scholarly journals Open-label, single-centre, cluster-randomised controlled trial to Evaluate the Potential Impact of Computerisedantimicrobial stewardship (EPIC) on the antimicrobial use after cardiovascular surgeries: EPIC trial study original protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e039717
Author(s):  
Xin Yuan ◽  
Kai Chen ◽  
Wei Zhao ◽  
Shuang Hu ◽  
Fei Yu ◽  
...  
Keyword(s):  
Decision Support ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Antimicrobial Use ◽  
Single Centre ◽  
Open Label ◽  
Cluster Randomised ◽  
Potential Impact ◽  
Randomised Controlled

IntroductionInappropriate antimicrobial use increases the prevalence of antimicrobial-resistant bacteria. Surgeons are reluctant to implement recommendations of guidelines in clinical practice. Antimicrobial stewardship (AMS) is effective in antimicrobial management, but it remains labour intensive. The computerised decision support system (CDSS) has been identified as an effective way to enable key elements of AMS in clinical settings. However, insufficient evidence is available to evaluate the efficacy of computerised AMS in surgical settings.Methods and analysisThe Evaluate of the Potential Impact of Computerised AMS trial is an open-label, single-centre, two-arm, cluster-randomised, controlled trial, which aims to determine whether a multicomponent CDSS intervention reduces overall antimicrobial use after cardiovascular surgeries compared with usual clinical care in a specialty hospital with a big volume of cardiovascular surgeries. Eighteen cardiovascular surgical teams will be randomised 1:1 to either the intervention or the control arm. The intervention will consist of (1) re-evaluation alerts and decision support for the duration of antimicrobial treatment decision, (2) re-evaluation alerts and decision support for the choice of antimicrobial, (3) quality control audit and feedback. The primary outcome will be the overall systemic antimicrobial use measured in days of therapy (DOT) per admission and DOT per 1000 patient-days over the whole intervention period (6 months). Secondary outcomes include a series of indices to evaluate antimicrobial use, microbial resistance, perioperative infection outcomes, patient safety, resource consumption, and user compliance and satisfaction.Ethics and disseminationThe Ethics Committee in Fuwai Hospital approved this study (2020-1329). The results of the trial will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT04328090.

scholarly journals SMARThealth Pregnancy: Feasibility and Acceptability of a Complex Intervention for High-Risk Pregnant Women in Rural India: Protocol for a Pilot Cluster Randomised Controlled Trial

2021 ◽  
Vol 2 ◽  
Author(s):  
Shobhana Nagraj ◽  
Stephen H. Kennedy ◽  
Vivekananda Jha ◽  
Robyn Norton ◽  
Lisa Hinton ◽  
...  
Keyword(s):  
Decision Support ◽  
Pilot Study ◽  
High Risk ◽  
Randomised Controlled Trial ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Rural India ◽  
Cluster Randomised ◽  
Randomised Controlled

Introduction: India is in the process of a major epidemiological transition towards non-communicable diseases. Cardiovascular disease (CVD) is the leading cause of death in women in India. Predisposing independent risk factors include pregnancy-related conditions, e.g., hypertensive disorders of pregnancy (HDP) and gestational diabetes (GDM) - also associated with significant perinatal mortality and morbidity. Early identification, referral and management of pregnant women at increased risk of future CVD may offer opportunities for prevention. In rural India, Community Health Workers (CHWs) provide most antenatal and postnatal care. Innovative solutions are required to address integrated care for rural women during transitions between antenatal, postnatal and general health services. The George Institute's SMARThealth Programme has shown that CHWs in rural India screening non-pregnant adults for cardiovascular risk, using a decision support system, is feasible. Building on this, we developed a targeted training programme for CHWs and a complex system-level intervention that uses mobile clinical decision support for CHWs and primary care doctors to screen high-risk pregnant women. In addition to addressing HDP and GDM, the intervention also screens for anaemia in pregnancy.Methods/Design: A pilot study will be undertaken in two diverse rural districts of India: Jhajjar (Haryana) and Guntur (Andhra Pradesh). Two Primary Health Centre clusters will be randomised to intervention or control groups at each study site. The primary objective of this pilot study is to explore the feasibility and acceptability of the SMARThealth Pregnancy intervention. Secondary objectives are to estimate: (a) prevalence rates of moderate to severe anaemia, HDPs and GDM at the study sites; (b) referral and follow-up rates, and (c) mean haemoglobin and blood pressure values at the routine 6 week postnatal visit. A process evaluation will be conducted to explore the acceptability of the SMARThealth Pregnancy intervention for pregnant women and healthcare workers using qualitative methods.Discussion: It is anticipated that the findings of this pilot study will help determine the feasibility and acceptability of the SMARThealth Pregnancy intervention, and highlight how the intervention might be further developed for evaluation in a larger, cluster randomised controlled trial.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT03968952.

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