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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT02020317
First received: December 12, 2013
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention
Hyperkalemia
Behavioral: decision support in potassium-inc. drug-drug-interactions

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Clinical Decision Support System for Quality Assurance in Potassium-Increasing Drug-Drug-Interactions

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Impact on serum potassium monitoring during potassium-increasing drug-drug-interactions [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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:
  • Frequency of hyperkalemia during potassium-increasing drug-drug-interactions [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Frequency of potassium-increasing drug-drug-interactions ordered in the presence of hyperkalemia [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Frequency of transfers to the ICU during potassium-increasing drug-drug-interactions in function of the serum potassium level [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Frequency of death during potassium-increasing drug-drug-interactions in the presence or absence of hyperkalemia [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Change in frequency distribution of serum potassium monitoring intervals [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Response of physicians to the computer-based alerts and reminders [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 3000
Study Start Date: January 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02020317

Contacts
Contact: Emmanuel Eschmann, MD emmanuel.eschmann@usz.ch
Contact: Juerg Blaser, PhD, Prof juerg.blaser@usz.ch

Locations
Switzerland
University Hospital Zurich, Center for Clinical Research, Research Center for Medical Informatics Recruiting
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
  More Information

Publications:
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02020317     History of Changes
Other Study ID Numbers: FZMI-KEK-ZH-Nr. 2013
Study First Received: December 12, 2013
Last Updated: June 20, 2014
Health Authority: Switzerland: Ethikkommission

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

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

ClinicalTrials.gov processed this record on October 22, 2014