Impact of Mulstidisciplinary Medication Assessment Review in Surgery Departments

NCT03827031 | Recruiting

• 1 other identifier: NIMAO/2017-02/JMK-01
• Study Type: interventional
• Target: 297
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Chronic Disease

Keywords

Drug Safety; Clinical Pharmacy; General Practice; Surgery; Geriatrics; Medication Review

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Proportion of proposed medication modifications made by the clinical pharmacist accepted by the clinical doctor during the Multidisciplinary Medication Review in the experimental groups

  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

  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)

  Hospital discharge (maximum 30 days)

Study Arms (3)

Control group

NO INTERVENTION

B1 interventional group

EXPERIMENTAL

Other: Mutlidisciplinary medication Review (MMR)

B2 interventional group

EXPERIMENTAL

Other: Mutlidisciplinary medication Review (MMR); Other: Mutlidisciplinary medication Review (MMR) with community pharmacist follow-up

Interventions

Mutlidisciplinary medication Review (MMR) OTHER

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

B1 interventional group; B2 interventional group

Mutlidisciplinary medication Review (MMR) with community pharmacist follow-up OTHER

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.

B2 interventional group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• The subject is participating in another category I interventional 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (4)

Chu de Grenoble

Grenoble, 38043, France

NOT YET RECRUITING

CHU de Montpellier

Montpellier, France

RECRUITING

Nimes University Hospital

Nîmes, 30029, France

RECRUITING

CHU de Toulouse

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-Marie Kinowski

  Nîmes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Marie Kinowski

CONTACT

+33(0)4.66.68.31.04; jean.marie.kinowski@chu-nimes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: February 1, 2019
• Study Start: July 18, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 20, 2025

Record last verified: 2025-08

Locations

FR (4)