Trial Implementation Research Articles

Multisite usability and safety trial of an immersive virtual reality implementation of a work organization system for autistic learners: implications for technology design

AbstractThe increased availability of low-cost, standalone and immersive virtual reality (VR) can facilitate adoption in autism education. An immersive VR implementation of the individual work system (IWS) from the TEACCH® approach has the potential to be a safe and predictable environment for autistic learners with or without intellectual disability. This study is a multi-site usability and safety trial examining an immersive VR implementation of the IWS co-designed with autistic pupils and their teachers from three educational centers in the UK, Spain, and Turkey. Twenty-one autistic students aged between 6 and 17 years were involved in the study, six of whom had an intellectual disability. The students tested a total of 164 customized tasks. All participants were able to finish all the tasks. No significant safety issues were identified. The student’s average score on the SUS Usability Scale was 85.36 points. A linear regression analysis showed that autistic children with intellectual disability scored significantly lower on feasibility than children without intellectual disability (p < 0.01) across all locations. This study concluded that an immersive VR-IWS proved usable and safe for the 21 students. However, our findings highlight the need for further adaptations and further research on those with an intellectual disability before recommending universal use. Our findings also have implications for game design for learners with special educational needs.

Quantum-Secured Data Centre Interconnect in a field environment

In the evolving landscape of quantum technology, the increasing prominence of quantum computing poses a significant threat to the security of conventional public key infrastructure. Quantum key distribution (QKD), an established quantum technology at a high readiness level, emerges as a viable solution with commercial adoption potential. QKD facilitates the establishment of secure symmetric random bit strings between two geographically separated, trustworthy entities, safeguarding communications from potential eavesdropping. In particular, data centre interconnects can leverage the potential of QKD devices to ensure the secure transmission of critical and sensitive information in preserving the confidentiality, security, and integrity of their stored data. In this article, we present the successful implementation of a QKD field trial within a commercial data centre environment that utilises the existing fibre network infrastructure. The achieved average secret key rate of 2.392 kbps and an average quantum bit error rate of less than 2% demonstrate the commercial feasibility of QKD in real-world scenarios. As a use case study, we demonstrate the secure transfer of files between two data centres through the Quantum-Secured Virtual Private Network, utilising secret keys generated by the QKD devices. %This demonstration marks a significant milestone in the deployment of QKD across Singapore, establishing a foundation for widespread adoption and enhancing the infrastructure for practical, quantum-safe communication in commercial environments.

Multicomponent Intervention to Improve Acute Myocardial Infarction Care in Tanzania: Protocol for a Pilot Implementation Trial.

Although the incidence of acute myocardial infarction (AMI) is rising in sub-Saharan Africa, the uptake of evidence-based care for the diagnosis and treatment of AMI is limited throughout the region. In Tanzania, studies have revealed common misdiagnosis of AMI, infrequent administration of aspirin, and high short-term mortality rates following AMI. This study aims to evaluate the implementation and efficacy outcomes of an intervention, the Multicomponent Intervention to Improve Acute Myocardial Infarction Care (MIMIC), which was developed to improve the delivery of evidence-based AMI care in Tanzania. This single-arm pilot trial will be conducted in the emergency department (ED) at a referral hospital in northern Tanzania. The MIMIC intervention will be implemented by the ED staff for 1 year. Approximately 400 adults presenting to the ED with possible AMI symptoms will be enrolled, and research assistants will observe their care. Thirty days later, a follow-up survey will be administered to assess mortality and medication use. The primary outcome will be the acceptability of the MIMIC intervention, which will be measured by the Acceptability of Intervention Measurement (AIM) instrument. Acceptability will further be assessed via in-depth interviews with key stakeholders. Secondary implementation outcomes will include feasibility and fidelity. Secondary efficacy outcomes will include the following: the proportion of participants who receive electrocardiogram and cardiac biomarker testing, the proportion of participants with AMI who receive aspirin, 30-day mortality among participants with AMI, and the proportion of participants with AMI taking aspirin 30 days following enrollment. Implementation of MIMIC began on September 1, 2023. Enrollment is expected to be completed by September 1, 2024, and the first results are expected to be published by December 31, 2024. This study will be the first to evaluate an intervention for improving AMI care in sub-Saharan Africa. If MIMIC is found to be acceptable, the findings from this study will inform a future cluster-randomized trial to assess effectiveness and scalability. ClinicalTrials.gov NCT04563546; https://clinicaltrials.gov/study/NCT04563546. DERR1-10.2196/59917.

