Design and Rationale of ‘Tackling Acute Kidney Injury', a Multicentre Quality Improvement Study

Abstract

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.

An Organizational-Level Program of Intervention for AKI: A Pragmatic Stepped Wedge Cluster Randomized Trial

“…Predefined secondary outcomes included incidence of hospital-acquired AKI, AKI progression to higher stages, incidence of individual AKI stages, and length of hospital stay (LoS). 16 We defined hospital-acquired AKI as that with its onset .24 hours after hospital admission, and AKI progression was defined as an increase of one or more AKI stages from time of detection. 23 After LoS analysis, a post hoc analysis was undertaken for duration of AKI (calculated as days between first and last serum creatinine results that met the definition of AKI).…”

“…Over a 27-month period, we conducted a multicenter, pragmatic, stepped wedge cluster randomized trial (SWCRT). The study was conducted using a published protocol, 16 which was consistent with the extension to cluster randomized trials of the Consolidated Standards Of Reporting Trials 2010 document 1 7 and recommendations for SWCRTs. 18 The protocol and statistical analysis plan were published on the National Health Service (NHS) England Think Kidneys Program website 19 and are included in Supplemental Material.…”

“…Introduction of the intervention was supported by a structured approach to change management described elsewhere. 16 This included permissive tailoring of the elements of the intervention to fit each hospital's local context, but the same basic elements were present across all sites. The electronic AKI detection system was uniform across all sites, conforming with a nationally mandated specification.…”

“…A total of 18,887 admissions in which the patient was discharged alive were included in the LoS quantile regression analyses. The median hospital LoS for all AKI admissions was 9 days (interquartile range, [4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19]. LoS was reduced in the intervention period as shown in Figure 2.…”

Changing Paradigms in Acute Kidney Injury: From Mechanisms to Management

“…Functional stress testing with diuretics was discussed as techniques to establish the integrity of the tubules and capacity of the kidney to provide a novel technique to evaluate patients with AKI. Protocol management and follow-up for AKI patients has been a controversial area given the heterogeneity of the disease; however, the experience from the UK described by Selby et al [12,13] to improve the basic care of AKI appears to be promising in improving outcomes.…”