Value of electronic alerts for acute kidney injury in high-risk wards: a pilot randomized controlled trial.
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SUBMITTER: Wu Y
PROVIDER: S-EPMC6096658 | biostudies-literature | 2018 Aug
REPOSITORIES: biostudies-literature
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Value of electronic alerts for acute kidney injury in high-risk wards: a pilot randomized controlled trial.
Wu Yanhua Y Chen Yuanhan Y Li Shaowen S Dong Wei W Liang Huaban H Deng Miaoyi M Chen Yingnan Y Chen Shixin S Liang Xinling X
International urology and nephrology 20180319 8
<h4>Purpose</h4>To investigate the application value of "electronic alerts" ("e-alerts") for acute kidney injury (AKI) among high-risk wards of hospitals.<h4>Methods</h4>A prospective, randomized, controlled study was conducted. We developed an e-alert system for AKI and ran the system in intensive care units and divisions focusing on cardiovascular disease. The e-alert system diagnosed AKI automatically based on serum creatinine levels. Patients were assigned randomly to an e-alert group (467 p ...[more]
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Project description:ObjectiveTo determine whether electronic health record alerts for acute kidney injury would improve patient outcomes of mortality, dialysis, and progression of acute kidney injury.DesignDouble blinded, multicenter, parallel, randomized controlled trial.SettingSix hospitals (four teaching and two non-teaching) in the Yale New Haven Health System in Connecticut and Rhode Island, US, ranging from small community hospitals to large tertiary care centers.Participants6030 adult inpatients with acute kidney injury, as defined by the Kidney Disease: Improving Global Outcomes (KDIGO) creatinine criteria.InterventionsAn electronic health record based "pop-up" alert for acute kidney injury with an associated acute kidney injury order set upon provider opening of the patient's medical record.Main outcome measuresA composite of progression of acute kidney injury, receipt of dialysis, or death within 14 days of randomization. Prespecified secondary outcomes included outcomes at each hospital and frequency of various care practices for acute kidney injury.Results6030 patients were randomized over 22 months. The primary outcome occurred in 653 (21.3%) of 3059 patients with an alert and in 622 (20.9%) of 2971 patients receiving usual care (relative risk 1.02, 95% confidence interval 0.93 to 1.13, P=0.67). Analysis by each hospital showed worse outcomes in the two non-teaching hospitals (n=765, 13%), where alerts were associated with a higher risk of the primary outcome (relative risk 1.49, 95% confidence interval 1.12 to 1.98, P=0.006). More deaths occurred at these centers (15.6% in the alert group v 8.6% in the usual care group, P=0.003). Certain acute kidney injury care practices were increased in the alert group but did not appear to mediate these outcomes.ConclusionsAlerts did not reduce the risk of our primary outcome among patients in hospital with acute kidney injury. The heterogeneity of effect across clinical centers should lead to a re-evaluation of existing alerting systems for acute kidney injury.Trial registrationClinicalTrials.gov NCT02753751.
| S-EPMC8034420 | biostudies-literature
Project description: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 ?mol/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.
| S-EPMC4475457 | biostudies-literature
Project description:IntroductionAcute kidney injury (AKI) is common among hospitalised patients and under-recognised by providers and yet carries a significant risk of morbidity and mortality. Electronic alerts for AKI have become more common despite a lack of strong evidence of their benefits. We designed a multicentre, randomised, controlled trial to evaluate the effectiveness of AKI alerts. Our aim is to highlight several challenges faced in the design of this trial, which uses electronic screening, enrolment, randomisation, intervention and data collection.Methods and analysisThe design and implementation of an electronic alert system for AKI was a reiterative process involving several challenges and limitations set by the confines of the electronic medical record system. The trial will electronically identify and randomise 6030 adults with AKI at six hospitals over a 1.5-2 year period to usual care versus an electronic alert containing an AKI-specific order set. Our primary outcome will be a composite of AKI progression, inpatient dialysis and inpatient death within 14 days of randomisation. During a 1-month pilot in the medical intensive care unit of Yale New Haven Hospital, we have demonstrated feasibility of automating enrolment and data collection. Feedback from providers exposed to the alerts was used to continually improve alert clarity, user friendliness and alert specificity through refined inclusion and exclusion criteria.Ethics and disseminationThis study has been approved by the appropriate ethics committees for each of our study sites. Our study qualified for a waiver of informed consent as it presents no more than minimal risk and cannot be feasibly conducted in the absence of a waiver. We are committed to open dissemination of our data through clinicaltrials.gov and submission of results to the NIH data sharing repository. Results of our trial will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT02753751; Pre-results.
