Contemporary clinical trials最新文献

{"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}

{"title":"Increasing parent help-seeking for child mental health: A study protocol for the growing minds check-in, an online universal screening tool","authors":"Talia Carl ,&nbsp;Lucy A. Tully ,&nbsp;Rebecca K. McLean ,&nbsp;Mark R. Dadds ,&nbsp;David J. Hawes ,&nbsp;Cathrine Mihalopoulos ,&nbsp;Mary Lou Chatterton ,&nbsp;Frank Oberklaid ,&nbsp;Allison M. Waters ,&nbsp;Dianne Shanley ,&nbsp;Marie B.H. Yap ,&nbsp;Warren G. Cann ,&nbsp;Thomas Carlick ,&nbsp;Jaimie C. Northam","doi":"10.1016/j.cct.2024.107801","DOIUrl":"10.1016/j.cct.2024.107801","url":null,"abstract":"<div><h3>Background</h3><div>Early identification and intervention for mental health (MH) problems in childhood offers lifelong benefits. Many children with MH problems do not receive appropriate help. To address this need, an online universal MH screening tool, the Growing Minds Check-In for parents/caregivers (GMCI-P), was developed to provide feedback to parents on their children's MH, identify children at risk of MH problems, and link parents to evidence-based online programs/information, with the goal of facilitating parent help-seeking, and ultimately reducing the prevalence of child MH problems.</div></div><div><h3>Methods/design</h3><div>A randomised controlled trial (RCT) with 440 parents/caregivers will be conducted to 1) examine the efficacy of GMCI-P for increasing parent help-seeking; 2) explore acceptability; and 3) cost-effectiveness. Participants will be Australian parents/caregivers with a child aged from birth to 17 years, 6 months, who will be randomly allocated to GMCI-P (intervention) or waitlist control (WLC) group, and complete baseline measures. The intervention group will complete the GMCI-P immediately, the post-GMCI-P intervention questions, a three-month and six-month follow-up. The WLC group will receive access to GMCI-P after their three-month follow-up but will not be followed up further. The primary outcome is parent help-seeking behaviour for child MH, and secondary outcomes include child MH, parenting, parent wellbeing, acceptability, cost-effectiveness, and unintended negative effects.</div></div><div><h3>Discussion</h3><div>The results from this study will provide efficacy, acceptability and cost-effectiveness data on a universal online, parent-report child MH Check-In. These results can be used to inform public policy on universal screening for child MH.</div><div><strong>Trial registration:</strong> ACTRN12624000098538</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"149 ","pages":"Article 107801"},"PeriodicalIF":2.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142913655","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}

{"title":"Corrigendum to “Preventing severe hypoglycemia in adults with type 2 diabetes (PHT2): Design, delivery and evaluation framework for a randomized controlled trial” [Contemp Clin Trials 2024 Apr:139:107456, pgs 1–11]","authors":"James D. Ralston ,&nbsp;Melissa Anderson ,&nbsp;Janet Ng ,&nbsp;Ayat Bashir ,&nbsp;Kelly Ehrlich ,&nbsp;Dena Burns-Hunt ,&nbsp;Meredith Cotton ,&nbsp;Laurel Hansell ,&nbsp;Clarissa Hsu ,&nbsp;Helen Hunt ,&nbsp;Andrew J. Karter ,&nbsp;Shaula M. Levy ,&nbsp;Evette Ludman ,&nbsp;Lawrence Madziwa ,&nbsp;Emily M. Omura ,&nbsp;Kristine Rogers ,&nbsp;Brandie Sevey ,&nbsp;James A.M. Shaw ,&nbsp;Susan M. Shortreed ,&nbsp;Umesh Singh ,&nbsp;Laura Yarborough","doi":"10.1016/j.cct.2024.107767","DOIUrl":"10.1016/j.cct.2024.107767","url":null,"abstract":"","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"149 ","pages":"Article 107767"},"PeriodicalIF":2.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143078566","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":"Multi-domain Online Therapeutic Investigation Of Neurocognition (MOTION) – A randomized comparative-effectiveness study of two remotely delivered mind-body interventions for older adults with cognitive decline","authors":"Linda L. Chao ,&nbsp;Deborah E. Barnes ,&nbsp;Margaret A. Chesney ,&nbsp;Wolf E. Mehling ,&nbsp;Jennifer A. Lee ,&nbsp;Cynthia Benjamin ,&nbsp;Helen Lavretsky ,&nbsp;Linda Ercoli ,&nbsp;Prabha Siddarth ,&nbsp;Katherine L. Narr","doi":"10.1016/j.cct.2025.107811","DOIUrl":"10.1016/j.cct.2025.107811","url":null,"abstract":"<div><h3>Background</h3><div>Research suggest that mind-body movement programs have beneficial effects on cognitive outcomes for older adults with cognitive decline. However, few studies have directly compared specific approaches to mind-body movement or studied the impact of remote program delivery.