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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02071472
Other study ID # DCIC 13 16
Secondary ID
Status Active, not recruiting
Phase N/A
First received November 28, 2013
Last updated April 25, 2014
Start date April 2014
Est. completion date February 2016

Study information

Verified date April 2014
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Ministry of Health
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1076
Est. completion date February 2016
Est. primary completion date October 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Other:
DP medication reconciliation


Locations

Country Name City State
France Pharmacy Department - University Hospital of Grenoble Grenoble Isère

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other Number of participants with a documented adverse drug event over the perioperative period within the first 30 days after surgery Yes
Other Demographic, clinical and therapeutic characteristics of all included participants at inclusion No
Other Number of participants having an electronic pharmaceutical record (DP) open at inclusion No
Primary Number of participants with a potential or documented adverse drug event collected by using trigger tool method within the first 30 days after surgery No
Secondary Number of medications reported by the anesthesiologist in the medical record winthin 2 to 4 weeks between anesthesiogist consultation and surgery No
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