Contemporary clinical trials最新文献

{"title":"Design and rationale for a randomized clinical trial testing the efficacy of a lifestyle physical activity intervention for people with HIV and engaged in unhealthy drinking","authors":"","doi":"10.1016/j.cct.2024.107632","DOIUrl":"10.1016/j.cct.2024.107632","url":null,"abstract":"<div><h3>Background</h3><p>Among people living with HIV (PLWH), unhealthy drinking presents an increased risk for negative outcomes. Physical inactivity and sedentariness raise additional health risks. Despite evidence that physical activity (PA) is associated with improved physical and mental functioning and reduced alcohol cravings, there have been no PA studies conducted with PLWH engaged in unhealthy drinking. We describe a study protocol of a remote lifestyle physical activity (LPA) intervention to increase PA and reduce alcohol consumption among PLWH.</p></div><div><h3>Methods</h3><p>Using online advertisements, 220 low-active PLWH engaged in unhealthy drinking will be recruited and randomized nationwide. After providing informed consent and completing a baseline interview, participants will receive a Fitbit. Participants will complete 15 days of ecologic momentary assessment through a phone application and up to 15 days of Fitbit wear time. Following this period, participants will be randomly assigned to a Fitbit-only control condition or a LPA and Fitbit intervention condition. Health counselors meet with control participants once (and have 6 subsequent brief check ins on Fibit use) and with intervention participants 7 times for PA counseling over a 12-week period. Follow-up assessments will be conducted at 3- and 6-months post-randomization. We hypothesize that individuals in the LPA and Fitbit condition will have lower rates of alcohol consumption and higher rates of PA at 6-month follow-up.</p></div><div><h3>Conclusion</h3><p>The randomized controlled trial described in this paper investigates remote methods to influence multimorbidity among PLWH using a LPA approach for increasing PA and reducing alcohol consumption.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141632914","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":"Underrepresentation of black individuals in pivotal trials for novel anticancer drugs: Potential consequence of using estimated creatinine clearance to assess kidney function?","authors":"","doi":"10.1016/j.cct.2024.107631","DOIUrl":"10.1016/j.cct.2024.107631","url":null,"abstract":"<div><h3>Background</h3><p>Black individuals are historically underrepresented in oncology clinical trials. One potential reason for this is the prevalence of kidney disease in Black individuals, utilization of estimated creatinine clearance as a surrogate for glomerular filtration rate (GFR) in oncology, and GFR-based trial eligibility criteria. We characterized the representation of racial minorities in anticancer agent pivotal trials and examined if GFR-based trial eligibility criteria impact the proportion of Black individuals in trial populations.</p></div><div><h3>Methods</h3><p>We constructed a data repository for anticancer drugs FDA-approved from 2015 to 2019 and associated pivotal trials, from which we extracted trial population racial compositions and GFR-based trial eligibility criteria. We calculated the participation-to-incidence ratio (PIR) and participation-to-mortality ratio (PMR) for a variety of cancer sites, where PIR or PMR &gt;1.2 and &lt;0.8 indicate overrepresentation and underrepresentation, respectively. We evaluated the relationship between GFR eligibility cutoffs and the proportion of Black enrollees with Spearman rank correlation coefficient.</p></div><div><h3>Results</h3><p>We assessed 24,698 patients in 74 trials. Black individuals were underrepresented in all trials (PIR ≤0.48, PMR ≤0.50). For trials with GFR-based eligibility criteria (<em>n</em> = 49), a lower GFR cutoff was modestly associated with a higher proportion of Black enrollees (<em>r</em> = −0.29, <em>p</em> = 0.039). This relationship was strengthened for trials that only used estimated creatinine clearance to estimate GFR (<em>r</em> = −0.43, <em>p</em> = 0.004).</p></div><div><h3>Conclusions</h3><p>GFR-related eligibility, and specifically the use of estimated creatinine clearance, may contribute to Black individuals being disproportionately excluded from cancer clinical trials. This highlights the need for implementation of contemporary GFR equations and other interventions to boost racial minority trial enrollment.