Dataset Information

Electronic early notification of sepsis in hospitalized ward patients: a study protocol for a stepped-wedge cluster randomized controlled trial.

ABSTRACT:

Background

To evaluate the effect of screening for sepsis using an electronic sepsis alert vs. no alert in hospitalized ward patients on 90-day in-hospital mortality.

Methods

The SCREEN trial is designed as a stepped-wedge cluster randomized controlled trial. Hospital wards (total of 45 wards, constituting clusters in this design) are randomized to have active alert vs. masked alert, 5 wards at a time, with each 5 wards constituting a sequence. The study consists of ten 2-month periods with a phased introduction of the intervention. In the first period, all wards have a masked alert for 2 months. Afterwards the intervention (alert system) is implemented in a new sequence every 2-month period until the intervention is implemented in all sequences. The intervention includes the implementation of an electronic alert system developed in the hospital electronic medical records based on the quick sequential organ failure assessment (qSOFA). The alert system sends notifications of "possible sepsis alert" to the bedside nurse, charge nurse, and primary medical team and requires an acknowledgment in the health information system from the bedside nurse and physician. The calculated sample size is 65,250. The primary endpoint is in-hospital mortality by 90 days.

Discussion

The trial started on October 1, 2019, and is expected to complete patient follow-up by the end of October 2021.

Trial registration

ClinicalTrials.gov NCT04078594 . Registered on September 6, 2019.

SUBMITTER: Arabi YM

PROVIDER: S-EPMC8503718 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature

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Publications

Electronic early notification of sepsis in hospitalized ward patients: a study protocol for a stepped-wedge cluster randomized controlled trial.

Arabi Yaseen M YM Alsaawi Abdulmohsen A Al Zahrani Mohammed M Al Khathaami Ali M AM AlHazme Raed H RH Al Mutrafy Abdullah A Al Qarni Ali A Al Shouabi Ahmed A Al Qasim Eman E Abdukahil Sheryl Ann SA Al-Rabeah Fawaz K FK Al Ghamdi Huda H Al Ghamdi Ebtisam E Alansari Mariam M Abuelgasim Khadega A KA Alatassi Abdulaleem A Alchin John J Al-Dorzi Hasan M HM Ghamdi Abdulaziz A AA Al-Hameed Fahad F Alharbi Ahmad A Hussein Mohamed M Jastaniah Wasil W AlKatheri Mufareh Edah ME AlMarhabi Hassan H Mustafa Hani T HT Jones Joan J Al-Qahtani Saad S Qahtani Shaher S Qureshi Ahmad S AS Salih Salih Bin SB Alselaim Nahar N Tashkandi Nabiha N Vishwakarma Ramesh Kumar RK AlWafi Emad E Alyami Ali H AH Alyousef Zeyad Z

Trials 20211011 1

<h4>Background</h4>To evaluate the effect of screening for sepsis using an electronic sepsis alert vs. no alert in hospitalized ward patients on 90-day in-hospital mortality.<h4>Methods</h4>The SCREEN trial is designed as a stepped-wedge cluster randomized controlled trial. Hospital wards (total of 45 wards, constituting clusters in this design) are randomized to have active alert vs. masked alert, 5 wards at a time, with each 5 wards constituting a sequence. The study consists of ten 2-month pe ...[more]

PMID: 34635151

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Project description:BackgroundIt is unclear whether screening for sepsis using an electronic alert in hospitalized ward patients improves outcomes. The objective of the Stepped-wedge Cluster Randomized Trial of Electronic Early Notification of Sepsis in Hospitalized Ward Patients (SCREEN) trial is to evaluate whether an electronic screening for sepsis compared to no screening among hospitalized ward patients reduces all-cause 90-day in-hospital mortality.Methods and designThis study is designed as a stepped-wedge cluster randomized trial in which the unit of randomization or cluster is the hospital ward. An electronic alert for sepsis was developed in the electronic medical record (EMR), with the feature of being active (visible to treating team) or masked (inactive in EMR frontend for the treating team but active in the backend of the EMR). Forty-five clusters in 5 hospitals are randomized into 9 sequences of 5 clusters each to receive the intervention (active alert) over 10 periods, 2 months each, the first being the baseline period. Data are extracted from EMR and are compared between the intervention (active alert) and control group (masked alert). During the study period, some of the hospital wards were allocated to manage patients with COVID-19. The primary outcome of all-cause hospital mortality by day 90 will be compared using a generalized linear mixed model with a binary distribution and a log-link function to estimate the relative risk as a measure of effect. We will include two levels of random effects to account for nested clustering within wards and periods and two levels of fixed effects: hospitals and COVID-19 ward status in addition to the intervention. Results will be expressed as relative risk with a 95% confidence interval.ConclusionThe SCREEN trial provides an opportunity for a novel trial design and analysis of routinely collected and entered data to evaluate the effectiveness of an intervention (alert) for a common medical problem (sepsis in ward patients). In this statistical analysis plan, we outline details of the planned analyses in advance of trial completion. Prior specification of the statistical methods and outcome analysis will facilitate unbiased analyses of these important clinical data.Trial registrationClinicalTrials.gov NCT04078594 . Registered on September 6, 2019.

