Electronic audit and feedback intervention with action implementation toolbox to improve pain management in intensive care: protocol for a laboratory experiment and cluster randomised trial

IntroductionFasting is frequently imposed to patients before extubation in the intensive care unit based on scheduled surgery guidelines. This practice has never been evaluated among critically ill patients and may delay extubation, increase nursing workload and reduce caloric intake. We are hypothesising that continuous enteral nutrition until extubation represents a safe alternative compared with fasting prior to extubation in the intensive care unit.Methods and analysisAdult patients ventilated more than 48 hours and receiving pre-pyloric enteral nutrition for more than 24 hours are included in this open-label cluster randomised parallel group non-inferiority trial. The participating centres are randomised allocated to continued enteral nutrition until extubation or 6-hour fasting (with concomitant gastric suctioning when feasible) prior to extubation. The primary outcome is extubation failure (ie, reintubation within 7 days following extubation).Ethics and disseminationThis study has been approved by the national ethics review board (comité de protection, des personnes Sud Mediterranée III No 2017.10.02 bis) and patients are included after informed consent. Results will be submitted for publication in peer-reviewed journals.Trial registration numberClinicalTrials.gov Registry (NCT03335345).

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Re: Effect of Body Surface Decolonisation on Bacteriuria and Candiduria in Intensive Care Units: An Analysis of a Cluster-Randomised Trial

The Journal of Urology ◽

10.1016/j.juro.2016.04.033 ◽

2016 ◽

Vol 196 (1) ◽

pp. 115-116

Author(s):

Edward M. Schaeffer

Keyword(s):

Intensive Care ◽

Intensive Care Units ◽

Body Surface ◽

Randomised Trial ◽

Cluster Randomised Trial ◽

Cluster Randomised

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Statistical Analysis Plan for the MSK DI AF trial

10.31219/osf.io/prnd2 ◽

2021 ◽

Author(s):

Laurent Billot ◽

Denise O'Connor ◽

Brigit Maguire ◽

Dina Schram ◽

Robert Ma ◽

...

Keyword(s):

Statistical Analysis ◽

Diagnostic Imaging ◽

Randomised Trial ◽

Statistical Analysis Plan ◽

Primary Objective ◽

Audit And Feedback ◽

Cluster Randomised Trial ◽

Cluster Randomised ◽

Trial Testing ◽

Australian General Practice

The primary objective of the MSK DI AF trial is to estimate the effectiveness of audit and feedback for reducing diagnostic imaging requests for 11 musculoskeletal imaging services in high requesting GPs in Australia compared with control. It is a 5-arm partial 2 x 2 factorial cluster randomised trial testing variations in the design and delivery of audit and feedback for reducing musculoskeletal diagnostic imaging requests in Australian general practice. This statistical analysis plan pre-specifies all analyses and was prepared while blinded to the randomised allocation.

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Implementation of the ERAS (Enhanced Recovery After Surgery) protocol for colorectal cancer surgery in the Piemonte Region with an Audit and Feedback approach: study protocol for a stepped wedge cluster randomised trial: a study of the EASY-NET project

BMJ Open ◽

10.1136/bmjopen-2020-047491 ◽

2021 ◽

Vol 11 (6) ◽

pp. e047491

Author(s):

Eva Pagano ◽

Luca Pellegrino ◽

Federica Rinaldi ◽

Valentina Palazzo ◽

Danilo Donati ◽

...

