JAMA Network Open最新文献

{"title":"Error in Conflict of Interest Disclosures.","authors":"","doi":"10.1001/jamanetworkopen.2025.41219","DOIUrl":"https://doi.org/10.1001/jamanetworkopen.2025.41219","url":null,"abstract":"","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 10","pages":"e2541219"},"PeriodicalIF":9.7,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145251032","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Self-Help App for Depression in People With Intellectual Disabilities: A Randomized Clinical Trial.","authors":"Swantje Borsutzky, Lina Hannah Paul, Lara Rolvien, Steffen Moritz","doi":"10.1001/jamanetworkopen.2025.36364","DOIUrl":"https://doi.org/10.1001/jamanetworkopen.2025.36364","url":null,"abstract":"<p><strong>Importance: </strong>Individuals with intellectual disabilities (IDs) are at increased risk for mental health problems, including depression. However, access to effective therapeutic interventions is often limited.</p><p><strong>Objective: </strong>To evaluate the feasibility, acceptance, and efficacy of a self-help smartphone app designed to reduce depressive symptoms and improve self-esteem and quality of life in individuals with IDs.</p><p><strong>Design, setting, and participants: </strong>In this 2-arm randomized clinical trial, adults with IDs and depressive symptoms were enrolled online in Germany between April 1 and August 10, 2023. Of the 135 individuals who accessed the survey, 99 met the eligibility criteria. Participants were recruited via social media, third parties (eg, care institutions), and workplaces. Data were collected at baseline and after the intervention. Statistical analyses included complete case and intention-to-treat (ITT) approaches.</p><p><strong>Intervention: </strong>Participants were randomly assigned (1:1) to either the intervention group using a smartphone app in easy-to-read German mainly on cognitive behavioral therapy or a waiting list control group. Participants in both groups continued to receive care as usual, which may include routine psychosocial support, daily structure provided by caregivers, and access to general health services.</p><p><strong>Main outcomes and measures: </strong>The primary outcome was a reduction in depressive symptoms, measured by the Glasgow Depression Scale for People With a Learning Disability. Secondary outcomes were improvements in self-esteem, quality of life, and participant satisfaction.</p><p><strong>Results: </strong>Among the 99 participants (mean [SD] age, 34.9 [12.6] years; 54 [54.5%] female), 92 completed the postintervention assessment. The intervention group showed a significant reduction in depressive symptoms compared with the control group in ITT analyses (F1,97 = 7.52; P = .007; ηp2 = 0.072; medium effect size), as well as significant improvements in quality of life (F1,97 = 5.09; P = .03; ηp2 = 0.050; small to medium effect size) and in self-esteem (F1,97 = 17.94; P < .001; ηp2 = 0.156; large effect size). Complete case analyses yielded consistent results on most outcome measures. High satisfaction ratings were reported.</p><p><strong>Conclusions and relevance: </strong>In this randomized clinical trial, a self-guided smartphone app demonstrated efficacy in reducing depressive symptoms and enhancing quality of life and self-esteem among individuals with IDs. The findings suggest that smartphone-based interventions can provide effective support for this underserved population.</p><p><strong>Trial registration: </strong>German Clinical Trials Register Identifier: DRKS00030858.</p>","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 10","pages":"e2536364"},"PeriodicalIF":9.7,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145251063","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Right-Sizing Testing Before Elective Surgery for Patients With Low Risk.","authors":"Nicole M Mott, Dana Greene, Erin Kim, Valerie Mefford, Anthony Cuttitta, Faelan Jacobson-Davies, Shawna N Smith, Eve A Kerr, Anthony L Edelman, Michael Mathis, Michael Englesbe, Hari Nathan, Lesly A Dossett","doi":"10.1001/jamanetworkopen.2025.35750","DOIUrl":"10.1001/jamanetworkopen.2025.35750","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Importance: &lt;/strong&gt;Guidelines recommend against testing before low-risk surgery in healthy patients because it offers no benefit and may cause harm. However, testing remains prevalent, highlighting the need for a deimplementation strategy that can be broadly applied across health care settings.