Contemporary clinical trials最新文献

{"title":"Protecting households on exposure to newly diagnosed index multidrug-resistant tuberculosis patients: Study protocol for the PHOENIx phase 3 clinical trial","authors":"Michelle A. Kendall ,&nbsp;Michael D. Hughes ,&nbsp;Soyeon Kim ,&nbsp;Lisa A. Aaron ,&nbsp;Linda Naini ,&nbsp;Nishi Suryavanshi ,&nbsp;N. Sarita Shah ,&nbsp;Vanessa Rouzier ,&nbsp;Jeffrey Hafkin ,&nbsp;Thucuma Sise ,&nbsp;Justine Beck ,&nbsp;Barbara E. Heckman ,&nbsp;Jessica E. Haberer ,&nbsp;Mark Harrington ,&nbsp;Kimberly K. Scarsi ,&nbsp;Anneke C. Hesseling ,&nbsp;Susan Swindells ,&nbsp;Gavin J. Churchyard ,&nbsp;Amita Gupta","doi":"10.1016/j.cct.2025.108084","DOIUrl":"10.1016/j.cct.2025.108084","url":null,"abstract":"<div><h3>Introduction</h3><div>Data to guide tuberculosis (TB) preventive treatment (TPT) of close contacts of people with multidrug-resistant tuberculosis (MDR-TB) are limited. While levofloxacin-based TPT has been shown safe and efficacious, alternatives are needed for those exposed to fluoroquinolone-resistant <em>Mycobacterium tuberculosis (M. tb)</em>. The PHOENIx trial evaluates whether using a novel nitroimidazole, delamanid, in high-risk household contacts (HHCs) of patients with MDR-TB reduces their risk of developing active TB.</div></div><div><h3>Methods/Design</h3><div>PHOENIx is a phase 3, open-label, multicenter clinical trial with a cluster-randomized superiority design (households form the clusters). The study objectives are to compare efficacy and safety of 26 weeks of delamanid versus isoniazid for preventing confirmed or probable TB during 96 weeks of follow-up among HHCs of adults with pulmonary MDR-TB. HHCs are defined as young children &lt;5 years, people living with HIV or non-HIV immunosuppression, or people with evidence of <em>M. tb</em> infection. The study was originally designed to enroll 3452 HHCs to provide 90 % power to detect a 50 % reduction in the cumulative proportion of HHCs developing confirmed or probable TB during 96 weeks of follow-up from 5 % in the isoniazid arm to 2.5 % in the delamanid arm. The design included a sample size re-evaluation to address uncertainty in study design assumptions.</div></div><div><h3>Discussion</h3><div>Preventing MDR-TB is a global priority. Alternatives to levofloxacin-based TPT are needed since fluoroquinolone resistance is growing. PHOENIx, a phase 3 trial evaluating delamanid, is poised to inform WHO guidelines.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"158 ","pages":"Article 108084"},"PeriodicalIF":1.9,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145136758","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":"Design of a cluster randomized multi-level intervention to decrease barriers to minority cancer patient referral and enrollment to cancer clinical trials: The ACT WONDER2S study","authors":"Dana E. Rollison ,&nbsp;Melany A. Garcia ,&nbsp;Rossybelle P. Amorrortu ,&nbsp;Yayi Zhao ,&nbsp;Brian Mittman ,&nbsp;Kea Turner ,&nbsp;Kedar Kirtane ,&nbsp;Hatem Soliman ,&nbsp;Margaret M. Byrne ,&nbsp;Cathy Meade ,&nbsp;Clement K. Gwede ,&nbsp;Steven Eschrich ,&nbsp;Jun Yin ,&nbsp;Nathanael B. Stanley ,&nbsp;Lindsay Fuzzell ,&nbsp;Delilah Hernandez ,&nbsp;Elliott-Tapia-Kwan ,&nbsp;Susan T. Vadaparampil","doi":"10.1016/j.cct.2025.108096","DOIUrl":"10.1016/j.cct.2025.108096","url":null,"abstract":"<div><h3>Introduction</h3><div>Non-Hispanic (NH) Black/African American (AA) and Hispanic cancer patients are underrepresented in cancer clinical trials (CCTs) due to patient, physician, and system-level barriers. Therefore, multi-level approaches are critical to address barriers to CCT participation. Presented here are the study design and baseline characteristics of ACT WONDER²S, a multi-level intervention (MLI) aimed to decrease barriers to NH Black/AA and Hispanic patient referral and enrollment in CCTs.</div></div><div><h3>Methods</h3><div>ACT WONDER²S is an MLI including community outreach and digital interventions for community and Moffitt Cancer Center (MCC) populations. Geospatial analytics were used to identify clusters of census tracts (“priority zones”) with high NH Black/AA and Hispanic populations for intervention deployment. Priority zones were then matched on population characteristics and randomized to receive the intervention (<em>n</em> = 7) or to serve as controls (n = 7). Baseline characteristics of the priority zones were described using US Census data and other public sources.