Contemporary clinical trials最新文献

{"title":"Effectiveness of out-of-pocket cost COMmunication and financial navigation (CostCOM) in cancer patients: Study protocol for ECOG-ACRIN EAQ222CD","authors":"Gelareh Sadigh ,&nbsp;Fenghai Duan ,&nbsp;Ilana F. Gareen ,&nbsp;Judy Hancock ,&nbsp;JoRean D. Sicks ,&nbsp;Sarah Hawley ,&nbsp;Veena Shankaran ,&nbsp;Mylin Torres ,&nbsp;Lynne I. Wagner ,&nbsp;Ruth C. Carlos","doi":"10.1016/j.cct.2025.107889","DOIUrl":"10.1016/j.cct.2025.107889","url":null,"abstract":"<div><h3>Background</h3><div>High out-of-pocket costs (OOPC) of cancer treatment and lost income result in financial hardship. There is compelling evidence that OOPC communication complemented by financial navigation and counseling will decrease financial hardship by enabling cancer patients to anticipate and accommodate treatment costs and proactively seek financial assistance.</div></div><div><h3>Methods</h3><div>This is a two-arm randomized controlled trial enrolling 720 patients with newly diagnosed solid tumors (stratified by non-metastatic vs. metastatic) who plan to receive anticancer systemic therapy at one of the participating NCI Community Oncology Research Practices (NCORP). Participants are randomized to receive four up to 1-h remote counseling sessions which include systemic therapy OOP cost communication, financial navigation and counseling (CostCOM intervention) vs. enhanced usual care with provision of an informational brochure for Patient Advocate Foundation (PAF), a national non-profit financial navigation organization (EUC). Patients will complete surveys at baseline, 3, 6, and 12 months after enrollment. Our goals are to compare the effectiveness of CostCOM vs. EUC at 12 months on (1) patient-reported cost-related cancer care nonadherence, defined as any self-reported incident of delay, forgo, stop or change in cancer care due to cost concerns and (2) patient-reported material financial hardship, financial worry, and quality of life; and to (3) conduct a process evaluation to examine practice providers' and CostCOM arm patients' satisfaction with the intervention and their perceptions of barriers and facilitators to CostCOM. A successful CostCOM is a scalable and financially sustainable program that can improve cancer care delivery, patients' experience, and health outcomes.</div><div>Trial registration: <span><span>NCT06295367</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"153 ","pages":"Article 107889"},"PeriodicalIF":2.0,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143725003","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":"Implementation of a seamless phase 2/3 study design in the setting of an emergent infectious disease pandemic: Lessons learned from the ACTIV-2 platform COVID-19 treatment trial.","authors":"Mark J Giganti, Kara W Chew, Carlee Moser, Joseph J Eron, Mauricio Pinilla, Jonathan Z Li, Justin Ritz, Arzhang Cyrus Javan, David Alain Wohl, Eric S Daar, Judith S Currier, Davey M Smith, Michael D Hughes","doi":"10.1016/j.cct.2025.107887","DOIUrl":"https://doi.org/10.1016/j.cct.2025.107887","url":null,"abstract":"<p><p>Seamless phase 2/3 study designs provide a framework for a more efficient trial. During the COVID-19 pandemic, such study designs were considered particularly appealing as there was an urgent global need to rapidly identify effective therapeutics. However, limited in vivo safety and efficacy data was available early in the pandemic to inform decisions. As part of the ACTIV-2 study, we implemented a phase 2/3 platform trial to evaluate multiple candidate treatments for non-hospitalized adults with COVID-19. In addition to an adequate safety profile, the decision to graduate an agent from phase 2 to phase 3 was based on showing treatment effects on clinical or laboratory markers. Decision criteria evolved over time as more data became available during the global pandemic. A seamless transition and approximately 20 % reduction in total sample size was achieved for one agent, amubarvimab plus romlusevimab. Using both simulation studies and actual results from graduation assessments of five ACTIV-2 candidate therapeutics, we provide a discussion of lessons learned from our implementation and recommendations for future seamless trials of interventions for emergent infections.</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"107887"},"PeriodicalIF":2.0,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143729187","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 multisite, parallel-group, randomized clinical trial comparing a brief tele-cognitive behavioral therapy intervention (BRIGHT) with attention control for the reduction of body image-related distress among head and neck cancer survivors","authors":"Evan M. Graboyes ,&nbsp;Stacey N. Maurer ,&nbsp;Emily Kistner-Griffin ,&nbsp;Kent Armeson ,&nbsp;Ella Starr ,&nbsp;Taylor McLeod ,&nbsp;Wendy E. Balliet ,&nbsp;Jacquelyn Doenges ,&nbsp;Olga Slavin-Spenny ,&nbsp;Jessica R. Vanderlan ,&nbsp;Andrew Day ,&nbsp;Patrik Pipkorn ,&nbsp;Sidharth V. Puram ,&nbsp;Samantha H. Tam ,&nbsp;Kenneth J. Ruggiero ,&nbsp;Katherine R. Sterba","doi":"10.1016/j.cct.2025.107888","DOIUrl":"10.1016/j.cct.2025.107888","url":null,"abstract":"<div><div>One in four head and neck cancer (HNC) survivors experience clinically significant body image distress (BID), a devastating psychosocial morbidity that adversely affects quality of life. To date, effective interventions for these patients are lacking. BRIGHT (Building a Renewed ImaGe after Head and neck cancer Treatment), a brief cognitive behavioral treatment (CBT), has shown potential efficacy as a novel treatment paradigm for HNC survivors with BID. The primary objective of this randomized clinical trial (RCT) is to test the hypothesis that BRIGHT improves BID among HNC survivors relative to an Attention Control (AC) intervention. In this multisite RCT, <em>N</em> = 180 HNC survivors with BID will be randomized 1:1 to six weeks of BRIGHT or AC of dose and delivery-matched survivorship education. Outcomes are assessed at baseline and 2, 3, 6, and 9-months post-randomization. The primary endpoint is the IMAGE-HN (Inventory to Measure and Assess imaGe disturbancE–Head and Neck) score, a validated patient-reported outcome of HNC-related BID. Secondary endpoints include the HN Shame and Stigma Scale, the PROMIS SF v1.0-Depression 8a, Anxiety 8a, and Ability to Participate in Social Activities 8a, the Beck Scale for Suicidal Ideation, and the EORTC QLQ-HN35 Trouble with Social Eating and Trouble with Social Contact subscales. The trial will also evaluate whether the effect of BRIGHT on BID is mediated through improvements in automatic thinking and body image coping strategies. Findings from this multisite RCT will provide a rigorous test of the efficacy of BRIGHT as the first evidence-based strategy to manage BID among HNC survivors.</div></div><div><h3>Trial registration ID</h3><div><span><span>NCT05442957</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"153 ","pages":"Article 107888"},"PeriodicalIF":2.0,"publicationDate":"2025-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143725097","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":"Restricted mean survival time based on Wu-Kolassa estimator compared to Kaplan-Meier estimator","authors":"Yaoshi Wu ,&nbsp;John Kolassa ,&nbsp;Ning Dong","doi":"10.1016/j.cct.2025.107877","DOIUrl":"10.1016/j.cct.2025.107877","url":null,"abstract":"<div><h3>Objective</h3><div>The purpose of the paper is to introduce the Wu-Kolassa estimator (WKE) and the RMST based on it for its less biased estimation and substantial power gain, compared to the Kaplan-Meier estimator (KME), to researchers working in medical and health sciences to evaluate and compare patient survival times.</div></div><div><h3>Results</h3><div>The seven numerical studies showed that the power gain in WKE-based RMST analysis can reach more than 80 %, depending on the size of the study and the trend of failure rate. For the phase III study of iniparib plus gemcitabine and carboplatin (GCI) versus gemcitabine and carboplatin (GC) in patients with metastatic triple-negative breast cancer, GCI is superior to GC demonstrated by WKE-based RMST analysis (point estimate of treatment difference in RMST = 0.807; 95 % CI: 0.0214 to 1.592, 1.5 times higher than the estimate based on KME = 0.542; 95 % CI: −0.385 to 1.470). For the phase III trial that studied ovarian suppression (os) with tamoxifen or exemestane, tamoxifen plus os is superior to tamoxifen alone using WKE-based RMST (point estimate of difference = 0.228; 95 % CI: 0.016 to 0.439, more than 2-fold higher than the estimated difference based on KME = 0.113; 95 % CI: −0.008 to 0.234).</div></div><div><h3>Conclusions</h3><div>The Wu-Kolassa estimator is superior to the Kaplan-Meier estimator as it reduces the estimation bias and increases the power in the RMST analysis when the censoring rate is high or when the reference group has more censoring data than the test group.