Hospital-wide ELectronic medical record evaluated computerised decision support system to improve outcomes of Patients with staphylococcal bloodstream infection (HELP): study protocol for a multicentre stepped-wedge cluster randomised trial

IntroductionStaphylococci are the most commonly identified pathogens in bloodstream infections. Identification of Staphylococcus aureus in blood culture (SAB) requires a prompt and adequate clinical management. The detection of coagulase-negative staphylococci (CoNS), however, corresponds to contamination in about 75% of the cases. Nevertheless, antibiotic therapy is often initiated, which contributes to the risk of drug-related side effects. We developed a computerised clinical decision support system (HELP-CDSS) that assists physicians with an appropriate management of patients with Staphylococcus bacteraemia. The CDSS is evaluated using data of the Data Integration Centers (DIC) established at each clinic. DICs transform heterogeneous primary clinical data into an interoperable format, and the HELP-CDSS displays information according to current best evidence in bacteraemia treatment. The overall aim of the HELP-CDSS is a safe but more efficient allocation of infectious diseases specialists and an improved adherence to established guidelines in the treatment of SAB.Methods and analysisThe study is conducted at five German university hospitals and is designed as a stepped-wedge cluster randomised trial. Over the duration of 18 months, 135 wards will change from a control period to the intervention period in a randomised stepwise sequence. The coprimary outcomes are hospital mortality for all patients to establish safety, the 90-day disease reoccurrence-free survival for patients with SAB and the cumulative vancomycin use for patients with CoNS bacteraemia. We will use a closed, hierarchical testing procedure and generalised linear mixed modelling to test for non-inferiority of the CDSS regarding hospital mortality and 90-day disease reoccurrence-free survival and for superiority of the HELP-CDSS regarding cumulative vancomycin use.Ethics and disseminationThe study is approved by the ethics committee of Jena University Hospital and will start at each centre after local approval. Results will be published in a peer-reviewed journal and presented at scientific conferences.Trial registration numberDRKS00014320.

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Cluster randomised trial of a computer based decision support system (CDSS) and decision aid for patients with high blood pressure in the community

http://isrctn.org/> ◽

10.1186/isrctn25487120 ◽

2013 ◽

Author(s):

Tom Fahey

Keyword(s):

Blood Pressure ◽

Decision Support ◽

Decision Support System ◽

High Blood Pressure ◽

Support System ◽

Decision Aid ◽

Randomised Trial ◽

Cluster Randomised Trial ◽

Cluster Randomised ◽

Computer Based

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Implementation and evaluation of short peripheral intravenous catheter flushing guidelines: a stepped wedge cluster randomised trial

BMC Medicine ◽

10.1186/s12916-020-01728-1 ◽

2020 ◽

Vol 18 (1) ◽

Author(s):

Samantha Keogh ◽

Caroline Shelverton ◽

Julie Flynn ◽

Gabor Mihala ◽

Saira Mathew ◽

...

Keyword(s):

Patient Outcomes ◽

Control Period ◽

Randomised Trial ◽

Intervention Group ◽

Trial Registration ◽

Cluster Randomised Trial ◽

Stepped Wedge ◽

Intention To Treat ◽

Cluster Randomised ◽

The Impact

Abstract Background Peripheral intravenous catheters (PIVCs) are ubiquitous medical devices, crucial to providing essential fluids and drugs. However, post-insertion PIVC failure occurs frequently, likely due to inconsistent maintenance practice such as flushing. The aim of this implementation study was to evaluate the impact a multifaceted intervention centred on short PIVC maintenance had on patient outcomes. Methods This single-centre, incomplete, stepped wedge, cluster randomised trial with an implementation period was undertaken at a quaternary hospital in Queensland, Australia. Eligible patients were from general medical and surgical wards, aged ≥ 18 years, and requiring a PIVC for > 24 h. Wards were the unit of randomisation and allocation was concealed until the time of crossover to the implementation phase. Patients, clinicians, and researchers were not masked but infections were adjudicated by a physician masked to allocation. Practice during the control period was standard care (variable practice with manually prepared flushes of 0.9% sodium chloride). The intervention group received education reinforcing practice guidelines (including administration with manufacturer-prepared pre-filled flush syringes). The primary outcome was all-cause PIVC failure (as a composite of occlusion, infiltration, dislodgement, phlebitis, and primary bloodstream or local infection). Analysis was by intention-to-treat. Results Between July 2016 and February 2017, 619 patients from 9 clusters (wards) were enrolled (control n = 306, intervention n = 313), with 617 patients comprising the intention-to-treat population. PIVC failure was 91 (30%) in the control and 69 (22%) in the intervention group (risk difference − 8%, 95% CI − 14 to − 1, p = 0.032). Total costs were lower in the intervention group. No serious adverse events related to study intervention occurred. Conclusions This study demonstrated the effectiveness of post-insertion PIVC flushing according to recommended guidelines. Evidence-based education, surveillance and products for post-insertion PIVC management are vital to improve patient outcomes. Trial registration Trial submitted for registration on 25 January 2016. Approved and retrospectively registered on 4 August 2016. Ref: ACTRN12616001035415.