Remote coaching for supporting the implementation of treatment for depression in primary care in Madhya Pradesh, India: protocol for a cluster randomized controlled trial.

Upwards of ninety percent of individuals living with depression in India do not have access to evidence-based treatments, especially in rural areas. Integrating these treatments into primary care is essential for bridging this care gap. This trial aims to evaluate whether a remote coaching implementation support strategy, referred to as Enhanced Implementation Support, is superior to routine support, referred to as Routine Implementation Support, in supporting the delivery of collaborative depression care in rural primary care centers. Employing a cluster-randomized hybrid type-III implementation trial design, 14 primary care facilities in Sehore district, Madhya Pradesh, will implement a collaborative depression care package based on the WHO's mhGAP program. Facilities will be randomized to either Enhanced Implementation Support or the Routine Implementation Support control condition. Enhanced Implementation Support consists of remote coaching and technical assistance, supplemented with in-person visits, and guided by the Plan-Do-Study-Act implementation cycles. The primary implementation outcome is the proportion of outpatients screened for depression by facility staff, with secondary outcomes including the proportions of outpatients who screen positive for depression, are referred to the medical officer, and initiate treatment. Secondary patient outcomes include proportion of patients who achieve reduction in depression symptom severity at 3-month follow up. Acceptability, feasibility, and fidelity of the depression care package will be assessed through routine observations collected during field visits, facility audits, and qualitative exit interviews with facility staff. Costs of delivering the Enhanced Implementation Support strategy will also be estimated. This trial can inform efforts to integrate depression care in rural primary care facilities in a low-resource setting, and illuminate whether external coaching support is superior relative to existing implementation support for achieving these goals. NCT05264792.

The implementation and evaluation of a mock trial using a flipped classroom pedagogy in practical nursing education.

Background: This quality improvement study explores the implementation and evaluation of a mock trial within a flipped classroom pedagogy to help first-year practical nursing learners meet the class objectives. Methods: Sixty-two (N=62) practical nursing learners participated in a mock trial as part of their first year Nursing Arts course at Bow Valley College in July 2022. The mock trial was evaluated using qualitative and quantitative data collection. Results: The thematic analysis suggested that a mock trial using a flipped classroom pedagogy may be an effective way of teaching course objectives. The learners reported a moderate to high level of confidence in managing challenging situations after participating in the mock trial. Conclusions: The study highlights the potential benefits of incorporating a mock trial using a flipped classroom pedagogy in practical nursing education.

Patient and family views on research priorities and design of clinical trials and research studies in pediatric multiple sclerosis.

This survey study aimed to (1) identify patient/family research priorities in pediatric-onset multiple sclerosis (POMS), and (2) delineate optimized methods for research study/clinical trials design, engagement, and implementation. Participants were as follows: (1) parents of a child (<18 years) with POMS enrolled in a national registry, (2) adolescents (13-17 years) with POMS in the registry, and (3) adults (18-40 years) with POMS receiving care at a registry affiliated clinic. Of 293 eligible participants, 192 completed surveys. Experiences with health care and medications were generally positive but there remain areas of priority improvement. Incentives to participate in clinical trials included medications previously tested and in pill form, bloodwork/study visits required ⩾ every 3 months, cognitive testing ⩽1 hour, compensation for travel and time, ability to continue current multiple sclerosis (MS) medication, option to take study medication if on placebo, and individualized study feedback. Priorities for clinical research were (1) psychosocial impact, (2) cognitive/academic impact, (3) environmental risk, and (4) nutrition. Results highlighted the importance of a holistic approach to study design and a focus on the impact of disease on daily life to best engage patients and families in POMS clinical trials and research.

