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

June 5, 2015 updated by: University of Zurich
To investigate the impact of reminders for serum potassium monitoring and of hyperkalemia alerts during potassium-increasing drug-drug-interactions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

3341

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • ZH
      • Zurich, ZH, Switzerland, 8091
        • University Hospital Zurich, Center for Clinical Research, Research Center for Medical Informatics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Juerg Blaser, PhD, Prof, University Hospital Zurich, Center for Clinical Research, Research Center for Medical Informatics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

December 12, 2013

First Submitted That Met QC Criteria

December 23, 2013

First Posted (Estimate)

December 24, 2013

Study Record Updates

Last Update Posted (Estimate)

June 8, 2015

Last Update Submitted That Met QC Criteria

June 5, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FZMI-KEK-ZH-Nr. 2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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