scholarly journals Impact of Electronic Versus Paper Vital Sign Observations on Length of Stay in Trauma Patients: Stepped-Wedge, Cluster Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
David CW Wong ◽  
Julia Knight ◽  
Jacqueline Birks ◽  
Lionel Tarassenko ◽  
Peter J Watkinson
Keyword(s):  
Length Of Stay ◽  
Vital Sign ◽  
Controlled Trial ◽  
Early Warning Score ◽  
Trauma Patients ◽  
Stepped Wedge ◽  
Documentation System ◽  
Stay Time ◽  
Paper Documentation ◽  
Cluster Randomized

BACKGROUND Electronic recording of vital sign observations (e-Obs) has become increasingly prevalent in hospital care. The evidence of clinical impact for these systems is mixed. OBJECTIVE The objective of our study was to assess the effect of e-Obs versus paper documentation (paper) on length of stay (time between trauma unit admission and “fit to discharge”) for trauma patients. METHODS A single-center, randomized stepped-wedge study of e-Obs against paper was conducted in two 26-bed trauma wards at a medium-sized UK teaching hospital. Randomization of the phased intervention order to 12 study areas was computer generated. The primary outcome was length of stay. RESULTS A total of 1232 patient episodes were randomized (paper: 628, e-Obs: 604). There were 37 deaths in hospital: 21 in the paper arm and 16 in the e-Obs arm. For discharged patients, the median length of stay was 5.4 (range: 0.2-79.0) days on the paper arm and 5.6 (range: 0.1-236.7) days on the e-Obs arm. Competing risks regression analysis for time to discharge showed no difference between the treatment arms (subhazard ratio: 1.05; 95% CI 0.82-1.35; P=.68). A greater proportion of patient episodes contained an Early Warning Score (EWS) ≥3 using the e-Obs system than using paper (subhazard ratio: 1.63; 95% CI 1.28-2.09; P<.001). However, there was no difference in the time to the subsequent observation, “escalation time” (hazard ratio 1.05; 95% CI 0.80-1.38; P=.70). CONCLUSIONS The phased introduction of an e-Obs documentation system was not associated with a change in length of stay. A greater proportion of patient episodes contained an EWS≥3 using the e-Obs system, but this was not associated with a change in “escalation time.” CLINICALTRIAL ISRCTN Registry ISRCTN91040762; http://www.isrctn.com/ISRCTN91040762 (Archived by WebCite at http://www.webcitation.org/72prakGTU)

scholarly journals Narrative enhancement and cognitive therapy (NECT) to improve social functioning in people with serious mental illness: study protocol for a stepped-wedge cluster randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
J. Dubreucq ◽  
M. Faraldo ◽  
M. Abbes ◽  
B. Ycart ◽  
H. Richard-Lepouriel ◽  
...  
Keyword(s):  
Mental Illness ◽  
Randomized Controlled Trial ◽  
Cognitive Therapy ◽  
Social Functioning ◽  
Serious Mental Illness ◽  
Controlled Trial ◽  
Control Group ◽  
Stepped Wedge ◽  
Randomized Controlled ◽  
Cluster Randomized

Abstract Background Self-stigma is highly prevalent in serious mental illness (SMI) and is associated with poorer clinical and functional outcomes. Narrative enhancement and cognitive therapy (NECT) is a group-based intervention combining psychoeducation, cognitive restructuring and story-telling exercises to reduce self-stigma and its impact on recovery-related outcomes. Despite evidence of its effectiveness on self-stigma in schizophrenia-related disorders, it is unclear whether NECT can impact social functioning. Methods This is a 12-centre stepped-wedge cluster randomized controlled trial of NECT effectiveness on social functioning in SMI, compared to treatment as usual. One hundred and twenty participants diagnosed with schizophrenia, bipolar disorder or borderline personality disorder will be recruited across the 12 sites. The 12 centres participating to the study will be randomized into two groups: one group (group 1) receiving the intervention at the beginning of the study (T0) and one group (group 2) being a control group for the first 6 months and receiving the intervention after (T1). Outcomes will be compared in both groups at T0 and T1, and 6-month and 12-month outcomes for groups 1 and 2 will be measured without a control group at T2 (to evaluate the stability of the effects over time). Evaluations will be conducted by assessors blind to treatment allocation. The primary outcome is personal and social performance compared across randomization groups. Secondary outcomes include self-stigma, self-esteem, wellbeing, quality of life, illness severity, depressive symptoms and personal recovery. Discussion NECT is a promising intervention for reducing self-stigma and improving recovery-related outcomes in SMI. If shown to be effective in this trial, it is likely that NECT will be implemented in psychiatric rehabilitation services with subsequent implications for routine clinical practice. Trial registration ClinicalTrials.gov NCT03972735. Trial registration date 31 May 2019.

scholarly journals Early recognition and response to increases in surgical site infections using optimized statistical process control charts—the Early 2RIS Trial: a multicenter cluster randomized controlled trial with stepped wedge design

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Deverick J. Anderson ◽  
Iulian Ilieş ◽  
Katherine Foy ◽  
Nicole Nehls ◽  
James C. Benneyan ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Process Control ◽  
Statistical Process Control ◽  
Controlled Trial ◽  
Surgical Site Infections ◽  
Stepped Wedge ◽  
Statistical Process ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
Traditional Surveillance

Abstract Background Surgical site infections (SSIs) cause significant patient suffering. Surveillance and feedback of SSI rates is an evidence-based strategy to reduce SSIs, but traditional surveillance methods are slow and prone to bias. The objective of this cluster randomized controlled trial (RCT) is to determine if using optimized statistical process control (SPC) charts for SSI surveillance and feedback lead to a reduction in SSI rates compared to traditional surveillance. Methods The Early 2RIS Trial is a prospective, multicenter cluster RCT using a stepped wedge design. The trial will be performed in 29 hospitals in the Duke Infection Control Outreach Network (DICON) and 105 clusters over 4 years, from March 2016 through February 2020; year one represents a baseline period; thereafter, 8–9 clusters will be randomized to intervention every 3 months over a 3-year period using a stepped wedge randomization design. All patients who undergo one of 13 targeted procedures at study hospitals will be included in the analysis; these procedures will be included in one of six clusters: cardiac, orthopedic, gastrointestinal, OB-GYN, vascular, and spinal. All clusters will undergo traditional surveillance for SSIs; once randomized to intervention, clusters will also undergo surveillance and feedback using optimized SPC charts. Feedback on surveillance data will be provided to all clusters, regardless of allocation or type of surveillance. The primary endpoint is the difference in rates of SSI between the SPC intervention compared to traditional surveillance and feedback alone. Discussion The traditional approach for SSI surveillance and feedback has several major deficiencies because SSIs are rare events. First, traditional statistical methods require aggregation of measurements over time, which delays analysis until enough data accumulate. Second, traditional statistical tests and resulting p values are difficult to interpret. Third, analyses based on average SSI rates during predefined time periods have limited ability to rapidly identify important, real-time trends. Thus, standard analytic methods that compare average SSI rates between arbitrarily designated time intervals may not identify an important SSI rate increase on time unless the “signal” is very strong. Therefore, novel strategies for early identification and investigation of SSI rate increases are needed to decrease SSI rates. While SPC charts are used throughout industry and healthcare to improve and optimize processes, including other types of healthcare-associated infections, they have not been evaluated as a tool for SSI surveillance and feedback in a randomized trial. Trial registration ClinicalTrials.govNCT03075813, Registered March 9, 2017.

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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