</div></div><div><h3>Methods</h3><div>In a 3-arm randomized controlled trial (RCT) for older adults with cognitive impairment, we are comparing a multidomain mind-body program that emphasizes movement, body awareness, personal meaningfulness, and social connection, and a traditional Chinese mind-body exercise (Tai Chi) to a health and wellness education control condition. All 3 interventions are delivered remotely two times per week (onehour per session) for 12 weeks. The two active interventions are live-streamed. Outcomes are assessed prior to, after, and 6-months after the interventions. The co-primary outcomes are changes on the Alzheimer's Disease Assessment Scale – Cognitive Subscale (ADAS-cog) and brain functional connectivity in the Default Mode Network (DMN). Secondary outcomes include measures of specific cognitive domains (e.g., executive function, attention), mobility, and self-report measures of general well-being, quality of life, social engagement, self- and attention-regulation.</div></div><div><h3>Conclusion</h3><div>This RCT will directly compare the effects of two mind-body movement programs versus an education control delivered remotely over 12 weeks on cognitive, neuroimaging, and participant-reported outcomes. If successful, these programs may provide scalable strategies for slowing cognitive decline, which could potentially delay dementia onset in some individuals.</div><div><strong>Trial registration ID:</strong> <span><span>NCT05217849</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"149 ","pages":"Article 107811"},"PeriodicalIF":2.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142982652","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}

{"title":"Preterm-birth-prevention with Lactobacillus crispatus oral probiotics: Protocol for a double blinded randomised placebo-controlled trial (the PrePOP study)","authors":"Gillian A. Corbett ,&nbsp;Siobhan Corcoran ,&nbsp;Conor Feehily ,&nbsp;Benedetta Soldati ,&nbsp;Anthony Rafferty ,&nbsp;David A. MacIntyre ,&nbsp;Paul D. Cotter ,&nbsp;Fionnuala M. McAuliffe","doi":"10.1016/j.cct.2024.107776","DOIUrl":"10.1016/j.cct.2024.107776","url":null,"abstract":"<div><h3>Introduction</h3><div>Effective spontaneous preterm birth (sPTB) prevention is an urgent unmet clinical need. Vaginal depletion of <em>Lactobacillus crispatus</em> is linked to sPTB. This trial will investigate impact of an oral <em>Lactobacillus</em> spp. probiotic product containing an <em>L. crispatus</em> strain with other <em>Lactobacilli</em> spp., on the maternal vaginal and gut microbiome in pregnancies high-risk for sPTB.</div></div><div><h3>Methods</h3><div>A double-blind, placebo-controlled, randomised trial will be performed at the National Maternity Hospital Dublin, Ireland. Inclusion criteria are women with history of sPTB or mid-trimester loss, cervical surgery (cone biopsy or two previous large-loop-excision-of-transformation-zone) or uterine anomaly. The intervention is oral supplementation for twelve weeks with probiotic or identical placebo. The probiotic will contains:</div><div>◦ 4 billion CFU <em>Lactobacillus crispatus</em> Lbv 88(2x10⁹CFU/Capsule)</div><div>◦ 4 billion CFU <em>Lactobacillus rhamnosus</em> Lbv 96(2x10⁹CFU/Capsule)</div><div>◦ 0.8 billion CFU <em>Lactobacillus jensenii</em> Lbv 116(0.4x10⁹CFU/Capsule)</div><div>◦ 1.2 billion CFU <em>Lactobacillus gasseri</em> Lbv 150(0.6x10⁹CFU/Capsule).</div><div>Investigators and participants will be blinded to assignment.</div></div><div><h3>Results</h3><div>The primary outcome is detectable <em>L. crispatus</em> in the vaginal microbiome after twelve weeks of treatment, measured using high-throughput DNA sequencing. A total of 126 women are required to detect a 25 % increase in detectable <em>L. crispatus.</em> Secondary outcomes include impact of intervention on the gut microbiome and metabolome, rate of sPTB and mid-trimester loss, neonatal outcomes and maternal morbidity.</div></div><div><h3>Conclusions</h3><div>This randomised trial will investigate ability of an oral probiotic containing <em>L. crispatus</em> to increase its abundance in the vaginal microbiome, both directly by horizontal transfer and indirectly via microbiome and metabolome of the gut.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"149 ","pages":"Article 107776"},"PeriodicalIF":2.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142863273","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}

