1. Can the integration of new rules into a clinical decision support system reduce the incidence of acute kidney injury and hyperkalemia among hospitalized older adults: a protocol for a stepped-wedge, cluster-randomized trial (DETECT-IP).
- Author
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Payen A, Tlili NE, Cousein E, Ferret L, Le Bozec A, Lenglet A, Marcilly R, Pilven P, Potier A, Rousselière C, Soula J, Robert L, and Beuscart JB
- Subjects
- Humans, Aged, Incidence, Hospitalization, Drug-Related Side Effects and Adverse Reactions prevention & control, Drug-Related Side Effects and Adverse Reactions epidemiology, Age Factors, Female, Hyperkalemia epidemiology, Hyperkalemia diagnosis, Hyperkalemia prevention & control, Acute Kidney Injury prevention & control, Acute Kidney Injury diagnosis, Acute Kidney Injury epidemiology, Decision Support Systems, Clinical, Randomized Controlled Trials as Topic, Multicenter Studies as Topic
- Abstract
Background: Clinical decision support systems (CDSSs) enable the automated, real-time detection of situations associated with a risk of adverse drug events (ADEs). However, the effectiveness of CDSS in reducing ADEs has yet to be demonstrated. We have chosen to focus on the detection of ADE such as hyperkalemia and/or acute kidney injury (AKI), which are common among hospitalized older adults. The present study's primary objective is to use a CDSS to reduce the number of ADEs (such as AKI and/or hyperkalemia) that occur in hospitalized older adults., Methods: This is a multicenter, stepped-wedge, cluster-randomized study involving five hospitals. Each hospital will start with a control period (i.e., routine care, during which each center's CDSS is deactivated) and then switch to an intervention period (during which the CDSS is activated). The intervention will be the use of a CDSS and a strategy for managing and transmitting alerts to clinical pharmacists. The rules concerning AKI and hyperkalemia have been drafted and reviewed by a multidisciplinary group. Each rule created in the CDSS is associated with a standardized procedure, based on a review of the literature. Older patients (aged 65 or over) admitted to a participating general medicine ward, a surgical ward, or obstetrics ward will be eligible for inclusion after the provision of verbal informed consent., Discussion: This study will assess the effectiveness of the CDSS in reducing the incidence of AKI and hyperkalemia. The implementation of the CDSS can assist clinical pharmacists in their daily work and is expected to prevent ADEs., Trial Registration: ClinicalTrials.gov Identifier: NCT05923983. Registered February 02, 2023., Competing Interests: Declarations Ethics approval and consent to participate {24} The study protocol has been evaluated and authorized by the relevant institutional IEC/IRB (CPP Sud-Méditerranée IV, Montpellier, France; reference: 2021-A03211-40). The study sponsor (Lille University Hospital) is responsible for all administrative procedures. In accordance with French legislation, all the patients or their legal representative will be given verbal information about the study during the inclusion visit and will also receive a study information sheet. The patient can refuse to participate at any time. The study protocol has been registered with the French Consultative Committee on Information Processing in Medical Research and the French National Data Protection Commission. This trial was registered at ClinicalTrials.gov (NCT05923983) on February 9, 2023: with the title “DETECT-IP: a Clinical Decision Support System and Intelligent Procedures to Counter Some Adverse Drug Events in Older Hospital Patients”). Any substantial change in the protocol is subject to a written amendment submitted to the sponsor, who must seek approval from the IEC/IRB and authorization by the competent authority or authorities before implementation. All amendments to the protocol must be made known to all the study’s investigators. Consent for publication {32} Not applicable-The participant information materials and informed consent form are available from the corresponding author on request. Competing interests {28} The authors declare that they have no competing interests., (© 2024. The Author(s).)
- Published
- 2024
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