Medication Assessment Through Real Time Information eXcha... | NCT03076853

Studies
Medication Assessment Through Real Time Information eXchange - Distributed Pharmaceutical Record System

NCT03076853

Sponsor

Centre Hospitalier Universitaire de Nice

Status

Completed

Last Update Posted

Mar 10, 2017Actual

Enrollment

511Actual

Phase

Not provided

Conditions

Patients With Pharmaceutical Record

Interventions

Opening of the Pharmaceutical Record

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 3, 2016Actual

Primary Completion Date

Jun 30, 2016Actual

Completion Date

Jun 30, 2016Actual

First Submitted Date

Feb 27, 2017

First Submission Date that Met QC Criteria

Mar 6, 2017

First Posted Date

Mar 10, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2017

Last Update Posted Date

Mar 10, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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: 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

511Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with Pharmaceutical Record			Other: Opening of the Pharmaceutical Record

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Opening of the Pharmaceutical Record	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients in Anesthesia, Emergency and Geriatric departments with Pharmaceutical Record

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Nice		Nice		06000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided