NCT02071472

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,076

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 26, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

April 28, 2014

Status Verified

April 1, 2014

Enrollment Period

1.5 years

First QC Date

November 28, 2013

Last Update Submit

April 25, 2014

Conditions

Electronic Health Records

Outcome Measures

Primary Outcomes (1)

  • Number of participants with a potential or documented adverse drug event collected by using trigger tool method

    within the first 30 days after surgery

Secondary Outcomes (1)

  • Number of medications reported by the anesthesiologist in the medical record

    winthin 2 to 4 weeks between anesthesiogist consultation and surgery

Other Outcomes (3)

  • Number of participants with a documented adverse drug event over the perioperative period

    within the first 30 days after surgery

  • Demographic, clinical and therapeutic characteristics of all included participants

    at inclusion

  • Number of participants having an electronic pharmaceutical record (DP) open

    at inclusion

Study Arms (2)

DP medication reconciliation

EXPERIMENTAL

medication reconciliation by a pharmacist using an electronic pharmaceutical record associated to the anesthesiologist consultation for planned surgery patients.

Other: DP medication reconciliation

control

NO INTERVENTION

conventional anesthesiologist consultation for planned surgery patients

Interventions

DP medication reconciliationOTHER
DP medication reconciliation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pharmacy Department - University Hospital of Grenoble

Grenoble, Isère, 38043, France

Location

Related Publications (1)

  • Chapuis C, Bosson JL, Bardet JD, Lepelley M, Sourd D, Roustit M, Allenet B, Chanoine S, Albaladejo P, Bedouch P. Electronic pharmaceutical record for best possible medication history at preoperative evaluation to prevent postoperative adverse events: a quasi-experimental study. BMJ Open Qual. 2025 Mar 3;14(1):e003022. doi: 10.1136/bmjoq-2024-003022.

    PMID: 40032596DERIVED

Study Officials

  • Pierrick BEDOUCH, PharmD, PhD

    University Hospital, Grenoble

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2013

First Posted

February 26, 2014

Study Start

April 1, 2014

Primary Completion

October 1, 2015

Study Completion

February 1, 2016

Last Updated

April 28, 2014

Record last verified: 2014-04

Locations

FR(1)