</div></div><div><h3>Results</h3><div>Approximately 16.5 % and 35.8 % of the intervention priority zones are NH Black/AA or Hispanic, respectively. There are no statistically significant differences between groups in total population size (paired <em>t</em>-test <em>p</em>-value = 0.63), proportions of NH Black/AA (<em>p</em> = 0.13) and Hispanic populations (<em>p</em> = 0.17), or distance in miles from MCC (<em>p</em> = 0.64). The estimated number of cancer cases and CCT enrollment rates at baseline are also similar between groups.</div></div><div><h3>Conclusion</h3><div>If shown to be effective in increasing referral and enrollment of NH Black/AA and Hispanic cancer patients to CCTs, ACT WONDER²⁾S can be deployed across other geographic settings, thereby reducing disparities to CCT referral and enrollment on a national scale.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"158 ","pages":"Article 108096"},"PeriodicalIF":1.9,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145136763","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 randomized trial of self-management support for people with chronic obstructive pulmonary disease using lay health coaches","authors":"Nikita Agrawal ,&nbsp;Meredith Case ,&nbsp;Peter K. Lindenauer ,&nbsp;Danielle McDermott ,&nbsp;Keith M. Diaz ,&nbsp;Jennifer Oscherician Utkin ,&nbsp;Juan Wisnivesky ,&nbsp;Alex Federman","doi":"10.1016/j.cct.2025.108095","DOIUrl":"10.1016/j.cct.2025.108095","url":null,"abstract":"<div><div>Successful management of chronic obstructive pulmonary disease (COPD) centers on patient self-management behaviors (SMB) such as controller medication adherence, use of action plans, smoking cessation and more. Individuals with COPD face a number of barriers to effective self-management, including medical comorbidities, cognitive and mental health disorders, and socioeconomic factors. Poor self-management contributes significantly to poor health outcomes in patients with COPD. However, prior research has demonstrated that interventions to improve SMB must be multifaceted and tailored to individual patients' specific barriers to be most effective. This randomized control study will test a 6-month self-management support intervention in 300 adults with Global Initiative for Chronic Obstructive Lung Disease (GOLD) classifications B or E. The intervention is called Supporting self-Management Behaviors in Adults with COPD (SAMBA). It uses health coaches to identify and address barriers to SMB, support home-based pulmonary rehabilitation, and promote use of as-needed antibiotics and oral corticosteroids for early treatment of acute COPD exacerbations. SAMBA will be compared to a time and attention matched control treatment consisting of general COPD education. We hypothesize that patients receiving SAMBA will have better COPD medication adherence, greater exercise capacity, more improved COPD symptoms and quality of life, and fewer hospitalizations and ED visits than control patients.</div></div><div><h3>Clinical trial registration number</h3><div><span><span>NCT06634810</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"158 ","pages":"Article 108095"},"PeriodicalIF":1.9,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145136774","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 telehealth MOM study: Protocol for a randomized controlled trial of the telehealth multi-component optimal model (MOM) of postpartum care.","authors":"Jennifer A Callaghan-Koru, Nirvana Manning, James P Selig, Hari Eswaran, Stacy Tiemeyer, Sarah J Rhoads","doi":"10.1016/j.cct.2025.108085","DOIUrl":"https://doi.org/10.1016/j.cct.2025.108085","url":null,"abstract":"<p><strong>Objectives: </strong>This cross-sectional study of hospital emergency departments (EDs) in Arkansas sought to: 1) assess ED experiences and capabilities related to obstetric emergencies, and; 2) characterize the differences in ED practices for pregnant and postpartum patients between hospitals with and without obstetric services.</p><p><strong>Methods: </strong>Online survey invitations were distributed to department managers at hospital EDs across Arkansas in August 2023. The 40-question survey collected hospital characteristics, ED experiences with and capacity to manage obstetric emergencies, and staff training history and interest. Responses were descriptively analyzed, and differences in proportions between hospitals with and without obstetric services were tested.