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The effect of ICU-tailored drug-drug interaction (DDI) alerts on medication prescribing and monitoring


- candidate number29864
- NTR NumberNTR7631
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-nov-2018
- Secondary IDsZonMw dossiernummer: 80-83600-98-40140
- Public TitleThe effect of ICU-tailored drug-drug interaction (DDI) alerts on medication prescribing and monitoring
- Scientific TitleThe effect of ICU-tailored drug-drug interaction (DDI) alerts on medication prescribing and monitoring
- ACRONYMSIMPLIFY
- hypothesisClinical decision support systems (CDSSs) provide alerts warning the physician for DDIs during prescribing of medication. Lack of fit between a clinical setting and CDSS alerts cause low specificity (i.e. low clinical relevance) of alerts. Low specificity leads to alert fatigue and thereby to ignoring (important) alerts, compromising medication safety. Therefore, we hypothesize that by improving the specificy of DDI alerts, alert fatigue will be reduced. This in turn will decrease the risk of ignoring clinically relevant alerts, and eventually the number of DDIs.
- Healt Condition(s) or Problem(s) studiedIntensive care, Drug interactions, Medication safety
- Inclusion criteriapartcipating ICUs: Dutch Intensive Care Units using Metavision as a patient data management system.
- Exclusion criteriaPatients: patients admitted to one of the participating ICUs under the age of 18 will be excluded.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-nov-2018
- planned closingdate1-sep-2019
- Target number of participants9000
- InterventionsA clinical decision support system will be implemented that produces alerts to warn for DDIs that are clinically relevant for the ICU setting. Participating ICUs will receive a training for use of the clinical decision support system.

Study design:
This study comprises of 9 clusters (ICUs) that receive the intervention (tailored alerts for potential drug-drug interactions) in a stepwise manner. The study period is 10 months, each month one cluster (ICU) starts with the intervention while the clusters that did not receive the intervention yet serve as a control group.
- Primary outcomeChange in the incidence of clinically relevant potential drug-drug interactions per 1000 medication administrations
- Secondary outcome- The number of (clinically relevant) potential drug-drug interactions per patient

- The proportion of patients admitted to the ICU with at least one (clinically relevant) potential drug-drug interactions

- ICU length of stay

- The override rate of (clinically relevant) potential drug- drug interaction alerts

- The number of ADEs related to drug-drug interactions per 1000 medication administrations

- The proportion of appropriately handled clinically relevant potential drug-drug interactions
- TimepointsData analysis to determine the effect of the intervention subsequently involves comparison of the data points in the control section (varying from 0-8 months) of the wedge with those in the intervention section (varying from 2-10 months).
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Tinka Bakker
- CONTACT for SCIENTIFIC QUERIES Ameen Abu-Hanna
- Sponsor/Initiator Amsterdam UMC, location Academic Medical Center (AMC)
- Funding
(Source(s) of Monetary or Material Support)
ZonMw
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD26-nov-2018 - 3-dec-2018


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