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

Abstract

Background: Variable standards of care may contribute to poor outcomes associated with AKI. We evaluated whether a multifaceted intervention (AKI e-alerts, an AKI care bundle, and an education program) would improve delivery of care and patient outcomes at an organizational level.

Methods: A multicenter, pragmatic, stepped-wedge cluster randomized trial was performed in five UK hospitals, involving patients with AKI aged ≥18 years. The intervention was introduced sequentially across fixed three-month periods according to a randomly determined schedule until all hospitals were exposed. The primary outcome was 30-day mortality, with pre-specified secondary endpoints and a nested evaluation of care process delivery. The nature of the intervention precluded blinding, but data collection and analysis were independent of project delivery teams.

Results: We studied 24,059 AKI episodes, finding an overall 30-day mortality of 24.5%, with no difference between control and intervention periods. Hospital length of stay was reduced with the intervention (decreases of 0.7, 1.1, and 1.3 days at the 0.5, 0.6, and 0.7 quantiles, respectively). AKI incidence increased and was mirrored by an increase in the proportion of patients with a coded diagnosis of AKI. Our assessment of process measures in 1048 patients showed improvements in several metrics including AKI recognition, medication optimization, and fluid assessment.

Conclusions: A complex, hospital-wide intervention to reduce harm associated with AKI did not reduce 30-day AKI mortality but did result in reductions in hospital length of stay, accompanied by improvements in in quality of care. An increase in AKI incidence likely reflected improved recognition.

Keywords: AKI; acute renal failure; care bundle; clinical nephrology; e-alert; education.

Graphical abstract

Figure 1.

Schematic of the stepped wedge study design. After a 6-month period of baseline data collection, the intervention (hospital-wide AKI e-alert, care bundle, and education program) was sequentially introduced to participating sites across fixed 3-month periods of time until all sites were exposed to the intervention. Data collection occurred at each step of the wedge, including in the postintervention period. The 3-month time period during which a site introduced the intervention, when it was expected not to have reached full effect on outcomes, was considered a transition period and excluded from analyses. All sites had a minimum of one 1-month period of exposure to the intervention after the transition period. The sequence was determined by random number generation, and the order of the hospitals was as follows: (1) Frimley, (2) Bradford, (3) Ashford and St. Peters, (4) Leeds General Infirmary, and (5) Leeds St. James.

Figure 2.

Reduction in hospital length of stay in the intervention period, as shown by quantile regression analysis. LoS is shown on the y axis at different quantiles of the distribution. The solid line represents the estimated changes in LoS distribution quantiles from before to after the introduction of the intervention across the different quantiles of the distribution after adjustment for time, age, sex, comorbid conditions, cluster (hospital), and seasonality, and the shaded area represents the 95% confidence interval (95% CI). Results show a reduced LoS during the intervention period (from quantiles 0.5 upward; effect size and median LoS at individual quantiles are shown in the table).

Figure 3.

Reduction in AKI duration in the intervention period, as shown by quantile regression analysis. AKI duration is shown on the y axis at different quantiles of the distribution. The solid line represents the estimated changes in AKI duration distribution quantiles from before to after the introduction of the intervention across the different quantiles of the distribution after adjustment for time, age, sex, comorbid conditions, cluster (hospital), and seasonality, and the shaded area represents the 95% confidence interval (95% CI). Results show a reduced AKI duration during the intervention period (from quantiles 0.8 onward; effect size and median AKI duration at individual quantiles are shown in the table).

Figure 4.

Improvements in processes of care with the intervention. Urinary catheterization was included as a balancing measure, and we did not observe an unintended increase in the proportion of patients catheterized for reasons other than relief of urinary obstruction.