Electronic Pharmaceutical Record Used for Medication Reconciliation by a Pharmacist Associated to the Anesthesiologist Consultation (DP-CONCIL)

April 25, 2014 updated by: University Hospital, Grenoble

Evaluation of the Impact of an Electronic Pharmaceutical Record Used for Medication Reconciliation by a Pharmacist Associated to the Anesthesiologist Consultation

The objective is to evaluate the impact of an electronic pharmaceutical record used for medication reconciliation by a pharmacist associated to the anesthesiologist consultation

Experimental intervention:

medication reconciliation by a pharmacist using an electronic pharmaceutical record before the anesthesiologist consultation for planned surgery patients. The clinical pharmacist communicates the recommendations regarding the drug therapy to the anesthesiologist orally and using a specific formulary.

Control intervention:

Conventional anesthesiologist consultation for planned surgery patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Anesthesiology consultation is mandatory in France for planned surgery. It is part of the concept of anesthesia safety. The main goal is to assess the anesthetic and surgical risk including clinical and drug features likely to interfere with the anesthesia. The medication reconciliation is a central part of this consultation especially in order to assess the allergic risk and hemostasis disorders.

However, access to comprehensive and reliable data concerning the consumption of health products by the patient represents a major challenge. The "Dossier Pharmaceutique" (DP) is an electronic pharmaceutical record including medications (prescribed medications, over the counter medications, complementary and alternative medicines) delivered by community pharmacists over a four month period. Hospital pharmacists have access to the DP of hospitalized patients in order to improve the quality of the medication reconciliation. These informations regarding medication of the patients will be shared with anesthesiologists.

Study Type

Interventional

Enrollment (Anticipated)

1076

Phase

  • Not Applicable

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

  • France
    • Isère
      • Grenoble, Isère, France, 38043
        • Pharmacy Department - University Hospital of Grenoble

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patient coming for anesthetics consultation before a planned surgery
  • age above18
  • available electronic pharmaceutical record (DP)
  • at least one medication prescribed before hospital admission

Exclusion Criteria:

  • Minor patients ou majors protected by law
  • Not speaking French patient
  • Person who are not free by law or administrative decision

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

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DP medication reconciliation
medication reconciliation by a pharmacist using an electronic pharmaceutical record associated to the anesthesiologist consultation for planned surgery patients.
Other: DP medication reconciliation
No Intervention: control
conventional anesthesiologist consultation for planned surgery patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with a potential or documented adverse drug event collected by using trigger tool method
Time Frame: within the first 30 days after surgery
within the first 30 days after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of medications reported by the anesthesiologist in the medical record
Time Frame: winthin 2 to 4 weeks between anesthesiogist consultation and surgery
winthin 2 to 4 weeks between anesthesiogist consultation and surgery

Other Outcome Measures

Outcome Measure
Time Frame
Number of participants with a documented adverse drug event over the perioperative period
Time Frame: within the first 30 days after surgery
within the first 30 days after surgery
Demographic, clinical and therapeutic characteristics of all included participants
Time Frame: at inclusion
at inclusion
Number of participants having an electronic pharmaceutical record (DP) open
Time Frame: at inclusion
at inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Study Chair: Pierrick BEDOUCH, PharmD, PhD, University Hospital, Grenoble

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

April 1, 2014

Primary Completion (Anticipated)

October 1, 2015

Study Completion (Anticipated)

February 1, 2016

Study Registration Dates

First Submitted

November 28, 2013

First Submitted That Met QC Criteria

February 21, 2014

First Posted (Estimate)

February 26, 2014

Study Record Updates

Last Update Posted (Estimate)

April 28, 2014

Last Update Submitted That Met QC Criteria

April 25, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • DCIC 13 16

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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