Contemporary clinical trials最新文献

{"title":"Evaluation of the efficacy and safety of a novel xanthine oxidase inhibitor, tigulixostat, in gout patients with hyperuricemia: Design of the EURELIA 1 and EURELIA 2 studies","authors":"Kenneth G. Saag ,&nbsp;Nicola Dalbeth ,&nbsp;Chi-yuan Hsu ,&nbsp;Chang-Fu Kuo ,&nbsp;George Nuki ,&nbsp;Fernando Perez-Ruiz ,&nbsp;William B. White ,&nbsp;Ali Hariri ,&nbsp;Yunjung Lee ,&nbsp;Younghwan Jang ,&nbsp;Song Han ,&nbsp;Hyon K. Choi","doi":"10.1016/j.cct.2025.107843","DOIUrl":"10.1016/j.cct.2025.107843","url":null,"abstract":"<div><h3>Background</h3><div>Gout is a chronic disease of monosodium urate crystal deposition caused by elevated serum urate (SU). Gout may progress from acute episodic attacks to a disabling chronic deforming arthropathy. Allopurinol and febuxostat are the most widely prescribed urate-lowering drugs, however, these agents have potential adverse events and are seldom titrated to achieve a target SU level. Tigulixostat is a novel non-purine selective xanthine oxidase inhibitor for gout with hyperuricemia which has demonstrated potent <em>in vitro</em> and <em>in vivo</em> urate lowering activity and is being further investigated in humans for regulatory approvals.</div></div><div><h3>Methods</h3><div>The Phase 3 program for tigulixostat consists of two clinical trials: EURELIA 1 and EURELIA 2. EURELIA 1 is a randomized, multi-regional, double-blind, parallel-group, placebo-controlled study to assess the safety and efficacy of 6 months of tigulixostat (100, 200, or 300 mg) in gout patients with hyperuricemia (<em>n</em> = 350).</div><div>EURELIA 2 is a randomized, multi-regional, double-blind, double-dummy, parallel-group, active comparator (allopurinol titrated up to 800 mg) and placebo-controlled study to assess the safety and efficacy of tigulixostat (100, 200, or 300 mg) up to 12 months in gout patients with hyperuricemia (<em>n</em> = 2542).</div><div>The primary endpoint for both studies is to determine the proportion of patients with SU levels &lt;6.0 mg/dL sustained at for 3 months (Months 4, 5, and 6).</div></div><div><h3>Conclusions</h3><div>EURELIA 1 and EURELIA 2 studies will be able to adequately determine the efficacy and safety of tigulixostat compared to both placebo and allopurinol.</div></div><div><h3>Trial registration number</h3><div>For EURELIA 1, the <span><span>clinicaltrials.gov</span><svg><path></path></svg></span> identifier is <span><span>NCT05586958</span><svg><path></path></svg></span>. For EURELIA 2, the <span><span>clinicaltrials.gov</span><svg><path></path></svg></span> identifier is <span><span>NCT05586971</span><svg><path></path></svg></span> and the EU CT number is 2022–501421–20-00. The sponsor for both trials is LG Chem, Ltd. (Seoul, South Korea).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"151 ","pages":"Article 107843"},"PeriodicalIF":2.0,"publicationDate":"2025-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143390230","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Treating seizures faster: The quality improvement in time to treat status epilepticus (QuITT-SE) multicenter randomized stepped wedge clinical trial protocol","authors":"Adam P. Ostendorf ,&nbsp;Tobias Loddenkemper ,&nbsp;Lindsey A. Morgan ,&nbsp;Brian Appavu ,&nbsp;Raquel Farias-Moeller ,&nbsp;Dana Harrar ,&nbsp;Craig Press ,&nbsp;Nicholas S. Abend ,&nbsp;William D. Gaillard ,&nbsp;Shasha Bai ,&nbsp;Mariah Eisner ,&nbsp;Lauren McHenry ,&nbsp;Emily Kroshus ,&nbsp;Kathryn Vannatta ,&nbsp;Howard P. Goodkin","doi":"10.1016/j.cct.2025.107831","DOIUrl":"10.1016/j.cct.2025.107831","url":null,"abstract":"<div><h3>Background</h3><div>Acute seizures may evolve into status epilepticus (SE), prolonged and self-sustaining seizures that may result in brain injury or death. Rapid treatment with a benzodiazepine (BZD) is most effective. However, SE treatment remains delayed in many cases. We previously performed a single-center quality improvement study which resulted in more rapid treatment, decreased intensive care utilization, and decreased cost. Now, we are conducting a multicenter trial to test the hypothesis that pragmatic changes in treating acute inpatient seizures reduce time and are implementable across diverse hospital settings.