Impact of Mulstidisciplinary Medication Assessment Review in Surgery Departments (CHIROPMEV)

Implementation and Impact of Multidisciplinary Medication Review in Surgery Departments on Medication Management of Elderly Patients

The presence of a clinical pharmacist (for their pharmacological expertise) and a general practitioner (for their somatic expertise) in surgery departments would contribute to improve the management of medications in elderly patients.

Study Overview

• Status: Recruiting
• Conditions: Chronic Disease
• Intervention / Treatment: Other: Mutlidisciplinary medication Review (MMR); Other: Mutlidisciplinary medication Review (MMR) with community pharmacist follow-up

• Study Type: Interventional
• Enrollment (Estimated): 297
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean-Marie Kinowski; Phone Number: +33(0)4.66.68.31.04; Email: jean.marie.kinowski@chu-nimes.fr

Study Locations

• France
  • Grenoble, France, 38043
    • Not yet recruiting
    • CHU de Grenoble
    • Contact: Pierrick BEDOUCH; Phone Number: 04 76 76 54 97; Email: PBedouch@chu-grenoble.fr
  • Montpellier, France
    • Recruiting
    • CHU de Montpellier
    • Principal Investigator: Maxime Villiet
    • Contact: Maxime Villiet; Phone Number: 04 67 33 85 62; Email: m-villiet@chu-montpellier.fr
    • Sub-Investigator: François Canovas
    • Sub-Investigator: Hubert Blain
  • Nîmes, France, 30029
    • Recruiting
    • Nîmes University Hospital
    • Sub-Investigator: Géraldine LEGUELINEL-BLACHE, PharmaD
    • Sub-Investigator: Jean-Marie KINOWSKI, PharmaD
    • Sub-Investigator: Hélène RICHARD, PharmaD
    • Principal Investigator: Chloe CHOUKROUN, PharmaD
    • Contact: Anissa Megzari; Phone Number: +33 (0)4.66.68.42.36; Email: drc@chu-nimes.fr
  • Toulouse, France
    • Recruiting
    • Chu de Toulouse
    • Contact: Julien Jouglen; Phone Number: 05 67 77 10 55; Email: jouglen.j@chu-toulouse.fr
    • Principal Investigator: Julien Jouglen
    • Sub-Investigator: Pierre Mansat
    • Sub-Investigator: Fatemeh Nourhashemi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The patient (or their representative) has given his consent and signed the consent form.
• The patient is affiliated to a health insurance programme.
• The patient is at least 65 years old (≥) treated by at least (≥) five medications for at least (≥) 6 months
• The patient is available for a follow-up of 3 months.
• The patient is hospitalized in the surgery department.
• Patient with a Trivalle score greater than or equal to 2 (≥).
• Patient living in a nursing home or going back home after hospitalization.

Exclusion Criteria:

• The subject is participating in another category I interventional study.
• The subject is in an exclusion period determined by another study.
• The subject is under safeguard of justice.
• It is not possible to give the patient (or his/her trusted-person) informed information.
• Palliative care

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: B1 interventional group	Other: Mutlidisciplinary medication Review (MMR); The clinical pharmacist performs medication reconciliation and pharmaceutical analysis. The physician performs a clinical examination and analysis of the medical record. Both participate in a collaborative interview. The hospital physician calls the community pharamcist to discuss proposed changes on the order and to establish a new prescription. At the end of the stay, the clinical pharmacist will conduct an exit interview with the patient. Three months after discharge, the patient's community pharmacist will be contacted to assess whether the changes proposed in the MMR were accepted
Experimental: B2 interventional group	Other: Mutlidisciplinary medication Review (MMR); The clinical pharmacist performs medication reconciliation and pharmaceutical analysis. The physician performs a clinical examination and analysis of the medical record. Both participate in a collaborative interview. The hospital physician calls the community pharamcist to discuss proposed changes on the order and to establish a new prescription. At the end of the stay, the clinical pharmacist will conduct an exit interview with the patient. Three months after discharge, the patient's community pharmacist will be contacted to assess whether the changes proposed in the MMR were accepted; Other: Mutlidisciplinary medication Review (MMR) with community pharmacist follow-up; Multidisciplinary medication review (MMR) The clinical pharmacist performs medication reconciliation and pharmaceutical analysis. The physician performs a clinical examination and analysis of the medical record. Both participate in a collaborative interview. The hospital physician calls the community physician to discuss proposed changes on the order and to establish a new prescription. At the end of the stay, the clinical pharmacist will conduct an exit interview with the patient. Community follow-up A summary of the follow-up report stating the therapeutic modifications (called below multidisciplinary correspondence documents) will be sent to the community pharmacist and physician. Within 2 months of discharge, the pharmacist performs a follow-up of medication changes accepted and not accepted by the community physician. Three months after discharge, the patient's community pharmacist will be contacted to assess whether the changes proposed in the MMR were accepted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in iatrogenic drug risk in intervention groups versus control group	Proportion of patients transitioning from intermediate or high to low risk according to Trivalle score (a score between 0-10. A score 0-1 constitutes a low ADE risk (12%), score 2-5 represents an average risk (32%), and a score 6-10 represents a high risk (53%)	3 months after hospitalization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of proposed medication modifications made by the clinical pharmacist accepted by the clinical doctor during the Multidisciplinary Medication Review in the experimental groups	Number of modifications accepted/number of modifications proposed	Hospital discharge (maximum 30 days)
Number of potentially inappropriate medications per patient in each group		Hospital discharge (maximum 30 days)
Proportion of proposed medication modifications made by the collaborative team accepted and/or made permanent	Number of modifications accepted/number of modifications proposed	3 months after hospital discharge
Number of potentially inappropriate medications per patient in each group		3 months after hospital discharge
Time required for Multidisciplinary Medication Review in the interventional groups (B1 and B2)	Hours	Hospital discharge (maximum 30 days)
Time required for ransmitting multidisciplinary correspondence documents in B2 group	Hours	Hospital discharge (maximum 30 days)
Number of multidisciplinary correspondence documents sent to the community acotors in B2 group		Hospital discharge (maximum 30 days)
Description of mode of diffusion of multidisciplinary correspondence documents in the B2 group	email, fax or letter	Hospital discharge (maximum 30 days)
Description of reason for non-transmission of multidisciplinary correspondence documents in the B2 group		Hospital discharge (maximum 30 days)
Rate of patients for whom a follow-up review of proposed medication changes has been performed by the pharmacist in the B2 group		2 months post discharge
Number of multidisciplinary correspondence documents transmitted by community pharmacist in group B2		2 months post hospital discharge
Rate of patients with at least one rehospitalization in each group		3 months after hospital discharge
Mortality rate in each group		3 months after hospital discharge
Healthcare team satisfaction in interventional groups (B1, B2)	Custom-built 7-part questionnaire	3 months after hospital discharge
patient satisfaction in all groups (A, B1, B2)	questionnaire	3 months after hospital discharge

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Jean-Marie Kinowski, Nîmes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2022
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: August 22, 2018
• First Submitted That Met QC Criteria: January 30, 2019
• First Posted (Actual): February 1, 2019

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Surgery; General Practice; Geriatrics; Drug Safety; Clinical Pharmacy; Medication Review
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: NIMAO/2017-02/JMK-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No