</p><p><strong>Results: </strong>Managers for 51 (61 %) of the 84 eligible EDs responded. Seventy-one percent of EDs (35/49) had an urgent transport of a pregnant or postpartum patient, and 43 % (20/47) had a birth in the prior 12 months. EDs in hospitals without obstetric services were less likely to have a birth (27 % v. 56 %), to have capacity to perform some obstetric procedures such as administering uterotonic drugs (58 % v. 100 %), and to require assessment of postpartum status in the electronic health record (0 % v. 33 %). The majority (19/35; 54 %) of responding ED managers had not offered obstetric emergency training to staff in the last two years.</p><p><strong>Conclusions: </strong>While obstetric emergencies are not uncommon in the Arkansas hospital EDs represented in this study, many EDs have gaps in their preparedness to identify and manage these cases. Key opportunities for improving preparedness in this sample include training staff and requiring assessment of both pregnancy and postpartum status for women of reproductive age.</p><p><strong>Bottom line: </strong>There is limited data on Emergency Department (ED) practices related to obstetric complications. We conducted a cross-sectional survey with managers of 51 (61 %) hospital-based EDs in Arkansas to assess EDs' experiences with, and capability to manage, obstetric emergencies. During the prior year, a precipitous birth occurred at roughly 1 in 3 EDs, and an urgent transport of a pregnant or postpartum patient occurred at 2 in 3 EDs. Key opportunities to improve ED practices include implementing consistent assessment of postpartum status and providing staff training on obstetric topics.</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"108085"},"PeriodicalIF":1.9,"publicationDate":"2025-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145111452","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":"Feasibility of an ADAPTive intervention to improve food security and Maternal-Child Health (ADAPT-MCH): Protocol for a pilot sequential multiple assignment randomized trial","authors":"Deepak Palakshappa ,&nbsp;Rebecca J. Stone ,&nbsp;Brenda Ramirez ,&nbsp;Sarah E. White ,&nbsp;Joseph Rigdon ,&nbsp;Richa Bundy ,&nbsp;Sally G. Eagleton ,&nbsp;Nicole Caudill ,&nbsp;Heather Martin ,&nbsp;Mayte Grundseth ,&nbsp;Scott Best ,&nbsp;Morgana Mongraw-Chaffin ,&nbsp;Kristina H. Lewis ,&nbsp;Kimberly Montez","doi":"10.1016/j.cct.2025.108086","DOIUrl":"10.1016/j.cct.2025.108086","url":null,"abstract":"<div><h3>Background</h3><div>Food insecurity affects up to 30 % of pregnancies and is associated with worse maternal and infant health. Healthcare systems are implementing interventions to assist patients with food insecurity, but rather than providing a single intervention, adaptively providing interventions could be a more effective strategy. The objective of this study is to determine the feasibility of adaptively providing interventions to assist pregnant patients who report being food-insecure.</div></div><div><h3>Methods/design</h3><div>We will conduct a pilot sequential multiple assignment randomized trial at obstetrics clinics from one health system. Adults (<em>N</em> = 60) who are pregnant and food-insecure will be randomized at their initial prenatal visit to one of two first-stage interventions for 3 months: 1) electronic health record (EHR) referral to WIC or 2) EHR-referral to WIC + care navigation. Participants who do not have ≥2-point improvement in food insecurity after 3 months will be re-randomized to one of two second-stage interventions for an additional 3 months: weekly delivery of 1) produce or 2) medically-tailored meals. In Aim 1, we will determine the feasibility of recruitment, and in Aim 2, we will evaluate the feasibility of re-randomization, retention, and data collection. In Aim 3, we will advance our understanding of how, why, and under what circumstances participants achieved improvements through semi-structured interviews.</div></div><div><h3>Conclusions</h3><div>This will be the first study to test an adaptive intervention to assist pregnant patients with food insecurity and will inform a future fully-powered trial. Given the growing interest among health systems, an efficacious, adaptive food insecurity intervention could be broadly disseminated.</div></div><div><h3>Trial registration</h3><div>The study was registered with <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (<span><span>NCT06942598</span><svg><path></path></svg></span>) on April 23, 2025.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"158 ","pages":"Article 108086"},"PeriodicalIF":1.9,"publicationDate":"2025-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145102796","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 psychosocial pain management to improve opioid use disorder treatment outcomes study: Protocol for a randomized controlled trial","authors":"Mark Ilgen ,&nbsp;Frederic Blow ,&nbsp;John D. Piette ,&nbsp;Jason Goldstick ,&nbsp;Mandy Lewis ,&nbsp;William Priest ,&nbsp;Harshpreet Matharu ,&nbsp;Michael Bourgoise ,&nbsp;Chelsea Young ,&nbsp;Doctor Ashe ,&nbsp;Amanda Price ,&nbsp;Lewei (Allison) Lin","doi":"10.1016/j.cct.2025.108081","DOIUrl":"10.1016/j.cct.2025.108081","url":null,"abstract":"<div><h3>Background</h3><div>People with opioid use disorder (OUD) often experience comorbid chronic pain, which complicates treatment of both conditions. Medications for opioid use disorders (MOUD), specifically buprenorphine, are the standard of care for OUD and can be helpful for pain; however, a major challenge to sustaining effectiveness has been limited retention in buprenorphine treatment. Prior research has highlighted the efficacy of psychosocial treatments for pain management; although, research remains limited on integrated approaches to improve OUD outcomes among people/patients with chronic pain. This randomized controlled trial, called the Persist Study, investigated whether a psychosocial pain management intervention (PPMI) was more effective than Enhanced Usual Care (EUC) for MOUD patients with chronic pain.</div></div><div><h3>Methods</h3><div>This was a randomized trial of remotely delivered PPMI vs EUC for adults receiving MOUD who have chronic pain. Our study recruited nationally from MOUD clinics and through targeted online advertisements. Target enrollment was 200 participants randomly assigned to either PPMI (<em>n</em> = 100) or EUC (n = 100) conditions. The PPMI consisted of eight 1-h sessions and the EUC included two 15-min sessions conducted over a 6-week timespan. Primary outcomes measured retention on buprenorphine over 3 months, whereas secondary outcomes measured longer-term MOUD retention, pain level, pain-related functioning, and frequency of substance use over 12 months.</div></div><div><h3>Discussion</h3><div>The Persist Study tested a remotely delivered, manualized, psychosocial intervention for co-occurring chronic pain in patients prescribed buprenorphine treatment for OUD. Study results will inform efforts to improve retention and treatment outcomes among patients receiving MOUD who also have chronic pain.</div><div><strong>Trial registration:</strong> This clinical trial has been registered with <span><span>ClincialTrials.gov</span><svg><path></path></svg></span> under ID <span><span>NCT04433975</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"158 ","pages":"Article 108081"},"PeriodicalIF":1.9,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145091421","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":"NutriConnect: Enhancing health and food security through sustainable solutions and partnerships: Design and protocol of a pragmatic comparative effectiveness trial","authors":"Sang Gune K. Yoo ,&nbsp;Rachel G. Tabak ,&nbsp;Stephanie Mazzucca-Ragan ,&nbsp;Allison Primo ,&nbsp;Doneisha Bohannon ,&nbsp;Derek Hashimoto ,&nbsp;Charles W. Goss ,&nbsp;Jason HY Wu ,&nbsp;Eghonghon Eromosele ,&nbsp;Ihab Hassanieh ,&nbsp;Adam Hively ,&nbsp;Abygail Martinez ,&nbsp;Jinli Wang ,&nbsp;Mark D. Huffman ,&nbsp;Jing Li","doi":"10.1016/j.cct.2025.108083","DOIUrl":"10.1016/j.cct.2025.108083","url":null,"abstract":"<div><h3>Background</h3><div>Food insecurity and poor dietary intake contribute to health disparities, particularly among socioeconomically disadvantaged populations. Produce prescription programs aim to improve access to fruits and vegetables (F&amp;V) for those with diet-sensitive conditions, but comparative effectiveness data are limited.</div></div><div><h3>Objective</h3><div>To compare the impact of two produce prescription strategies, NutriConnect Credit (grocery coupons) and NutriConnect Delivery (home-delivered F&amp;V boxes), on dietary intake, food security, and health outcomes among socioeconomically disadvantaged populations who have been recently hospitalized with diet-sensitive conditions.