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To assess the feasibility of a multifaceted, multicomponent deimplementation strategy entitled Right-Sizing Testing Before Elective Surgery (RITE-Size), hypothesizing it would be feasible to execute with 80% of milestones met on time.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design, setting, and participants: &lt;/strong&gt;This quality improvement study was conducted from March 1 to August 31, 2024, at 3 hospitals of varying characteristics in Michigan. The intervention was structured into 3 phases (baseline, preparation, and active deimplementation) and further divided into 6 milestones (ie, key steps in the deimplementation process). Eligible preoperative tests included bloodwork and cardiopulmonary evaluations (eg, blood cell counts, metabolic panels, chest radiography, and electrocardiography) performed within 30 days of elective laparoscopic cholecystectomy, inguinal hernia repair, or breast lumpectomy in healthy adults.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Interventions: &lt;/strong&gt;The intervention included site visits, coaching sessions, data review, initiation of consensus processes for deimplementation, and distribution of strategy components (eg, decision support tools).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Main outcomes and measures: &lt;/strong&gt;The primary outcome was milestone completion. Secondary outcomes included acceptability and appropriateness, as assessed by the Acceptability of Intervention Measure (AIM) and the Intervention Appropriateness Measure (IAM). Additionally, barriers and facilitators to implementation were evaluated through semistructured interviews, along with testing rates derived from claims data.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;A total of 203 patients (mean [SD] age, 57 [17] years; 117 [57.6%] female) who underwent procedures of interest were identified. All milestones were achieved on time. The intervention had high acceptability and appropriateness among stakeholders (median [IQR], 20 of 20 [18-20] for AIM and 20 of 20 [16-20] for IAM). Key facilitators included small, cohesive, perioperative teams and the incorporation of the intervention into policy, supported by auditing and feedback systems. Barriers included the need for ongoing education and coordination across large health care systems. Testing rates significantly decreased across all sites from 68.0% (51 of 75) to 40.3% (25 of 62) (P = .001).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions and relevance: &lt;/strong&gt;This quality improvement study of a multifaceted, multicomponent deimplementation strategy to reduce unnecessary preoperative testing at diverse hospital sites demonstrated feasibility of expanding this work in a stepped-wedge cluster randomized trial. These results suggest that hospital systems can use this ","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 10","pages":"e2535750"},"PeriodicalIF":9.7,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12501813/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145232712","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Risk of Parkinson Disease Among Patients With Restless Leg Syndrome.","authors":"Myeonghwan Bang, Dougho Park, Jong Hun Kim, Hyoung Seop Kim","doi":"10.1001/jamanetworkopen.2025.35759","DOIUrl":"10.1001/jamanetworkopen.2025.35759","url":null,"abstract":"<p><strong>Importance: </strong>The association between restless leg syndrome (RLS) and Parkinson disease (PD) remains unclear. Clarifying this association and the role of the dopaminergic pathway may improve understanding of the pathophysiology between these 2 diseases.</p><p><strong>Objectives: </strong>To assess whether RLS is a risk factor for developing PD and whether the dopamine pathway is meaningfully associated with RLS and PD.</p><p><strong>Design, setting, and participants: </strong>This retrospective cohort study used data from the Korean National Health Insurance Service Sample Cohort from 2002 to 2019. Statistical analyses were performed between September 2024 and March 2025. Patients with RLS and PD were identified based on codes from the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision and matched to individuals without RLS. For the secondary analysis, the dopamine agonist (DA)-treated group was operationally defined as patients with RLS who received DA during 2 or more distinct clinical visits, while those who did not meet this criterion were classified as the DA-nontreated group.