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"152 ","pages":"Article 107877"},"PeriodicalIF":2.0,"publicationDate":"2025-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143680513","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":"An adaptive imputation method of missing data for sparsely retrieved dropouts in treatment policy strategy","authors":"Chuanji Yuan ,&nbsp;Zhenyu Yang ,&nbsp;Jiaqing Liu ,&nbsp;Xiaozhou Li ,&nbsp;Bokai Chen ,&nbsp;Tao Han ,&nbsp;Qian Yu ,&nbsp;Zuojing Li","doi":"10.1016/j.cct.2025.107886","DOIUrl":"10.1016/j.cct.2025.107886","url":null,"abstract":"<div><div>The ICH E9 R1 Addendum suggests using a treatment-policy strategy as an approach to handle intercurrent events for estimating de facto estimand. Under this strategy, regardless of the occurrence of intercurrent events, the value for the variable of interest is analyzed. After discontinuing treatment, participants who remain in the trial to complete the assessment of the primary endpoints are referred to as retrieved dropouts, while early withdrawal by participants results in missing data. To mitigate the effects of missing data, strategies like mixed model for repeated measures or the retrieved dropout multiple imputation method are used. The bias of retrieved dropout methods is relatively small. However, if retrieved dropouts are scarce, it could significantly inflate variance.</div><div>This article introduces an innovative adaptive model that refines the On/Off Intercepts with Common Slopes using Residuals (RD_OICSR) model, which is a model within the retrieved dropout methods, and evaluates it using simulated data from a depression trial. The findings indicate that when the proportion of retrieved dropouts falls below the predetermined threshold set by researchers, our method minimizes unrealistic variance inflation by incorporating data from placebo completers. Conversely, the model adaptively matches the RD_OICSR model. This ensures that irrespective of the retrieved dropouts' proportions, the analysis remains accurate.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"152 ","pages":"Article 107886"},"PeriodicalIF":2.0,"publicationDate":"2025-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143691386","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":"A study protocol to engage religious leaders to reduce blood pressure in Tanzanian communities: A cluster randomized trial","authors":"Bazil Kavishe ,&nbsp;Megan Willkens ,&nbsp;Agrey H. Mwakisole ,&nbsp;Fredrick Kalokola ,&nbsp;Elialilia Okello ,&nbsp;Philip Ayieko ,&nbsp;Edmund Kisanga ,&nbsp;Myung Hee Lee ,&nbsp;Saidi Kapiga ,&nbsp;Jennifer A. Downs ,&nbsp;Robert Peck","doi":"10.1016/j.cct.2025.107884","DOIUrl":"10.1016/j.cct.2025.107884","url":null,"abstract":"<div><h3>Background</h3><div>Most people with hypertension in Sub-Saharan Africa are unaware of their status. Low perceived need for hypertension screening, low trust in biomedical health care, unhealthy norms for diet and exercise, and prioritization of spiritual over physical health are key barriers to blood pressure (BP) control in Tanzanian communities. We seek to determine whether engaging religious leaders to screen for hypertension and educate communities on cardiovascular health can lead to a sustained community BP reduction.</div></div><div><h3>Methods</h3><div>This trial aims to determine the efficacy of an intervention that engages religious leaders to reduce BP in Tanzanian communities. After refinement of the intervention following pilot testing, a hybrid type I randomized control trial will be conducted across 20 rural communities (10 intervention and 10 control communities). The intervention will consist of educational sessions for religious leaders, equipping them to provide community cardiovascular health teachings, and BP screening organized jointly by religious leaders and health care workers. We will measure the reduction in mean community BP and changes in hypertension awareness and treatment, diet, physical activity, body mass index, and waist circumference after one year. Key elements that contribute to the intervention's implementation and effectiveness to strengthen its adoption and broader use during and after the intervention up to 24 months will be evaluated.</div></div><div><h3>Discussion</h3><div>Community-level barriers to BP control inhibit awareness and treatment of hypertension in Tanzania. Through innovative partnerships with trusted religious leaders, we seek to study an intervention with the potential to reduce BP and improve overall community health.