</div></div><div><h3>Methods</h3><div>In this three-arm pilot trial, recently hospitalized adults with food or financial insecurity and elevated cardiovascular risk were randomized (1:1:1) to Credit, Delivery, or enhanced usual care. The primary outcome is between group difference in change in F&amp;V intake at 6 months. Secondary outcomes include food security and self-reported health-related quality of life. Implementation outcomes are assessed using the PRISM/RE-AIM framework.</div></div><div><h3>Conclusion</h3><div>NutriConnect seeks to provide evidence on the effectiveness and feasibility of two produce prescription strategies to inform scalable “Food is Medicine” programs targeting nutrition-related health disparities.</div><div><strong>Trial registration number:</strong> <span><span>NCT06263751</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"158 ","pages":"Article 108083"},"PeriodicalIF":1.9,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145091327","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":"Early identification of functional somatic disorders in an internal medicine diagnostic clinic: The DISTRESS trial","authors":"Michael M. Madsen ,&nbsp;Christian Trolle ,&nbsp;Lotte V. Fynne ,&nbsp;Michele Colombo ,&nbsp;Rasmus L. Pedersen ,&nbsp;Vibeke N. Sørensen ,&nbsp;Susan R. Christensen ,&nbsp;Per Fink ,&nbsp;Lise K. Gormsen","doi":"10.1016/j.cct.2025.108082","DOIUrl":"10.1016/j.cct.2025.108082","url":null,"abstract":"<div><h3>Background</h3><div>Functional Somatic Disorders (FSDs) affect approximately 10 % of the general population (1) and often lead to reduced quality of life, extensive diagnostic evaluations and increased healthcare costs. The DISTRESS (Diagnostic Intervention in Secondary care Targeting patients Referred for Evaluation of bodily Stress Symptoms) trial protocol describes a randomised clinical trial evaluating a novel FSD Diagnostic Clinic, with the aim of providing early diagnosis and thereby helping patients and clinicians bring the diagnostic odyssey to a definitive and meaningful conclusion.</div></div><div><h3>Methods/design</h3><div>This pragmatic, randomised trial employs allocation concealment and blinded outcome assessment, although the randomisation allocation is unavoidably unmasked to patients and clinicians due to the nature of the intervention. Patients with suspected FSD are randomised 1:1 to either the FSD Diagnostic Clinic, where internal medicine specialists (internists) undertake the FSD diagnostic process, or to usual diagnostic assessment. The two co-primary outcomes evaluate (a) healthcare utilization and (b) costs-effectiveness, assessed alongside health-related quality of life measured by the SF-36 survey at 12 months post-intervention. Secondary outcomes include relevant clinical outcomes and overall public expenses.</div></div><div><h3>Discussion</h3><div>The DISTRESS trial addresses challenges in diagnosing FSDs by evaluating a novel Diagnostic Clinic model and its impact on patient outcomes, cost-effectiveness, and healthcare utilization. Insights from separately conducted qualitative studies will complement the trial by assessing the clinic's acceptability and integration within the healthcare system. By training internists to diagnose and manage FSDs using approaches typically employed by FSD specialists, the FSD Diagnostic Clinic expands access to timely care within a stepped care model.</div></div><div><h3>Trial Registration</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> Identifier: <span><span>NCT06025617</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"158 ","pages":"Article 108082"},"PeriodicalIF":1.9,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145091383","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":"Evaluating partner-involved financial incentive treatments for smoking cessation in dual-smoker couples: A randomized controlled trial protocol","authors":"Michelle R. vanDellen ,&nbsp;Emma Bales ,&nbsp;Brittnee M. Hampton ,&nbsp;Eshita Jain ,&nbsp;Ye Shen ,&nbsp;Jayani Jayawardhana ,&nbsp;Steven R.H. Beach ,&nbsp;Ashley H. Chinchilla ,&nbsp;James M. MacKillop","doi":"10.1016/j.cct.2025.108076","DOIUrl":"10.1016/j.cct.2025.108076","url":null,"abstract":"<div><h3>Background</h3><div>Individuals who smoke combustible nicotine cigarettes and are partnered with another smoker are less likely to quit smoking than other smokers. Financial incentives for cessation increase individual abstinence. However, these interventions have not been examined using a dyadic approach that targets the couple rather than an individual. The current study will evaluate two variants of a dyadic financial incentive intervention for smoking cessation in dual-smoking couples.