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 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.

Recovering from critical illness in hospital

2016 ◽  
Author(s):  
Saxon Ridley
Keyword(s):  
Intensive Care ◽  
Critical Illness ◽  
Adverse Events ◽  
General Ward ◽  
Organ Support ◽  
Icu Discharge ◽  
Short Period ◽  
P Recovery ◽  
The Impact

Recovery from critical illness may not be smooth and uneventful for the patient. Complications and adverse events may beset the patient and lead to intensive care unit (ICU) re-admission. Problems upsetting patients after discharge may be a manifestation of post-intensive care syndrome, new or recurrent organ failure. Avoiding post-ICU complications may be prevented by ensuring a well-planned transition from ICU to the general ward. This may be achieved by minimizing the impact and duration of organ support, defining a structured rehabilitation programme prior to ICU discharge. After discharge a short period spent on an intermediate care unit with higher nursing staff ratios, together with follow-up on the general ward will help identify and treat any new problems. Unfortunately, re-admission may be required to effectively treat some complications. There are recognized risk factors for ICU re-admission and these should be used to warn of the increased likelihood of adverse events to aid appropriate planning avoiding re-admission to ICU.

scholarly journals Full title: My Baby’s Movements: a stepped-wedge cluster-randomised controlled trial of a fetal movement awareness intervention to reduce stillbirths

2021 ◽  
Author(s):  
Vicki Flenady ◽  
Glen Gardener ◽  
David Ellwood ◽  
Michael Coory ◽  
Megan Weller ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Stillbirth Rate ◽  
Stepped Wedge ◽  
Calendar Time ◽  
Cluster Randomised ◽  
Maternity Hospitals ◽  
Randomised Controlled ◽  
The Impact

Objective The My Baby’s Movements (MBM) trial aimed to evaluate the impact on stillbirth rates of a multifaceted awareness package (MBM intervention). Design Stepped-wedge cluster-randomised controlled trial. Setting Twenty-seven maternity hospitals in Australia and New Zealand. Population Women with a singleton pregnancy without major fetal anomaly ≥28 weeks’ gestation from August 2016-May 2019. Methods The MBM intervention was implemented at randomly assigned time points with sequential introduction into 8 clusters of 3-5 hospitals at four-monthly intervals. The stillbirth rate was compared in the control and intervention periods. Generalised linear mixed models controlled for calendar time, clustering, and hospital effects. Outcome Measures Stillbirth at ≥28 weeks’ gestation. Results There were 304,853 births with 290,219 meeting inclusion criteria: 150,079 in control and 140,140 in intervention periods. The stillbirth rate during the intervention was lower than the control period (2.2/1000 births versus 2.4, odds ratio [OR] 0.91, 95% Confidence Intervals [CI] 0.78-1.06, p=0.22). The decrease was larger across calendar time with 2.7/1000 in the first 18 months versus 2.0/1000 in the last 18 months (OR 0.74; 95% CI 0.63-0.86; p≤0.01). Following adjustment, stillbirth rates between the control and intervention periods were not significantly different: (aOR 1.18, 95% CI 0.93-1.50; p=0.18). No increase in secondary outcomes, including obstetric intervention or adverse neonatal outcome, was evident. Conclusion The MBM intervention did not reduce stillbirths beyond the downward trend over time, suggesting hospitals may have implemented best practice in DFM management outside their randomisation schedule. The role of interventions for raising awareness of DFM remains unclear

scholarly journals The impact of critical care transition programs on outcomes after intensive care unit (ICU) discharge: can we get there from here?

2016 ◽  
Vol 8 (7) ◽  
pp. 1374-1376 ◽  
Author(s):  
Regis Goulart Rosa ◽  
Juçara Gasparetto Maccari ◽  
Ricardo Viegas Cremonese ◽  
Tulio Frederico Tonietto ◽  
Rafael Viegas Cremonese ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Critical Care ◽  
Intensive Care ◽  
Transition Programs ◽  
Care Transition ◽  
Icu Discharge ◽  
The Impact

scholarly journals Intensive care units follow-up: a scoping review protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e037725
Author(s):  
Danielle Prevedello ◽  
Marco Fiore ◽  
Jacques Creteur ◽  
J C Preiser
Keyword(s):  
Quality Of Life ◽  
Intensive Care ◽  
Scoping Review ◽  
Grey Literature ◽  
Icu Discharge ◽  
Scoping Reviews ◽  
The Impact

IntroductionIncreasing numbers of patients are surviving critical illness, leading to growing concern about the potential impact of the long-term consequences of intensive care on patients, families and society as a whole. These long-term effects are together known as postintensive care syndrome and their presence can be evaluated at intensive care unit (ICU) follow-up consultations. However, the services provided by these consultations vary across hospitals and units, in part because there is no validated standard model to evaluate patients and their quality of life after ICU discharge. We describe a protocol for a scoping review focusing on models of ICU follow-up and the impact of such strategies on improving patient quality of life.Methods and analysisIn this scoping review, we will search the literature systematically using electronic databases (MEDLINE - from database inception to June 15th 2020) and a grey literature search. We will involve stakeholders as recommended by the Joanna Briggs Institute approach developed by Peters et al. The research will be conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines.Ethics and disseminationThis study does not require ethics approval, because data will be obtained through a review of published primary studies. The results of our evaluation will be published in a peer-reviewed journal and will also be disseminated through presentations at national and international conferences.

scholarly journals Menstrual cups and cash transfer to reduce sexual and reproductive harm and school dropout in adolescent schoolgirls: study protocol of a cluster-randomised controlled trial in western Kenya

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Garazi Zulaika ◽  
Daniel Kwaro ◽  
Elizabeth Nyothach ◽  
Duolao Wang ◽  
Emily Zielinski-Gutierrez ◽  
...  
Keyword(s):  
School Dropout ◽  
Cash Transfer ◽  
Sub Saharan Africa ◽  
School Level ◽  
Early Marriage ◽  
Western Kenya ◽  
Link Type ◽  
Cluster Randomised ◽  
Randomised Controlled ◽  
The Impact

Abstract Background Adolescent girls in sub-Saharan Africa are disproportionally vulnerable to sexual and reproductive health (SRH) harms. In western Kenya, where unprotected transactional sex is common, young females face higher rates of school dropout, often due to pregnancy, and sexually transmitted infections (STIs), including HIV. Staying in school has shown to protect girls against early marriage, teen pregnancy, and HIV infection. This study evaluates the impact of menstrual cups and cash transfer interventions on a composite of deleterious outcomes (HIV, HSV-2, and school dropout) when given to secondary schoolgirls in western Kenya, with the aim to inform evidence-based policy to improve girls’ health, school equity, and life-chances. Methods Single site, 4-arm, cluster randomised controlled superiority trial. Secondary schools are the unit of randomisation, with schoolgirls as the unit of measurement. Schools will be randomised into one of four intervention arms using a 1:1:1:1 ratio and block randomisation: (1) menstrual cup arm; (2) cash transfer arm, (3) cups and cash combined intervention arm, or (4) control arm. National and county agreement, and school level consent will be obtained prior to recruitment of schools, with parent consent and girls’ assent obtained for participant enrolment. Participants will be trained on safe use of interventions, with all arms receiving puberty and hygiene education. Annually, the state of latrines, water availability, water treatment, handwashing units and soap in schools will be measured. The primary endpoint is a composite of incident HIV, HSV-2, and all-cause school dropout, after 3 years follow-up. School dropout will be monitored each term via school registers and confirmed through home visits. HIV and HSV-2 incident infections and risk factors will be measured at baseline, mid-line and end-line. Intention to treat analysis will be conducted among all enrolled participants. Focus group discussions will provide contextual information on uptake of interventions. Monitoring for safety will occur throughout. Discussion If proved safe and effective, the interventions offer a potential contribution toward girls’ schooling, health, and equity in low- and middle-income countries. Trial registration ClinicalTrials.gov NCT03051789, 15th February 2017.

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