Design and implementation of a Type-2 hybrid, prospective randomized trial of opioid agonist therapies integration into primary care clinics in Ukraine

IntroductionUkraine has high HIV prevalence, concentrated among people who inject drugs (PWID), mostly of opioids. Maintenance on opioid agonist therapies (OAT) is the most effective evidence-based treatment for opioid use disorder. As PWID experience high morbidity and mortality from preventable and treatable non-communicable diseases, international agencies recommend integrating OAT into primary care centers (PCC). MethodsA randomized, type-2 hybrid implementation trial was carried out to compare outcomes of OAT integration in PCC to OAT delivery at specialty treatment centers (STC) – standard-of-care. Tele-education supporting PCC providers in managing OAT, HIV, tuberculosis and non-communicable diseases along with pay-for-performance incentives were used to facilitate implementation. Consenting patients underwent 1:2 randomization to either STC or PCC. Quality health indicators (QHIs), a composite percentage of recommended primary and specialty services accessed by patients (blood/urine tests, cancer screenings, etc.), were defined as efficacy outcomes and were assessed by participant self-report at baseline and every 6 months over 24 months and electronic chart reviews after the completion of the follow-up. The primary outcome is defined as the difference in composite QHI scores at 24 months, in which a repeated measures likelihood-based mixed model with missing at random assumptions will be used. Providers at PCC completed surveys at baseline, 12 and 24 months to assess implementation outcomes including changes in stigma and attitudes towards OAT and PWID. Preliminary resultsAmong the 1459 participants allocated to STC (N = 509) or PCC (N = 950), there were no differences in clinical and demographic characteristics. Self-reported prevalences were available for HIV (42 %), HCV (57 %), and prior tuberculosis (17 %). Study retention at 6, 12, 18, and 24 months was as 91 %, 85 %, 80 %, and 74 %, respectively. ConclusionPWID have a high prevalence of medical comorbidities and integrating OAT into primary care settings has the potential to improve the health of PWID. Findings from this study can help guide implementation of integrated care in Ukraine and throughout similar low-resource, high-burden countries in the Eastern European and Central Asian region.

Predictors of effective kangaroo mother care, exclusive breastfeeding, and skin-to-skin contact among low birthweight newborns in Amhara, Ethiopia.

Globally, 20% of all newborns are born with low birth weight (LBW). There is, therefore, an urgent need to expedite the delivery of high-impact, evidenced-based, and low-cost interventions such as kangaroo mother care (KMC (defined as continuous skin-to-skin care) and exclusive breastfeeding for this vulnerable group. A multinational World Health Organization (WHO)-supported consortium created and tested the impact of locally-specific and globally-informed phases of KMC care on KMC uptake/scale-up across multiple sites. Here we report on the study of KMC predictors that is nested within Amhara's KMC implementation trial in Amhara, Ethiopia. We used multivariate logistic regression phases to identify diverse predictors of KMC, skin-to-skin contact, and exclusive breastfeeding at hospital discharge and day 28 of life. We analysed data from 860 LBW newborns. At day 28, implementation period (adjusted odds ratio (aOR) = 3.2-5.0), hospital facility (aOR = 3.0-4.6), and having multiple births (aOR = 0.31) were the strongest predictors of effective KMC. Meanwhile, previous death of a newborn, type of health facility where delivery occurred, and previous LBW delivery were predictors of effective KMC at both time points. No single factor predicted KMC, skin-to-skin contact, and exclusive breastfeeding at all time points and across all implementation periods. Having multiple births was a negative predictor for skin-to-skin contact, while the implementation period and having older fathers (>29 years) were strong positive predictors for exclusive breastfeeding at both discharge and day 28. Mothers with a previous history of neonatal death and current skin-to-skin-care uptake strongly predicted exclusive breastfeeding uptake at both time points. At discharge, however, having a history of preterm birth and neonatal death strongly predicted exclusive breastfeeding uptake, while multiple current births, current very LBW newborns, and the use of standard binders decreased the likelihood of exclusive breastfeeding. To achieve the effective KMC coverage target of ≥80% in Ethiopia, KMC scale-up phases may have to consider the key predictors of KMC, EBF, and SSC to effectively target beneficiaries.

Using Systems Engineering and Implementation Science to Design an Implementation Package for Preoperative Comprehensive Geriatric Assessment Among Older Adults Having Major Abdominal Surgery: Protocol for a 3-Phase Study.

