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Implementing customized genomic sequencing reports to empower providers in safety-net neonatal intensive care units.

PURPOSE: Through our implementation study providing rapid genomic sequencing (rGS) in safety-net neonatal intensive care units (NICUs), we investigated the feasibility and perceived usefulness of customized "clinical interpretive reports" (CIRs) to help neonatal providers with interpreting, disclosing, and managing care based on rGS results. METHODS: Enrolled infants received rGS through a clinically accredited vendor. We developed 5 CIR types to provide customized interpretation of rGS results and link results to clinical management considerations, research opportunities, and resources. We developed workflows to triage, create, and deliver CIRs within 3 business days. Providers received the vendor reports and CIRs, disclosed results, and completed post-disclosure surveys. We analyzed summary statistics for the first 100 cases. RESULTS: We delivered 97 of 100 CIRs (97%) within our goal time frame (average 1.3 days) and provided clinical management recommendations in 40 of 100 (40%). Neonatal providers completed the post-disclosure surveys for 86 of 100 disclosures (86%). Most reported using the CIR before disclosure (80/86, 93%) and found it helpful at providing useful information beyond the vendor report (79/80, 99%). CONCLUSION: It is feasible and useful to develop customized rGS reports to assist non-genetics providers in safety-net NICU settings. Similar approaches may hold promise for equitably advancing genomic care in non-NICU settings.

Humans

Pandemic-Related Disruptions and Hepatocellular Carcinoma Surveillance in Safety-Net Settings.

IMPORTANCE: Pandemic-related disruptions in cirrhosis care resulted in major gaps and delays in surveillance for hepatocellular carcinoma (HCC). Whether these initial declines improved and rebounded to prepandemic levels remains unclear. OBJECTIVE: To evaluate contemporary clinical practice data on HCC surveillance utilization from before the COVID-19 pandemic to 4 years after the onset of the pandemic among safety-net populations with cirrhosis. DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study was conducted at 5 safety-net health systems in the US. Adults with cirrhosis were evaluated longitudinally across 3 time periods: March 1, 2018, to February 29, 2020 (pre-COVID-19 period), March 1, 2020, to February 28, 2022 (COVID-19 era), and March 1, 2022, to February 29, 2024 (post-COVID-19 period). MAIN OUTCOMES AND MEASURES: The primary outcome was undergoing HCC surveillance identified using Current Procedural Terminology codes for ultrasonography, computed tomography, and magnetic resonance imaging, and corresponding International Statistical Classification of Diseases, Tenth Revision, Clinical Modification diagnosis codes for indication. Comparisons of HCC surveillance across time periods used paired t tests, and comparisons of HCC surveillance between subgroups within the same time period used χ2 tests. RESULTS: Among 6940 patients with cirrhosis, 4001 (57.7%) were men (median [IQR] age, 58 [52-64] years), 206 (3.0%) were Asian, 1720 (24.8%) were Hispanic, 1672 (24.1%) were non-Hispanic Black or African American, and 3081 (44.4%) were non-Hispanic White. The proportion who underwent HCC surveillance within 6 months after diagnosis was 30.8% (1940 patients) in the pre-COVID-19 era, which declined to 21.1% (1468 patients) in the COVID-19 era, and remained at 22.3% (1405 patients) in the post-COVID-19 era. Consistent trends were observed among men and women and among all age and race groups, except for Asian individuals, for whom there was an observed increase in the post-COVID-19 era. Similar trends of low HCC surveillance post-COVID-19 were observed across insurance types but was particularly concerning among uninsured or indigent care covered patients, among whom only 116 of 997 (11.9%) underwent surveillance in the most recent period. CONCLUSIONS AND RELEVANCE: In this observational study of US safety-net populations with cirrhosis, rates of HCC surveillance following pandemic-related declines remained persistently low even up to 4 years after the onset of the COVID-19 pandemic, with fewer than 1 in 4 patients having undergone guideline-concordant HCC surveillance.

Humans

Care Navigation for Methamphetamine Use Disorder: A Randomized Clinical Trial.

IMPORTANCE: Stimulant-involved deaths continue to increase in the US, and methamphetamine use remains a weighty public health concern. Treating methamphetamine use disorders is complicated. Contingency management has demonstrated the best effectiveness but is not widely implemented. OBJECTIVE: To examine the effectiveness of dedicated care navigation in linking patients to treatment. DESIGN, SETTING, AND PARTICIPANTS: This prospective randomized clinical trial was conducted at an integrated safety-net health system in Denver, Colorado, between April 10, 2023, and December 31, 2024. Eligible participants were 18 years or older who had a methamphetamine-related encounter in an acute care setting; those with involuntary treatment holds, substance treatment in past 90 days or actively seeking treatment, and inability to provide consent were excluded. Participants completed baseline, 30-day, and 90-day study visits. INTERVENTION: Dedicated care navigation, incorporating contingency management principles, with a focus on addressing health-related social needs. MAIN OUTCOMES AND MEASURES: Linkage to treatment within 30 and 90 days of enrollment defined as a composite measure of at least 1 of the following: electronic health record data indicating a visit at the health system's substance treatment clinic, a behavioral health encounter at an outpatient clinic, temporary residential treatment, or self-reported treatment on the 30- and/or 90-day follow-up survey. RESULTS: Of 192 participants enrolled in the Beginning Early and Assertive Treatment for Methamphetamine Use trial, 156 (81.3%) were male, and the median age was 39 (IQR, 31-47) years. Most participants were unstably housed (163 [84.9%]), not currently employed (158 [82.3%]), and without regular access to a working phone (94 [49.0%]). Of the 96 participants randomized to the intervention, 60 (62.5%) engaged in 2 or more navigation sessions, 45 (46.9%) completed the 30-day study visit, and 47 (49.0%) completed the 90-day study visit compared with 44 (46.3%) and 37 (38.5%), respectively, of the 96 randomized to the control arm. No statistically significant differences in treatment linkage were observed at 30 days (24 participants [25.0%] in both arms; risk ratio, 1.00 [95% CI, 0.61-1.63]) or 90 days post enrollment, (32 [33.3%] in intervention vs 24 [25.0%] in control arms; risk ratio, 1.33 [95% CI, 0.85-2.09]). CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, integrating principles of contingency management into the intervention may have increased engagement with a dedicated care navigator but did not increase likelihood of linkage to treatment for methamphetamine use disorder. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT06033365.

Humans