Acute Medical Patients Hospitalized in Internal MedicinePhase 4PERMINCT01633307
Decrease the Frequency of Inappropriate Intravenous Lines in Internal Medicine
A Phase 4 study testing Education in people with Acute Medical Patients Hospitalized in Internal Medicine, run by Hopital Lariboisière.
Trial summary
Aim: to determine whether a nationwide teaching program delivered to medical doctors can decrease the use of inappropriate intravenous lines in internal medicine Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Medical Patients Hospitalized in Internal Medicine
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to May 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Internal medicine department
Who cannot join
None listed.
About this study
Official title: 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
Read the 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%.
- Being tested
- Education
- Keywords
- education, intravenous infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
Teaching program
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Intervention (Teaching program) Receives: Other: Education |
| Control group | No intervention | No teaching program |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of inappropriate intravenous infusion in internal medicine department
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startJan 2007
- Primary completionApr 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Medical Patients Hospitalized in Internal MedicineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Lariboisière
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephane Mouly, MD PhD, Hopital Lariboisière
- Investigators
- stephane J mouly, MD PhD, Principal investigator, Hopital Lariboisiere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633307
- Sponsor's protocol ID
- PERMI
- Acronym
- PERMI
- Status last verified
- Jun 2012
- First submitted
- 19 Jun 2012
- Last updated
- 4 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Champion K, Mouly S, Lloret-Linares C, Lopes A, Vicaut E, Bergmann JF; PERMI Investigators Committee. Optimizing the use of intravenous therapy in internal medicine. Am J Med. 2013 Oct;126(10):925.e1-9. doi: 10.1016/j.amjmed.2013.03.028. Epub 2013 Aug 3.
PubMed 23920107
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Nationwide Teaching Program on the Frequency of Inappropriate Intravenous Lines in Internal Medicine: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01633307
- Acronym / sponsor ID
- PERMI / PERMI
- Keywords
- education, intravenous infusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Hopital LariboisièreUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Apr 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 4 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim: to determine whether a nationwide teaching program delivered to medical doctors can decrease the use of inappropriate intravenous lines in internal medicine
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: EducationIntervention (Teaching program) |
| Control group | No intervention | –No teaching program |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Internal medicine department
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationTeaching program | Other | Experimental |
Primary outcome
frequency of inappropriate intravenous infusion in internal medicine department
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2012.
- Derived from this study: PubMed 23920107Champion K, Mouly S, Lloret-Linares C, Lopes A, Vicaut E, Bergmann JF; PERMI Investigators Committee. Optimizing the use of intravenous therapy in internal medicine. Am J Med. 2013 Oct;126(10):925.e1-9. doi: 10.1016/j.amjmed.2013.03.028. Epub 2013 Aug 3.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
stephane J mouly, MD PhD principal investigator
Hopital Lariboisiere
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Education in people with Acute Medical Patients Hospitalized in Internal Medicine, run by Hopital Lariboisière.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of inappropriate intravenous infusion in internal medicine department. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01633307, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2012.