scholarly journals Enhanced Recovery after Intensive Care (ERIC): study protocol for a stepped-wedge cluster randomized controlled trial to evaluate the effectiveness of a critical care telehealth program on process quality and functional outcomes

2020 ◽  
Author(s):  
Christine Adrion ◽  
Björn Weiss ◽  
Nicolas Paul ◽  
Elke Berger ◽  
Reinhard Busse ◽  
...  
Keyword(s):  
Intensive Care ◽  
Quality Improvement ◽  
Critical Illness ◽  
Standard Of Care ◽  
Stepped Wedge ◽  
Randomized Controlled ◽  
Link Type ◽  
Icu Discharge ◽  
Cluster Randomized

ABSTRACTIntroductionSurvival after critical illness has noticeably improved over the last decades due to advances in critical care medicine. Besides, there are an increasing number of elderly patients with chronic diseases being treated in the intensive care unit (ICU). More than half of the survivors of critical illness suffer from medium- or long-term cognitive, psychological and/or physical impairments after ICU discharge, which is recognized as post intensive care syndrome (PICS). There are evidence- and consensus-based quality indicators (QIs) in intensive care medicine, which have a positive influence on patients’ long-term outcomes if adhered to.Methods and analysisThe protocol of a multicentre, pragmatic, stepped wedge cluster-randomized controlled, quality improvement trial is presented. During three predefined steps, 12 academic hospitals in Berlin and Brandenburg, Germany, are randomly selected to move in a 1-way crossover from the control to the intervention condition. After a multifactorial training programme on QIs and clinical outcomes for site personnel ICUs will receive an adapted, interprofessional protocol for a complex telehealth intervention comprising of daily telemedical rounds at ICU. The targeted sample size is 1431 patients. The primary objective of this trial is to evaluate the effectiveness of the intervention on the adherence to 8 QIs daily measured during the patient’s ICU stay, compared to standard of care. Furthermore, the impact on long-term recovery such as PICS-related patient-centred outcomes including health-related quality-of-life, mental health, clinical assessments of cognition and physical function, all-cause mortality, and cost-effectiveness 3 and 6 months after ICU discharge will be evaluated.Ethics and disseminationThis protocol was approved by the ethics committee of the Charité Universitätsmedizin, Berlin, Germany (EA1/006/18). The results will be published in a peer-reviewed journal and presented at conferences. Study findings will also be disseminated via the website (https://www.eric-projekt.de).Trial registration numberClinicalTrials.gov NCT03671447 (https://clinicaltrials.gov/ct2/show/NCT03671447, 22 August 2018)ARTICLE SUMMARYStrengths and limitations of this study▪Telemedicine-based care potentially improves the adherence to quality indicators (QIs) in intensive care medicine, which accelerate patient recovery and improve long-term outcomes after critical illness.▪ERIC is the first large-scale cluster-randomized controlled trial to be carried out in ICUs in Berlin and Brandenburg, Germany, comparing the clinical and cost effectiveness of a telehealth-based quality improvement intervention to standard of care.▪By employing a stepped-wedge design, this quality improvement study will allow each cluster to act as its own control and preserve the internal validity of the study, with a potential for confounding by secular trends.▪The nature of the intervention does not allow blinding of study personnel and eligible patients at ICUs and might be confronted with cross-contamination and staff turnover.▪ERIC allows getting a comprehensive evaluation from the patient’s perspective, healthcare staff and health economics and assessing its suitability to become standard of care.

scholarly journals Enhanced Recovery after Intensive Care (ERIC): study protocol for a German stepped wedge cluster randomised controlled trial to evaluate the effectiveness of a critical care telehealth program on process quality and functional outcomes

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e036096 ◽  
Author(s):  
Christine Adrion ◽  
Bjoern Weiss ◽  
Nicolas Paul ◽  
Elke Berger ◽  
Reinhard Busse ◽  
...  
Keyword(s):  
Critical Care ◽  
Intensive Care ◽  
Critical Illness ◽  
Stepped Wedge ◽  
Link Type ◽  
Cluster Randomised ◽  
Icu Discharge ◽  
Randomised Controlled ◽  
The Impact

IntroductionSurvival after critical illness has noticeably improved over the last decades due to advances in critical care medicine. Besides, there is an increasing number of elderly patients with chronic diseases being treated in the intensive care unit (ICU). More than half of the survivors of critical illness suffer from medium-term or long-term cognitive, psychological and/or physical impairments after ICU discharge, which is recognised as post-intensive care syndrome (PICS). There are evidence-based and consensus-based quality indicators (QIs) in intensive care medicine, which have a positive influence on patients’ long-term outcomes if adhered to.Methods and analysisThe protocol of a multicentre, pragmatic, stepped wedge cluster randomised controlled, quality improvement trial is presented. During 3 predefined steps, 12 academic hospitals in Berlin and Brandenburg, Germany, are randomly selected to move in a one-way crossover from the control to the intervention condition. After a multifactorial training programme on QIs and clinical outcomes for site personnel, ICUs will receive an adapted, interprofessional protocol for a complex telehealth intervention comprising of daily telemedical rounds at ICU. The targeted sample size is 1431 patients. The primary objective of this trial is to evaluate the effectiveness of the intervention on the adherence to eight QIs daily measured during the patient’s ICU stay, compared with standard of care. Furthermore, the impact on long-term recovery such as PICS-related, patient-centred outcomes including health-related quality of life, mental health, clinical assessments of cognition and physical function, all-cause mortality and cost-effectiveness 3 and 6 months after ICU discharge will be evaluated.Ethics and disseminationThis protocol was approved by the ethics committee of the Charité—Universitätsmedizin, Berlin, Germany (EA1/006/18). The results will be published in a peer-reviewed scientific journal and presented at international conferences. Study findings will also be disseminated via the website (www.eric-projekt.net).Trial registration numberClinicalTrials.gov Registry (NCT03671447).