{"title":"Ketamine treatment in youth for fast reduction of suicidality and engagement in psychotherapy: A randomized placebo-controlled trial protocol","authors":"Noreen A. Reilly-Harrington ,&nbsp;Tatiana Falcone ,&nbsp;David A. Jobes ,&nbsp;Christina Deisz ,&nbsp;Claire Flannery ,&nbsp;Amber Wolf ,&nbsp;Bo Hu ,&nbsp;Amit Anand","doi":"10.1016/j.cct.2024.107777","DOIUrl":"10.1016/j.cct.2024.107777","url":null,"abstract":"<div><h3>Background</h3><div>Suicide is a leading cause of death in young persons. While ketamine has demonstrated rapid anti-suicidal effects, its safety and efficacy in youth has not been fully investigated. The Collaborative Assessment and Management of Suicidality (CAMS), a suicide-focused treatment shown to decrease suicidal ideation and symptom distress, has never been studied in combination with ketamine.</div></div><div><h3>Objectives</h3><div>This study investigates whether ketamine infusion, as compared to placebo, rapidly reduces severe suicidality in youth and young adults and enhances effectiveness of CAMS to decrease suicidality after acute treatment and at 3-month follow-up. We explore whether participants who receive ketamine, as compared to placebo, have decreased suicidality, suicide attempts, emergency department visits for suicidality, and psychiatric readmissions over 3-month follow-up.</div></div><div><h3>Methods</h3><div>This randomized controlled trial is enrolling 140 participants (ages 14–30) hospitalized with severe suicidal ideation or after attempted suicide. While hospitalized, participants are randomized to receive up to 6 treatments of either ketamine or placebo. Concurrently, participants engage in CAMS sessions, starting while inpatient and continuing post-discharge for up to 12 sessions via telehealth or until resolution of suicidality criteria are met. Monthly follow-up assessments are conducted for 3 months.</div></div><div><h3>Discussion</h3><div>Historically, hospital admissions have not decreased suicidal behavior following discharge. We hypothesize that ketamine, as compared to placebo, will lead to rapid improvement in suicidality and enhance engagement in CAMS, requiring significantly fewer sessions to resolve high-risk suicidality after discharge. We hypothesize that the ketamine group will have decreased suicidality, suicide attempts, and readmissions compared to the placebo group over 3-month follow-up.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"149 ","pages":"Article 107777"},"PeriodicalIF":2.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142821898","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":"Randomized clinical trial protocol of an app-based intervention to prevent postpartum depression","authors":"Ellen Poleshuck ,&nbsp;Debra Fox ,&nbsp;Beau Abar ,&nbsp;Daniel Maeng ,&nbsp;Tamara Bilinski ,&nbsp;Lauren Beers ,&nbsp;Jules Rosen ,&nbsp;Caron Zlotnick","doi":"10.1016/j.cct.2024.107800","DOIUrl":"10.1016/j.cct.2024.107800","url":null,"abstract":"<div><h3>Purpose</h3><div>To develop and evaluate the effectiveness of an asynchronously delivered app, InBloom, for postpartum depression (PPD) prevention relative to an evidence-based synchronously delivered in-person intervention, ROSE (Reach Out, Stay Strong, Essentials for mothers of newborns) for depression and return on investment via a prospective randomized controlled trial and quasi-experimental cohort analyses.</div></div><div><h3>Background</h3><div>PPD affects 1 in 7 gestational parents in the US, causing emotional distress, consequences for infant development and child adjustment, disruptions in family relationships, and financial burden. ROSE is an evidence-based intervention administered as four in-person group sessions plus one postpartum booster session. Despite ROSE's demonstrated effectiveness, pragmatic barriers impact disseminating an in-vivo group intervention broadly to people at risk for PPD. If effective, an app may help overcome implementation barriers.</div></div><div><h3>Design</h3><div>We will develop an app based on the ROSE intervention, recruit 152 pregnant people ≥18 years, 17–32 weeks' gestation, and with risk factors for PPD, and randomize participants either to InBloom or ROSE. Primary outcomes are depression and return on investment (ROI). Hypothesized mechanisms are perceived access, engagement, and satisfaction with the intervention. Control groups include historical control subjects from the largest ROSE trial for depression outcomes and Electronic Health Record (EHR) data on concurrent patients from the same clinics not offered InBloom or ROSE for ROI outcomes.