- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01633307
Decrease the Frequency of Inappropriate Intravenous Lines in Internal Medicine (PERMI)
July 3, 2012 updated by: Stephane Mouly, MD PhD, Hopital Lariboisière
Effect of a Nationwide Teaching Program on the Frequency of Inappropriate Intravenous Lines in Internal Medicine: A Randomized Controlled Trial
Aim: to determine whether a nationwide teaching program delivered to medical doctors can decrease the use of inappropriate intravenous lines in internal medicine
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Nationwide multicentre randomized prospective controlled trial enrolling 59 french internal medicine departments.
During the first study visit, we collected data of patients with intravenous infusions from each participating centre in order to determine the number and frequency of inappropriate intravenous lines.
Using a computerized randomization process (on a 1:1 basis), the participating centres were randomized; Half centres (interventional group) received an educational program consisting of educational material and two educational sessions; the other half did not receive the educational program (control group).
The educational program provided medical doctors with posters and slides containing information on valid indications for the prescription and use of intravenous infusions (inability to drink or eat, malabsorption, medication only available intravenously with no oral equivalent).
Based on a previous pilot study, we assumed that the the frequency of inappropriate intravenous lines with be approximately 20% at baseline and hypothesize that the nationwide teaching program will decrease this frequency by 50%.
Study Type
Interventional
Enrollment (Actual)
59
Phase
- Phase 4
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:
- Internal medicine department
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
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental
Intervention (Teaching program)
|
Teaching program
|
No Intervention: Control group
No teaching program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
frequency of inappropriate intravenous infusion in internal medicine department
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: stephane J mouly, MD PhD, Hôpital Lariboisière
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.
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, 2007
Primary Completion (Actual)
April 1, 2007
Study Completion (Actual)
May 1, 2007
Study Registration Dates
First Submitted
June 19, 2012
First Submitted That Met QC Criteria
July 3, 2012
First Posted (Estimate)
July 4, 2012
Study Record Updates
Last Update Posted (Estimate)
July 4, 2012
Last Update Submitted That Met QC Criteria
July 3, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PERMI
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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