Clinical trial NCT02020317: Clinical Decision Support System for Quality Assurance in Potassium-Increasing Drug-Drug-Interactions
Official title: Clinical Decision Support System for Quality Assurance in Potassium-Increasing Drug-Drug-Interactions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperkalemia
Keywords: drug interactions
Drug Monitoring
Potassium
Hyperkalemia
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2013-12-24
Enrollment: 3341
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To investigate the impact of reminders for serum potassium monitoring and of hyperkalemia alerts during potassium-increasing drug-drug-interactions.

Detailed description: The development of hyperkalemia during potassium-increasing drug-drug-interactions (DDIs) is associated with (i) unknown or elevated serum potassium level at onset of treatment and (ii) insufficient monitoring of serum potassium during therapy. However, potassium-increasing DDIs are frequently started despite an unknown or elevated serum potassium level, and monitoring intervals often exceed 48 hours.

This study investigates the impact of reminders for serum potassium monitoring and hyperkalemia alerts. Both reminders and alerts are displayed in the electronic patient chart of in-patients treated with potassium-increasing DDIs.

Eligibility criteria: Inclusion criteria:

* in-patients treated with concurrent potassium-increasing drugs

Exclusion criteria:

* outpatients; in-patients on wards without computerized physician order entry (i.e. patients treated in the ICU)

Primary outcomes:
measure: Impact on serum potassium monitoring during potassium-increasing drug-drug-interactions
timeFrame: 1 year
Secondary outcomes:
measure: Frequency of hyperkalemia during potassium-increasing drug-drug-interactions
timeFrame: 1 year
measure: Frequency of potassium-increasing drug-drug-interactions ordered in the presence of hyperkalemia
timeFrame: 1 year
measure: Frequency of transfers to the ICU during potassium-increasing drug-drug-interactions in function of the serum potassium level
timeFrame: 1 year
measure: Frequency of death during potassium-increasing drug-drug-interactions in the presence or absence of hyperkalemia
timeFrame: 1 year
measure: Change in frequency distribution of serum potassium monitoring intervals
timeFrame: 1 year
measure: Response of physicians to the computer-based alerts and reminders
timeFrame: 1 year
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Center for Clinical Research, Research Center for Medical Informatics
state: ZH
Study officials:
affiliation: University Hospital Zurich, Center for Clinical Research, Research Center for Medical Informatics
name: Juerg Blaser, PhD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eschmann E, Beeler PE, Kaplan V, Schneemann M, Zund G, Blaser J. Patient- and physician-related risk factors for hyperkalaemia in potassium-increasing drug-drug interactions. Eur J Clin Pharmacol. 2014 Feb;70(2):215-23. doi: 10.1007/s00228-013-1597-2. Epub 2013 Oct 23.
citation: Eschmann E, Beeler PE, Zund G, Blaser J. Evaluation of alerts for potassium-increasing drug-drug-interactions. Stud Health Technol Inform. 2013;192:1056.