</p><p><strong>Exposures: </strong>Diagnosis of RLS and treatment with DAs.</p><p><strong>Main outcomes and measures: </strong>Development of PD. To compare the time to PD diagnosis across groups, a restricted mean survival time (RMST) analysis was conducted.</p><p><strong>Results: </strong>A total of 9919 patients with RLS and 9919 matched controls were included. The mean (SD) age at enrollment was 50.1 (16.3) years in the control group (6225 women [62.8%]) and 50.3 (16.0) years in the RLS group (6225 women [62.8%]). The incidence of PD was 1.0% (99 of 9919) in the control group and 1.6% (158 of 9919) in the RLS group. At the prespecified time horizon of 15 years (τ = 15), the RMST to PD diagnosis was 14.93 years in the control group and 14.88 years in the RLS group, resulting in a difference of -0.05 years (95% CI, -0.07 to -0.03 years). Compared with the control group, the DA-nontreated RLS group (n = 6842) showed a significantly shorter RMST to PD diagnosis (difference, -0.09 years [95% CI, -0.12 to -0.06 years]) and a higher incidence rate (143 of 6842 [2.1%]). The DA-treated RLS group (n = 3077) showed a significantly longer RMST to PD diagnosis (difference, 0.03 years [95% CI, 0.01-0.06 years]) and a lower incidence rate (15 of 3077 [0.5%]).</p><p><strong>Conclusions and relevance: </strong>In this cohort study, RLS was associated with an increased risk of developing PD. Furthermore, patients with RLS who were not treated with DAs tended to be at increased risk of developing PD, whereas those who were treated with DAs tended to be at decreased risk compared with the control group. These findings suggest that the pathophysiological connection between RLS and PD may involve mechanisms beyond the dopaminergic pathway.</p>","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 10","pages":"e2535759"},"PeriodicalIF":9.7,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12501809/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145232718","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Gemcitabine and Cisplatin Plus Polymeric Micellar Paclitaxel and Survival in Advanced Biliary Tract Cancer: A Randomized Clinical Trial.","authors":"Hyehyun Jeong, Changhoon Yoo, Ilhwan Kim, Jung Hun Kang, Jae Ho Jeong, Kwonoh Park, Sang-Bo Oh, Inkeun Park, Sun Jin Sym, Jaekyung Cheon, Hyewon Ryu, Jun Eul Hwang, Ji Sung Lee, Baek-Yeol Ryoo, Kyu-Pyo Kim","doi":"10.1001/jamanetworkopen.2025.34560","DOIUrl":"10.1001/jamanetworkopen.2025.34560","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Importance: &lt;/strong&gt;Limited prospective data exist on the role of adding taxane to standard chemotherapy in the first-line treatment of advanced biliary tract cancers, especially in the Asian population, where biliary tract cancers are most prevalent.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To assess the efficacy and safety of polyethoxylated castor oil-free polymeric micelle formulation of paclitaxel (hereafter, polymeric micellar paclitaxel), in combination with gemcitabine and cisplatin in patients with untreated advanced biliary tract cancers.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design, setting, and participants: &lt;/strong&gt;This open-label, phase 3 randomized clinical trial was conducted across 7 centers in South Korea from September 1, 2019, to October 31, 2022. Patients were eligible if they had previously untreated, locally advanced unresectable, recurrent, or metastatic adenocarcinoma of the bile duct, were aged 19 to 79 years, had an Eastern Cooperative Oncology Group Performance Status of 0 to 2, and had measurable or evaluable lesions according to Response Evaluation Criteria in Solid Tumorsversion 1.1.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Interventions: &lt;/strong&gt;Patients were randomized to receive either polymeric micellar paclitaxel, 100 mg/m2; gemcitabine, 800 mg/m2; and cisplatin, 25 mg/m2; on days 1 and 8 or gemcitabine, 1000 mg/m2, and cisplatin, 25 mg/m2, on days 1 and 8 every 21 days. A total of 9 cycles were planned for both groups.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Main outcomes and measures: &lt;/strong&gt;The primary end point was overall survival. Secondary end points included investigator-assessed and blinded independent central review-assessed progression-free survival, objective response rate, and safety.