Patients With Pharmaceutical RecordMATRIX-DPRSNCT03076853
Medication Assessment Through Real Time Information eXchange - Distributed Pharmaceutical Record System
An observational study of Patients With Pharmaceutical Record, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Pharmaceutical Record
- What is being tested?
- Opening of the Pharmaceutical Record
- How many people
- 511 participants
- Where
- 1 siteFrance
- Study dates
- 3 Apr 2016to 30 Jun 2016
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in Anesthesia, Emergency and Geriatric departments with Pharmaceutical Record
Who may be able to join
- 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
Who cannot join
- Minors
- Patients without administrative or judicial freedom if the authorization of the legal representative can not be collected.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Patients With Pharmaceutical Record
- Being tested
- Opening of the Pharmaceutical Record
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opening of the Pharmaceutical RecordOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Pharmaceutical Record | Not described Receives: Other: Opening of the Pharmaceutical Record |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modification of the medical prescription linked to the use of the pharmaceutical record
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study start3 Apr 2016
- Primary completion30 Jun 2016
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Pharmaceutical RecordStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 511 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076853
- Sponsor's protocol ID
- 13-PREPS-01
- Acronym
- MATRIX-DPRS
- Status last verified
- Mar 2017
- First submitted
- 27 Feb 2017
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Assessment Through Real Time Information eXchange - Distributed Pharmaceutical Record System
- ClinicalTrials.gov ID
- NCT03076853
- Acronym / sponsor ID
- MATRIX-DPRS / 13-PREPS-01
- Conditions
- Patients With Pharmaceutical Record
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 511 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 3 Apr 2016 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 10 Mar 2017 (actual)
- 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.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Pharmaceutical Record | – | Other: Opening of the Pharmaceutical Record |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in Anesthesia, Emergency and Geriatric departments with Pharmaceutical Record
Key inclusion criteria (6 listed)
- Patients in pre-anesthesia consultation for scheduled intervention.
- Patients admitted for fainting fit
- Patients admitted to geriatrics
Key exclusion criteria (2 listed)
- Minors
- Patients without administrative or judicial freedom if the authorization of the legal representative can not be collected.
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 |
|---|---|---|
| Opening of the Pharmaceutical RecordAfter 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. | Other | Patients with Pharmaceutical Record |
Primary outcome
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.
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 10 Mar 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Pharmaceutical Record, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 6 inclusion and 2 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 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Modification of the medical prescription linked to the use of the pharmaceutical record (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2017.