training and consultation) in preparation for a larger study of the effect of this strategy on reducing clinician anxiety, improving self-efficacy, and increasing use of the Columbia Suicide Severity Rating Scale and the Safety Planning Intervention in outpatient mental health settings. Aim 1 of this study is to use participatory design methods to develop and refine the EBIS in collaboration with a stakeholder advisory board. Aim 2 is to iteratively refine the EBIS with up to 15 clinicians in a pilot field test using rapid cycle prototyping. Aim 3 is to test the refined EBIS in a pilot implementation trial. Forty community mental health clinicians will be randomized 1:1 to receive either IAU or IAU + EBIS for 12 weeks. Our primary outcomes are EBIS acceptability and feasibility, measured through questionnaires, interviews, and recruitment and retention statistics. Secondary outcomes are the engagement of target implementation mechanisms (clinician anxiety and self-efficacy related to implementation) and preliminary effectiveness of EBIS on implementation outcomes (adoption and fidelity) assessed via mixed methods (questionnaires, chart-stimulated recall, observer-coded role plays, and interviews). DISCUSSION: Outcomes from this study will yield insight into the feasibility and utility of directly targeting clinician anxiety and self-efficacy as mechanistic processes informing the implementation of suicide prevention EBPs. Results will inform a fully powered hybrid effectiveness-implementation trial to test EBIS' effect on implementation and patient outcomes. TRIAL REGISTRATION: Clinical Trials Registration Number: NCT05172609 . Registered on 12/29/2021.

A whole blood microsampling furosemide assay: development, validation and use in a pediatric pharmacokinetic study.

Background: Furosemide is a commonly used diuretic for the treatment of edema. The pharmacokinetics of furosemide in neonates as they mature remains poorly understood. Microsampling assays facilitate research in pediatric populations. Results: We developed and validated a liquid chromatography-tandem mass spectrometry method for the quantitation of furosemide in human whole blood with volumetric absorptive microsampling (VAMS) devices (10 µl). Furosemide was stable in human whole blood VAMS under the study's assay conditions. This work established stability for furosemide for 161 days when stored as dried microsamples at -78°C. Conclusion: This method is being applied for the quantitation of furosemide in whole blood VAMS in an ongoing prospective pediatric clinical study. Representative clinical data are reported.

Development, validation, and implementation of an UHPLC-MS/MS method for the quantitation of furosemide in infant urine samples.

Furosemide is a diuretic drug used to increase urine flow in order to reduce the amount of salt and water in the body. It is commonly utilized to treat preterm infants with chronic lung disease of prematurity. There is a need for a simple and reliable quantitation of furosemide in human urine. We have developed and validated an ultra-high performance liquid chromatography-tandem mass spectrometry method for furosemide quantitation in human urine with an assay range of 0.100-50.0 µg/ml. Sample preparation involved solid-phase extraction with 10 µl of urine. Intra-day accuracies and precisions for the quality control samples were 94.5-106 and 1.86-10.2%, respectively, while inter-day accuracies and precision were 99.2-102 and 3.38-7.41%, respectively. Recovery for furosemide had an average of 23.8%, with an average matrix effect of 101%. Furosemide was stable in human urine under the assay conditions. Stability for furosemide was shown at 1 week (room temperature, 4, -20 and -78°C), 6 months (-78°C), and through three freeze-thaw cycles. This robust assay demonstrates accurate and precise quantitation of furosemide in a small volume (10 µl) of human urine. It is currently being implemented in an ongoing pediatric clinical study.

Modified Lapidus vs Scarf Osteotomy Outcomes for Treatment of Hallux Valgus Deformity.

BACKGROUND: The Lapidus procedure and scarf osteotomy are indicated for the operative treatment of hallux valgus; however, no prior studies have compared outcomes between the procedures. The aim of this study was to compare clinical and radiographic outcomes between patients with symptomatic hallux valgus treated with the modified Lapidus procedure versus scarf osteotomy. METHODS: This retrospective cohort study included patients treated by 1 of 7 fellowship-trained foot and ankle surgeons. Inclusion criteria were age older than 18 years, primary modified Lapidus procedure or scarf osteotomy for hallux valgus, minimum 1-year postoperative Patient-Reported Outcomes Measurement Information System (PROMIS) scores, and minimum 3-month postoperative radiographs. Revision cases were excluded. Clinical outcomes were assessed using 6 PROMIS domains. Pre- and postoperative radiographic parameters were measured on anteroposterior (AP) and lateral weightbearing radiographs. Statistical analysis utilized targeted minimum-loss estimation (TMLE) to control for confounders. RESULTS: A total of 136 patients (73 Lapidus, 63 scarf) with an average of 17.8 months of follow-up were included in this study. There was significant improvement in PROMIS physical function scores in the modified Lapidus (mean change, 5.25; P < .01) and scarf osteotomy (mean change, 5.50; P < .01) cohorts, with no significant differences between the 2 groups (P = .85). After controlling for bunion severity, the probability of having a normal postoperative intermetatarsal angle (IMA; <9 degrees) was 25% lower (P = .04) with the scarf osteotomy compared with the Lapidus procedure. CONCLUSION: Although the modified Lapidus procedure led to a higher probability of achieving a normal IMA, both procedures yielded similar improvements in 1-year patient-reported outcome measures. LEVEL OF EVIDENCE: Level III, retrospective cohort.