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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2015

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.

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: computer-based reminders and alerts
    • Behavioral: display of computer-based reminders for serum potassium monitoring and hyperkalemia alerts (decision support in potassium-inc. drug-drug-interactions)
  • No Intervention: no computer-based reminders or alerts
    • Behavioral: no display of computer-based reminders for serum potassium monitoring and hyperkalemia alerts

Clinical Trial Outcome Measures

Primary Measures

  • Impact on serum potassium monitoring during potassium-increasing drug-drug-interactions
    • Time Frame: 1 year
    • 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

Secondary Measures

  • Frequency of hyperkalemia during potassium-increasing drug-drug-interactions
    • Time Frame: 1 year
  • Frequency of potassium-increasing drug-drug-interactions ordered in the presence of hyperkalemia
    • Time Frame: 1 year
  • Frequency of transfers to the ICU during potassium-increasing drug-drug-interactions in function of the serum potassium level
    • Time Frame: 1 year
  • Frequency of death during potassium-increasing drug-drug-interactions in the presence or absence of hyperkalemia
    • Time Frame: 1 year
  • Change in frequency distribution of serum potassium monitoring intervals
    • Time Frame: 1 year
  • Response of physicians to the computer-based alerts and reminders
    • Time Frame: 1 year

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Zurich
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Juerg Blaser, PhD, Prof, Principal Investigator, University Hospital Zurich, Center for Clinical Research, Research Center for Medical Informatics

References

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.

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

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