A randomized clinical trial assessing the effect of automated medication-targeted alerts on acute kidney injury outcomes.
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SUBMITTER: Wilson FP
PROVIDER: S-EPMC10192367 | biostudies-literature | 2023 May
REPOSITORIES: biostudies-literature
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A randomized clinical trial assessing the effect of automated medication-targeted alerts on acute kidney injury outcomes.
Wilson F Perry FP Yamamoto Yu Y Martin Melissa M Coronel-Moreno Claudia C Li Fan F Cheng Chao C Aklilu Abinet A Ghazi Lama L Greenberg Jason H JH Latham Stephen S Melchinger Hannah H Mansour Sherry G SG Moledina Dennis G DG Parikh Chirag R CR Partridge Caitlin C Testani Jeffrey M JM Ugwuowo Ugochukwu U
Nature communications 20230517 1
Acute kidney injury is common among hospitalized individuals, particularly those exposed to certain medications, and is associated with substantial morbidity and mortality. In a pragmatic, open-label, National Institutes of Health-funded, parallel group randomized controlled trial (clinicaltrials.gov NCT02771977), we investigate whether an automated clinical decision support system affects discontinuation rates of potentially nephrotoxic medications and improves outcomes in patients with AKI. Pa ...[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:BackgroundAcute 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.MethodsIn 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.FindingsBetween 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).InterpretationAn electronic alert system for acute kidney injury did not improve clinical outcomes among patients in hospital.FundingPenn Center for Healthcare Improvement and Patient Safety.
| S-EPMC4475457 | 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
Project description:PURPOSE:To investigate the application value of "electronic alerts" ("e-alerts") for acute kidney injury (AKI) among high-risk wards of hospitals. METHODS: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 patients) or non-e-alert group (408 patients). Only the e-alert group could receive pop-up messages. RESULTS:The sensitivity, specificity, Youden Index and accuracy of the AKI e-alert system were 99.8, 97.7, 97.5 and 98.1%, respectively. The prevalence of the diagnosis for AKI and expanded-AKI (AKI or multiple-organ failure) in the e-alert group was higher than that in the non-e-alert group (AKI 7.9 and 2.7%, P = 0.001; expanded-AKI 16.3 and 6.1%, P < 0.001). The prevalence of nephrology consultation in the e-alert group was higher than that in the non-e-alert group (9.0 and 3.7%, P = 0.001). There was no significant difference in the prevalence dialysis, rehabilitation of renal function or death in the two groups. CONCLUSION:The e-alert system described here was a reliable tool to make an accurate diagnosis of AKI.
| S-EPMC6096658 | biostudies-literature
Project description:ImportanceDespite the expansion of published electronic alerts for acute kidney injury (AKI), there are still concerns regarding their effect on the clinical outcomes of patients.ObjectiveTo evaluate the effect of the AKI alert combined with a care bundle on the care and clinical outcomes of patients with hospital-acquired AKI.Design, setting, and participantsThis single-center, double-blind, parallel-group randomized clinical trial was conducted in a tertiary teaching hospital in Nanjing, China, from August 1, 2019, to December 31, 2021. The inclusion criteria were inpatient adults aged 18 years or older with AKI, which was defined using the Kidney Disease: Improving Global Outcomes creatinine criteria. Participants were randomized 1:1 to either the alert group or the usual care group, which were stratified by medical vs surgical ward and by intensive care unit (ICU) vs non-ICU setting. Analyses were conducted on the modified intention-to-treat population.InterventionsA programmatic AKI alert system generated randomization automatically and sent messages to the mobile telephones of clinicians (alert group) or did not send messages (usual care group). A care bundle accompanied the AKI alert and consisted of general, nonindividualized, and nonmandatory AKI management measures.Main outcomes and measuresThe primary outcome was maximum change in estimated glomerular filtration rate (eGFR) within 7 days after randomization. Secondary patient-centered outcomes included death, dialysis, AKI progression, and AKI recovery. Care-centered outcomes included diagnostic and therapeutic interventions for AKI.ResultsA total of 2208 patients (median [IQR] age, 65 [54-72] years; 1560 males [70.7%]) were randomized to the alert group (n = 1123) or the usual care group (n = 1085) and analyzed. Within 7 days of randomization, median (IQR) maximum absolute changes in eGFR were 3.7 (-6.4 to 19.3) mL/min/1.73 m2 in the alert group and 2.9 (-9.2 to 16.9) mL/min/1.73 m2 in the usual care group (P = .24). This result was robust in all subgroups in an exploratory analysis. For care-centered outcomes, patients in the alert group had more intravenous fluids (927 [82.6%] vs 670 [61.8%]; P < .001), less exposure to nonsteroidal anti-inflammatory drugs (56 [5.0%] vs 119 [11.0%]; P < .001), and more AKI documentation at discharge (560 [49.9%] vs 296 [27.3%]; P < .001) than patients in the usual care group. No differences were observed in patient-centered secondary outcomes between the 2 groups.Conclusions and relevanceResults of this randomized clinical trial showed that the electronic AKI alert did not improve kidney function or other patient-centered outcomes but changed patient care behaviors. The findings warrant the use of a combination of high-quality interventions and AKI alert in future clinical practice.Trial registrationClinicalTrials.gov Identifier: NCT03736304.
| S-EPMC10799260 | 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: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:BackgroundElectronic (e-)alerts for rising serum creatinine values are increasingly used as clinical indicators of acute kidney injury (AKI). The aim of this study was to investigate to what degree AKI episodes, as identified using e-alerts, correlated with coding for AKI in the hospital record for a national cohort of hospitalised children and examine whether coding corresponded with 30-day mortality after an AKI episode.MethodsA cross-section of AKI episodes based on alerts issued for children under 18 years in England during 2017 were linked to hospital records. Multivariable logistic regression was used to examine patient and clinical factors associated with AKI coding. Agreement between coding and 30-day mortality was examined at hospital level.Results6272 AKI episodes in 5582 hospitalised children were analysed. Overall, coding was poor (19.7%). Older age, living in the least deprived quintile (odds ratio (OR) 1.4, 95% Confidence Interval (CI) 1.1, 1.7) and higher peak AKI stage (stage 1 reference; stage 2 OR 2.0, 95% CI 1.7, 2.4; stage 3 OR 8.6, 95% CI 7.1, 10.6) were associated with higher likelihood of coding in the hospital record. AKI episodes during birth admissions were less likely to be coded (OR 0.4, 95% CI 0.3, 0.5). No correlation was seen between coding and 30-day mortality.ConclusionsThe proportion of AKI alert-identified episodes coded in the hospital record is low, suggesting under-recognition and underestimation of AKI incidence. Understanding the reasons for inequalities in coding, variation in coding between hospitals and how alerts can enhance clinical recognition is needed.
| S-EPMC11827200 | 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