| S-EPMC6549649 | biostudies-literature
Project description:Background and objectivesElectronic alerts for heterogenous conditions such as AKI may not provide benefit for all eligible patients and can lead to alert fatigue, suggesting that personalized alert targeting may be useful. Uplift-based alert targeting may be superior to purely prognostic-targeting of interventions because uplift models assess marginal treatment effect rather than likelihood of outcome.Design, setting, participants, & measurementsThis is a secondary analysis of a clinical trial of 2278 adult patients with AKI randomized to an automated, electronic alert system versus usual care. We used three uplift algorithms and one purely prognostic algorithm, trained in 70% of the data, and evaluated the effect of targeting alerts to patients with higher scores in the held-out 30% of the data. The performance of the targeting strategy was assessed as the interaction between the model prediction of likelihood to benefit from alerts and randomization status. The outcome of interest was maximum relative change in creatinine from the time of randomization to 3 days after randomization.ResultsThe three uplift score algorithms all gave rise to a significant interaction term, suggesting that a strategy of targeting individuals with higher uplift scores would lead to a beneficial effect of AKI alerting, in contrast to the null effect seen in the overall study. The prognostic model did not successfully stratify patients with regards to benefit of the intervention. Among individuals in the high uplift group, alerting was associated with a median reduction in change in creatinine of -5.3% (P=0.03). In the low uplift group, alerting was associated with a median increase in change in creatinine of +5.3% (P=0.005). Older individuals, women, and those with a lower randomization creatinine were more likely to receive high uplift scores, suggesting that alerts may benefit those with more slowly developing AKI.ConclusionsUplift modeling, which accounts for treatment effect, can successfully target electronic alerts for AKI to those most likely to benefit, whereas purely prognostic targeting cannot.
| S-EPMC5989673 | biostudies-literature
Project description:BackgroundAcute kidney injury is common in hospitalized patients, increases morbidity and mortality, and is under-recognized. To improve provider recognition, we previously developed an electronic alert system for acute kidney injury. To test the hypothesis that this electronic acute kidney injury alert could improve patient outcome, we designed a randomized controlled trial to test the effectiveness of this alert in hospitalized patients. The study design presented several methodologic, ethical, and statistical challenges.PurposeTo highlight the challenges faced and the solutions employed in the design and implementation of a clinical trial to determine whether the provision of an early electronic alert for acute kidney injury would improve outcomes in hospitalized patients. Challenges included how to randomize the delivery of the alert system and the ethical framework for waiving informed consent. Other methodologic challenges included the selection and statistical evaluation of our study outcome, a ranked-composite of a continuous covariate (creatinine) and two dichotomous outcomes (dialysis and death), and the use of the medical record as a source of trial data.MethodsWe have designed a randomized trial to assess the effectiveness of an electronic alert system for acute kidney injury. With broad inclusion criteria, and a waiver of informed consent, we enroll and randomize virtually every patient with acute kidney injury in our hospital.ResultsAs of 31 March 2014, we have enrolled 2373 patients of 2400 targeted. Pre-alert data demonstrated a strong association between severity of acute kidney injury and inpatient mortality with a range of 6.4% in those with mild, stage 1 acute kidney injury, to 29% among those with stage 3 acute kidney injury (p < 0.001). We judged that informed consent would undermine the scientific validity of the study and present harms that are out of proportion to the very low risk intervention.ConclusionOur study demonstrates the feasibility of designing an ethical randomized controlled trial of an early electronic alert for acute kidney injury without obtaining informed consent from individual participants. Our study outcome may serve as a model for other studies of acute kidney injury, insofar as our paradigm accounts for the effect that early death and dialysis have on assessment of acute kidney injury severity as defined by maximum achieved serum creatinine.
