Clinical Decision Support System for Quality Assurance in Potassium-Increasing Drug-Drug-Interactions

Hyperkalemia Clinical Trial

Official title:

Clinical Decision Support System for Quality Assurance in Potassium-Increasing Drug-Drug-Interactions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02020317
• Other study ID #: FZMI-KEK-ZH-Nr. 2013
• Status: Completed
• Phase: N/A
• First received: December 12, 2013
• Last updated: June 5, 2015
• Start date: January 2014
• Est. completion date: January 2015

Study information

• Verified date: June 2015
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3341
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Hyperkalemia

Intervention

Behavioral:
• decision support in potassium-inc. drug-drug-interactions
display of computer-based reminders for serum potassium monitoring and hyperkalemia alerts

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Center for Clinical Research, Research Center for Medical Informatics	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

Eschmann E, Beeler PE, Kaplan V, Schneemann M, Zünd 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. — View Citation

Eschmann E, Beeler PE, Zünd G, Blaser J. Evaluation of alerts for potassium-increasing drug-drug-interactions. Stud Health Technol Inform. 2013;192:1056. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact on serum potassium monitoring during potassium-increasing drug-drug-interactions	Rate of serum potassium monitoring intervals of < = 72 hours during potassium-increasing drug-drug-interactions in proportion to all serum potassium monitoring intervals during potassium-increasing drug-drug-interactions	1 year	Yes
Secondary	Frequency of hyperkalemia during potassium-increasing drug-drug-interactions		1 year	Yes
Secondary	Frequency of potassium-increasing drug-drug-interactions ordered in the presence of hyperkalemia		1 year	Yes
Secondary	Frequency of transfers to the ICU during potassium-increasing drug-drug-interactions in function of the serum potassium level		1 year	Yes
Secondary	Frequency of death during potassium-increasing drug-drug-interactions in the presence or absence of hyperkalemia		1 year	Yes
Secondary	Change in frequency distribution of serum potassium monitoring intervals		1 year	No
Secondary	Response of physicians to the computer-based alerts and reminders		1 year	No