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Correction: Implementing a structured model for osteoarthritis care in primary healthcare: A stepped-wedge cluster-randomised trial

PLoS Medicine ◽

10.1371/journal.pmed.1002993 ◽

2019 ◽

Vol 16 (12) ◽

pp. e1002993

Author(s):

Nina Østerås ◽

Tuva Moseng ◽

Leti van Bodegom-Vos ◽

Krysia Dziedzic ◽

Ibrahim Mdala ◽

...

Keyword(s):

Primary Healthcare ◽

Randomised Trial ◽

Cluster Randomised Trial ◽

Stepped Wedge ◽

Structured Model ◽

Cluster Randomised

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Effectiveness of Seasonal Malaria Chemoprevention in Children under Ten Years of Age in Senegal: A Stepped-Wedge Cluster-Randomised Trial

PLoS Medicine ◽

10.1371/journal.pmed.1002175 ◽

2016 ◽

Vol 13 (11) ◽

pp. e1002175 ◽

Cited By ~ 54

Author(s):

Badara Cissé ◽

El Hadj Ba ◽

Cheikh Sokhna ◽

Jean Louis NDiaye ◽

Jules F. Gomis ◽

...

Keyword(s):

Randomised Trial ◽

Cluster Randomised Trial ◽

Stepped Wedge ◽

Cluster Randomised ◽

Seasonal Malaria Chemoprevention

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Improving quality of care during childbirth in primary health centres: a stepped-wedge cluster-randomised trial in India

BMJ Global Health ◽

10.1136/bmjgh-2018-000907 ◽

2018 ◽

Vol 3 (5) ◽

pp. e000907 ◽

Cited By ~ 3

Author(s):

Ramesh Agarwal ◽

Deepak Chawla ◽

Minakshi Sharma ◽

Shyama Nagaranjan ◽

Suresh K Dalpath ◽

...

Keyword(s):

Quality Of Care ◽

Management Strategy ◽

Randomised Trial ◽

Cluster Randomised Trial ◽

Stepped Wedge ◽

Primary Health ◽

Cluster Randomised ◽

Primary Health Centres ◽

Health Centres

BackgroundLow/middle-income countries need a large-scale improvement in the quality of care (QoC) around the time of childbirth in order to reduce high maternal, fetal and neonatal mortality. However, there is a paucity of scalable models.MethodsWe conducted a stepped-wedge cluster-randomised trial in 15 primary health centres (PHC) of the state of Haryana in India to test the effectiveness of a multipronged quality management strategy comprising capacity building of providers, periodic assessments of the PHCs to identify quality gaps and undertaking improvement activities for closure of the gaps. The 21-month duration of the study was divided into seven periods (steps) of 3 months each. Starting from the second period, a set of randomly selected three PHCs (cluster) crossed over to the intervention arm for rest of the period of the study. The primary outcomes included the number of women approaching the PHCs for childbirth and 12 directly observed essential practices related to the childbirth. Outcomes were adjusted with random effect for cluster (PHC) and fixed effect for ‘months of intervention’.ResultsThe intervention strategy led to increase in the number of women approaching PHCs for childbirth (26 vs 21 women per PHC-month, adjusted incidence rate ratio: 1.22; 95% CI 1.17 to 1.28). Of the 12 practices, 6 improved modestly, 2 remained near universal during both intervention and control periods, 3 did not change and 1 worsened. There was no evidence of change in mortality with a majority of deaths occurring either during referral transport or at the referral facilities.ConclusionA multipronged quality management strategy enhanced utilisation of services and modestly improved key practices around the time of childbirth in PHCs in India.Trial registration numberCTRI/2016/05/006963.

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