| S-EPMC4156885 | biostudies-literature
Project description:OBJECTIVE:Around one in five emergency hospital admissions are affected by acute kidney injury (AKI). To address poor quality of care in relation to AKI, electronic alerts (e-alerts) are mandated across primary and secondary care in England and Wales. Evidence of the benefit of AKI e-alerts remains conflicting, with at least some uncertainty explained by poor or unclear implementation. The objective of this study was to identify factors relating to implementation, using Normalisation Process Theory (NPT), which promote or inhibit use of AKI e-alerts in secondary care. DESIGN:Mixed methods combining qualitative (observations, semi-structured interviews) and quantitative (survey) methods. SETTING AND PARTICIPANTS:Three secondary care hospitals in North East England, representing two distinct AKI e-alerting systems. Observations (>44?hours) were conducted in Emergency Assessment Units (EAUs). Semi-structured interviews were conducted with clinicians (n=29) from EAUs, vascular or general surgery or care of the elderly. Qualitative data were supplemented by Normalization MeAsure Development (NoMAD) surveys (n=101). ANALYSIS:Qualitative data were analysed using the NPT framework, with quantitative data analysed descriptively and using ?2 and Wilcoxon signed-rank test for differences in current and future normalisation. RESULTS:Participants reported familiarity with the AKI e-alerts but that the e-alerts would become more normalised in the future (p<0.001). No single NPT mechanism led to current (un)successful implementation of the e-alerts, but analysis of the underlying subconstructs identified several mechanisms indicative of successful normalisation (internalisation, legitimation) or unsuccessful normalisation (initiation, differentiation, skill set workability, systematisation). CONCLUSIONS:Clinicians recognised the value and importance of AKI e-alerts in their practice, although this was not sufficient for the e-alerts to be routinely engaged with by clinicians. To further normalise the use of AKI e-alerts, there is a need for tailored training on use of the e-alerts and routine feedback to clinicians on the impact that e-alerts have on patient outcomes.
| S-EPMC6924771 | biostudies-literature
Project description:BackgroundAutomated acute kidney injury (AKI) electronic alerts (e-alerts) are rule-based warnings triggered by changes in creatinine and are intended to facilitate earlier detection in AKI. We assessed the impact of the introduction in the Tayside region of UK in April 2015 of automated AKI e-alerts with an accompanying education programme.MethodsInterrupted time-series analysis using segmented regression was performed involving all adults with AKI aged ≥18 years who had a serum creatinine measured between 1 April 2013 and 31 March 2017. Analysis evaluated associations of AKI e-alert introduction on rate and severity (Stages 2-3) of AKI as well as mortality and occupied hospital bed days per patient per month in the population with AKI.ResultsThere were 32 320 episodes of AKI during the observation period. Implementation of e-alerts had no effect on the rate of any AKI [incidence rate ratio (IRR) 0.996, 95% confidence interval (CI) 0.991 to 1.001, P = 0.086] or on the rate of severe AKI (IRR 0.995, 95% CI 0.990 to 1.000, P = 0.061). Subgroup analysis found no impact on the rate or severity of AKI in hospital or in the community. Thirty-day mortality following AKI did not improve (IRR 0.998, 95% CI 0.987 to 1.009, P = 0.688). There was a slight reduction in occupied bed days (β-coefficient -0.059, 95% CI -0.094 to -0.025, P = 0.002).ConclusionsIntroduction of automated AKI e-alerts was not associated with a change in the rate, severity or mortality associated with AKI, but there was a small reduction in occupied hospital bed days.
