DETECT-IP: a Clinical Decision Support System and Intelligent Procedures to Counter Some Adverse Drug Events in Older Hospital Patients (DETECT-IP:)

June 26, 2023 updated by: University Hospital, Lille

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

4920

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Other: Clinical decision support
In the intervention group, the pharmaceutical validation will be based on routine care, often on entry to a ward and by analysis of all the alerts produced by the CDSS. Some alerts will result in a pharmaceutical intervention being provided to the medical team
Other: Control Group
Other: Will not receive Clinical Decision Support
In the control group, the pharmaceutical validation will be based on routine care, often on entry to a ward or in a particular situation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of adverse drug events such as acute renal failure and/or hyperkalemia in older hospitalized patients.
Time Frame: through study completion, an average of 20 days
through study completion, an average of 20 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of an adverse event related to the intervention provided ("change of prescription", "discontinuation of drug")
Time Frame: through study completion, an average of 20 days
through study completion, an average of 20 days
Therapeutic adaptations implemented in case of acute renal failure (ARF) or hyperkalemia upon hospital admission
Time Frame: through study completion, an average of 15 days
Therapeutic changes within 72 hours of a CDSS alert for acute renal failure or hyperkalemia. Therapeutic changes include discontinuation of drug therapy, introduction of a new drug, dose reduction or change of drug
through study completion, an average of 15 days
Relevance of CDSS alerts
Time Frame: through study completion, an average of 20 days
Relevance of CDSS alerts is defined in a standard way. Each CDSS alert is evaluated by a clinical pharmacist according to their own expertise and data available in the EHR. If the alert was deemed not relevant, the clinical pharmacist did not perform any pharmaceutical intervention. The CDSS software register the classification of the alert as "not relevant". This approach was used the last 4 years in our hospital and as been published in an article published in the International Journal of Medical Informatics: Cuvelier E, Robert L, Musy E, Rousselière C, Marcilly R, Gautier S, Odou P, Beuscart JB, Décaudin B. The clinical pharmacist's role in enhancing the relevance of a clinical decision support system. Int J Med Inform. 2021 Nov;155:104568. doi: 10.1016/j.ijmedinf.2021.104568. Epub 2021 Sep 2. PMID: 34537687
through study completion, an average of 20 days
Number of pharmaceutical interventions accepted
Time Frame: through study completion, an average of 20 days
When an alert is received by the pharmacist, it is analyzed and the pharmacist forwards a pharmaceutical intervention to the physician in charge of the patient to propose a modification of the treatment (dosage, dose, stop
through study completion, an average of 20 days
Changes in ADEs (Adverse Drug Event) prevention/management work process induced by the introduction of alerts
Time Frame: Through study completion, an average of 20 days
Changes in the work system are identified through a comparison of its elements (tools, tasks, organization, interactions, work environment, professionals), before and after the introduction of alerts, using qualitative system engineering methods.
Through study completion, an average of 20 days
Cost-effectiveness of the pharmaceutical intervention
Time Frame: through study completion, an average of 20 days
Use medico-economic data such as time spent treating an alert, cost of treating an adverse drug reaction to estimate the cost-effectiveness of the intervention
through study completion, an average of 20 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

Regional Agency of Sante Nord Pas-de-Calais
OméDIT (Observatory of Medicines, Medical Devices and Therapeutic Innovations

Investigators

  • Principal Investigator: Jean-Bapstiste Beuscart, MD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

February 9, 2023

First Submitted That Met QC Criteria

June 26, 2023

First Posted (Actual)

June 29, 2023

Study Record Updates

Last Update Posted (Actual)

June 29, 2023

Last Update Submitted That Met QC Criteria

June 26, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019_1030
  • 2021-A03211-40 (Other Identifier: ID-RCB number, ANSM)
  • AAP PREPS 2019 (Other Identifier: DGOS)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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