Keyword(s):

Colorectal Cancer ◽

Enhanced Recovery ◽

Enhanced Recovery After Surgery ◽

Randomised Trial ◽

Audit And Feedback ◽

Cluster Randomised Trial ◽

Stepped Wedge ◽

Colorectal Cancer Surgery ◽

Cluster Randomised ◽

Eras Protocol

IntroductionThe ERAS protocol (Enhanced Recovery After Surgery) is a multimodal pathway aimed to reduce surgical stress and to allow a rapid postoperative recovery. Application of the ERAS protocol to colorectal cancer surgery has been limited to a minority of hospitals in Italy. To promote the systematic adoption of ERAS in the entire regional hospital network in Piemonte an Audit and Feedback approach (A&F) has been adopted together with a cluster randomised trial to estimate the true impact of the protocol on a large, unselected population.MethodsA multicentre stepped wedge cluster randomised trial is designed for comparison between standard perioperative management and the management according to the ERAS protocol. The primary outcome is the length of hospital stay (LOS). Secondary outcomes are: incidence of postoperative complications, time to patients’ recovery, control of pain and patients’ satisfaction. With an A&F approach the adherence to the ERAS items is monitored through a dedicated area in the study web site. The study includes 28 surgical centres, stratified by activity volume and randomly divided into four groups. Each group is randomly assigned to a different activation period of the ERAS protocol. There are four activation periods, one every 3 months. However, the planned calendar and the total duration of the study have been extended by 6 months due to the COVID-19 pandemic.The expected sample size of about 2200 patients has a high statistical power (98%) to detect a reduction of LOS of 1 day and to estimate clinically meaningful changes in the other endpoints.Ethics and disseminationThe study protocol has been approved by the Ethical Committee of the coordinating centre and by all participating centres. Study results will be timely circulated within the hospital network and published in peer-reviewed journals.Trial registration numberNCT04037787.

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Menstrual health intervention and school attendance in Uganda (MENISCUS-2): a pilot intervention study

BMJ Open ◽

10.1136/bmjopen-2019-031182 ◽

2020 ◽

Vol 10 (2) ◽

pp. e031182 ◽

Cited By ~ 2

Author(s):

Catherine Kansiime ◽

Laura Hytti ◽

Ruth Nalugya ◽

Kevin Nakuya ◽

Prossy Namirembe ◽

...

Keyword(s):

Pain Management ◽

School Attendance ◽

Qualitative Interviews ◽

Randomised Trial ◽

Secondary Outcome ◽

Cluster Randomised Trial ◽

Behavioural Intervention ◽

Cluster Randomised ◽

Menstrual Health ◽

Pilot Intervention

ObjectivesAchieving good menstrual health and hygiene (MHH) is a public health challenge and there is little evidence to inform interventions. The aim of this study was to pilot test an intervention to improve MHH and school attendance in Uganda, in preparation for a future cluster-randomised trial.DesignLongitudinal study with pre–post evaluation of a pilot intervention.SettingTwo secondary schools in Entebbe, Uganda.ParticipantsOf the 473 eligible students in secondary 2 (S2) at baseline, 450 (95.1%; 232 girls and 218 boys) consented/assented. 369 students (188 girls; 81.0%; and 181 boys; 83.0%) participated in the endline survey.InterventionThe intervention comprised training teachers to improve delivery of government guidelines for puberty education, training in use of a menstrual kit and pain management, a drama skit, provision of analgesics and improvements to school water and sanitation hygiene facilities.Primary and secondary outcome measuresFeasibility and acceptability of delivering the intervention. Baseline and endline quantitative surveys were conducted, with qualitative interviews conducted at endline. School attendance was assessed using self-completed daily diaries among a nested cohort of 100 female students.ResultsThere were high levels of uptake of the individual and behavioural intervention components (puberty education, drama skit, menstrual hygiene management (MHM) kit and pain management). The proportion of girls reporting anxiety about next period decreased from 58.6% to 34.4%, and reported use of effective pain management increased from 76.4% to 91.4%. Most girls (81.4%) reported improved school toilet facilities, which improved their comfort managing menstruation. The diary data and qualitative data indicated a potential intervention impact on improving menstrual-related school absenteeism.ConclusionsThe pilot study showed that the multicomponent MHM intervention was acceptable and feasible to deliver, and potentially effective in improving menstruation knowledge and management. A cluster-randomised trial is needed to evaluate rigorously the intervention effects on MHM and school attendance.Trial registration numberNCT04064736; Pre-results.

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