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

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ClinicalTrials.gov Identifier: NCT02020317
Recruitment Status : Completed
First Posted : December 24, 2013
Last Update Posted : June 8, 2015
Sponsor:
Information provided by (Responsible Party):
University of Zurich

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

Condition or disease Intervention/treatment Phase
Hyperkalemia Behavioral: decision support in potassium-inc. drug-drug-interactions Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3341 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Clinical Decision Support System for Quality Assurance in Potassium-Increasing Drug-Drug-Interactions
Study Start Date : January 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)
Behavioral: decision support in potassium-inc. drug-drug-interactions
display of computer-based reminders for serum potassium monitoring and hyperkalemia alerts

No Intervention: no computer-based reminders or alerts
Behavioral: no display of computer-based reminders for serum potassium monitoring and hyperkalemia alerts



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Frequency of hyperkalemia during potassium-increasing drug-drug-interactions [ Time Frame: 1 year ]
  2. Frequency of potassium-increasing drug-drug-interactions ordered in the presence of hyperkalemia [ Time Frame: 1 year ]
  3. Frequency of transfers to the ICU during potassium-increasing drug-drug-interactions in function of the serum potassium level [ Time Frame: 1 year ]
  4. Frequency of death during potassium-increasing drug-drug-interactions in the presence or absence of hyperkalemia [ Time Frame: 1 year ]
  5. Change in frequency distribution of serum potassium monitoring intervals [ Time Frame: 1 year ]
  6. Response of physicians to the computer-based alerts and reminders [ Time Frame: 1 year ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020317


Locations
Switzerland
University Hospital Zurich, Center for Clinical Research, Research Center for Medical Informatics
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Juerg Blaser, PhD, Prof University Hospital Zurich, Center for Clinical Research, Research Center for Medical Informatics

Publications:
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02020317     History of Changes
Other Study ID Numbers: FZMI-KEK-ZH-Nr. 2013
First Posted: December 24, 2013    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: June 2015

Keywords provided by University of Zurich:
drug interactions
Drug Monitoring
Potassium
Hyperkalemia

Additional relevant MeSH terms:
Hyperkalemia
Water-Electrolyte Imbalance
Metabolic Diseases