Contemporary Clinical Trials Communications最新文献

{"title":"Iron mother- protocol for a randomised controlled trial of daily versus alternate day ferrous fumarate for the treatment of iron deficiency anaemia in pregnancy","authors":"F.E. O'Toole ,&nbsp;F.M. McAuliffe ,&nbsp;J.M. Fitzgerald ,&nbsp;G.A. Mealy ,&nbsp;R. Petkute ,&nbsp;L.A. Bolger ,&nbsp;A. Murphy-Cruse ,&nbsp;B. Soldati ,&nbsp;M. Galligan ,&nbsp;J.M. Walsh","doi":"10.1016/j.conctc.2025.101447","DOIUrl":"10.1016/j.conctc.2025.101447","url":null,"abstract":"<div><h3>Objective</h3><div>Iron deficiency anaemia (IDA) is the commonest haematological problem in pregnancy and has implications for maternal, fetal, and childhood health. Treatment, despite being inexpensive and readily available, remains challenging with issues relating to compliance, tolerability, and effectiveness. There is a lack of consensus regarding the optimal dosing of oral iron replacement in pregnancy. Emerging evidence from non-pregnant populations suggest that alternate day dosing may be as effective.</div></div><div><h3>Methods</h3><div>We propose a phase IV open label randomised controlled non-inferiority trial of daily versus alternate day ferrous fumarate for a 4-week period for the treatment of confirmed iron deficiency anaemia in pregnancy. Our study population comprises singleton pregnancies between 14+0- and 34+0-weeks’ gestation with a haemoglobin (Hb) of &lt;10.5g/dL and a ferritin of &lt;30μg/L. The intervention is alternate day ferrous fumarate 305mg (100mg elemental iron) and the comparator is daily ferrous fumarate 305mg. The primary endpoint, change in Hb from randomisation to week 4, will be analysed by linear regression, adjusting for baseline Hb level. Analysis will be conducted by intention-to-treat analysis with per protocol sensitivity analysis. Sample size was calculated on the assumption of no difference between primary endpoint means, a Type 1 error rate of 0.025, a power of 90 %, a standard deviation of 0.83 g/dL and a non-inferiority margin of −0.4 g/dL. Under these assumptions, 92 subjects per treatment arm would be required to test for non-inferiority.</div></div><div><h3>Conclusion</h3><div>We hypothesise that alternate day iron in pregnancy will be as effective as daily iron for the treatment of iron deficiency anaemia.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101447"},"PeriodicalIF":1.4,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143422260","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy of Ma'aljobon Aftimouni (Cuscuta Reflexa and whey) on HbA1c and blood glucose levels in patients with Type 2 Diabetes: A randomized triple-blind clinical trial","authors":"Fatemeh Mehrabi ,&nbsp;Ali Safdari ,&nbsp;Azam Moslemi ,&nbsp;Mehdi Salehi ,&nbsp;Ali Agharazi ,&nbsp;Mohammad Reza Rezvanfar","doi":"10.1016/j.conctc.2024.101401","DOIUrl":"10.1016/j.conctc.2024.101401","url":null,"abstract":"<div><h3>Introduction and objective</h3><div>Type 2 Diabetes is a common and chronic metabolic disease. Complementary and alternative medicine can provide a suitable option for demands for new treatments. Therefore, the present study aimed to investigate the effect of Persian medicine on the glycemic status of patients with Type 2 Diabetes.</div></div><div><h3>Method</h3><div>This randomized, controlled, and triple-blind trial study was conducted from November 2021 to August 2022 on 102 diabetic patients referred to the diabetes clinic in Iran. In this regard, patients with inclusion criteria were randomly divided into three groups <em>Ma'aljobon with Aftimoun</em> (n = 34), <em>Ma'aljobon without Aftimoon</em> (n = 34), and the control group (n = 34). The control group received a placebo of medicinal salt, light calcium carbonate, lactose, and carboxymethyl cellulose. In contrast, the treatment groups received 25 g of drug powder (in 250 cc of lukewarm water) on an empty stomach for 8 consecutive weeks. Patients' fasting blood sugar (FBS) levels and HbA1c were measured at the beginning and end of the intervention. Data were analyzed using SPSS 23, employing paired t-tests, ANOVA, and chi-square tests for comparison between groups.</div></div><div><h3>Results</h3><div>Data analysis was conducted on 90 patients with Type 2 Diabetes. The findings revealed a significant reduction in fasting blood sugar levels post-intervention in the Ma'aljobon Aftimouni group (134.27 ± 21.79 vs. 152.3 ± 31.37, mean difference 18.03 ± 5.63, 95 % CI: 6.53 to 29.53, p = 0.003). Additionally, a significant difference in HbA1c values was observed post-intervention in both the Ma'aljobon Aftimouni group (7.88 ± 0.77 vs. 8.09 ± 0.73, mean difference 0.21 ± 0.09, 95 % CI: 0.03 to 0.39, p = 0.031) and the Ma'aljobon without Aftimoun group (7.97 ± 0.84 vs. 8.25 ± 0.78, mean difference 0.28 ± 0.08, 95 % CI: 0.11 to 0.45, p = 0.002).