Is there a Role for Systematic Tools to Improve the Clinical Management of Patients with Acute Kidney Injury? Consensus Report of Acute Disease Quality Initiative XIX

Marlies Ostermann; Xiumin Xi; Jean-Louis Vincent; Raymond K Hsu

doi:10.4103/jtccm.jtccm_9_18

CONSENSUS

Year : 2019 | Volume : 1 | Issue : 2 | Page : 57-60

Is there a Role for Systematic Tools to Improve the Clinical Management of Patients with Acute Kidney Injury? Consensus Report of Acute Disease Quality Initiative XIX

Marlies Ostermann¹, Xiumin Xi², Jean-Louis Vincent³, Raymond K Hsu⁴
¹ Guy's and St Thomas' Hospital, London, UK
² Beijing Fuxin Hospital, Beijing, China
³ Department of Intensive Care, Erasme University Hospital, Brussels, Belgium
⁴ Division of Nephrology, University of California San Francisco, San Francisco, CA, USA

Date of Submission	21-Jul-2018
Date of Acceptance	24-Jan-2019
Date of Web Publication	27-Sep-2019

Correspondence Address:
Dr. Marlies Ostermann
Guy's and St Thomas' Hospital
UK

Source of Support: None, Conflict of Interest: None

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DOI: 10.4103/jtccm.jtccm_9_18

Abstract

Acute kidney injury (AKI) occurs in approximately 20% of hospitalized patients and is associated with increased morbidity and mortality. The care of hospitalized patients with AKI has been shown to be variable in clinical practices. Systematic tools including checklists, care bundles and medical algorithms have been developed and implemented to improve the care and outcomes of AKI patients. However, whether these systematic tools can improve the quality of care and outcomes of AKI patients is still unknown. The committee of the 19th Acute Disease Quality Initiative (ADQI) conference dedicated a workgroup with the task of developing a study protocol to investigate this question. A comprehensive literature search was performed using PubMed and Embase. Key questions and feasibility of potential study proposals were discussed during the conference. Then a two-step Delphi process was used to reach consensus regarding several aspects of the study protocol. The group suggested that patient risk assessment be included in the study protocol and the choice of systematic tool be depending on different clinical contexts. The group also proposed a two-phase study with the use of oliguria and systematic tool to investigate the quality of care and outcomes of AKI patients. Consensus was reached on a study protocol regarding the efficacy of using systematic tools to improve clinical management and outcomes of AKI patients.

Keywords: Acute kidney injury, algorithms, care bundle, check list, oliguria, systematic tool

How to cite this article:
Ostermann M, Xi X, Vincent JL, Hsu RK. Is there a Role for Systematic Tools to Improve the Clinical Management of Patients with Acute Kidney Injury? Consensus Report of Acute Disease Quality Initiative XIX. J Transl Crit Care Med 2019;1:57-60

How to cite this URL:
Ostermann M, Xi X, Vincent JL, Hsu RK. Is there a Role for Systematic Tools to Improve the Clinical Management of Patients with Acute Kidney Injury? Consensus Report of Acute Disease Quality Initiative XIX. J Transl Crit Care Med [serial online] 2019 [cited 2023 Mar 31];1:57-60. Available from: http://www.tccmjournal.com/text.asp?2019/1/2/57/268088

Introduction

The care of hospitalized patients with acute kidney injury (AKI) has been shown to be very variable in routine clinical practice with evidence of frequent delays in recognition, insufficient attention to fluid management and drug dosing, and inadequate management of complications of AKI.^{[1],[2],[3],[4],[5],[6]} There are several potential contributing factors including the diversity in providers caring for AKI patients, heterogeneity in patient characteristics across care settings, uncertainty in the evidence base of official recommendations, the presence of other more distracting life-threatening conditions, systematic failures, educational deficits, and lack of awareness about AKI. To improve the quality of care and patient outcomes, systematic tools have been proposed including simple checklists, care bundles, and medical algorithms [Table 1].

Table 1: Systematic tools to improve the quality of care and outcomes of patients with acute kidney injury

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Checklists are job aids used to reduce errors by compensating for potential limits of human memory and attention. They help to ensure consistency and completeness in carrying out a task. A basic example is a “to-do list.” Formalized checklist implementation in aviation has resulted in significant safety improvements in modern-day commercial aviation. Checklist use in the health-care setting has resulted in mixed outcomes,^[7],[8] with notable examples of checklists leading to both improvement ^[9] and nonimprovement ^[10] of outcomes.

Care bundles contain a small set of evidence-based practices or treatments intended for a defined population and care setting.^[11],[12] Each bundle element is relatively independent such that if one element is not implemented, the remaining elements are not impacted. According to the Institute for Healthcare Improvement, a care bundle is defined as “a structured method of improving processes of care and patient outcomes; a small, straight-forward set of evidence-based practices, treatments, and/or interventions for a defined patient population and care setting that, when implemented collectively, significantly improves the reliability of care and patient outcomes beyond that expected when implemented individually.”^[11] Examples of widely implemented bundles in the clinical setting include those focused on sepsis ^[13],[14] and care of central venous catheters.^[15]

Clinical algorithms include two or more sequential items that prompt an action based on the presence or absence of certain conditions. The intended purpose is to aid the operator in decision-making to minimize biases and to apply clinical care in a standardized and sequential order. As such, the steps of a clinical algorithm include decision points and individual branches based on the assessment of the status quo at each decision point. Clinical algorithms – also known as flowcharts ^[7] – may be integrated into electronic health records and developed as electronic clinical decision support systems.

