- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03076853
Medication Assessment Through Real Time Information eXchange - Distributed Pharmaceutical Record System (MATRIX-DPRS)
March 6, 2017 updated by: Centre Hospitalier Universitaire de Nice
The aim of MATRIX-DPRS is to assess the clinical and organizational impacts of the use of the medication record, opened, filled and managed by pharmacists (from private office and hospital units) by hospital physicians in private and public healthcare establishments (volunteers), for three clinical contexts: anaesthesiology visit before surgery, medications abuse and emergency hospitalization, medications and elderly hospitalisations.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
As part of the national 2012 PREPS call for proposals, a multidisciplinary research team was set up to design and develop methods in order to evaluate the efficiency and the performance of health data information systems.
This team is composed of physicians and researchers in medical informatics, hospital information systems, biostatistics, process analysis and management in healthcare, ergonomics and usability.
This study was aimed to evaluate the clinical and organizational impacts of the use of a new source of information brought by the pharmaceutical record, promoted by the national committee of pharmacists.
This record is opened and filled for each patient by the pharmacist.
It contains all the medication sold (prescribed by physician and OTC) by the patient.
This record is used by almost all the private pharmacists.
The French Health Ministry was looking for an evaluation of this new source of information by hospital physicians in order to be applied by any healthcare institution or organization wishing to evaluate the added value of its investments or recommendations (example: ARS (French Regional Health Agency), DGOS (French Directorate General of Health Services), etc.) in the information system.
Study Type
Observational
Enrollment (Actual)
511
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
-
-
-
Nice, France, 06000
- CHU de Nice
-
-
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
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients in Anesthesia, Emergency and Geriatric departments with Pharmaceutical Record
Description
Inclusion Criteria:
Concerning Anesthesia department:
- Patients in pre-anesthesia consultation for scheduled intervention.
Concerning Emergencies department:
- Patients admitted for fainting fit
Regarding patients hospitalized in geriatrics:
- Patients admitted to geriatrics
Exclusion Criteria:
- Minors
- Patients without administrative or judicial freedom if the authorization of the legal representative can not be collected.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with Pharmaceutical Record
|
After a first prescription without the pharmaceutical record, the study investigator has to open the pharmaceutical record to obtain some additional data.
After, he has to choose between maintain or modify his first prescription.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modification of the medical prescription linked to the use of the pharmaceutical record
Time Frame: 3 months
|
The primary outcome measure is to evaluate the impact of the use of the pharmaceutical record on th medical prescription.
The doctor writes a first medical prescription without using the pharmaceutical record and a second with the pharmaceutical record.The changes are analyzed.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this 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 (ACTUAL)
April 3, 2016
Primary Completion (ACTUAL)
June 30, 2016
Study Completion (ACTUAL)
June 30, 2016
Study Registration Dates
First Submitted
February 27, 2017
First Submitted That Met QC Criteria
March 6, 2017
First Posted (ACTUAL)
March 10, 2017
Study Record Updates
Last Update Posted (ACTUAL)
March 10, 2017
Last Update Submitted That Met QC Criteria
March 6, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 13-PREPS-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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