Clinical trial NCT05923983: DETECT-IP: a Clinical Decision Support System and Intelligent Procedures to Counter Some Adverse Drug Events in Older Hospital Patients
Official title: Reduction of Acute Renal Failure and/or Hyperkaliemia Adverse Drug Events in Older Inpatients by Incorporating Specific Rules Into a Computerized Support System and Dedicated Procedures: a Randomized Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patient Acceptance of Health Care
Acute Renal Failure
Keywords: Acute renal failure
hyperkaliemia
older people
computerized decision support system
stepped-wedge
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: OméDIT (Observatory of Medicines, Medical Devices and Therapeutic Innovations
name: Regional Agency of Sante Nord Pas-de-Calais
First posted: 2023-06-29
Enrollment: 4920
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Prospective, multicentre, controlled, single-blind, randomised cluster study with stepped-wedge permutations. The centres (hospitals) will be the clusters.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Current evidence shows that computerized decision support systems (CDSS) have shown to be insufficiently effective to prevent adverse drug reactions (ADRs) at large scale (e.g. whole hospital). Several barriers for successful implementation of CDSS have been identified: over-alerting, lack of specificity of rules, and physician interruption during prescription. The effectiveness of CDSS could be increased in two ways. Firstly, by creating rules that are more specific to a given adverse drug reaction: the current study focuses on acute renal failure and hyperkalemia (two serious and frequent ADR in older hospitalized patients). Secondly, by involving the pharmacist in the review of the alerts so that he/she can transmit, if deemed necessary, a pharmaceutical recommendation to the clinician. This procedure will reduce over-alerting and prevent task interruption.

The hypothesis is that the use of specific rules created by a multidisciplinary team and implemented in a CDSS, combined with a strategy for managing and transmitting alerts, can reduce specific ADRs such as hyperkalemia and acute renal failure.


Eligibility criteria: Inclusion Criteria:

* Hospitalized for 3 days or more in an MCO (medicine surgery obstetrics) department participating in the study
* Patient who gave oral consent to participate in the study
* Socially insured patient

Exclusion Criteria:

* Patient discharged or died before D3 of hospitalization
* Patient in palliative care or end of life on entry to the service
* Person under legal protection (curatorship)
* Lack of coverage by the social security system, Failure to obtain oral consent to participate in the study

Primary outcomes:
measure: Number of adverse drug events such as acute renal failure and/or hyperkalemia in older hospitalized patients.
timeFrame: through study completion, an average of 20 days
Secondary outcomes:
measure: Presence of an adverse event related to the intervention provided ("change of prescription", "discontinuation of drug")
timeFrame: through study completion, an average of 20 days
measure: Therapeutic adaptations implemented in case of acute renal failure (ARF) or hyperkalemia upon hospital admission
timeFrame: through study completion, an average of 15 days
measure: Relevance of CDSS alerts
timeFrame: through study completion, an average of 20 days
measure: Number of pharmaceutical interventions accepted
timeFrame: through study completion, an average of 20 days
measure: Changes in ADEs (Adverse Drug Event) prevention/management work process induced by the introduction of alerts
timeFrame: Through study completion, an average of 20 days
measure: Cost-effectiveness of the pharmaceutical intervention
timeFrame: through study completion, an average of 20 days
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Lille
name: Jean-Bapstiste Beuscart, MD
role: PRINCIPAL_INVESTIGATOR
References: