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

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

Detailed Description
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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.

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

Conditions
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Hyperkalemia

Intervention / Treatment
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* Behavioral: decision support in potassium-inc. drug-drug-interactions


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: computer-based reminders and alerts<br>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<br>* display of computer-based reminders for serum potassium monitoring and hyperkalemia alerts<br>|
| No Intervention: no computer-based reminders or alerts<br>Behavioral: no display of computer-based reminders for serum potassium monitoring and hyperkalemia alerts | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug interactions, Drug Monitoring, Potassium, Hyperkalemia