Older Americans, a growing segment of the population, have an increasing need for surgical services, and they experience a disproportionate burden of postoperative complications compared to their younger counterparts. A preoperative comprehensive geriatric assessment (pCGA) is recommended to reduce risk and improve surgical care delivery for this population, which has been identified as vulnerable. The pCGA optimizes multiple chronic conditions and factors commonly overlooked in routine preoperative planning, including physical function, polypharmacy, nutrition, cognition, mental health, and social and environmental support. The pCGA has been shown to decrease postoperative morbidity, mortality, and length of stay in a variety of surgical specialties. Although national guidelines recommend the use of the pCGA, a paucity of strategic guidance for implementation limits its uptake to a few academic medical centers. By applying implementation science and human factors engineering methods, this study will provide the necessary evidence to optimize the implementation of the pCGA in a variety of health care settings. The purpose of this paper is to describe the study protocol to design an adaptable, user-centered pCGA implementation package for use among older adults before major abdominal surgery. This protocol uses systems engineering methods to develop, tailor, and pilot-test a user-centered pCGA implementation package, which can be adapted to community-based hospitals in preparation for a multisite implementation trial. The protocol is based upon the National Institutes of Health Stage Model for Behavioral Intervention Development and aligns with the goal to develop behavioral interventions with an eye to real-world implementation. In phase 1, we will use observation and interviews to map the pCGA process and identify system-based barriers and facilitators to its use among older adults undergoing major abdominal surgery. In phase 2, we will apply user-centered design methods, engaging health care providers, patients, and caregivers to co-design a pCGA implementation package. This package will be applicable to a diverse population of older patients undergoing major abdominal surgery at a large academic hospital and an affiliate community site. In phase 3, we will pilot-test and refine the pCGA implementation package in preparation for a future randomized controlled implementation-effectiveness trial. We anticipate that this study will take approximately 60 months (April 2023-March 2028). This study protocol will generate (1) a detailed process map of the pCGA; (2) an adaptable, user-centered pCGA implementation package ready for feasibility testing in a pilot trial; and (3) preliminary pilot data on the implementation and effectiveness of the package. We anticipate that these data will serve as the basis for future multisite hybrid implementation-effectiveness clinical trials of the pCGA in older adults undergoing major abdominal surgery. The expected results of this study will contribute to improving perioperative care processes for older adults before major abdominal surgery. DERR1-10.2196/59428.

Adjudication of Self-reported Symptomatic Stone Recurrence in the Prevention of Urinary Stones With Hydration Trial

ObjectiveTo assess accuracy of self-reported stone events in a large clinical trial by adjudication against the weight of documentation for spontaneous stone passage or surgical intervention. MethodsParticipants in the Prevention of Urinary Stones with Hydration (PUSH) trial were randomized to a multi-component behavioral intervention or control arm to increase and maintain high fluid intake. The primary endpoint was urinary stone events including symptomatic stone passage or procedural intervention. An independent adjudication committee blinded to randomization assignments reviewed all events. Confirmed clinical stone events required typical stone symptoms and documentation of stone passage (e.g., via photograph, clinical record) and/or surgical intervention. Events with typical symptoms and self-described stone passage but without objective documentation of passage were also considered as meeting the primary endpoint and classified separately as patient-reported passage. Non-events did not meet either criteria. ResultsAt time of this blinded analysis, a total of 1658 participants were randomized and had a median follow-up of 19 months. Self-reported stone events (n=217) were adjudicated by the committee as either confirmed clinical events (134; 61.8%), patient-reported passage (71; 32.7%), or non-events (12; 5.5%). Confirmed clinical events consisted of stone passage in 66/134 and procedural interventions in 68/134 (53 for symptoms and 15 without symptoms). ConclusionsRigorous adjudication revealed that self-reported stone events in the PUSH trial overwhelmingly represented clinically documented passage, surgical intervention, and patient-reported passage outside healthcare settings, with only 5.5% failing to satisfy adjudication criteria. Similar adjudication and classification processes warrant consideration for implementation in future stone trials. Clinical Trials RegistrationNCT03244189

A Cautionary Tale: Digital Clinical Trial Implementation of a Couples-Based HIV Prevention Study among Transgender Women and Their Partners in the United States.