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 

scholarly journals Healthcare trajectories before and after critical illness: population-based insight on diverse patients clusters

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Youenn Jouan ◽  
Leslie Grammatico-Guillon ◽  
Noémie Teixera ◽  
Claire Hassen-Khodja ◽  
Christophe Gaborit ◽  
...  
Keyword(s):  
Septic Shock ◽  
Mechanical Ventilation ◽  
Intensive Care ◽  
Critical Illness ◽  
Length Of Stay ◽  
Population Based ◽  
Hospital Length Of Stay ◽  
Healthcare Use ◽  
Icu Admission ◽  
Icu Discharge

Abstract Background The post intensive care syndrome (PICS) gathers various disabilities, associated with a substantial healthcare use. However, patients’ comorbidities and active medical conditions prior to intensive care unit (ICU) admission may partly drive healthcare use after ICU discharge. To better understand retative contribution of critical illness and PICS—compared to pre-existing comorbidities—as potential determinant of post-critical illness healthcare use, we conducted a population-based evaluation of patients’ healthcare use trajectories. Results Using discharge databases in a 2.5-million-people region in France, we retrieved, over 3 years, all adult patients admitted in ICU for septic shock or acute respiratory distress syndrome (ARDS), intubated at least 5 days and discharged alive from hospital: 882 patients were included. Median duration of mechanical ventilation was 11 days (interquartile ranges [IQR] 8;20), mean SAPS2 was 49, and median hospital length of stay was 42 days (IQR 29;64). Healthcare use (days spent in healthcare facilities) was analyzed 2 years before and 2 years after ICU admission. Prior to ICU admission, we observed, at the scale of the whole study population, a progressive increase in healthcare use. Healthcare trajectories were then explored at individual level, and patients were assembled according to their individual pre-ICU healthcare use trajectory by clusterization with the K-Means method. Interestingly, this revealed diverse trajectories, identifying patients with elevated and increasing healthcare use (n = 126), and two main groups with low (n = 476) or no (n = 251) pre-ICU healthcare use. In ICU, however, SAPS2, duration of mechanical ventilation and length of stay were not different across the groups. Analysis of post-ICU healthcare trajectories for each group revealed that patients with low or no pre-ICU healthcare (which represented 83% of the population) switched to a persistent and elevated healthcare use during the 2 years post-ICU. Conclusion For 83% of ARDS/septic shock survivors, critical illness appears to have a pivotal role in healthcare trajectories, with a switch from a low and stable healthcare use prior to ICU to a sustained higher healthcare recourse 2 years after ICU discharge. This underpins the hypothesis of long-term critical illness and PICS-related quantifiable consequences in healthcare use, measurable at a population level.

scholarly journals Frequency of repositioning for preventing pressure ulcers in patients hospitalized in ICU: protocol of a cluster randomized controlled trial

BMC Nursing ◽  
2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Olga L. Cortés ◽  
Mauricio Herrera-Galindo ◽  
Juan Carlos Villar ◽  
Yudi A. Rojas ◽  
María del Pilar Paipa ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Critical Care ◽  
Pressure Ulcers ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Link Type ◽  
Cluster Randomized ◽  
The Impact

Abstract Background Despite being considered preventable, ulcers due to pressure affect between 30 and 50% of patients at high and very high risk and susceptibility, especially those hospitalized under critical care. Despite a lack of evidence over the efficacy in prevention against ulcers due to pressure, hourly repositioning in critical care as an intervention is used with more or less frequency to alleviate pressure on patients’ tissues. This brings up the objective of our study, which is to evaluate the efficacy in prevention of ulcers due to pressure acquired during hospitalization, specifically regarding two frequency levels of repositioning or manual posture switching in adults hospitalized in different intensive care units in different Colombian hospitals. Methods A nurse-applied cluster randomized controlled trial of parallel groups (two branches), in which 22 eligible ICUs (each consisting of 150 patients), will be randomized to a high-frequency level repositioning intervention or to a conventional care (control group). Patients will be followed until their exit from each cluster. The primary result of this study is originated by regarding pressure ulcers using clusters (number of first ulcers per patient, at the early stage of progression, first one acquired after admission for 1000 days). The secondary results include evaluating the risk index on the patients’ level (Hazard ratio, 95% IC) and a description of repositioning complications. Two interim analyses will be performed through the course of this study. A statistical difference between the groups < 0.05 in the main outcome, the progression of ulcers due to pressure (best or worst outcome in the experimental group), will determine whether the study should be put to a halt/determine the termination of the study. Conclusion This study is innovative in its use of clusters to advance knowledge of the impact of repositioning as a prevention strategy against the appearance of ulcers caused by pressure in critical care patients. The resulting recommendations of this study can be used for future clinical practice guidelines in prevention and safety for patients at risk. Trial registration PENFUP phase-2 was Registered in Clinicaltrials.gov (NCT04604665) in October 2020.

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.

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