</div></div><div><h3>Conclusion</h3><div>The findings showed that daily consumption of Ma'aljobon supplements on an empty stomach before breakfast may have a beneficial effect on the glycemic indices of patients. However, further studies seem to be necessary in this regard.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"43 ","pages":"Article 101401"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11683214/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142915746","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Left ventromedial prefrontal cortex inhibitory rTMS as an anti-stress intervention in opioid use disorder: Trial design","authors":"Tabitha E. Moses ,&nbsp;Danielle Lenz ,&nbsp;Leslie H. Lundahl ,&nbsp;Nicholas A. Mischel ,&nbsp;Christine Rabinak ,&nbsp;Mark K. Greenwald","doi":"10.1016/j.conctc.2024.101414","DOIUrl":"10.1016/j.conctc.2024.101414","url":null,"abstract":"<div><h3>Background</h3><div>In people with substance use disorders (SUDs), stress-exposure can impair executive function, and increase craving and likelihood of drug-use recurrence. Research shows that acute stressors increase drug-seeking behavior; however, mechanisms underlying this effect are incompletely understood. The Competing Neurobehavioral Decisions System theory posits that persons with SUDs may have hyperactive limbic reward circuitry and hypoactive executive control circuitry.</div></div><div><h3>Objective</h3><div>To investigate how inhibitory repetitive transcranial magnetic stimulation (rTMS) targeting the left ventromedial prefrontal cortex (vmPFC) may alter stress-induced executive dysfunction, emotion dysregulation, and drug-seeking in people with opioid use disorder.</div></div><div><h3>Methods</h3><div>We will examine effects of a psychological stressor combined with inhibitory (1Hz) left vmPFC rTMS in participants (N = 24) receiving opioid agonist treatment. Participants undergo guided imagery of autobiographical stressors paired with 10 sessions of active vmPFC rTMS vs. sham (within-subject randomized crossover). Stress-induced dysfunction will be indexed with cognitive (e.g., executive function), affective (e.g., emotional arousal), and behavioral (e.g., opioid-seeking) measures pre- and post-rTMS. To confirm changes are associated with altered neural activity in targeted regions, we will measure event-related potentials during key tasks using EEG. We hypothesize that stressors will increase executive dysfunction, emotion dysregulation, and drug-seeking, and that left vmPFC inhibitory rTMS will decrease limbic activation, which could translate to reduced craving and drug-seeking.</div></div><div><h3>Conclusion</h3><div>Our findings should offer insights into how neural networks modulate drug-seeking and associated dysfunctions in people with SUDs. The results of this and similar studies can advance theory and neuromodulation interventions for people with SUDs.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"43 ","pages":"Article 101414"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11719330/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142972506","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Corrigendum to “Protocol for double-blind RCT of acupuncture for vulvodynia” [Contemp. Clin. Trials Commun. (2022) 1–8 101029]","authors":"Judith M. Schlaeger ,&nbsp;Marie L. Suarez ,&nbsp;Jennifer E. Glayzer ,&nbsp;William H. Kobak ,&nbsp;Monya Meinel ,&nbsp;Alana D. Steffen ,&nbsp;Larisa A. Burke ,&nbsp;Heather A. Pauls ,&nbsp;Yingwei Yao ,&nbsp;Miho Takayama ,&nbsp;Hiroyoshi Yajima ,&nbsp;Ted J. Kaptchuk ,&nbsp;Nobuari Takakura ,&nbsp;David Foster ,&nbsp;Diana J. Wilkie","doi":"10.1016/j.conctc.2024.101422","DOIUrl":"10.1016/j.conctc.2024.101422","url":null,"abstract":"","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"43 ","pages":"Article 101422"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11784261/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143081677","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Utilization of an undergraduate emergency department research associate program for the screening and recruitment of research subjects with heart failure into a clinical study","authors":"Dillon J. Dzikowicz ,&nbsp;Brenda Hernandez-Romero ,&nbsp;Nancy Wood ,&nbsp;Beau W. Abar ,&nbsp;David H. Adler ,&nbsp;Linwei Wang ,&nbsp;Wojciech Zareba","doi":"10.1016/j.conctc.2024.101410","DOIUrl":"10.1016/j.conctc.2024.101410","url":null,"abstract":"<div><h3>Background</h3><div>Enrolling heart failure (HF) patients in clinical studies is challenging. Emergency department (ED) may use students as research associates programs, such as the University of Rochester Medical Center (URMC) ED Research Associate (EDRA) program, to screen and consent patients for clinical studies. This manuscript examines the effectiveness of the URMC EDRA program in consenting HF patients into a clinical study.