A multi-center trial is underway to determine if integrating new rules into a clinical decision support system (CDSS) can reduce the incidence of acute kidney injury (AKI) and hyperkalemia in hospitalized patients. The study, published in Trials Journal, is a stepped-wedge, cluster-randomized, controlled trial being conducted across five centers and focuses on patients aged 65 and over.
The intervention involves using a CDSS that analyzes real-time data and generates alerts for situations where there is a risk of an adverse drug event (ADE) or a confirmed ADE. Clinical pharmacists then examine the alerts, verify their technical validity, and evaluate their pharmaceutical relevance. If necessary, they issue a pharmaceutical intervention (PI) to the medical team in charge of the patient. The study includes 12 rules for preventing ADEs (six for AKI and six for hyperkalemia) and 19 rules for monitoring the event (18 for AKI and one for hyperkalemia).
CDSS Intervention Details
Before the trial, an expert group drafted the rules in a semi-natural language based on scientific literature and clinical expertise. The rules were then coded in computer language in collaboration with industrial partners (Keenturtle and Quinten). The rules were tested in real life in the five investigating centers, using a CDSS mode in which alerts are visible only to the centers’ principal investigators. This approach enabled the detection of errors in how the rules were drafted. Standardized courses of action for each rule were created based on a review of the literature and proofread by a committee of experts.
The intervention is carried out in addition to the usual care. During the intervention phase, the CDSS is used to detect a risk of AKI or hyperkalemia or confirmed AKI or hyperkalemia. An alert is triggered when the patient’s data matches all the rule’s criteria. The clinical pharmacist analyzes the alert from a technical and pharmaceutical viewpoints. Depending on the standardized course of action, the pharmacist may issue a PI to the medical team in charge of the patient.
Outcome Measures
The primary outcome is the occurrence of one or both of the following events: AKI and/or hyperkalemia. Hyperkalemia is defined as a high blood potassium value (usually > 5.0 mmol/L), with the cut-off set by each hospital’s lab. The definition of AKI is based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria: elevation in creatinine by a factor of 1.5 over a period of 7 days or less (AKI stage 1).
Secondary outcomes include:
- Safety of the intervention: Any ADE associated with a change in prescription.
- Indicator of the pharmaceutical relevance: The number of alerts leading to a PI being sent on to the medical team divided by the total number of alerts for the same rule triggered by the CDSS and analyzed by a pharmacist.
- Indicator of medical relevance: The number of the PIs accepted by the medical team is divided by the total number of PIs for the same rule sent by the pharmacists following a CDSS alert. The CLEO scale is applied to all the PIs sent to the medical team.
- Time period for prescription changes: The respective mean time intervals between the issuance of an alert by the CDSS, the analysis of the alert by the pharmacist, the transmission of the PI to the medical team, and the decision to accept (or not) the PI by the medical team.
- Health economic assessment: (i) the intervention cost, corresponding to the mean time spent creating and integrating the rules into the CDSS; (ii) the usage cost, corresponding to the time spent analyzing alerts triggered during the study; and (iii) the intervention cost, corresponding to the cost of preventing and managing AKI or hyperkalemia during a hospital stay.
- Organizational impact of using a CDSS: The role of each professional (senior physicians, junior physicians, nurses, clinical pharmacists and medical biologists), their work processes, and the technologies used in the management of medication-related iatrogenic events (hyperkalemia and AKI).
Sample Size and Recruitment
The study aims to recruit a total of 4920 patients (164 per cluster and per phase). Patients are recruited in certain wards of each hospital, in which the pharmacists and physicians have agreed to participate in the study and are covered by the CDSS. The recruitment process is assisted by the use of two documents: (i) a detailed study information sheet given to the patient upon arrival in the ward and (ii) a plain-language study summary flyer for the patients and their families.