This study investigates baseline differences in couples enrolled in the "It Takes Two" HIV prevention intervention for transgender women and their partners, comparing in-person participation pre-COVID-19 and digital participation during the pandemic. Among 52 couples (40% in-person, 60% digital), bivariate analyses revealed that in-person participants were more likely to be African American, have cisgender male partners, report higher unemployment, incarceration histories, greater relationship stigma, and lower relationship quality. The findings highlight the limitations of digital modalities in engaging transgender women of color and those with structural vulnerabilities. The study emphasizes that reliance on digital methods in HIV research jeopardizes the inclusion of those lacking technological access and literacy, especially communities disproportionately impacted by HIV. Researchers must incorporate hybrid or in-person options and engage communities to ensure equity and inclusion, thus overcoming barriers and ensuring comprehensive population reach in HIV prevention studies.

The Fletcher-Cox Pathway: A Unique View on Clinical Trial Education

PurposeThere currently are no established formal mentorship and training program for radiation oncology (RO) trainees to learn trial design, creation, writing, or implementation. There only exists informal training on analyzing clinical trials in RO residency programs. The integration of a longitudinal formal training and mentorship program for clinical trialists - consisting of clinical trial education, design, mentorship, and implementation during the RO residency education will give residents not only formal teaching in the subject, but strong tools and requisite mentorship in hopes to help them succeed as future academic physicians and leaders in the field of radiation oncology. Methods and MaterialsWe developed a clinical trial training pathway in 2018 at XXX, proposing it as a pilot program. The “Fletcher-Cox Pathway” was accepted with a highly positive response by trainees. and is is now offered as a standard option to RO trainees at our institution. ResultsWith the guidance of their principal investigator (PI), residents participating in this pathway design and submit a clinical trial for institutional review board (IRB) review. In 2019, after implementation of the pilot program, 4 of the incoming 7 residents joined the pathway. The program continues, and the current cohort of trainees have received training in clinical trials design andworked with dedicated mentor(s) regarding clinical trial ideas; their studies are currently accruing patients. ConclusionsThis pilot program has been viewed by trainees and mentors as successful; it highlights how a structured approach meets a clear need within RO training. We envision the creation of a national platform to increase access, whereby programs adopt this clinical trialist educational pathway, which ultimately leads to the development of a robust clinical trial community with communal resources. We hope that this not only improves and provides educational initiatives to all trainees but also initiates further collaboration.

A Streamlined Strategy for Basophil Activation Testing in a Multicenter Phase III Clinical Trial

BackgroundThe basophil activation test (BAT) has been limited to research settings due to technical issues. Novel approaches using dry, ready-to-use reagents and streamlined protocols offer greater flexibility and may open opportunities for easier implementation in clinical research. ObjectiveUsing a streamlined BAT (sBAT) strategy and the settings of the baseline study of the EPITOPE trial of EPicutaneous ImmunoTherapy (EPIT™) for peanut allergy, we aimed to assess the feasibility of implementing BAT in a multicenter trial and to evaluate its utility in predicting the outcomes of peanut double-blind placebo-controlled food challenge (DBPCFC). MethodsWhole blood samples were collected from subjects aged 1-3 years (n=241) undergoing baseline eligibility DBPCFC in the EPITOPE study across 15 clinical sites in North America. After preparation with sBAT reagents, processed samples were analyzed in a single central laboratory within 5 days of collection and preparation. The eliciting dose (ED) at DBPCFC was determined using PRACTALL criteria. Using a machine learning (ML) approach which incorporated BAT-derived features, clinical characteristics, and peanut-specific IgE, the ability to predict outcomes of interest (ED [<300 mg or >300 mg] and use of epinephrine) was assessed using data randomly split into training (n=182) and validation (n=59) subsets. ResultsThe expression of basophil activation markers CD203c and CD63 correlated with ED and severity outcomes of DBPCFC. Most informative concentrations of peanut extract in the sBAT assay for these associations were 1 and 10 ng/ml. Using ML to assess the ability to predict the outcomes of DBPCFC, the best models using only the BAT-derived features provided relatively high sensitivities of 0.86 and 0.85 for predicting eliciting dose and epinephrine use, respectively, while specificities were lower, ranging from 0.60 to 0.80. While including specific IgE and SPT data in addition to those from sBAT did not improve the ability to identify individuals most at risk for severe reactions, it did improve the ability to identify patients with an eliciting dose above 300 mg. ConclusionIn addition to facilitating implementation in multicenter trials, sBAT retains the potential of BAT to characterize allergic patients and confirms its potential to contribute to predicting the outcome of oral food challenges.

Analysis of clinical study registration characteristics of traditional medicine for the treatment of type 2 diabetes mellitus based on the International Clinical Trials Registry Platform

Objective: To analyze clinical trials of traditional medicine (including Chinese herbal medicine and nonpharmacological therapies) for the treatment of type 2 diabetes mellitus (T2DM) registered in the International Clinical Trials Registry Platform (ICTRP), and accordingly to explore their clinical trial registration characteristics, development trend and intervention status, in an attempt to provide references for future research design, diagnosis and management of traditional Chinese medicine therapy for T2DM. Methods: The clinical trials related to Chinese herbal medicine and nonpharmacological therapies for treating T2DM were retrieved on the ICTRP online from the time of database construction to August 13, 2023, to analyze the time of registration, country and institution of the study, source of funding, type and design of the study, randomization and blinding methods, clinical staging, therapeutic measures, and main therapeutic effect indexes. Descriptive statistical analysis was performed using R4.3.0 and Excel software. Results: A total of 774 clinical trials for T2DM treatment were included, of which 127 were traditional herbal therapies and 647 were nonpharmacological therapies. The T2DM clinical trial registration institutions were distributed in 50 countries worldwide involving 15 clinical registration platforms, with the most registrations in Iran, China, and Australia, and the top 3 registration platforms were the Iranian Clinical Trial Registry, the Australian New Zealand Clinical Trials Registry, and the ICTRP. Universities (551, 71.19%) were the main funding sources. Intervention studies (750, 96.90%) were the primary study type, including randomized controlled trials (432, 56. 4%), and 225 studies mentioned the blinding method. A total of 530 (68.48%) with a sample size ≤100 were included. Study phases were predominantly phase 2 and phase 3 (108, 51.43%). The interventions of traditional medicine for T2DM were composed of Chinese herbal medicines (mainly ginseng and astragalus compound), nonpharmacological therapies (mainly exercise and diet therapies), and 2 or more comprehensive treatment regimes. According to the type of study design, the first 3 main therapeutic indexes were fasting blood glucose (286 times), glycated hemoglobin (282 times), and insulin resistance (120 times), and the top 3 secondary therapeutic indexes were body mass index (179 times), fasting blood glucose (175 times), and glycated hemoglobin (134 times). Conclusion: The study dissects the current status and trend of registration of clinical trials on traditional medicine for T2DM treatment. The number of trial registrations is on the rise year by year, and there are obvious geographical differences in the countries and platforms of registration. The trial design is mainly randomized controlled blind trials with a sample size of &lt;100, and the main interventions are nonpharmacological therapies. Correct and standardized registration of clinical trials and timely reporting of study results are greatly important to facilitate the implementation of clinical trials, reduce publication bias, provide high-level diagnostic and therapeutic bases for clinical practice guidelines, and develop effective treatment strategies. This study is expected to help other scholars, health care professionals, patients, and the public to understand the latest research trends and hotspots in this field and provide certain references and inspirations for the future research design and clinical practice of traditional Chinese medicine in the treatment of T2DM.

Electronic nudges for sustained influenza vaccination uptake in older adults: the nationwide randomized NUDGE-FLU-2 trial.

Digital letter interventions have proven effective in increasing influenza vaccination rates. In this trial, we sought to further refine these strategies and investigated whether the effectiveness of the strategies could be sustained across consecutive influenza seasons. We enrolled all eligible Danish citizens 65 years of age or older in a nationwide registry-based randomized implementation trial during the 2023-2024 influenza season. Households of participants were randomly assigned in a 2.45:1:1:1:1:1:1 ratio to usual care or six different behaviorally informed electronic letter-based nudges delivered before the influenza vaccination period. The primary endpoint was receipt of influenza vaccination. Statistical analyses accounted for household-level clustering. A total of 881,373 participants (mean age 74.1 ± 6.5 years, 52.1% female) were randomized across 649,487 households. The primary endpoint was met; influenza vaccination rates were higher in the pooled intervention letter group compared to usual care (76.32% versus 76.02%; difference, 0.31 percentage points; 99.29% confidence interval, 0.00-0.61; P = 0.007). Although no individual letter significantly increased influenza vaccination rates, the directionality of effect was consistent across all letters. Effectiveness was particularly pronounced in participants who had not received influenza vaccination during the preceding season (Pinteraction = 0.010). Effectiveness was consistent regardless of whether participants had received a similar electronic letter-based nudge in the preceding season (Pinteraction = 0.26). In summary, electronic letter-based nudges successfully increased influenza vaccination among older adults, and our results suggest that these highly scalable strategies can be implemented effectively and safely across consecutive vaccination seasons.ClinicalTrials.gov registration: NCT06030726 .

Strategies for Implementing GlobalConsent to Prevent Sexual Violence in University Men (SCALE): study protocol for a national implementation trial

BackgroundGlobally, women 15–24 years are at heightened risk of sexual violence victimization, a risk factor for adverse mental, physical, and behavioral health outcomes. Sexual violence is common at universities and most often perpetrated by men, yet few evidence-based prevention strategies targeting men have been tested in low- and middle-income countries. GlobalConsent is a six-module, web-based educational program adapted from an efficacious U.S.-based program. Nine months post-treatment in a randomized trial in Vietnam, GlobalConsent reduced men’s sexually violent behavior (odds ratio [OR] = 0.71, 95%CI 0.50–1.00) and increased prosocial intervening behavior (OR = 1.51, 1.00–2.28) relative to an attention-control. Evidence regarding optimal implementation strategies for scale up is needed.MethodsWe will randomize six medical universities in North, Central, and South Vietnam to deliver GlobalConsent using two different packages of implementation strategies that vary in intensity. Higher-intensity strategies will include greater (1) pre- and post-implementation engagement with university leaders and faculty and (2) greater pre-implementation outreach, follow-up, and incentives for students to promote engagement and completion of GlobalConsent. Higher intensity universities will receive additional training and support for their added activities. We will compare implementation drivers and outcomes, intervention effectiveness, and cost-effectiveness across the two implementation bundles. Our mixed-methods comparative interrupted time series design includes (1) qualitative interviews and quantitative surveys with university leaders and implementation teams to assess implementation barriers and facilitators; (2) repeated surveys with leaders and faculty, implementation teams, and male students to assess multilevel implementation drivers and outcomes; (3) repeated surveys with male students to assess behavioral outcomes (sexual violence and intervening behavior) and mediating variables (knowledge, attitudes, affect, and capacities); and (4) time diaries and cost tracking to assess cost-effectiveness of the two implementation-strategies bundles.DiscussionThis project is the first to assess packages of implementation strategies to deliver an efficacious web-based sexual violence prevention program for undergraduate men across all regions of Vietnam and synergizes with a violence-prevention training initiative (D43TW012188). This approach will produce rigorous evidence about how to disseminate GlobalConsent nationally, which holds promise to reduce gender-based health inequities linked to sexual violence as GlobalConsent is brought to scale.Trial registrationNCT06443541. Retrospectively registered with ClinicalTrials.gov. Registered on June 05, 2024.

The Sowers of Seeds: A Qualitative Analysis of the Role of Palliative Care Educators in Facilitating Goals-of-Care Conversations and Palliative Care Referrals.