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;A total of 150 patients (median [range] age, 65 [41-79] years; 87 [58%] male) were randomly assigned to the study (74 in the gemcitabine and cisplatin combined with polymeric micellar paclitaxel group and 76 in the gemcitabine and cisplatin group). The study was prematurely terminated due to slow patient accrual. The median (IQR) follow-up duration was 10.4 (6.5-16.7) months. The median overall survival was 12.0 (95% CI, 9.9-15.8) months in the gemcitabine and cisplatin combined with polymeric micellar paclitaxel group and 11.1 (95% CI, 9.7-13.5) months in the gemcitabine and cisplatin group (hazard ratio, 0.94; 95% CI, 0.63-1.41; P = .76). Both blinded independent central review-assessed and investigator-assessed progression-free survival as well as the objective response rates did not differ significantly between the 2 groups. No unanticipated safety signals were observed.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions and relevance: &lt;/strong&gt;In this randomized clinical trial, gemcitabine and cisplatin combined with polymeric micellar paclitaxel did not improve survival compared with gemcitabine and cisplatin combined in patients with previously untreated advanced biliary tract cancer. This study provides further evidence regarding the limitations of intensified chemother","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 10","pages":"e2534560"},"PeriodicalIF":9.7,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12489695/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145199488","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Where Do the Children Go?-Learning From Medicaid Data.","authors":"Jeffrey S Schiff, Susan Kennedy","doi":"10.1001/jamanetworkopen.2025.36244","DOIUrl":"https://doi.org/10.1001/jamanetworkopen.2025.36244","url":null,"abstract":"","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 10","pages":"e2536244"},"PeriodicalIF":9.7,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145238879","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cost-Utility Analysis of Accelerated and Standard Strategies for Renal Replacement Therapy Initiation.","authors":"Jeff Round, Ilke Akpinar, Charles Yan, Natasha Patel, Sasha van Katwyk, Carmel Montgomery, Ron Wald, Sean M Bagshaw","doi":"10.1001/jamanetworkopen.2025.35343","DOIUrl":"10.1001/jamanetworkopen.2025.35343","url":null,"abstract":"<p><strong>Importance: </strong>Little is known about the long-term costs and outcomes related to strategies for timing of initiation of kidney replacement therapy (KRT) in critically ill patients with severe acute kidney injury (AKI).</p><p><strong>Objective: </strong>To estimate the cost-utility and cost-effectiveness of accelerated KRT initiation compared with standard KRT initiation in critically ill patients with AKI.</p><p><strong>Design, setting, and participants: </strong>In this economic evaluation, a state-transition model was developed using data from the Standard vs Accelerated Initiation of Renal Replacement Therapy in AKI (STARRT-AKI) trial, a multicenter, multinational randomized clinical trial of critically ill patients with severe AKI conducted between October 2015 and September 2019. Trial data were linked to administrative health databases in Alberta, Canada, to estimate costs and long-term clinical outcomes. The model included 4 health states: no chronic kidney disease, severe chronic kidney disease, KRT dependent, and dead. Costs are reported in 2024 Canadian dollars. Data were analyzed from February 2022 to November 2024.</p><p><strong>Exposure: </strong>Initiation of KRT.</p><p><strong>Main outcomes and measures: </strong>The primary outcome for the economic evaluation was cost per quality-adjusted life-year (QALY) gained. The QALY is a combined measure of patient quality of life and length of life. Expected costs, QALYs, incremental cost-effectiveness ratio (ICER), and incremental net monetary benefit (INMB) were estimated on the basis of 5000 Monte Carlo simulations.</p><p><strong>Results: </strong>A total of 146 patients from the STARRT-AKI trial were included in the analysis, with 73 patients (mean [SD] age, 59.67 [14.5] years; 52 men [71.3%]) randomized to receive accelerated initiation and 73 patients (mean [SD] age, 61.88 [12.9] years; 48 men [65.8%]) randomized to receive standard initiation. Standard initiation was more costly per patient than accelerated initiation (mean [SD], $251 370 [$155 801] vs $231 518 [$183 302]) but generated more QALYs (mean [SD] 7.49 [2.03] QALYs vs 6.64 [1.76] QALYs). The ICER of standard initiation compared with accelerated initiation was $23 208, with an INMB of $22 648 (95% credible interval, $15 980-$29 316) when assuming a willingness to pay per QALY of $50 000.