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"152 ","pages":"Article 107884"},"PeriodicalIF":2.0,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143673514","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":"Structural innovation for hypoglycemia prevention in high-risk patients with type 2 diabetes: Design and implementation of a pragmatic, randomized, quality improvement trial","authors":"Minnie W. Chen ,&nbsp;Melissa M. Parker ,&nbsp;Andrew J. Karter ,&nbsp;Richard W. Grant ,&nbsp;Lisa K. Gilliam","doi":"10.1016/j.cct.2025.107885","DOIUrl":"10.1016/j.cct.2025.107885","url":null,"abstract":"<div><div>Severe hypoglycemia is a potentially life-threatening complication of diabetes treatment, associated with increased risks of falls, cardiovascular events, cognitive decline, and mortality. This critical public health concern remains inadequately recognized and addressed in many clinical settings. Here we describe the development of a clinical guideline and associated protocol for a quality improvement randomized trial for hypoglycemia prevention, embedded within an integrated healthcare system. First, we engaged expert clinical stakeholders and experienced guideline developers to create an evidence-based hypoglycemia prevention algorithm, “<strong>Hypoglycemia on a Page” (HOAP</strong>), which was published internally as a healthcare system guideline. After system-wide, passive dissemination of HOAP, a pragmatic, quality improvement, randomized trial was implemented to study the benefit of a proactive, HOAP protocol-driven outreach by a clinical pharmacist targeting hypoglycemia-prone patients with T2D (Intervention Arm) compared to usual care (Usual Care Arm). As the primary outcome, we will assess whether patients in the Intervention Arm are prescribed safer (less hypoglycemia-prone) diabetes regimens compared to the Usual Care Arm. We hypothesize that the proactive, protocol-driven outreach will result in safer diabetes regimens compared to HOAP dissemination alone. Secondary outcomes of interest include prescribing of glucagon (for rapid treatment of severe hypoglycemia episodes), prescribing and dispensing of continuous glucose monitoring (CGM), documenting hypoglycemia on the problem list, glycemic control (HbA1c &lt;8 %), and ED visit or hospital admission for hypoglycemia. This pragmatic clinical trial will evaluate a structural innovation that included care strategies designed to reduce harm, improve patient outcomes and reduce healthcare resource utilization and cost.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"152 ","pages":"Article 107885"},"PeriodicalIF":2.0,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143662922","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":"Corrigendum to \"Intervention to reduce barriers to type 1 diabetes self-management: Diabetes Journey study design and participant characteristics\" [Contemporary Clinical Trials 152 (2025) 107849].","authors":"Kimberly A Driscoll, Paige J Trojanowski, Desirée N Williford, Holly K O'Donnell, Erin Flynn, Constance A Mara, Sara E Wetter, Alexandra C Himelhoch, Hannah Manis, Alicia Pardon, Cheyenne M Reynolds, Emily R Shaffer, Bailey Tanner, Jessica Kichler, Laura Smith, Sarah Westen, Anastasia Albanese-O'Neill, Sarah D Corathers, Laura M Jacobsen, Amy Poetker, Matthew Schmidt, Avani C Modi","doi":"10.1016/j.cct.2025.107880","DOIUrl":"https://doi.org/10.1016/j.cct.2025.107880","url":null,"abstract":"","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"107880"},"PeriodicalIF":2.0,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656285","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":"Pirfenidone to prevent fibrosis in acute respiratory distress syndrome: The PIONEER study protocol.","authors":"Giacomo Monti, Matteo Marzaroli, Maria Teresa Tucciariello, Brian Ferrara, Francesco Meroi, Cristina Nakhnoukh, Massimo Zambon, Giovanni Borghi, Fabio Guarracino, Marco Manazza, Valentina Ajello, Alessandro Belletti, Cesare Biuzzi, Valentina Plumari, Matteo Filippini, Raffaele Cuffaro, Gabriele Racanelli, Domenico Pontillo, Simon Rauch, Federico Mattia Oliva, Marco Tescione, Martina Baiardo Redaelli, Gabriele Melegari, Giulia Maj, Paolo Navalesi, Michele Gerardi, Alessio Caccioppola, Andrea Bruni, Andrea Ballotta, Camilla Ferri, Daniele Orso, Vincenzo Di Benedetto, Rubia Baldassarri, Giulia Franceschini, Ans Alamami, Laura Pasin, Alessandro Putzu, Carolina Soledad Romero Garcia, Yih-Sharng Chen, Alberto Noto, Andrey Yavorovskiy, Ludhmila Abrahao Hajjar, Andrea Cortegiani, Valery Likhvantsev, Aidos Konkayev, Gabriele Finco, Gabriele Sales, Luca Brazzi, Gianluca Paternoster, Rinaldo Bellomo, Alberto Zangrillo, Giovanni Landoni, Nora Di Tomasso","doi":"10.1016/j.cct.2025.107883","DOIUrl":"https://doi.org/10.1016/j.cct.2025.107883","url":null,"abstract":"<p><strong>Background: </strong>Pulmonary fibrosis is a major complication of the Acute Respiratory Distress Syndrome (ARDS). Pirfenidone is an approved treatment for idiopathic pulmonary fibrosis. It may attenuate ARDS-related fibrosis and decrease the need for prolonged ventilation. Accordingly, we aimed to evaluate the effect of pirfenidone on ventilator-free days in patients with ARDS.