Elsevier

The Lancet

Volume 385, Issue 9981, 16–22 May 2015, Pages 1966-1974
The Lancet

Articles
Automated, electronic alerts for acute kidney injury: a single-blind, parallel-group, randomised controlled trial

https://doi.org/10.1016/S0140-6736(15)60266-5Get rights and content

Summary

Background

Acute kidney injury often goes unrecognised in its early stages when effective treatment options might be available. We aimed to determine whether an automated electronic alert for acute kidney injury would reduce the severity of such injury and improve clinical outcomes in patients in hospital.

Methods

In this investigator-masked, parallel-group, randomised controlled trial, patients were recruited from the hospital of the University of Pennsylvania in Philadelphia, PA, USA. Eligible participants were adults aged 18 years or older who were in hospital with stage 1 or greater acute kidney injury as defined by Kidney Disease Improving Global Outcomes creatinine-based criteria. Exclusion criteria were initial hospital creatinine 4·0 mg/dL (to convert to μmol/L, multiply by 88·4) or greater, fewer than two creatinine values measured, inability to determine the covering provider, admission to hospice or the observation unit, previous randomisation, or end-stage renal disease. Patients were randomly assigned (1:1) via a computer-generated sequence to receive an acute kidney injury alert (a text-based alert sent to the covering provider and unit pharmacist indicating new acute kidney injury) or usual care, stratified by medical versus surgical admission and intensive care unit versus non-intensive care unit location in blocks of 4–8 participants. The primary outcome was a composite of relative maximum change in creatinine, dialysis, and death at 7 days after randomisation. All analyses were by intention to treat. This study is registered with ClinicalTrials.gov, number NCT01862419.

Findings

Between Sept 17, 2013, and April 14, 2014, 23 664 patients were screened. 1201 eligible participants were assigned to the acute kidney injury alert group and 1192 were assigned to the usual care group. Composite relative maximum change in creatinine, dialysis, and death at 7 days did not differ between the alert group and the usual care group (p=0·88), or within any of the four randomisation strata (all p>0·05). At 7 days after randomisation, median maximum relative change in creatinine concentrations was 0·0% (IQR 0·0–18·4) in the alert group and 0·6% (0·0–17·5) in the usual care group (p=0·81); 87 (7·2%) patients in the alert group and 70 (5·9%) patients in usual care group had received dialysis (odds ratio 1·25 [95% CI 0·90–1·74]; p=0·18); and 71 (5·9%) patients in the alert group and 61 (5·1%) patients in the usual care group had died (1·16 [0·81–1·68]; p=0·40).

Interpretation

An electronic alert system for acute kidney injury did not improve clinical outcomes among patients in hospital.

Funding

Penn Center for Healthcare Improvement and Patient Safety.

Introduction

Acute kidney injury affects up to 10% of patients admitted to hospital, and carries with it a great increased risk of mortality.1, 2, 3, 4, 5, 6, 7, 8 In the past ten years, consensus definitions for acute kidney injury have become increasingly sensitive, with a goal of detecting earlier, milder disease.9, 10, 11 The most recent guideline, from the Kidney Disease Improving Global Outcomes (KDIGO) working group, defines acute kidney injury as an absolute increase of serum creatinine of 0·3 mg/dL (to convert to μmol/L, multiply by 88·4) within 48 h or a relative increase of 50% in 7 days.11 Some studies have suggested that even smaller changes in serum creatinine, as little as 0·1 mg/dL, are associated with substantial increases in the risk of death, dialysis, and other morbidities.5, 6, 7, 12, 13, 14, 15, 16

Although individual trials of therapeutic interventions have been negative,17, 18, 19, 20 consensus statements by expert panels of nephrologists have repeatedly recommended tailored early treatment including drug dose adjustment, nephrotoxin avoidance, and attention to fluid balance.10, 11 Although the benefits of such interventions have not been rigorously tested in clinical trial settings, the recommendations are based on sound scientific principles and have the potential to improve clinical outcomes. Early implementation, however, is restricted by the fact that providers frequently fail to notice small changes, and sometimes even substantial changes, in serum creatinine.14, 21, 22, 23 For example, we have previously reported that more than 25% of patients whose creatinine doubled during a stay in hospital had no chart documentation of acute kidney injury, and failure to document acute kidney injury was independently associated with increased mortality.24

Automated alerts have recently emerged as a major instrument to influence clinician behaviour. In the hospital setting, randomised trials have shown the efficacy of alerts to reduce drug interactions,25, 26 increase the rate of venous thromboembolism prophylaxis,27 and improve the rates of various other preventive measures to positively influence outcomes.28 A recent synthesis of the results of several studies examining clinical decision support systems noted that 57% affect practitioner behaviour, whereas only 30% have shown a positive effect on patient outcomes.29 Because acute kidney injury is a complex syndrome that might benefit from personalised, early intervention, automated alerts have the potential to improve the clinical course of patients affected by this condition. We aimed to determine whether an automated electronic alert for acute kidney injury would reduce the severity of acute kidney injury and improve clinical outcomes in patients in hosptial.

Research in context

Evidence before this study

We searched PubMed, Embase, and ClinicalTrials.gov for articles published between Jan 1, 1900, and Jan 7, 2014, examining the effect of alerts for acute kidney injury. We used high-performance information search filters to identify studies of acute kidney injury. We further filtered these studies using the search terms “alert”, “monitoring”, and “point of care” and restricted results to human studies. We identified several observational studies documenting the institution of electronic alerts for acute kidney injury; nearly all recommended randomised trials be performed. One before-after study, noted more rapid improvement in RIFLE class during the alert period than in the pre-alert period.

Added value of this study

This is the first randomised trial to assess the effectiveness of automated alerting for acute kidney injury. In a large and diverse patient population, such alerts showed no obvious clinical benefit. It is of concern that one prespecified subgroup showed increased use of health-care resources (nephrology consult and dialysis) in the alert group of the study.

Implications of all the available evidence

Alerts for acute kidney injury might improve proxy measures of kidney function, but might not improve clinical outcomes. Health-care agencies should be aware of the potential for increased resource use in the absence of clinical benefit where alerts are instituted.

Section snippets

Study design and participants

In this single-blind, parallel-group, randomised controlled trial, patients were recruited from the hospital of the University of Pennsylvania in Philadelphia, PA, USA, a tertiary care hospital serving the Philadelphia metropolitan area that has a wide referral base. Eligible participants were adults aged 18 years or older who were in hospital with acute kidney injury as defined by the KDIGO creatinine-based criteria.11 Using the electronic medical record system, we devised a computerised

Results

Between Sept 17, 2013, and April 14, 2014, 23 664 patients were screened for the development of acute kidney injury.11 After application of our exclusion criteria, 2393 patients were randomised; of whom 1201 were assigned to the acute kidney injury alert group and 1192 were assigned to the usual care group (figure 1). There were 1044 (44%) patients in the medical ward stratum, 278 (12%) in the medical ICU stratum, 627 (26%) in the surgical ward stratum, and 444 (19%) in the surgical ICU

Discussion

In this study, we assessed the effectiveness of an automated, electronic alert system for acute kidney injury that used existing, ubiquitously-used paging technology within our tertiary care hospital. Although no other randomised trials have been reported, several studies have examined electronic alerting for use in various populations. A study in a large UK hospital showed the feasibility of sending electronic alerts to providers whose patients had acute kidney injury, but the absence of a

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