Electronic Alerts for Acute Kidney Injury Amelioration (ELAIA-1): A completely electronic, multicentre, randomised controlled trial: Design and rationale

Marina Mutter, Melissa Martin, Yu Yamamoto, Aditya Biswas, Boian Etropolski, Harold Feldman, Amit Garg, Noah Gourlie, Stephen Latham, Haiqun Lin, Paul M. Palevsky, Chirag Parikh, Erica Moreira, Ugochukwu Ugwuowo, Francis P. Wilson

Research output: Contribution to journalArticle

Abstract

Introduction Acute 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 analysis The 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 dissemination This 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 number NCT02753751; Pre-results.

Original languageEnglish (US)
Article numbere025117
JournalBMJ open
Volume9
Issue number5
DOIs
StatePublished - May 1 2019

Fingerprint

Acute Kidney Injury
Randomized Controlled Trials
Random Allocation
Inpatients
Ethics Committees
Information Dissemination
Electronic Health Records
Informed Consent
Ethics
Intensive Care Units
Publications
Dialysis
Morbidity
Mortality

Keywords

  • Acute kidney injury
  • acute renal failure
  • clinical decision support
  • electronic health record
  • randomized, alert

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Electronic Alerts for Acute Kidney Injury Amelioration (ELAIA-1) : A completely electronic, multicentre, randomised controlled trial: Design and rationale. / Mutter, Marina; Martin, Melissa; Yamamoto, Yu; Biswas, Aditya; Etropolski, Boian; Feldman, Harold; Garg, Amit; Gourlie, Noah; Latham, Stephen; Lin, Haiqun; Palevsky, Paul M.; Parikh, Chirag; Moreira, Erica; Ugwuowo, Ugochukwu; Wilson, Francis P.

In: BMJ open, Vol. 9, No. 5, e025117, 01.05.2019.

Research output: Contribution to journalArticle

Mutter, M, Martin, M, Yamamoto, Y, Biswas, A, Etropolski, B, Feldman, H, Garg, A, Gourlie, N, Latham, S, Lin, H, Palevsky, PM, Parikh, C, Moreira, E, Ugwuowo, U & Wilson, FP 2019, 'Electronic Alerts for Acute Kidney Injury Amelioration (ELAIA-1): A completely electronic, multicentre, randomised controlled trial: Design and rationale', BMJ open, vol. 9, no. 5, e025117. https://doi.org/10.1136/bmjopen-2018-025117
Mutter, Marina ; Martin, Melissa ; Yamamoto, Yu ; Biswas, Aditya ; Etropolski, Boian ; Feldman, Harold ; Garg, Amit ; Gourlie, Noah ; Latham, Stephen ; Lin, Haiqun ; Palevsky, Paul M. ; Parikh, Chirag ; Moreira, Erica ; Ugwuowo, Ugochukwu ; Wilson, Francis P. / Electronic Alerts for Acute Kidney Injury Amelioration (ELAIA-1) : A completely electronic, multicentre, randomised controlled trial: Design and rationale. In: BMJ open. 2019 ; Vol. 9, No. 5.
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AU - Martin, Melissa

AU - Yamamoto, Yu

AU - Biswas, Aditya

AU - Etropolski, Boian

AU - Feldman, Harold

AU - Garg, Amit

AU - Gourlie, Noah

AU - Latham, Stephen

AU - Lin, Haiqun

AU - Palevsky, Paul M.

AU - Parikh, Chirag

AU - Moreira, Erica

AU - Ugwuowo, Ugochukwu

AU - Wilson, Francis P.

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N2 - Introduction Acute 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 analysis The 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 dissemination This 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 number NCT02753751; Pre-results.

AB - Introduction Acute 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 analysis The 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 dissemination This 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 number NCT02753751; Pre-results.

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