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1551714424002143/pdfft?md5=ca4affbde7e96d6a559f480b25968e30&pid=1-s2.0-S1551714424002143-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141632917","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":"DHA supplementation for early preterm birth prevention: An application of Bayesian finite mixture models to adaptive clinical trial design optimization","authors":"","doi":"10.1016/j.cct.2024.107633","DOIUrl":"10.1016/j.cct.2024.107633","url":null,"abstract":"<div><h3>Background</h3><p>Early preterm birth (ePTB) - born before 34 weeks of gestation - poses a significant public health challenge. Two randomized trials indicated an ePTB reduction among pregnant women receiving high-dose docosahexaenoic acid (DHA) supplementation. One of them is Assessment of DHA on Reducing Early Preterm Birth (ADORE). A survey employed in its secondary analysis identified women with low DHA levels, revealing that they derived greater benefits from high-dose DHA supplementation. This survey's inclusion in future trials can provide critical insights for informing clinical practices.</p></div><div><h3>Objective</h3><p>To optimize a Phase III trial design, ADORE Precision, aiming at assessing DHA supplement (200 vs. 1000 mg/day) on reducing ePTB among pregnant women with a low baseline DHA.</p></div><div><h3>Methods</h3><p>We propose a Bayesian Hybrid Response Adaptive Randomization (RAR) Design utilizing a finite mixture model to characterize gestational age at birth. Subsequently, a dichotomized ePTB outcome is used to inform trial design using RAR. Simulation studies were conducted to compare a Fixed Design, an Adaptive Design with early stopping, an ADORE-like Adaptive RAR Design, and two new Hybrid Designs with different hyperpriors.</p></div><div><h3>Discussion</h3><p>Simulation reveals several advantages of the RAR designs, such as higher allocation to the more promising dose and a trial duration reduction. The proposed Hybrid RAR Designs addresses the statistical power drop observed in Adaptive RAR. The new design model shows robustness to hyperprior choices. We recommend Hybrid RAR Design 1 for ADORE Precision, anticipating that it will yield precise determinations, which is crucial for advancing our understanding in this field.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1551714424002167/pdfft?md5=3b687da7fc0db1e426254c81b5a85463&pid=1-s2.0-S1551714424002167-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141626237","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":"Rationale and methodology for examining the combination of aerobic exercise and cognitive rehabilitation on new learning and memory in persons with multiple sclerosis and mobility disability: Protocol for a randomized controlled trial","authors":"Carly L.A. Wender ,&nbsp;Odalys Arbelaez ,&nbsp;Tien T. Tong ,&nbsp;Amber Salter ,&nbsp;Glenn R. Wylie ,&nbsp;Robert W. Motl ,&nbsp;Brian M. Sandroff ,&nbsp;Nancy D. Chiaravalloti","doi":"10.1016/j.cct.2024.107630","DOIUrl":"10.1016/j.cct.2024.107630","url":null,"abstract":"<div><h3>Background</h3><p>This paper describes the protocol for a Phase I/II, parallel-group, single-blind randomized controlled trial (RCT). The RCT investigates the combined effects of 12-weeks of aerobic exercise training (AET) integrated with virtual reality (VR) and cognitive rehabilitation (CR) on new learning and memory in 78 persons with multiple sclerosis (MS) who have mobility disability and objective impairments in learning and memory.</p></div><div><h3>Methods</h3><p>Participants will undergo baseline assessments consisting of neuropsychological testing, neuroimaging, self-report questionnaires, and cardiorespiratory fitness. Participants will then be randomized into one of two conditions using concealed allocation: aerobic cycling exercise that incorporates VR combined with CR or stretching and toning (i.e., active control; S/T) combined with CR. Participants will be masked regarding the intent of the conditions. After 7-weeks of exercise alone, the 5-week Kessler Foundation modified Story Memory Technique (KF-mSMT®) will be integrated into the training. After the 12-week training period, participants will complete the same measures as at baseline administered by treatment-blinded assessors. Primary study outcomes include new learning and memory (NLM) measured by a small battery of neuropsychological assessments that assess list learning (California Verbal Learning Test-II), prose memory (Memory Assessment Scale), visuospatial memory (Brief Visuospatial Memory Test-Revised), and everyday memory (Ecological Memory Simulations). Secondary study outcomes include neuroimaging outcomes of hippocampal structure, function, and connectivity.