</div></div><div><h3>Methods/Design</h3><div>We designed a multicenter stepped wedge cluster randomized trial with three unidirectional 12-month steps following one baseline step. After dissemination visits, sites will attempt to implement a standardized bundle consisting of: (1) standardize default BZD to non-IV; (2) target treatment time within 10 min; (3) relocate and bundle items for BZD administration to a single location; (4) prioritize basic seizure first aid as initial assessment; (5) implement SE-specific documentation templates; (6) implement multidisciplinary site QI teams. Our primary outcome is median time from seizure diagnosis to BZD administration. Secondary outcomes are median changes in Pediatric Cerebral Performance Category score, ICU transfer rate, and cost of hospitalization. We will study implementation outcomes using mixed methods based on the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework.</div></div><div><h3>Discussion</h3><div>QuITT-SE is designed to test the effect and implementation of a pragmatic set of interventions on treatment times in SE. If successful, results will provide a generalizable roadmap for broad implementation through healthcare systems that should improve outcomes in SE.</div><div><strong>Trial registration:</strong> <span><span>Clinicaltrials.gov</span><svg><path></path></svg></span> (NCT06194747). Funded by the National Institutes of Health (R01NS133037).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"151 ","pages":"Article 107831"},"PeriodicalIF":2.0,"publicationDate":"2025-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143387539","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Promoting daily engagement in meaningful activity (DEMA) for people with cognitive impairment and their caregivers: Protocol for a randomized clinical trial","authors":"Amy J. Katz ,&nbsp;Pei-Shiu Chang ,&nbsp;Sujuan Gao ,&nbsp;Liana G. Apostolova ,&nbsp;Richard T. Passey ,&nbsp;Ziyi Yang ,&nbsp;Dane Ceniza ,&nbsp;Yvonne Lu","doi":"10.1016/j.cct.2025.107836","DOIUrl":"10.1016/j.cct.2025.107836","url":null,"abstract":"<div><h3>Background</h3><div>Nearly one-third of older American adults have cognitive impairment (mild cognitive impairment or subjective cognitive decline). Cognitive impairment (CI) has an extraordinary impact on older adults, caregivers (CG), and society. Deteriorating life satisfaction in persons with CI (PwCI) and their primary CG is a prevalent problem. However, there is a paucity of research on a strength-based, positive health approach, and supportive care for PwCI and their CG.</div></div><div><h3>Objectives</h3><div>The promoting re-engagement in meaningful activity (PRIMA) study is a randomized controlled trial to test the efficacy of the Daily Engagement in Meaningful Activity (DEMA) intervention for PwCI and their CGs. The primary aim is to test DEMA's efficacy for improving life satisfaction in PwCI and their CGs over time. The second aim evaluates how the intervention improves activity performance, decreases depressive symptoms and anxiety in PwCI and CGs, and reduces CG burden over time. The third aim is to explore the treatment's efficacy among a sub-sample of PwCIs with (and without) depressive symptoms (Patient Health Questionnaire (PHQ)-9 ≥ 5 at baseline) for improvement in health outcomes over time.</div></div><div><h3>Methods</h3><div>The study population consists of dyads, a PwCI and their CG. The PwCI must be 60 years old and have CI. A total of 200 PwCI-CG dyads will be randomized to the DEMA or attention control group. Outcome assessments are conducted over 9-months (baseline, 10 days-, 3- and 6- months post-intervention).</div></div><div><h3>Discussion</h3><div>The DEMA results will inform care for the broader PwCI and CG population in community and home-based settings.