Back to resultsClinical Decision Support System for Quality Assurance in Potassium-Increasing Drug-Drug-Interactions
Primary Purpose
Hyperkalemia
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
decision support in potassium-inc. drug-drug-interactions
Sponsored by
About this trial
This is an interventional health services research trial for Hyperkalemia focused on measuring drug interactions, Drug Monitoring, Potassium, Hyperkalemia
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)
Sites / Locations
- University Hospital Zurich, Center for Clinical Research, Research Center for Medical Informatics
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
computer-based reminders and alerts
no computer-based reminders or alerts
Arm Description
Behavioral: display of computer-based reminders for serum potassium monitoring and hyperkalemia alerts (decision support in potassium-inc. drug-drug-interactions)
Behavioral: no display of computer-based reminders for serum potassium monitoring and hyperkalemia alerts
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Frequency of hyperkalemia during potassium-increasing drug-drug-interactions
Frequency of potassium-increasing drug-drug-interactions ordered in the presence of hyperkalemia
Frequency of transfers to the ICU during potassium-increasing drug-drug-interactions in function of the serum potassium level
Frequency of death during potassium-increasing drug-drug-interactions in the presence or absence of hyperkalemia
Change in frequency distribution of serum potassium monitoring intervals
Response of physicians to the computer-based alerts and reminders
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02020317
Brief Title
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
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperkalemia
Keywords
drug interactions, Drug Monitoring, Potassium, Hyperkalemia
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3341 (Actual)
8. Arms, Groups, and Interventions
Arm Title
computer-based reminders and alerts
Arm Type
Active Comparator
Arm Description
Behavioral: display of computer-based reminders for serum potassium monitoring and hyperkalemia alerts (decision support in potassium-inc. drug-drug-interactions)
Arm Title
no computer-based reminders or alerts
Arm Type
No Intervention
Arm Description
Behavioral: no display of computer-based reminders for serum potassium monitoring and hyperkalemia alerts
Intervention Type
Behavioral
Intervention Name(s)
decision support in potassium-inc. drug-drug-interactions
Intervention Description
display of computer-based reminders for serum potassium monitoring and hyperkalemia alerts
Primary Outcome Measure Information:
Title
Impact on serum potassium monitoring during potassium-increasing drug-drug-interactions
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Frequency of hyperkalemia during potassium-increasing drug-drug-interactions
Time Frame
1 year
Title
Frequency of potassium-increasing drug-drug-interactions ordered in the presence of hyperkalemia
Time Frame
1 year
Title
Frequency of transfers to the ICU during potassium-increasing drug-drug-interactions in function of the serum potassium level
Time Frame
1 year
Title
Frequency of death during potassium-increasing drug-drug-interactions in the presence or absence of hyperkalemia
Time Frame
1 year
Title
Change in frequency distribution of serum potassium monitoring intervals
Time Frame
1 year
Title
Response of physicians to the computer-based alerts and reminders
Time Frame
1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juerg Blaser, PhD, Prof
Organizational Affiliation
University Hospital Zurich, Center for Clinical Research, Research Center for Medical Informatics
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Center for Clinical Research, Research Center for Medical Informatics
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
24150532
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.
Results Reference
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PubMed Identifier
23920830
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.
Results Reference
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Clinical Decision Support System for Quality Assurance in Potassium-Increasing Drug-Drug-Interactions
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