Use of systematic tools in acute kidney injury

Within the past decade, seminal reports from the United Kingdom (UK) National Confidential Enquiry into Patient Outcome and Death appraising the quality of AKI care suggested significant deficits in the care of AKI patients,^[3],[4] such as delayed (or missed) recognition of AKI and failure to monitor urine output and withhold nephrotoxins. Care bundles and other systematic tools have since been developed and implemented to help improve the quality of care for patients with AKI.^[16] Although systematic tools have the potential to improve the management of AKI patients, their role has not been rigorously evaluated in routine clinical practice.

Kolhe et al. recently examined the impact of an AKI care bundle in combination with an electronic AKI alert in a single tertiary hospital in the UK and found that compliance with the care bundle was associated with lower mortality and reduced progression of AKI to higher stages.^[17],[18] Joslin et al. reported that the implementation of an AKI care bundle along with a program of enhanced education in a tertiary care center in London, UK resulted in the earlier recognition of AKI and appropriate discontinuation of nephrotoxic drugs, but fluid management and hospital mortality did not improve.^[19] Other programs aimed to improve the metrics of AKI care have also been developed and implemented in selected UK hospitals ^{[20],[21],[22]} with thus far variable success rates in improving the awareness of AKI and complying with individual components of AKI risk assessment. A recent study by Mendu et al. showed that the use of a structured decision-making algorithm to optimize initiation and discontinuation of renal replacement therapy in the Intensive Care Unit of a tertiary hospital in Boston, Massachusetts, was associated with reduced mortality rates.^[23]

Whether there is a role for a systematic tool to improve the quality of care and outcome of patients with AKI in China is not known. The aim of the Acute Disease Quality Initiative (ADQI) working Party 1 was to develop a study protocol to investigate this question.

Methods

The ADQI process has been described previously. Before the conference in Wuhan, China in April 2017, we performed a comprehensive literature search to summarize existing data. PubMed and Embase were searched using the following terms “AKI” or “acute renal failure” together with either “care bundle,” “bundle,” “checklist,” or “algorithm.” We also checked the reference lists of retrieved articles for relevant papers.

During the conference, core concepts and study proposals were developed and presented to the entire ADQI consensus group. The key questions considered by the working group are shown in [Table 2]. A series of breakout sessions and plenary presentations allowed debate and discussion about the feasibility of potential study proposals and the chances of successful conduct in the Chinese health-care environment. All viewpoints, but particularly the knowledge and insight of local expert members, were considered during the process of refining the study protocol.

Table 2: Key questions to consider when developing a study protocol to investigate the role of systematic tools to improve the quality of care of patients with acute kidney injury

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Results

General consideration

In the first instance, we developed a generic flowchart to address the previously identified research key questions [Figure 1].

Figure 1: Generic flowchart to address the previously identified research key questions

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By consensus, it was decided that a study investigating the role of a systematic tool to improve the management and outcome of AKI needed to include a general patient risk assessment, ideally using routinely available parameters as demonstrated in [Figure 2]. It was also acknowledged that the final choice of systematic tool and its components to address a clinical issue of concern depended on the setting, the desired actions, the outcome of interest, and the relevant user group.

Figure 2: Risk Assessment

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Final study proposal

Oliguria is a frequent occurrence in hospitalized patients. The management is very variable worldwide especially in patients with AKI. In response, the group decided to develop a protocol for a two-phase study to investigate whether the quality of care and outcome of AKI patients with oliguria could be improved with the use of a systematic tool containing different items as outlined in [Figure 3].

Figure 3: Potential elements of different systematic tools to improve management of oliguria acute kidney injury

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Based on the views of local expert members and supported by general consensus, it was decided to address the research question in two phases. The first phase includes a prospective, observational study to describe the current management of oliguria in routine clinical practice to inform the key components of the systematic tool and to gather data for a power calculation of a future study. The second phase entails a randomized controlled study where patients with oliguria are randomized to management as guided by a checklist versus standard clinical care, as shown in [Figure 4]. To simplify the study and to improve the feasibility, a cluster randomization process at hospital level was proposed. The primary outcome is the time to first creatinine check after randomization as a marker of process of general care. Secondary outcomes are severity of AKI within 72 h of randomization, treatment with renal replacement therapy, and length of stay in hospital.

Figure 4: Proposal for clinical trial addressing aspects of acute kidney injury care

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Given the relative paucity of literature on use of systematic tools in AKI, we performed preliminary power calculations based on the data by Kolhe et al.^[17] It was estimated that a total sample size of 1300 in each arm of the trial would be necessary, targeting a standard two-tailed alpha error 0.05 and beta error of 0.20 (not encompassing more complex statistics necessary for the proposed clustered design).

Discussion

The proposed study protocol has various strengths and potential limitations.

Strengths

Large patient pool
Simple randomization procedure
Low-cost intervention
Pragmatic
Depending on the results, the implementation of an AKI checklist into routine clinical practice should be relatively easy
High chance that results will also apply to other countries with different health-care arrangements.

Limitations

Inclusion of a heterogenous patient population with the different degrees of AKI and medical needs
The individual actions prompted by an oliguria checklist may be of variable quality
The maximum time when checklist should be completed was not set
The value of an oliguria checklist may be reduced if it is not accompanied by a structured educational program.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

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