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"151 ","pages":"Article 107836"},"PeriodicalIF":2.0,"publicationDate":"2025-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143390231","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Disease progression trajectory curves to estimate saved time in Alzheimer's disease trials","authors":"Guogen Shan ,&nbsp;Yahui Zhang ,&nbsp;Zhixin Tang ,&nbsp;Guoqiao Wang ,&nbsp;Samuel S. Wu","doi":"10.1016/j.cct.2025.107814","DOIUrl":"10.1016/j.cct.2025.107814","url":null,"abstract":"<div><div>With the recent successful disease-modifying therapies against Alzheimer's disease (AD), there have been discussions on easily interpretable measures for treatment effects. Among them, saved time for patients treated with a new drug as compared to patients randomized to the placebo group offers easier interpretation than the reduced percentage in outcome decline at last visit which were commonly used in AD trials. The existing method to calculate saved time utilized the disease progression trajectory of the placebo group and the treatment effect at the last visit. We propose to develop two new methods that use disease progression trajectories of both groups: (1) slope adjusted method; and (2) area under the curve method. We used data from the two donanemab trials and the donepezil trial to illustrate the application of the proposed methods and conducted simulation studies to compare these methods. When a drug has a constant treatment effect over time or early and middle difference in the disease progression, the area under the curve method often has the saved time being longer than the existing method. When the treatment effect is an increasing function of time before the last visit as observed in disease-modifying therapy trials, the slope adjusted method could have a larger saved time as compared to the existing method. In many cases, the area under the curve method often has the smallest standard deviation of saved time.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"151 ","pages":"Article 107814"},"PeriodicalIF":2.0,"publicationDate":"2025-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143381767","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Remote clinical trial to test mechanisms of ‘practice quitting’ treatment: Trial design and methodological report","authors":"Amanda R. Mathew ,&nbsp;Breeann Lynae Hatten ,&nbsp;Maritza Esqueda-Medina ,&nbsp;Karisa Gramajo ,&nbsp;Chen Yeh ,&nbsp;Elizabeth F. Avery ,&nbsp;Sumihiro Suzuki ,&nbsp;Karen Cropsey ,&nbsp;Matthew J. Carpenter","doi":"10.1016/j.cct.2025.107832","DOIUrl":"10.1016/j.cct.2025.107832","url":null,"abstract":"<div><h3>Background</h3><div>Tobacco use disorder is a chronic, relapsing health condition that necessitates a chronic care approach. However, there are limited treatment strategies relevant to individuals who smoke across a continuum of motivation to quit. Further, there is no clear understanding of the mechanisms underlying treatment strategies to engage individuals who are not yet ready to quit smoking.</div></div><div><h3>Methods</h3><div>The current study will enroll 780 individuals who smoke and are unmotivated to quit within the next month through a nationwide remote clinical trial (NCT 05513872). Participants are randomized to receive Practice Quitting or Motivational Interviewing counseling, with or without Nicotine Replacement Therapy product sampling. The primary outcome is incidence of an attempt to quit by 6 months post-treatment. The analytic strategy will examine treatment effects on quit attempts and smoking cessation, along with hypothesized treatment mediators to determine mechanisms of treatment outcomes.</div></div><div><h3>Conclusion</h3><div>Individuals who are not yet ready to quit smoking are a critical group to target in population health management efforts for smoking cessation. We discuss key methodological considerations relevant to the design of future remote and mechanistic clinical trials for smoking cessation.