Electronic Pharmaceutical Record Used for Medication Reconciliation by a Pharmacist Associated to the Anesthesiologist Consultation

Electronic Health Records Clinical Trial

— DP-CONCIL  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02071472
• Other study ID #: DCIC 13 16
• 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

• Electronic Health Records

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