</div></div><div><h3>Methods</h3><div>The URMC EDRA program recruited and consented HF patients presenting at URMC's ED. Research associates in the EDRA program identified potential patients based on age (&gt;18 years) and chief complaints indicative of HF. After identifying potential patients, a thorough chart review was conducted, and any uncertainties were discussed with the patient and treating provider before patients were consented into the study. Descriptive statistics were used to assess the program's effectiveness.</div></div><div><h3>Results</h3><div>Over one fiscal year, the URMC EDRA program screened 1669 unique patients, of whom 118 (7.1 %) were consented. Consented patients tended to be younger (65 ± 12 years) than those who refused consent (70 ± 14 years) (p = 0.007). Of the 1551 patients not consented, 1021 (65.8 %) were deemed ineligible. Compared to a full time research associate, the URMC EDRA program was cheaper and more productive.</div></div><div><h3>Conclusion</h3><div>The URMC EDRA program was highly effective in screening and consenting HF patients, successfully consenting 118 patients (14 per month). This is a significant achievement, especially given the study's strict inclusion and exclusion criteria. Compared to other studies and a full time research associate, the URMC EDRA program demonstrated remarkable productivity.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"43 ","pages":"Article 101410"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11696846/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142932932","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A mind-body resilience intervention for emotional distress in cardiac arrest survivors and their informal caregivers – Recovering together after cardiac arrest: Protocol for an open pilot trial","authors":"Danielle La Camera ,&nbsp;Jonathan Elmer ,&nbsp;Sarah M. Perman ,&nbsp;Michael W. Donnino ,&nbsp;Ona Wu ,&nbsp;Robert A. Parker ,&nbsp;Ana-Maria Vranceanu ,&nbsp;Alexander M. Presciutti","doi":"10.1016/j.conctc.2024.101426","DOIUrl":"10.1016/j.conctc.2024.101426","url":null,"abstract":"<div><h3>Background</h3><div>Chronic emotional distress among cardiac arrest (CA) survivors and their caregivers is prevalent and worsens quality of life and recovery. Interventions to prevent chronic distress post-CA are needed. We developed <em>Recovering Together after Cardiac Arrest</em> (RT-CA), an intervention to increase resiliency in CA survivor-caregiver dyads (pairs).</div></div><div><h3>Method</h3><div>We will conduct an open pilot clinical trial of RT-CA to examine preliminary feasibility and refine the intervention based on participant feedback. We will enroll at least 7 CA survivor-caregiver dyads during their hospitalization at a single academic medical center. We will identify eligible survivors by screening admission reports and through referrals from medical staff. <em>Inclusion criteria</em>: Survivors - sufficient cognitive status to meaningfully participate (Short Form of the Mini Mental State Exam ≥5). Dyads - English-speakers; one member must have clinically significant distress (≥8 on either Hospital Anxiety and Depression Scale subscale). <em>Procedure:</em> dyads will participate in 6, 30–45 min sessions with a study clinician. Sessions will include mind-body coping skills training and provision of anticipatory guidance and resources to navigate CA-survivorship. Dyads will complete pre- and post-test measures of emotional distress and treatment targets. We will calculate frequencies and proportions of our primary outcomes (feasibility - recruitment, assessments, adherence, therapist fidelity and acceptability/credibility). After completing post-test assessments, dyads will provide feedback via exit interviews. We will integrate qualitative and quantitative data using explanatory-sequential mixed-methods.</div></div><div><h3>Discussion</h3><div>We will use our findings to refine RT-CA content and study procedures. If successful, RT-CA has potential to significantly improve quality of survivorship for CA survivors and their caregivers.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"43 ","pages":"Article 101426"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11757219/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143047795","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The METEMP protocol: Massed exposure therapy enhanced with MDMA for PTSD","authors":"Jessica L. Maples-Keller,&nbsp;Boadie W. Dunlop,&nbsp;Barbara O. Rothbaum","doi":"10.1016/j.conctc.2024.101400","DOIUrl":"10.1016/j.conctc.2024.101400","url":null,"abstract":"<div><div>This article describes the rationale and the specific methods for an open label pilot trial of 100 mg MDMA in combination with massed exposure therapy for PTSD, a treatment which involves daily exposure therapy sessions for two weeks which has found to be effective. We review the need for novel PTSD treatments and the existing research on MDMA-assisted therapy, and then describe the rationale for this novel treatment approach, including combining MDMA with a gold standard treatment, translational support for this treatment, strong dissemination potential, and strengths of providing massed exposure treatment. The specific methods of the open label pilot study are presented, followed by conclusions and future directions for this research. This study will enroll at least 15 adults with PTSD over the next 2 years in order to identify feasibility and lead to a manual describing how to combine MDMA with exposure therapy, tested in a randomized, placebo-controlled trial, with significant promise for dissemination and improving our ability to treat PTSD.