Project description:BackgroundAn Early Warning Score is a clinical risk score based upon vital signs intended to aid recognition of patients in need of urgent medical attention. The use of an escalation of care policy based upon an Early Warning Score is mandated as the standard of practice in British hospitals. Electronic systems for recording vital sign observations and Early Warning Score calculation offer theoretical benefits over paper-based systems. However, the evidence for their clinical benefit is limited. Previous studies have shown inconsistent results. The majority have employed a "before and after" study design, which may be strongly confounded by simultaneously occurring events. This study aims to examine how the implementation of an electronic early warning score system, System for Notification and Documentation (SEND), affects the recognition of clinical deterioration occurring in hospitalised adult patients.MethodsThis study is a non-randomised stepped wedge evaluation carried out across the four hospitals of the Oxford University Hospitals NHS Trust, comparing charting on paper and charting using SEND. We assume that more frequent monitoring of acutely ill patients is associated with better recognition of patient deterioration. The primary outcome measure is the time between a patient's first observations set with an Early Warning Score above the alerting threshold and their subsequent set of observations. Secondary outcome measures are in-hospital mortality, cardiac arrest and Intensive Care admission rates, hospital length of stay and system usability measured using the System Usability Scale. We will also measure Intensive Care length of stay, Intensive Care mortality, Acute Physiology and Chronic Health Evaluation (APACHE) II acute physiology score on admission, to examine whether the introduction of SEND has any effect on Intensive Care-related outcomes.DiscussionThe development of this protocol has been informed by guidance from the Agency for Healthcare Research and Quality (AHRQ) Health Information Technology Evaluation Toolkit and Delone and McLeans's Model of Information System Success. Our chosen trial design, a stepped wedge study, is well suited to the study of a phased roll out. The choice of primary endpoint is challenging. We have selected the time from the first triggering observation set to the subsequent observation set. This has the benefit of being easy to measure on both paper and electronic charting and having a straightforward interpretation. We have collected qualitative measures of system quality via a user questionnaire and organisational descriptors to help readers understand the context in which SEND has been implemented.

Project description:BackgroundRecently, more and more men who have sex with men (MSM) look for casual partners through online dating platforms in China. However, most are unable to know their partners' HIV and other sexually transmitted diseases (STD) statuses, leading to the rapid increase in HIV infection among Chinese MSM. Effective partner notification is urgently needed to increase the risk awareness of MSM and prevent HIV and other STDs transmission. However, the traditional intervention mainly targets to the HIV-positive MSM and the effect is not promising. Our study aims to provide Internet-based partner notification, along with a series of health services for HIV-negative MSM to protect them from HIV and other STDs.MethodsA pragmatic stepped wedge cluster randomized controlled trial design is used to evaluate the effectiveness of a new intervention paradigm, which aims to reduce HIV and other STDs incidences among MSM in China. Through integrating a mobile health (mHealth) service application (app) to the current HIV and other STDs prevention and control methods, the new paradigm provides partner notification of HIV, syphilis, hepatitis B, and hepatitis C statuses. A total of 6172 MSM in 16 districts of Beijing, China will be recruited and randomized to sequentially receive partner notification intervention through the app at 6-month intervals. The primary outcomes are HIV incidence and the additional cost of the intervention. The secondary outcomes include incidences of syphilis, hepatitis B, and hepatitis C, disease transmission social networks, testing adherence, knowledge of HIV and STDs control, health self-responsibility awareness, changes of high risk behaviors and other related outcomes. The generalized linear mixed models (GLMM) will be used to analyze the differences of outcomes in the control period and in the intervention period.DiscussionWe expect that the HIV incidence will be significantly lower and the secondary outcomes will also be improved with providing health service of partner notification through mhealth intervention. The feasible and affordable public health intervention paradigm will have implications for HIV and STDs prevention and control among MSM and other key populations.Trial registrationClinicalTrials.gov, NCT04349748 . Registered on 16 April 2020.

Project description:IntroductionCardiac arrest is a critical condition, and patients often experience postcardiac arrest syndrome (PCAS) even after the return of spontaneous circulation (ROSC). Administering a restricted amount of oxygen in the early phase after ROSC has been suggested as a potential therapy for PCAS; however, the optimal target for arterial partial pressure of oxygen or peripheral oxygen saturation (SpO2) to safely and effectively reduce oxygen remains unclear. Therefore, we aimed to validate the efficacy of restricted oxygen treatment with 94%-95% of the target SpO2 during the initial 12 hours after ROSC for patients with PCAS.Methods and analysisER-OXYTRAC (early restricted oxygen therapy after resuscitation from cardiac arrest) is a nationwide, multicentre, pragmatic, single-blind, stepped-wedge cluster randomised controlled trial targeting cases of non-traumatic cardiac arrest. This study includes adult patients with out-of-hospital or in-hospital cardiac arrest who achieved ROSC in 39 tertiary centres across Japan, with a target sample size of 1000. Patients whose circulation has returned before hospital arrival and those with cardiac arrest due to intracranial disease or intoxication are excluded. Study participants are assigned to either the restricted oxygen (titration of a fraction of inspired oxygen with 94%-95% of the target SpO2) or the control (98%-100% of the target SpO2) group based on cluster randomisation per institution. The trial intervention continues until 12 hours after ROSC. Other treatments for PCAS, including oxygen administration later than 12 hours, can be determined by the treating physicians. The primary outcome is favourable neurological function, defined as cerebral performance category 1-2 at 90 days after ROSC, to be compared using an intention-to-treat analysis.Ethics and disseminationThis study has been approved by the Institutional Review Board at Keio University School of Medicine (approval number: 20211106). Written informed consent will be obtained from all participants or their legal representatives. Results will be disseminated via publications and presentations.Trial registration numberUMIN Clinical Trials Registry (UMIN000046914).

Project description:IntroductionMost potential kidney transplant donors in the UK are aged over 60 years, yet increasing donor age is associated with poorer graft survival and function. Urgent preimplantation kidney biopsy can identify chronic injury, and may aid selection of better 'quality' kidneys from this group. However, the impact of biopsy on transplant numbers remains unproven. The PreImplantation Trial of Histopathology In renal Allografts (PITHIA) study will assess whether the introduction of a national, 24 hours, digital histopathology service increases the number, and improves outcomes, of kidneys transplanted in the UK from older deceased donors.Methods and analysisPITHIA is an open, multicentre, stepped-wedge cluster randomised study, involving all UK adult kidney transplant centres. At 4-monthly intervals, a group of 4-5 randomly selected clusters (transplant centres) will be given access to remote, urgent, digital histopathology (total intervention period, 24 months). The trial has two primary end points: it is powered for an 11% increase in the proportion of primary kidney offers from deceased donors aged over 60 years that are transplanted, and a 6 mL/min increase in the estimated glomerular filtration rate of recipients at 12 months post-transplant. This would equate to an additional 120 kidney transplants performed in the UK annually. Trial outcome data will be collected centrally via the UK Transplant Registry held by NHS Blood and Transplant (NHSBT) and will be analysed using mixed effects models allowing for clustering within centres and adjusting for secular trends. An accompanying economic evaluation will estimate the cost-effectiveness of the service to the National Health Service.Ethics and disseminationThe study has been given favourable ethical opinion by the Cambridge South Research Ethics Committee and is approved by the Health Research Authority. We will present our findings at key transplant meetings, publish results within 4 years of the trial commencing and support volunteers at renal patient groups to disseminate the trial outcome.Trial registration numberISRCTN11708741; Pre-results.

Dataset Information

Electronic early notification of sepsis in hospitalized ward patients: a study protocol for a stepped-wedge cluster randomized controlled trial.

Background

Methods

Discussion

Trial registration

Publications

Electronic early notification of sepsis in hospitalized ward patients: a study protocol for a stepped-wedge cluster randomized controlled trial.

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