Optimal care for seriously ill and older patients often involves advance care planning (ACP), goals-of-care (GOC) conversations, and specialty palliative care consultation, three sometimes overlapping, yet distinct practices. Insufficient staffing and investment in these areas have limited their availability. We explored the facilitators and barriers to successful implementation of the VIDEO-PCE trial. The intervention aimed to increase patient engagement in ACP, GOC, and by establishing Palliative Care Educators, a new clinical role integrated into existing hospital wards. This qualitative interview study employed a semi-structured interview guide tailored to the interviewee's clinical role. The interviews elicited perceptions of the facilitators and barriers to integration of palliative care educators (PCEs) into existing workflows. We developed deductive codes a priori and inductive codes as we coded interview transcripts. Medical/surgical floor clinical colleagues, palliative care team members, and PCEs from both participating sites were interviewed. Twenty-four individuals were interviewed (12 clinical staff of medical and surgical wards, seven palliative care team members, and five PCEs). Four themes were identified: (1) The work completed by the PCEs provided a foundation for future palliative care involvement; (2) Constituting the new role in practice required revision and creativity; (3) Communication was important to providing continuity of care; and (4) Establishing trust catalyzed the acceptance of the role. The creation and implementation of a new role within existing clinical workflows posed some challenges but were felt to relieve staff from some work burden and allow more patients to engage in ACP and GOC conversations. ClinicalTrials.gov Identifier: NCT04857060.

Including Sexually and Gender Diverse Populations in 3,4-Methylenedioxymethamphetamine-Assisted Psychotherapy Trial Research.

Sexually and gender diverse (SGD) populations experience an increased prevalence and severity of posttraumatic stress disorder (PTSD) compared with the general population. Minority stress theory contextualizes this increased disease burden by outlining how stigma and discrimination (e.g., homophobia and transphobia) contribute to worse mental health outcomes. The standard-of-care pharmacotherapy for PTSD is associated with significant treatment resistance. 3,4-Methylenedioxymethamphetamine (MDMA)-assisted psychotherapy (MDMA-AP) has emerged as an investigational treatment for PTSD but has lacked consideration for SGD populations. This article explores next steps in clinical trial design and implementation for the study of MDMA-AP with SGD populations who have PTSD.

Implementation of Supreme Court Regulation No 7 of 2022 concerning electronic case administration and court proceedings at The Denpasar District Court

The implementation of electronic trials (e-Litigation) at the Denpasar District Court is a significant step forward in the modernization of the judicial system. This study aims to find out the implementation of the electronic trial and the obstacles encountered during its implementation. The research contributes by providing insights into the practical challenges of adopting electronic trials in a specific judicial context, potentially offering recommendations for overcoming these obstacles. The findings could be valuable for policymakers, legal practitioners, and other courts looking to optimize their own implementation of e-Court.

Increasing participation in resistance training using outdoor gyms: A study protocol for the ecofit type III hybrid effectiveness implementation trial

BackgroundIn this paper we outline the protocol for an implementation-effectiveness trial of ecofit, a multi-component mHealth intervention aimed at increasing participation in resistance and aerobic physical activity using the outdoor built environment (i.e., outdoor gyms) and social support. We have previously demonstrated the efficacy and effectiveness of the ecofit program in insufficiently active people with (or at risk of) type 2 diabetes and community-dwelling adults, respectively. The objective of this trial is to compare the effects of two implementation support models (i.e., ‘Low’ versus ‘Moderate’) on the reach (primary outcome), uptake, dose received, impact and fidelity of the ecofit program. Research design and methodsThis hybrid type III implementation-effectiveness study will be evaluated using a two-arm randomized controlled trial, including 16 outdoor gym locations in two large regional municipalities in New South Wales, Australia. Outdoor gym locations will be pair-matched, based on an established socio-economic status consensus-based index (high versus low), and randomized to the ‘Low’ (i.e., ecofit app only) or ‘Moderate’ (i.e., ecofit app, face-to-face workout sessions and QR codes) implementation support group. The primary outcome of ‘reach’ will be measured using a modified version of the ‘System for Observing Play and Recreation in Communities’, capturing outdoor gym use amongst community members. ConclusionThis implementation-effectiveness trial will evaluate the effects of different levels of implementation support on participation in resistance-focused physical activity using mHealth and outdoor gyms across the broader community. This may guide widespread dissemination for councils (municipalities) nation-wide wanting to promote outdoor gym usage. Trial registryThis trial was preregistered with the Australian and New Zealand Clinical Trial Registry (ACTRN12624000261516).