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

NCT ID: NCT05923983

Last Updated: 2023-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

4920 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-31

Study Completion Date

2024-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Patient Acceptance of Health Care Acute Renal Failure

Keywords

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Acute renal failure hyperkaliemia older people computerized decision support system stepped-wedge

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Prospective, multicentre, controlled, single-blind, randomised cluster study with stepped-wedge permutations. The centres (hospitals) will be the clusters.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention Group

Group Type EXPERIMENTAL

Clinical decision support

Intervention Type OTHER

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

Control Group

Group Type OTHER

Will not receive Clinical Decision Support

Intervention Type OTHER

In the control group, the pharmaceutical validation will be based on routine care, often on entry to a ward or in a particular situation

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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OméDIT (Observatory of Medicines, Medical Devices and Therapeutic Innovations

UNKNOWN

Sponsor Role collaborator

Regional Agency of Sante Nord Pas-de-Calais

OTHER

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Bapstiste Beuscart, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Central Contacts

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Jean-Baptiste Beuscart, MD

Role: CONTACT

Phone: 0320445962

Email: [email protected]

References

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Payen A, Tlili NE, Cousein E, Ferret L, Le Bozec A, Lenglet A, Marcilly R, Pilven P, Potier A, Rousseliere C, Soula J, Robert L, Beuscart JB. 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). Trials. 2024 Nov 18;25(1):779. doi: 10.1186/s13063-024-08569-w.

Reference Type DERIVED
PMID: 39558377 (View on PubMed)

Other Identifiers

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2021-A03211-40

Identifier Type: OTHER

Identifier Source: secondary_id

AAP PREPS 2019

Identifier Type: OTHER

Identifier Source: secondary_id

2019_1030

Identifier Type: -

Identifier Source: org_study_id