scholarly journals Statistical analysis plan for the Steppedwedge Cluster Randomized trial of Electronic Early Notification of sepsis in hospitalized ward patients (SCREEN)

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Yaseen M. Arabi ◽  
Ramesh Kumar Vishwakarma ◽  
Hasan M. Al-Dorzi ◽  
Eman Al Qasim ◽  
Sheryl Ann Abdukahil ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Relative Risk ◽  
Hospital Mortality ◽  
Randomized Trial ◽  
Fixed Effects ◽  
Cluster Randomized Trial ◽  
Statistical Analysis Plan ◽  
Control Group ◽  
Stepped Wedge ◽  
Cluster Randomized

Abstract Background It 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 design This 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. Conclusion The 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 registration ClinicalTrials.gov NCT04078594. Registered on September 6, 2019

scholarly journals Statistical Analysis Plan for the Stepped-wedge Cluster Randomized Controlled Trial of Electronic Early Notification of Sepsis in Hospitalized Ward Patients (SCREEN): a study protocol for a stepped-wedge cluster randomized controlled trial

2021 ◽  
Author(s):  
Yaseen M Arabi ◽  
Ramesh Kumar Vishwakarma ◽  
Hasan M Al-Dorzi ◽  
Eman Al Qasim ◽  
Sheryl Ann Abdukahil ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Statistical Analysis ◽  
Hospital Mortality ◽  
Controlled Trial ◽  
Statistical Analysis Plan ◽  
Cluster Randomized Controlled Trial ◽  
Stepped Wedge ◽  
Randomized Controlled ◽  
Link Type ◽  
Cluster Randomized

Abstract Background It is unclear whether screening for sepsis using an electronic alert in hospitalized ward patients improves outcomes. The objective of the Stepped-wedge Cluster Randomized Controlled Trial of Electronic Early Notification of Sepsis in Hospitalized Ward Patients (SCREEN) is to examine the effect of electronic screening for sepsis compared to no screening among hospitalized ward patients on all-cause 90-day hospital mortality. Methods This study is designed as a stepped-wedge cluster randomized controlled trial. A sepsis e-alert 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 hospital wards in 5 hospitals are randomized to active sepsis e-alert versus masked sepsis e-alert on 2-month sequences, with 5 wards in each sequence totaling 10 sequences. The primary endpoint is in-hospital mortality by 90 days. All data are extracted from EMR. Discussion The 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 (sepsis 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 outcomes analysis will facilitate unbiased analyses of these important clinical data. Trial registration ClinicalTrials.gov NCT04078594. Registered on September 6, 2019, https://clinicaltrials.gov/ct2/show/NCT04078594 Keywords Sepsis, Alert, Screening, qSOFA, mortality, electronic medical records 

Digital Adherence Technology for Tuberculosis Treatment Supervision: A Stepped-Wedge Cluster Randomized Trial

2020 ◽  
Author(s):  
Adithya Cattamanchi ◽  
Rebecca R. Crowder ◽  
Alex Kityamuwesi ◽  
Noah Kiwanuka ◽  
Maureen Lamunu ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Cluster Randomized Trial ◽  
Tuberculosis Treatment ◽  
Stepped Wedge ◽  
Cluster Randomized

scholarly journals Spread and scale of an electronic deprescribing software to improve health outcomes of older adults living in nursing homes: study protocol for a stepped wedge cluster randomized trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Marc-Eric Nadeau ◽  
Justine L. Henry ◽  
Todd C. Lee ◽  
Émilie Bortolussi-Courval ◽  
Carole Goodine ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomized Trial ◽  
Study Design ◽  
Long Term Care ◽  
Cluster Randomized Trial ◽  
Stepped Wedge ◽  
Term Care ◽  
Medication Reviews ◽  
Cluster Randomized