</div></div><div><h3>Trial registration</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> identifier: NCT05746572.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"43 ","pages":"Article 101400"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11784277/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143081681","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"“Salud Mamaria”, an internet-based psychoeducational program during the breast cancer diagnosis process: Protocol for a randomized controlled trial","authors":"Reyna Jazmín Martínez-Arriaga ,&nbsp;Alejandro Dominguez-Rodriguez ,&nbsp;Sergio Osvaldo Meza-Chavolla ,&nbsp;Yineth Alejandra Muñoz-Anacona ,&nbsp;Adrián Antonio Cisneros-Hernández ,&nbsp;Joel Omar González-Cantero ,&nbsp;Leivy Patricia González-Ramírez ,&nbsp;Paulina Erika Herdoiza-Arroyo ,&nbsp;Norma Alicia Ruvalcaba-Romero ,&nbsp;Fabiola Macías-Espinoza ,&nbsp;Said Jiménez","doi":"10.1016/j.conctc.2024.101397","DOIUrl":"10.1016/j.conctc.2024.101397","url":null,"abstract":"<div><h3>Background</h3><div>Some of the key challenges during the breast cancer diagnosis process include a lack of information and negative psychological consequences, such as distress and anxiety about the process. Implementing a psychoeducational program during the diagnosis process may enhance the well-being of women. “<em>Salud Mamaria</em>” is an Internet-Based Psychoeducational Program (IBPP) that comprises three interventions: A (“Improving Your Health Habits and Self-Care”), B (“Waiting for the Result of Your Biopsy”), and C (“Supporting You After Your Breast Cancer Diagnosis”).</div></div><div><h3>Objective</h3><div>1) To evaluate changes in the study variables following each of the three interventions (A, B, and C), and 2) To assess the differences in study variables between the IBPP and an active control group.</div></div><div><h3>Methods</h3><div>This is a superiority trial employing an experimental design with two independent groups: an experimental group and an active control group. All participants will be randomized to one of the two conditions. Anxiety symptoms, negative screening of consequences, sense of coherence, satisfaction with the intervention, and system usability will be measured. Patients will be assigned to an intervention based on their clinical situation: without cancer suspicion (A), with cancer suspicion (B), or diagnosed with cancer (C). Questionnaires will be administered via the online platform before and after each intervention.</div></div><div><h3>Conclusions</h3><div>A psychoeducational program implemented during the breast cancer screening and diagnosis process may promote the health and well-being of women. It may also encourage adherence to medical screening recommendations, mitigating the lack of information and reducing associated distress.</div></div><div><h3>Trial registration</h3><div>ClinicalTrials.gov <span><span>NCT05830461</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"43 ","pages":"Article 101397"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11722602/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142972503","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Design of INSPIRE: Evaluation of the effectiveness of practice facilitation on implementation of screening, brief interventions, referral to treatment and medication for unhealthy alcohol use identification and treatment in primary care","authors":"Jennifer Bannon ,&nbsp;Justin D. Smith ,&nbsp;Mark J. Van Ryzin ,&nbsp;Megan McHugh ,&nbsp;Jennifer Heinrich ,&nbsp;Theresa L. Walunas ,&nbsp;Abel N. Kho","doi":"10.1016/j.conctc.2024.101413","DOIUrl":"10.1016/j.conctc.2024.101413","url":null,"abstract":"<div><h3>Background</h3><div>Unhealthy alcohol use is a leading cause of preventable mortality and a risk factor for an array of social and health problems. The Intervention in Small primary care Practices to Implement Reduction in unhealthy alcohol use (INSPIRE) study is part of a nationwide campaign to improve the identification and treatment of patients engaging in unhealthy alcohol use.</div></div><div><h3>Methods</h3><div>We conducted a single arm, pragmatic study consisting of seventeen primary care practices in the Chicago metropolitan area, Wisconsin, and California across two waves with a 6-month latent period, a 12-month intervention period, followed by a 6-month sustainability period. Enrolled practices were independent, Federally Qualified Health Centers, network-based, and academic health centers. INSPIRE utilized the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework to examine implementation feasibility, fidelity, and performance of clinicians on practice adoption of screening, brief intervention, referral to treatment (SBIRT) and medication for unhealthy alcohol use (MAUD) activities in primary care clinics.</div></div><div><h3>Results</h3><div>Seventeen eligible primary care practices were enrolled over the course of 21 months beginning in March of 2020 through December of 2021. There was a pause in recruitment from March of 2020 through July of 2020 due to the Covid-19 pandemic. The majority of enrolled practices were small (&lt;6 clinicians) and were part of a network. 57 % of clinicians completed the educational modules in part or in full.</div><div>This paper will outline the INSPIRE protocol and design. Additionally, we will present practice demographic data, recruitment data and results related to on-line learning module completion.</div></div><div><h3>Conclusion</h3><div>The INSPIRE study will evaluate the ability of primary care clinicians in small practices to participate in practice education programs and implement standard screening and treatment protocols, adapted for documentation in the electronic health record (EHR). The study will also identify the factors that facilitated or hindered improvement and sustainability using quantitative and qualitative analysis methods.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"43 ","pages":"Article 101413"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11718291/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142972504","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Tools to improve discharge equity: Protocol for the pilot TIDE trial","authors":"Kirsten Austad ,&nbsp;Cecilia Thai ,&nbsp;Alegna Zavatti ,&nbsp;Nhi Nguyen ,&nbsp;Diana Bautista-Hurtado ,&nbsp;Patrick Kenney ,&nbsp;Noelia Lugo ,&nbsp;Joo H. Lee ,&nbsp;Howard Lanney ,&nbsp;Ziming Xuan ,&nbsp;Erika G. Cordova-Ramos ,&nbsp;Mari-Lynn Drainoni ,&nbsp;Brian Jack","doi":"10.1016/j.conctc.2024.101419","DOIUrl":"10.1016/j.conctc.2024.101419","url":null,"abstract":"<div><h3>Background</h3><div>Written discharge instructions after hospitalization promote patient understanding and positive clinical outcomes. Despite the rising prevalence of patients with non-English language preference (NELP) in the U.S., most hospitals do not routinely provide discharge instructions in their preferred language, thereby placing them at higher risk for medical errors and hospital readmission. Innovative solutions to close this implementation gap at hospital discharge for patients with NELP are needed. The Tools to Improve Discharge Equity (TIDE) intervention leverages communication practices proven effective in addressing communication barriers to create language concordant discharge tools from hospital discharge paperwork.</div></div><div><h3>Methods</h3><div>We present the protocol for a type I hybrid implementation-effectiveness pilot randomized trial. The TIDE intervention includes a translated medication calendar, pictographs, and an audio recording of the discharge instructions in the patient's preferred language. We will recruit an estimated 50 patient participants from the hospital's top four non-English language groups—Spanish, Haitian Creole, Cape Verdean Creole, and Vietnamese—as well as the nurse and in-person interpreter caring for them. Outcomes include patient recall of primary diagnosis and overall understanding of discharge instructions using a newly developed 24-point score, patient experience, implementation measures (acceptability, feasibility, and appropriateness), and clinical effectiveness (including hospital reutilization). A mixed methods evaluation will identify determinants of intervention uptake to guide selection of multi-level implementation strategies to test in a future hybrid type III trial.</div></div><div><h3>Discussion</h3><div>The TIDE intervention is the first hospital discharge intervention designed for patients with NELP. Result will inform future efforts to improve the safety and equity of the hospital discharge process.</div></div><div><h3>Trial registration</h3><div>clinicaltrials.gov <span><span>NCT05988229</span><svg><path></path></svg></span> (August 14, 2023) <span><span>https://classic.clinicaltrials.gov/ct2/show/NCT05988229</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"43 ","pages":"Article 101419"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11731754/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142984105","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}