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"151 ","pages":"Article 107832"},"PeriodicalIF":2.0,"publicationDate":"2025-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143381770","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Study protocol of a hybrid type 1 effectiveness-implementation multisite trial: Dialectical behavior therapy skills group for Veterans at high-risk for suicide attempt","authors":"Suzanne E. Decker ,&nbsp;Aimee Kroll-Desrosiers ,&nbsp;Kristin M. Mattocks ,&nbsp;Frances M. Aunon ,&nbsp;Elizabeth Galliford ,&nbsp;Eric C. DeRycke ,&nbsp;Neal Doran ,&nbsp;Scarlett Baird ,&nbsp;Jennifer K. Rielage ,&nbsp;Josephine Ridley ,&nbsp;Jenny Bannister ,&nbsp;Thorayya S. Giovannelli ,&nbsp;Brian S. Fuehrlein ,&nbsp;Chris Shriver ,&nbsp;Ethan Spana ,&nbsp;Mark Honsberger ,&nbsp;Stacey A. Demirelli ,&nbsp;Elena Shest ,&nbsp;Sara J. Landes ,&nbsp;Marianne Goodman ,&nbsp;Steve Martino","doi":"10.1016/j.cct.2025.107828","DOIUrl":"10.1016/j.cct.2025.107828","url":null,"abstract":"<div><h3>Background</h3><div>Veterans of the United States Armed Forces are at disproportionately high risk for suicide death, requiring indicated strategies to mitigate that risk. Dialectical Behavior Therapy (DBT) is effective for reducing suicide attempts in individuals with emotional dysregulation and repeat suicidal behaviors or self-directed violence, but is a comprehensive, multi-component, resource-intensive treatment. A more resource-efficient component of DBT, the DBT Skills Group as an adjunctive treatment, with therapist consultation team (DBT-SG), has been shown to be as efficacious as comprehensive DBT in non-veteran samples, but its effectiveness and factors affecting its implementation have not been studied in the Veterans Health Administration (VHA). This research aims to assess the effectiveness of DBT-SG among high-risk veterans with recent and repeated suicide attempts and emotion dysregulation while systematically evaluating implementation barriers and facilitators.</div></div><div><h3>Methods</h3><div>This hybrid type 1 effectiveness-implementation study will evaluate DBT-SG effectiveness among veterans at high-risk for suicide attempt with emotion dysregulation using a randomized controlled trial of 18 months duration. Study conditions are 24-session DBT-SG plus full-spectrum VHA mental health treatment-as-usual (TAU), or VHA TAU. Outcomes are assessed at 3-, 6-, 12-, and 18-months post-randomization. Before, during, and after the effectiveness trial, implementation determinants of DBT-SG as an adjunctive treatment in VHA will be assessed using a mixed methods evaluation grounded in the Integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework.</div></div><div><h3>Conclusions</h3><div>This study will provide evidence for DBT-SG effectiveness for veterans at high risk for suicide and information about barriers and facilitators to support more widespread facilitation of implementing adjunctive DBT-SG in VHA if it is found effective.</div><div>Clinical trials registration: <span><span>NCT05000749</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"151 ","pages":"Article 107828"},"PeriodicalIF":2.0,"publicationDate":"2025-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143381773","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of risk stratification and problem management plus (PM+) for pregnant women with HIV in Kenya (Tatua study): Protocol paper","authors":"Anna Helova ,&nbsp;Maricianah Onono ,&nbsp;Mercelline Ogolla-Onyando ,&nbsp;Emmah Ouma ,&nbsp;Rabbia Imran ,&nbsp;Laura K. Beres ,&nbsp;Karen Hampanda ,&nbsp;Kevin Owuor ,&nbsp;Jeff M. Szychowski ,&nbsp;Linnet Ongeri ,&nbsp;Lisa L. Abuogi ,&nbsp;Janet M. Turan","doi":"10.1016/j.cct.2025.107838","DOIUrl":"10.1016/j.cct.2025.107838","url":null,"abstract":"<div><h3>Background</h3><div>While many pregnant and postpartum women with HIV (PPWH) in the African Region successfully engage in HIV care, a substantial number still face significant barriers, including poor mental health and HIV stigma. These psychosocial barriers contribute to poor medication and clinic visit adherence, poor health outcomes, including unsuppressed viral load, and increased risk of perinatal transmission of HIV. To efficiently improve health outcomes within a resource-constrained health system, responsive and effective interventions are urgently needed to support women who are at the highest risk of sub-optimal outcomes.</div></div><div><h3>Objective</h3><div>To determine whether risk stratification of PPWH in conjunction with an evidence-based, tailored, lay health worker-delivered psychological intervention can optimize health outcomes for PPWH and their infants.