Acute kidney injury (AKI) is common and associated with extremely poor outcomes. While strategies to tackle deficiencies in basic care delivery are advocated, robust testing of their effectiveness is also needed. The Tackling AKI study was designed to test whether a complex intervention (consisting of an e-alert, care bundle and education programme) can be successfully implemented across a range of UK hospitals, and whether this will deliver improved patient outcomes. This multicentre, pragmatic clinical trial will employ a cluster randomised stepped wedge design to study this in all adult patients who sustain AKI in the 5 participating hospitals over a 2-year period. The intervention will be supported by a comprehensive change management framework. Data collection will include patient outcomes, process measures and a qualitative assessment of barriers and enablers to implementation. This article describes the rationale and design behind the Tackling AKI study.

Keywords:
Stepped-wedge cluster randomised trial, E-alert, Care bundle, Education
1.
Wang HE, Muntner P, Chertow GM, Warnock DG: Acute kidney injury and mortality in hospitalized patients. Am J Nephrol 2012;35:349-355.
2.
NHS England: Acute Kidney Injury (AKI) Programme. http://www.thinkkidneys.nhs.uk, 2014. http://www.england.nhs.uk/ourwork/patientsafety/akiprogramme/.
3.
KDIGO Work Group: KDIGO 2012 clinical practice guideline for acute kidney injury. Kidney Int Suppl 2012;2:1-141.
4.
NCEPOD: Acute Kidney Injury: Adding Insult to Injury. National Confidential Enquiry into Patient Outcome and Death, 2009.
5.
James MT, Wald R, Bell CM, Tonelli M, Hemmelgarn BR, Waikar SS, et al: Weekend hospital admission, acute kidney injury, and mortality. J Am Soc Nephrol 2010;21:845-851.
6.
Mehta RL, McDonald B, Gabbai F, Pahl M, Farkas A, Pascual MT, et al: Nephrology consultation in acute renal failure: does timing matter? Am J Med 2002;113:456-461.
7.
Stevens PE, Tamimi NA, Al-Hasani MK, Mikhail AI, Kearney E, Lapworth R, et al: Non-specialist management of acute renal failure. QJM 2001;94:533-540.
8.
Cox ZL, McCoy AB, Matheny ME, Bhave G, Peterson NB, Siew ED, et al: Adverse drug events during AKI and its recovery. Clin J Am Soc Nephrol 2013;8:1070-1078.
9.
Aitken E, Carruthers C, Gall L, Kerr L, Geddes C, Kingsmore D: Acute kidney injury: outcomes and quality of care. QJM 2013;106:323-332.
10.
Balasubramanian G, Al-Aly Z, Moiz A, Rauchman M, Zhang Z, Gopalakrishnan R, et al: Early nephrologist involvement in hospital-acquired acute kidney injury: a pilot study. Am J Kidney Dis 2011;57:228-234.
11.
Kolhe NV, Staples D, Reilly T, Merrison D, McIntyre CW, Fluck RJ, et al: Impact of compliance with a care bundle on acute kidney injury outcomes: a prospective observational study. PLoS One 2015;10:e0132279.
12.
Selby NM: Electronic alerts for acute kidney injury. Curr Opin Nephrol Hypertens 2013;22:637-642.
13.
Selby NM, Crowley L, Fluck RJ, McIntyre CW, Monaghan J, Lawson N, et al: Use of electronic results reporting to diagnose and monitor AKI in hospitalized patients. Clin J Am Soc Nephrol 2012;7:533-540.
14.
Xu G, Baines R, Westacott R, Selby N, Carr S: An educational approach to improve outcomes in acute kidney injury (AKI): report of a quality improvement project. BMJ Open 2014;4:e004388.
15.
Chong HP, Chandrasekar T: FR-PO493, STOP-acute kidney injury (AKI): a streamlined approach to the management AKI leads to reduction in mortality rates. J Am Soc Nephrol 2015;26:471A.
16.
Wilson FP, Shashaty M, Testani J, Aqeel I, Borovskiy Y, Ellenberg SS, et al: Automated, electronic alerts for acute kidney injury: a single-blind, parallel-group, randomised controlled trial. Lancet 2015;385:1966-1974.
17.
Selby NM, Hill R, Fluck RJ: Standardizing the early identification of acute kidney injury: the NHS England national patient safety alert. Nephron 2015;131:113-117.
18.
Hemming K, Haines TP, Chilton PJ, Girling AJ, Lilford RJ: The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting. BMJ 2015;350:h391.
19.
Campbell MK, Piaggio G, Elbourne DR, Altman DG; CONSORT Group: Consort 2010 statement: extension to cluster randomised trials. BMJ 2012;345:e5661.
20.
Siew ED, Ikizler TA, Matheny ME, Shi Y, Schildcrout JS, Danciu I, et al: Estimating baseline kidney function in hospitalized patients with impaired kidney function. Clin J Am Soc Nephrol 2012;7:712-719.
21.
Kellum JA, Sileanu FE, Murugan R, Lucko N, Shaw AD, Clermont G: Classifying AKI by urine output versus serum creatinine level. J Am Soc Nephrol 2015;26:2231-2238.
22.
Pawson R, Tilley N: Realistic Evaluation. London, Sage, 1997.
23.
Xu X, Nie S, Liu Z, Chen C, Xu G, Zha Y, et al: Epidemiology and clinical correlates of AKI in Chinese hospitalized adults. Clin J Am Soc Nephrol 2015;10:1510-1518.
24.
Hemming K, Girling A: A menu-driven facility for power and detectable-difference calculations in stepped-wedge cluster-randomized trials. Stata J 2014;14:363-380.
© 2016 S. Karger AG, Basel
2016
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