</div></div><div><h3>Methods</h3><div>Feasibility and tolerability of dyadic financial incentive treatments in dual-smoking couples has been established, along with their preliminary efficacy. The current study will utilize a large-scale clinical trial to systematically evaluate the efficacy and mechanisms of change of two variants of dyadic financial incentive interventions among 450 dual-smoking couples.</div></div><div><h3>Results</h3><div>The primary study outcome will be 6-month point-prevalence abstinence (self-report abstinence for 7 days + biochemical verification) among targets in dual-smoking couples. Partner abstinence at 6-months, and both target and partner abstinence at 1, 3, and 12 months will be examined as secondary outcomes. Potential treatment mechanisms, including motivational and relationship processes will be evaluated to inform future interventions.</div></div><div><h3>Discussion</h3><div>Individuals with smoking partners experience low motivation to quit and low success rates when they make quit attempts. Current evidence-based interventions target individuals in isolation from their social networks that strongly influence them. This approach represents a critical next step toward developing interventions that effectively capitalize on social network members to produce and sustain smoking cessation.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"158 ","pages":"Article 108076"},"PeriodicalIF":1.9,"publicationDate":"2025-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145079833","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":"Design and protocol of a pragmatic clinical trial to improve cognitive impairment detection in primary care","authors":"Bethany Crouse ,&nbsp;Rebecca C. Rossom ,&nbsp;A. Lauren Crain ,&nbsp;Patrick J. O'Connor ,&nbsp;Meghan M. JaKa ,&nbsp;Michael V. Maciosek ,&nbsp;Deepika Appana ,&nbsp;Rashmi Sharma ,&nbsp;Sally K. Gustafson ,&nbsp;Ann M. Werner ,&nbsp;Aleta L. Svitak ,&nbsp;Heidi L. Ekstrom ,&nbsp;Soo Borson ,&nbsp;Michael H. Rosenbloom ,&nbsp;Joann M. Sperl-Hillen ,&nbsp;Lauren R. O'Keefe ,&nbsp;Leah R. Hanson","doi":"10.1016/j.cct.2025.108080","DOIUrl":"10.1016/j.cct.2025.108080","url":null,"abstract":"<div><h3>Background</h3><div>The prevalence of cognitive impairment (CI) including Alzheimer's disease (AD) and related dementias (ADRD) continues to rise worldwide, but often goes undiagnosed leading to increased burden on patients and families. A clinical decision support system (CDSS) could improve care quality by assisting primary care clinicians (PCCs) to recognize, evaluate, diagnose, and manage patients with CI.</div></div><div><h3>Methods</h3><div>38 primary care clinics are randomized to receive the study intervention or usual care (UC). The study intervention consists of a cognitive impairment clinical decision support system (CI-CDSS) and a brief CI-focused training. The CI-CDSS utilizes electronic health record (EHR) data to alert PCCs of patients who may be at high risk for CI, determined by either an abnormal cognitive assessment or identification as high risk using a prototype prediction model developed for this study that estimates likelihood of developing CI in the next 3 years. It also provides tools and resources to evaluate and diagnose CI and gives recommendations for managing care of patients with CI.</div></div><div><h3>Endpoints</h3><div>The primary outcome is EHR documentation of CI diagnosis up to 18 months after accrual. Secondary outcomes include healthcare costs and PCC confidence in diagnosis and management of patients with CI.</div></div><div><h3>Conclusion</h3><div>This pragmatic, cluster-randomized, Phase III clinical trial aims to assess the effectiveness of a CDSS in increasing detection of CI in primary care. If successful, this system could provide up-to-date personalized recommendations for CI diagnosis and management to improve patient care.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"158 ","pages":"Article 108080"},"PeriodicalIF":1.9,"publicationDate":"2025-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145069211","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}