</div></div><div><h3>Methods</h3><div>Using human-centered design, we will adapt Problem Management Plus (PM+) with PPWH for in-person and mobile delivery formats to prevent sub-optimal treatment adherence and HIV care disengagement among PPWH in Kisumu, Kenya. We will test the adapted PM+ intervention among 120 PPWH randomized 1:1:1 to standard of care, in-person PM+, or mobile PM+ in a hybrid type 2 implementation effectiveness pilot trial. Implementation outcomes, including feasibility, acceptability, and intervention satisfaction, as well as preliminary effectiveness outcomes in mental health and HIV, will be evaluated.</div></div><div><h3>Expected study outcomes</h3><div>We anticipate that the adapted PM+ intervention will be highly acceptable and feasible to implement and have the potential to be effective at reducing care disengagement, viremia, and psychological distress in PPWH.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"151 ","pages":"Article 107838"},"PeriodicalIF":2.0,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143374118","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The short- and long-term effects of a fall prevention program on the frequency of falls following total knee replacement: A pragmatic single-blinded randomized controlled trial protocol","authors":"Hadeel Al-Saleh ,&nbsp;Eman Merza ,&nbsp;Bader Al-Adwanie ,&nbsp;Stephen Pearson ,&nbsp;Peter Malliaras","doi":"10.1016/j.cct.2025.107837","DOIUrl":"10.1016/j.cct.2025.107837","url":null,"abstract":"<div><h3>Background</h3><div>Falling following total knee replacement (TKR) is a significant issue, and can result in serious fatal and non-fatal injuries. The proposed study aims to investigate the short and long-term effects of integrating a falls prevention program into conventional physiotherapy versus just conventional physiotherapy on the number of falls, and any subsequent effects on balance, and functional ability among TKR patients.</div></div><div><h3>Methods and design</h3><div>This is a parallel group prospective (52 weeks) randomized single-blinded pragmatic controlled trial conducted at Alrazi Orthopedic Hospital, in Kuwait. Sample size will be 90 pariticpants (45 participants in each group). Particpants will be randomized to intervention or control group. Outcome measures will be collected at baseline, 12 weeks and 52 weeks by investigators who are blinded to treatment allocation. Primary outcome will be fall rate assessed at 52 weeks following the TKR surgery. Secondary outcomes will include knee range of motion, severity of pain, 10-m walk test, Timed Up and Go test, Berg Balance Scale, 30-s sit to stand, patient adherence to home program and patient's satisfaction. Two-way multivariate ANOVA (group × time) will be performed to assess the group (experimental and control group) differences over time (baseline, 12, and 52 weeks).</div></div><div><h3>Discussion</h3><div>Investigating the physiotherapy programs that could minimize or prevent the risk of falling among TKR patients seems important. The proposed study will be the first step toward determining the exercise program that could be effective in reducing the number of falls among TKR patients.</div><div><strong>Trial Registration</strong>: <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>, Identifier <span><span>NCT05642260</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"150 ","pages":"Article 107837"},"PeriodicalIF":2.0,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143372139","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Protocol for a national randomized controlled trial evaluating the Opioid Rapid Response System for overdose death prevention","authors":"Dametreea L. Carr ,&nbsp;Michael L. Hecht ,&nbsp;Michelle N. Shiota ,&nbsp;Mohan Zalake ,&nbsp;Janice Krieger ,&nbsp;Hye Jeong Choi","doi":"10.1016/j.cct.2025.107835","DOIUrl":"10.1016/j.cct.2025.107835","url":null,"abstract":"<div><h3>Introduction</h3><div>Deaths of opioid overdose are a serious public health concern throughout the U.S., transcending geographical and demographic categories. While naloxone can reverse an overdose and prevent death, it must be administered in a timely fashion. Efforts to get naloxone widely distributed contribute to harm reduction efforts, but more efficient strategies for recruiting people to carry and administer naloxone will increase the impact and advance prevention science. Yet, most existing programs are not evidence-based. The Opioid Rapid Response System (ORRS) was developed for these purposes.</div></div><div><h3>Methods</h3><div>A randomized controlled trial will be conducted in 9 communities in Pennsylvania, Arizona, and Washington to evaluate ORRS. The RCT will be conducted with pretest and posttest surveys administered to assess the effectiveness of the training. Focus groups will inform the development of the ORRS training. To increase the appeal of naloxone training for volunteers, recruitment strategies will focus on personal and social identity.</div></div><div><h3>Conclusion</h3><div>The Opioid Rapid Response System is a theory-driven program that recruits and trains lay citizens to respond to opioid overdose events. The program has the potential to advance knowledge of lay citizen recruitment and training, and to reduce deaths from overdoses.</div><div><strong><em>Trial registration</em></strong>: <span><span>NCT06238128</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"150 ","pages":"Article 107835"},"PeriodicalIF":2.0,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143254801","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Enhanced Advance care planning and life Review Longitudinal Intervention (EARLI): Protocol for a cluster randomized controlled cross-over trial of life story work and facilitated advance care planning among older Australian adults in community settings","authors":"Ava Karusoo-Musumeci ,&nbsp;Ling Yeoh ,&nbsp;Rebecca Walton ,&nbsp;Tiet-Hanh Dao-Tran ,&nbsp;Elizabeth Halcomb ,&nbsp;Kirsten A. Auret ,&nbsp;Josephine M. Clayton ,&nbsp;Susan Kurrle ,&nbsp;Elissa Campbell ,&nbsp;Michelle Hilgeman ,&nbsp;Ron Sinclair ,&nbsp;Anne Meller ,&nbsp;Simon Towler ,&nbsp;Caroline E. Edwards ,&nbsp;Tracy Comans ,&nbsp;Craig Sinclair","doi":"10.1016/j.cct.2024.107795","DOIUrl":"10.1016/j.cct.2024.107795","url":null,"abstract":"<div><h3>Background</h3><div>Advance care planning (ACP) is potentially helpful for older adults, however, the rate of uptake in community aged care settings is low. Previous pilot studies suggest that holistic, person-centered ACP approaches may be effective for older adults who experience functional impairment but do not necessarily have life-limiting conditions with clear prognoses. This paper describes the protocol of a randomized trial to test the effectiveness of combined life story work and facilitated ACP in promoting ACP engagement among older adults receiving community aged care services.</div></div><div><h3>Methods</h3><div>The Enhanced Advance care planning and life Review Longitudinal Intervention (EARLI) trial is an open-label, cross-over, cluster randomized controlled trial with 12 participating aged care organizations in New South Wales and Western Australia. Participants are aged 65 years or older, receiving home care services and capable of providing informed consent at initial recruitment. Recruitment occurs across a two-year period, with study sites randomized to receive the four-session intervention in the first or second year (or a single session ‘active control’ condition). Primary outcomes are participant-reported ACP engagement and ACP documentation in the aged care client record 12 weeks post-recruitment. Secondary outcomes include measures of decisional conflict, anxiety and depression, meaning-based coping and relationship quality. Analysis will take an intention-to-treat approach.</div></div><div><h3>Conclusion</h3><div>This trial tests a novel method of reaching older adults using a holistic, person-centered approach to promoting ACP engagement. Enhancing ACP engagement may reduce decisional conflict, minimize hospital admissions and improve outcomes for people and their families.</div><div>ANZCTR Trial Registration ID: ACTRN12622001399785.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"149 ","pages":"Article 107795"},"PeriodicalIF":2.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142913570","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}