- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02071472
Electronic Pharmaceutical Record Used for Medication Reconciliation by a Pharmacist Associated to the Anesthesiologist Consultation (DP-CONCIL)
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
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Isère
-
Grenoble, Isère, France, 38043
- Pharmacy Department - University Hospital of Grenoble
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
|
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
Sponsor
Investigators
- Study Chair: Pierrick BEDOUCH, PharmD, PhD, University Hospital, Grenoble
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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