</p><p><strong>Methods: </strong>In a multi-center, randomized, double-blind, placebo-controlled trial, we plan to randomly assign 130 adults invasively ventilated for ARDS to receive pirfenidone or placebo for up to 28 days. The primary outcome is days alive and ventilator free at 28 days. Secondary outcomes include ICU-free days, hospital free days all at 28 day, ICU mortality and hospital mortality. We will also assess fibroproliferative changes on high-resolution CT scans at ICU discharge and quality of life. Data analysis will be on an intention-to-treat basis.</p><p><strong>Discussion: </strong>The trial is ongoing and currently recruiting. It will be the first randomized controlled study to investigate whether, compared to placebo, pirfenidone reduces the number of days alive and ventilator-free in patients with ARDS. Its double-blind multicenter design will provide internal validity, minimal bias, and a degree of external validity. If our hypothesis is confirmed, this treatment would justify larger trials of this intervention.</p><p><strong>Trial registration: </strong>This trial was registered on ClinicalTrials.gov with the trial identification NCT05075161.</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"107883"},"PeriodicalIF":2.0,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143639481","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":"Improving maternal postpartum access to care through telemedicine (IMPACT): A multi-center randomized controlled trial of postpartum interventions to improve access and outcomes","authors":"Ran Zhang ,&nbsp;Sheree L. Boulet ,&nbsp;David B. Nelson ,&nbsp;Peggy Goedken ,&nbsp;Jacqueline Catchings ,&nbsp;Donald McIntire ,&nbsp;Marissa Platner ,&nbsp;Robert B. Martin ,&nbsp;Catherine Y. Spong ,&nbsp;Elaine L. Duryea","doi":"10.1016/j.cct.2025.107882","DOIUrl":"10.1016/j.cct.2025.107882","url":null,"abstract":"<div><h3>Background</h3><div>Postpartum care is essential for maternal health and significantly impacts long-term health outcomes, yet it remains inadequately addressed, particularly among Non-Hispanic Black and Hispanic individuals. The primary objective of the Improving Maternal Postpartum Access to Care through Telemedicine (IMPACT) study is to compare the effectiveness of two postpartum care models on early postpartum complication detection, hospital readmission prevention, postpartum health knowledge, quality of life, and chronic medical condition management among medically underserved individuals.</div></div><div><h3>Method</h3><div>The IMPACT study is a multi-center, randomized controlled trial conducted at Parkland Hospital in Dallas, Texas, and Grady Memorial Hospital in Atlanta, Georgia. It aims to compare two postpartum care models (intensive education vs. enhanced virtual care) among 3500 Non-Hispanic Black and Hispanic postpartum individuals of lower socioeconomic status. Phase I (year 1) involves collecting baseline data and refining the study based on patient feedback. Phase II (year 2–4) continues recruiting participants and assigns them to each model randomly. Data collection spans a one-year follow-up period (1 week, 6 weeks, 3 months, 6 months, and 1 year after enrollment), including maternal health outcomes, mental health assessments, laboratory tests, and patient-reported measures.</div></div><div><h3>Conclusion</h3><div>The IMPACT study provides an innovative approach to postpartum care, utilizing telemedicine to enhance access and education for underserved populations. The study findings will have significant implications for healthcare providers and policymakers, offering evidence-based guidance for optimizing postpartum care delivery and informing clinical guidelines that can help reduce maternal health disparities.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"152 ","pages":"Article 107882"},"PeriodicalIF":2.0,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143639477","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}