</p></div><div><h3>Conclusion</h3><p>If successful, this trial will provide the first Class I evidence supporting the unique combination of aerobic cycling exercise with VR and CR for treating MS-related learning and memory impairments in persons with mobility disability.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141603394","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":"Cross-validated risk scores adaptive enrichment (CADEN) design","authors":"Svetlana Cherlin,&nbsp;James M.S. Wason","doi":"10.1016/j.cct.2024.107620","DOIUrl":"10.1016/j.cct.2024.107620","url":null,"abstract":"<div><p>We propose a Cross-validated ADaptive ENrichment design (CADEN) in which a trial population is enriched with a subpopulation of patients who are predicted to benefit from the treatment more than an average patient (the sensitive group). This subpopulation is found using a risk score constructed from the baseline (potentially high-dimensional) information about patients. The design incorporates an early stopping rule for futility. Simulation studies are used to assess the properties of CADEN against the original (non-enrichment) cross-validated risk scores (CVRS) design which constructs a risk score at the end of the trial. We show that when there exists a sensitive group of patients, CADEN achieves a higher power and a reduction in the expected sample size compared to the CVRS design. We illustrate the application of the design in two real clinical trials. We conclude that the new design offers improved statistical efficiency over the existing non-enrichment method, as well as increased benefit to patients. The method has been implemented in an <span>R</span> package <span>caden</span>.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-07-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1551714424002039/pdfft?md5=8f1d150f0412d2ef24216a9e33b34029&pid=1-s2.0-S1551714424002039-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141558227","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":"The ESSAG-trial protocol: A randomized controlled trial evaluating the efficacy of offering a self-sampling kit by the GP to reach women underscreened in the routine cervical cancer screening program","authors":"","doi":"10.1016/j.cct.2024.107617","DOIUrl":"10.1016/j.cct.2024.107617","url":null,"abstract":"<div><h3>Background</h3><p>In Flanders (Belgium), women not screened for cervical cancer (CC) within the last three years receive an invitation letter from the regional screening organization, the Centre for Cancer Detection (CCD), encouraging them to have a cervical specimen taken by their general practitioner (GP) or gynecologist. However, the coverage for CC screening remains suboptimal (63%). The offer of a self-sampling kit (SSK, for HPV testing) by a GP may trigger participation among women who do not attend regular screening.</p></div><div><h3>Methods</h3><p>The ESSAG-trial is a cluster-randomized controlled trial with three arms, each including 1125 women aged 31–64 years, who were not screened for CC in the last 6 years. In arm A, GPs offer a SSK when eligible women consult for any reason. In arm B, women receive a personal GP signed invitation letter including an SSK at their home address. In the control arm, women receive the standard invitation letter from the CCD. The primary outcome is the response rate at three months after inclusion. Secondary outcomes are: screen test positivity; compliance with foreseen follow-up among screen-positives; costs per invited and per screened women; as well as contrasts between trial arms and between socio-demographic categories.</p></div><div><h3>Conclusion</h3><p>The ESSAG-trial will assess the effect of GP-based interventions using SSKs on CC screening participation among hard-to-reach populations. Findings will inform policymakers about feasible strategies on increasing CC screening that may be rolled-out throughout the whole region.</p></div><div><h3>Trial registration</h3><p><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>: <span><span>NCT05656976</span><svg><path></path></svg></span></p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-07-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141558246","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":"Fostering Inclusivity in Research Engagement for Underrepresented Populations in Parkinson's Disease: The FIRE-UP PD study","authors":"Juliana M. Ison ,&nbsp;Jonathan D. Jackson ,&nbsp;Helen Hemley ,&nbsp;Allison Willis ,&nbsp;Bernadette Siddiqi ,&nbsp;Eric A. Macklin ,&nbsp;Christine Ulysse ,&nbsp;Michael S. Fitts ,&nbsp;Tiffany T.