| S-EPMC7886568 | biostudies-literature
Project description:BackgroundInnovative care models are needed to address gaps in kidney care follow-up among acute kidney injury (AKI) survivors. We developed the multidisciplinary AKI in Care Transitions (ACT) program, which embeds post-AKI care in patients' primary care clinic.ObjectiveThe objective of this randomized pilot trial is to test the feasibility and acceptability of the ACT program and study protocol, including recruitment and retention, procedures, and outcome measures.MethodsThe study will be conducted at Mayo Clinic in Rochester, Minnesota, a tertiary care center with a local primary care practice. Individuals who are included have stage 3 AKI during their hospitalization, do not require dialysis at discharge, have a local primary care provider, and are discharged to their home. Patients unable or unwilling to provide informed consent and recipients of any transplant within 100 days of enrollment are excluded. Consented patients are randomized to receive the intervention (ie, ACT program) or usual care. The ACT program intervention includes predischarge kidney health education from nurses and coordinated postdischarge laboratory monitoring (serum creatinine and urine protein assessment) and follow-up with a primary care provider and pharmacist within 14 days. The usual care group receives no specific study-related intervention, and any aspects of AKI care are at the direction of the treating team. This study will examine the feasibility of the ACT program, including recruitment, randomization and retention in a trial setting, and intervention fidelity. The feasibility and acceptability of participating in the ACT program will also be examined in qualitative interviews with patients and staff and through surveys. Qualitative interviews will be deductively and inductively coded and themes compared across data types. Observations of clinical encounters will be examined for discussion and care plans related to kidney health. Descriptive analyses will summarize quantitative measures of the feasibility and acceptability of ACT. Participants' knowledge about kidney health, quality of life, and process outcomes (eg, type and timing of laboratory assessments) will be described for both groups. Clinical outcomes (eg, unplanned rehospitalization) up to 12 months will be compared with Cox proportional hazards models.ResultsThis study received funding from the Agency for Health Care Research and Quality on April 21, 2021, and was approved by the Institutional Review Board on December 14, 2021. As of March 14, 2023, seventeen participants each have been enrolled in the intervention and usual care groups.ConclusionsFeasible and generalizable AKI survivor care delivery models are needed to improve care processes and health outcomes. This pilot trial will test the ACT program, which uses a multidisciplinary model focused on primary care to address this gap.Trial registrationClinicalTrials.gov NCT05184894; https://www.clinicaltrials.gov/ct2/show/NCT05184894.International registered report identifier (irrid)DERR1-10.2196/48109.
| S-EPMC10242466 | biostudies-literature
Project description:The goal of this review is to describe the rationale for alerting systems for acute kidney injury, the challenges associated with alert implementation, and the efficacy (or lack thereof) of acute kidney injury alerts to date.
| S-EPMC5650118 | biostudies-literature
Project description:BackgroundFew studies describe the epidemiology of childhood acute kidney injury (AKI) nationally. Laboratories in England are required to issue electronic (e-)alerts for AKI based on serum creatinine changes. This study describes a national cohort of children who received an AKI alert and their clinical course.MethodsA cross-section of AKI episodes from 2017 are described. Hospital record linkage enabled description of AKI-associated hospitalizations including length of stay (LOS) and critical care requirement. Risk associations with critical care (hospitalized cohort) and 30-day mortality (total cohort) were examined using multivariable logistic regression.ResultsIn 2017, 7788 children (52% male, median age 4.4 years, interquartile range 0.9-11.5 years) experienced 8927 AKI episodes; 8% occurred during birth admissions. Of 5582 children with hospitalized AKI, 25% required critical care. In children experiencing an AKI episode unrelated to their birth admission, Asian ethnicity, young (<1 year) or old (16-<18 years) age (reference 1-<5 years), and high peak AKI stage had higher odds of critical care. LOS was higher with peak AKI stage, irrespective of critical care admission. Overall, 30-day mortality rate was 3% (n = 251); youngest and oldest age groups, hospital-acquired AKI, higher peak stage and critical care requirement had higher odds of death. For children experiencing AKI alerts during their birth admission, no association was seen between higher peak AKI stage and critical care admission.ConclusionsRisk associations for adverse AKI outcomes differed among children according to AKI type and whether hospitalization was related to birth. Understanding the factors driving AKI development and progression may help inform interventions to minimize morbidity.
| S-EPMC10387403 | biostudies-literature