</div></div><div><h3>Conclusion</h3><div>At the end of the trial, we will know if InBloom is a viable alternative to ROSE, allowing further implementation studies of an easy, low-cost distribution app to reduce risk of PPD.</div><div><span><span><strong>ClinicalTrials.gov</strong></span><svg><path></path></svg></span> <strong>Registration Identifier:</strong> <span><span>NCT05518162</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"149 ","pages":"Article 107800"},"PeriodicalIF":2.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142913681","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":"Advancing vaccine research in Africa: A comprehensive analysis of vaccine clinical trials landscape","authors":"Lindi Mathebula ,&nbsp;Thobile Malinga ,&nbsp;Chinwe Iwu-Jaja ,&nbsp;Duduzile Ndwandwe","doi":"10.1016/j.cct.2024.107779","DOIUrl":"10.1016/j.cct.2024.107779","url":null,"abstract":"<div><div>This study presents an in-depth analysis of vaccine clinical trials in Africa, emphasising the significance of local investments to address the continent's healthcare requirements. The research scrutinises vaccine trials across various African nations, focusing on trial distribution, phases, funding sources, recruitment sites, recruitment statuses, and age group participation.</div><div>The findings suggest substantial trial activity in countries like Kenya, Ghana, and Gambia, whereas nations like the Democratic Republic of the Congo and Tunisia exhibit minimal representation. Notably, COVID-19, HIV, and Yellow Fever vaccines prominently feature in the trials, with Phase 3 trials being the most prevalent. The presence of “Not Applicable” trials indicates adopting adaptive trial designs.</div><div>Analysis of funding patterns reveals substantial international and local support, reflecting an escalating commitment to vaccine research in Africa. Nevertheless, concerns persist regarding disparities in trial distribution and age group participation, underscoring the necessity for robust regulatory frameworks and augmented local R&amp;D capacity. Addressing these disparities can enhance the efficacy of vaccine research and elevate health outcomes across the African continent.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"149 ","pages":"Article 107779"},"PeriodicalIF":2.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142821887","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":"Clinical decision support to improve primary care obesity management in adults with diabetes: Clinic-randomized study design","authors":"MarySue Beran,&nbsp;Heidi L. Ekstrom,&nbsp;A. Lauren Crain,&nbsp;Stephanie A. Hooker,&nbsp;Lilian Chumba,&nbsp;Deepika Appana,&nbsp;Kay Kromrey,&nbsp;Gopikrishna Kunisetty,&nbsp;Zeke M. McKinney,&nbsp;Nicolaas P. Pronk,&nbsp;Rashmi Sharma,&nbsp;Jennifer Vesely,&nbsp;Patrick J. O'Connor","doi":"10.1016/j.cct.2025.107830","DOIUrl":"10.1016/j.cct.2025.107830","url":null,"abstract":"<div><h3>Background</h3><div>To promote use of lifestyle, pharmacologic, and surgical weight management options for adults with body mass index (BMI) ≥35 kg/m² and type 2 diabetes (T2D), this project implements and evaluates a weight loss clinical decision support (WL-CDS) intervention that provides patient-specific estimates of the risks and benefits of evidence-based obesity management options to primary care clinicians (PCCs) and patients at primary care clinical encounters.</div></div><div><h3>Methods</h3><div>We randomize 38 primary care clinics to either (a) usual care (UC), or (b) the WL- CDS intervention that provides patients and PCCs recommendations for lifestyle changes and patient-specific obesity management options and estimates of benefits and risks of weight loss medications, or metabolic bariatric surgery (MBS) when indicated.</div></div><div><h3>Primary endpoints</h3><div>Outcomes assessed at 18-months after a patient-specific index date are (a) referral of eligible patients for MBS evaluation; (b) initiation or active management of FDA-approved medications for weight loss; and (c) weight trajectory. Outcomes measured within 1 month of index date are patient-reported (d) shared decision making about weight loss options, and (e) intention to engage in weight loss.</div></div><div><h3>Conclusion</h3><div>This study will deepen our understanding of how patients and PCCs use WL-CDS generated information to inform selection of obesity care options for adults with T2D and BMI ≥35 kg/m².</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"150 ","pages":"Article 107830"},"PeriodicalIF":2.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143122267","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}