</p><p><strong>Conclusions and relevance: </strong>The findings of this economic evaluation suggest that standard KRT initiation may be cost-effective in a Canadian setting, but this finding was sensitive to postdischarge cost trajectories and regional variation in KRT dependence.</p>","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 10","pages":"e2535343"},"PeriodicalIF":9.7,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12495491/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145212650","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"JAMA Network Open.","authors":"","doi":"10.1001/jamanetworkopen.2025.40100","DOIUrl":"https://doi.org/10.1001/jamanetworkopen.2025.40100","url":null,"abstract":"","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 10","pages":"e2540100"},"PeriodicalIF":9.7,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145199516","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Error in the Byline.","authors":"","doi":"10.1001/jamanetworkopen.2025.40518","DOIUrl":"10.1001/jamanetworkopen.2025.40518","url":null,"abstract":"","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 10","pages":"e2540518"},"PeriodicalIF":9.7,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12492049/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145206480","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"AI-Driven Clinical Decision Support to Reduce Hospital-Acquired Venous Thromboembolism: A Trial Protocol.","authors":"Colin G Walsh, Yufei Long, Laurie Lovett Novak, Megan E Salwei, Benjamin Tillman, Benjamin French, Amanda S Mixon, Michelle E Law, Jacob Franklin, Peter J Embi","doi":"10.1001/jamanetworkopen.2025.35137","DOIUrl":"10.1001/jamanetworkopen.2025.35137","url":null,"abstract":"<p><strong>Importance: </strong>Hospital-acquired venous thromboembolism (HA-VTE) remains a leading cause of preventable death among hospitalized adults in the US. Despite numerous attempts to prognosticate HA-VTE with risk models, no single model has outperformed the rest, and the effectiveness of such models to drive prophylaxis decisions is unknown. Testing such systems in urban and rural settings may inform their generalizability.</p><p><strong>Objective: </strong>To conduct a randomized clinical trial to assess the effectiveness of artificial intelligence (AI)-driven clinical decision support (CDS) in reducing HA-VTE incidence in adults across urban and rural hospital settings.</p><p><strong>Design, setting, and participants: </strong>This parallel-group, single-blind, pragmatic randomized clinical trial is planned to be conducted from October 1, 2025, through September 30, 2027, by the Vanderbilt University Medical Center, a major academic health system in Tennessee. The study population will include adult (aged ≥18 years) patients admitted to medical, surgical, and intensive care units who may be at high risk for VTE and with no active or contraindication to deep vein thrombosis prophylaxis at Vanderbilt Adult Hospital in urban Nashville and 3 affiliated hospitals serving rural communities in Middle Tennessee.</p><p><strong>Intervention: </strong>Patients will be randomized 1:1 within the electronic health record to receive either VTE-AI-driven CDS (nudge practice alert [intervention arm]) or standard care using traditional risk assessment (control arm).</p><p><strong>Main outcome and measures: </strong>The primary outcome will be incidence of HA-VTE. Secondary trial outcomes will be process metrics, including length of stay, readmission rates, safety, and bleeding events. Outcomes will be analyzed using descriptive statistics and compared using Poisson regression.</p><p><strong>Discussion: </strong>Using a validated prognostic model, this study is one of the first to provide insights into whether AI-driven CDS can effectively reduce HA-VTE incidence without increasing adverse events. This study also is intended to provide insights into the usefulness of the same AI model implemented across urban and rural settings. The study's findings and statistical code will be shared with the public through peer-reviewed publication and ClinicalTrials.gov.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT06939803.</p>","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 10","pages":"e2535137"},"PeriodicalIF":9.7,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12495493/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145212588","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}