-H. Pham ,&nbsp;Mitra Afshari ,&nbsp;Pinky Agarwal ,&nbsp;Michael Aminoff ,&nbsp;Stephanie Bissonnette ,&nbsp;Michelle Fullard ,&nbsp;Tarannum S. Khan ,&nbsp;Danielle N. Larson ,&nbsp;Catherine Wielinski ,&nbsp;Angie V. Sanchez","doi":"10.1016/j.cct.2024.107619","DOIUrl":"10.1016/j.cct.2024.107619","url":null,"abstract":"<div><h3>Background</h3><p>Members of vulnerable populations are underrepresented in Parkinson's disease (PD) research. A complex web of research barriers perpetuates this gap. Community-based research methods are one approach to addressing this issue. The present PD study was designed to examine the effectiveness of community-based interventions to overcome barriers and increase research participation among underrepresented groups (URGs).</p></div><div><h3>Methods</h3><p>Eight study sites across the US were selected and paired based on proposed interventions with specific URGs. Surveys assessed knowledge and attitudes toward PD research. Finally, researchers examined whether the present study affected recruitment to Fox Insight, an online PD research study also recruiting at each site.</p></div><div><h3>Results</h3><p>In total, 474 participants were recruited. At post-intervention for the FIRE-UP PD Study, recruitment increased significantly in intervention compared to control sites among Black and African American non-Hispanic/Latino populations (<em>p</em> = 0.003), White Hispanic/Latino (<em>p</em> = 0.003) populations, and Not Listed Hispanic/Latino populations (<em>p</em> &lt; 0.001) as well as those with an educational attainment of a high school diploma/General Education Diploma (GED) (<em>p</em> = 0.009), and an income &lt;$20,000 (<em>p</em> = 0.005) or between $20,000–$34,999 (<em>p</em> &lt; 0.001). Study surveys measuring changes in awareness and attitudes toward PD research had mixed results. In Fox Insight, 181 participants were passively recruited with a shift toward more diverse participant demographics.</p></div><div><h3>Conclusion</h3><p>Research participation demographics reflective of the general population are critical to PD investigation and treatment. The FIRE-UP PD Study showed the effectiveness of localized community engagement strategies in increasing URG recruitment to PD research. Therefore, further PD research employing community-based methods to improve diverse participant recruitment is needed.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141544632","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 randomized controlled trial comparing backward walking to forward walking training on balance in multiple sclerosis: The TRAIN-MS trial","authors":"","doi":"10.1016/j.cct.2024.107621","DOIUrl":"10.1016/j.cct.2024.107621","url":null,"abstract":"<div><p>Balance impairment and accidental falls are a pervasive challenge faced by persons with multiple sclerosis (PwMS), significantly impacting their quality of life. While exercise has proven to be an effective intervention for improving mobility and functioning in PwMS, current exercise approaches predominantly emphasize forward walking (FW) and balance training, with variable improvements in balance and fall rates. Backward walking (BW) has emerged as a promising intervention modality for enhancing mobility and strength outcomes; however, significant gaps remain. Specifically, there is limited knowledge about the efficacy of BW interventions on outcomes such as static, anticipatory, and reactive balance, balance confidence, falls, and cognition. This randomized controlled trial aims to determine the feasibility, acceptability, and impact of 8-weeks of backward walking training (TRAIN-BW) as compared to forward walking training (TRAIN-FW). Ninety individuals with MS with self-reported walking dysfunction or ≥ 2 falls in the past 6 months will be randomized in blocks, stratified by sex and disease severity to either the TRAIN-BW or TRAIN-FW intervention groups. Adherence and retention rates will be used to determine feasibility and the Client Satisfaction Questionnaire will be used to assess acceptability. The primary outcomes will be static, anticipatory, and reactive balance. Secondary outcomes include walking velocity, balance confidence, concern about falling, cognition, physical activity, and fall rates measured prospectively for 6 months after post-testing. Additionally, the extent to which cognitive functioning influences response to intervention will be examined. Backward walking training may be an innovative intervention to address balance impairments and falls in persons with MS.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141544634","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 clinical trial to confirm the effectiveness of online guided self-help family-based treatment for adolescent anorexia nervosa","authors":"","doi":"10.1016/j.cct.2024.107618","DOIUrl":"10.1016/j.cct.2024.107618","url":null,"abstract":"<div><h3>Background</h3><p>The leading evidence-based treatment for anorexia nervosa (AN) in adolescents is Family-based Treatment (FBT). However, due to the intensive training requirements and lack of practitioners, it is often difficult for families to access FBT. Thus, innovations that improve access to care are needed. A pilot randomized study of a guided self-help version of Family-based Treatment (GSH-FBT) that utilized approximately 1/4 the amount of therapist time compared to FBT found that the approach was acceptable and appeared to achieve similar outcomes. The study protocol detailed in this manuscript compares the efficiency (clinician time) of GSH-FBT to Family-based Treatment via Videoconferencing (FBT-V) in a fully powered study in achieving clinical outcomes through a multi-site randomized clinical trial across the US and Ontario, Canada.</p></div><div><h3>Methods</h3><p>This study will randomize the families of adolescents ages 12–18 (<em>n</em> = 200) who meet DSM-5 criteria for AN to receive either GSH-FBT or FBT-V. Participants will be randomized to 15 sixty-minute sessions of FBT-V or to 10 twenty-minute sessions of online GSH-FBT. Major assessments will be conducted by a masked assessor at baseline, within treatment, at the end of treatment (EOT), and 6 and 12 months after the end of treatment (EOT). The primary outcomes of this study are changes to body weight and eating disorder cognitions relative to clinician time used (relative efficiency of treatment modality).</p></div><div><h3>Conclusions</h3><p>The findings of this study may help increase access to care by providing a time efficient, affordable, more scalable intervention for adolescent AN compared to standard FBT.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141544633","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 Tennessee Heart Health Network effectiveness study: A stepped wedge cluster randomized controlled trial to assess the effectiveness of statewide quality improvement cooperative participation on cardiovascular outcomes","authors":"","doi":"10.1016/j.cct.2024.107616","DOIUrl":"10.1016/j.cct.2024.107616","url":null,"abstract":"<div><h3>Background</h3><p>Cardiovascular disease (CVD) is the primary cause of premature morbidity and mortality in the United States and Tennessee ranks among the highest in CVD events. While patient-centered outcomes research (PCOR) evidence-based approaches that reach beyond the traditional doctor-patient visit hold promise to improve CVD care and prevent serious complications, most primary care providers lack time, knowledge, and infrastructure to implement these proven approaches. Statewide primary care quality improvement (QI) collaboratives hold potential to help address primary care needs, however, little is known regarding their effectiveness in improving uptake of PCOR evidence-based population health approaches and improving CVD outcomes. This study describes the design and implementation of a stepped-wedge cluster randomized controlled trial to assess the effectiveness of participation in a statewide quality improvement cooperative (The Tennessee Heart Health Network [TN-HHN]) on cardiovascular outcomes.</p></div><div><h3>Methods/design</h3><p>The TN-HHN Effectiveness Study randomized 77 practices to 4 waves (i.e., clusters), with each wave beginning three months after the start of the prior wave and lasting for 18 months. All practice clusters received one of three Network interventions, and outcomes are measured for each three months both in the control phase and the intervention phase. Primary outcomes include Center for Medicare and Medicaid Services measures for aspirin use, blood pressure control, cholesterol control, and smoking cessation (ABCS).</p></div><div><h3>Conclusions</h3><p>This trial, upon its conclusion, will allow us to assess the effect of participation in a statewide quality improvement cooperative on cardiovascular outcomes as well as key contributors to successful practice transformation.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141544635","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}