Abstract Background Medication overload or problematic polypharmacy is a major problem causing widespread harm, particularly to older adults. Taking multiple medications increases the risk of potentially inappropriate medications (PIMs), and residents in long-term care (LTC) are frequently prescribed 10 or more medications at once. One strategy to address this problem is for the physician and/or pharmacist to perform regular medication reviews; however, this process can be complicated and time-consuming. With a prescription review, medications may be decreased, changed, or stopped altogether. MedReviewRx is a software that runs an analysis using deprescribing rules to produce a report to guide medication reviews addressing medication overload for residents in LTC. Methods This study will employ a mixed methods effectiveness-implementation hybrid type 2 study design. To measure effectiveness, a stepped wedge cluster randomized trial design is planned, which allows us to approximate a randomized clinical trial. Approximately 1000 residents living in LTC will be recruited from five facilities in New Brunswick. The study will begin with 3 months of baseline data on rates of deprescribing. Thereafter, every 3 months a new cluster will enter the intervention mode. The intervention consists of medication reviews augmented with the MedReviewRx software, which will be used by staff and clinicians in the facilities. The estimated study duration is 18 months and the main outcome will be the proportion of patients with one or more PIMs deprescribed (reduced/stopped or changed to a safer alternative) in the 90 days following a prescription review. The goal is to study the impact of MedReviewRx on medication overload among older adults living in LTC. In typical fashion of a stepped wedge cluster randomized trial, each cluster acts as an internal control (before and after) as well as a control for the other clusters (external control). Qualitative data collected will include resident/caregiver attitudes towards deprescribing and semi-structured interviews with staff working in the long-term care homes. Discussion This study design addresses issues with seasonality and allows all clusters to participate in the intervention, which is an advantage when the intervention is related to quality improvement. This study will provide valuable information on PIM use, cost savings, and facilitators and challenges associated with medication reviews and deprescribing. This study represents an important step towards understanding and promoting tools to guide safe and rational reduction of PIM use among older adults. Trial registration NCT04762303, Registered February 21, 2021.

Variance formulae for multiphase stepped wedge cluster randomized trial

2020 ◽  
Vol 39 (28) ◽  
pp. 4147-4168 ◽  
Author(s):  
Pengyue Zhang ◽  
Abigail Shoben ◽  
Rebecca Jackson ◽  
Soledad Fernandez
Keyword(s):  
Randomized Trial ◽  
Cluster Randomized Trial ◽  
Stepped Wedge ◽  
Cluster Randomized

scholarly journals An Organizational-Level Program of Intervention for AKI: A Pragmatic Stepped Wedge Cluster Randomized Trial

2019 ◽  
Vol 30 (3) ◽  
pp. 505-515 ◽  
Author(s):  
Nicholas M. Selby ◽  
Anna Casula ◽  
Laura Lamming ◽  
John Stoves ◽  
Yohan Samarasinghe ◽  
...  
Keyword(s):  
Length Of Stay ◽  
Randomized Trial ◽  
Cluster Randomized Trial ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Organizational Level ◽  
Care Process ◽  
Standards Of Care ◽  
Stepped Wedge ◽  
Cluster Randomized

BackgroundVariable standards of care may contribute to poor outcomes associated with AKI. We evaluated whether a multifaceted intervention (AKI e-alerts, an AKI care bundle, and an education program) would improve delivery of care and patient outcomes at an organizational level.MethodsA multicenter, pragmatic, stepped-wedge cluster randomized trial was performed in five UK hospitals, involving patients with AKI aged ≥18 years. The intervention was introduced sequentially across fixed three-month periods according to a randomly determined schedule until all hospitals were exposed. The primary outcome was 30-day mortality, with pre-specified secondary endpoints and a nested evaluation of care process delivery. The nature of the intervention precluded blinding, but data collection and analysis were independent of project delivery teams.ResultsWe studied 24,059 AKI episodes, finding an overall 30-day mortality of 24.5%, with no difference between control and intervention periods. Hospital length of stay was reduced with the intervention (decreases of 0.7, 1.1, and 1.3 days at the 0.5, 0.6, and 0.7 quantiles, respectively). AKI incidence increased and was mirrored by an increase in the proportion of patients with a coded diagnosis of AKI. Our assessment of process measures in 1048 patients showed improvements in several metrics including AKI recognition, medication optimization, and fluid assessment.ConclusionsA complex, hospital-wide intervention to reduce harm associated with AKI did not reduce 30-day AKI mortality but did result in reductions in hospital length of stay, accompanied by improvements in in quality of care. An increase in AKI incidence likely reflected improved recognition.

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