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

Primary Purpose

Chronic Disease

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Mutlidisciplinary medication Review (MMR)
Mutlidisciplinary medication Review (MMR) with community pharmacist follow-up
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Disease focused on measuring Drug Safety, Clinical Pharmacy, General Practice, Surgery, Geriatrics, Medication Review

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chu de Grenoble
  • CHU de MontpellierRecruiting
  • Nimes University HospitalRecruiting
  • CHU de ToulouseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control group

B1 interventional group

B2 interventional group

Arm Description

Outcomes

Primary Outcome Measures

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%)

Secondary Outcome Measures

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

Full Information

First Posted
August 22, 2018
Last Updated
July 10, 2023
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT03827031
Brief Title
Impact of Mulstidisciplinary Medication Assessment Review in Surgery Departments
Acronym
CHIROPMEV
Official Title
Implementation and Impact of Multidisciplinary Medication Review in Surgery Departments on Medication Management of Elderly Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 18, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease
Keywords
Drug Safety, Clinical Pharmacy, General Practice, Surgery, Geriatrics, Medication Review

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
297 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Title
B1 interventional group
Arm Type
Experimental
Arm Title
B2 interventional group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Mutlidisciplinary medication Review (MMR)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Mutlidisciplinary medication Review (MMR) with community pharmacist follow-up
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in iatrogenic drug risk in intervention groups versus control group
Description
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%)
Time Frame
3 months after hospitalization
Secondary Outcome Measure Information:
Title
Proportion of proposed medication modifications made by the clinical pharmacist accepted by the clinical doctor during the Multidisciplinary Medication Review in the experimental groups
Description
Number of modifications accepted/number of modifications proposed
Time Frame
Hospital discharge (maximum 30 days)
Title
Number of potentially inappropriate medications per patient in each group
Time Frame
Hospital discharge (maximum 30 days)
Title
Proportion of proposed medication modifications made by the collaborative team accepted and/or made permanent
Description
Number of modifications accepted/number of modifications proposed
Time Frame
3 months after hospital discharge
Title
Number of potentially inappropriate medications per patient in each group
Time Frame
3 months after hospital discharge
Title
Time required for Multidisciplinary Medication Review in the interventional groups (B1 and B2)
Description
Hours
Time Frame
Hospital discharge (maximum 30 days)
Title
Time required for ransmitting multidisciplinary correspondence documents in B2 group
Description
Hours
Time Frame
Hospital discharge (maximum 30 days)
Title
Number of multidisciplinary correspondence documents sent to the community acotors in B2 group
Time Frame
Hospital discharge (maximum 30 days)
Title
Description of mode of diffusion of multidisciplinary correspondence documents in the B2 group
Description
email, fax or letter
Time Frame
Hospital discharge (maximum 30 days)
Title
Description of reason for non-transmission of multidisciplinary correspondence documents in the B2 group
Time Frame
Hospital discharge (maximum 30 days)
Title
Rate of patients for whom a follow-up review of proposed medication changes has been performed by the pharmacist in the B2 group
Time Frame
2 months post discharge
Title
Number of multidisciplinary correspondence documents transmitted by community pharmacist in group B2
Time Frame
2 months post hospital discharge
Title
Rate of patients with at least one rehospitalization in each group
Time Frame
3 months after hospital discharge
Title
Mortality rate in each group
Time Frame
3 months after hospital discharge
Title
Healthcare team satisfaction in interventional groups (B1, B2)
Description
Custom-built 7-part questionnaire
Time Frame
3 months after hospital discharge
Title
patient satisfaction in all groups (A, B1, B2)
Description
questionnaire
Time Frame
3 months after hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Marie Kinowski
Phone
+33(0)4.66.68.31.04
Email
jean.marie.kinowski@chu-nimes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Marie Kinowski
Organizational Affiliation
Nîmes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu de Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierrick BEDOUCH
Phone
04 76 76 54 97
Email
PBedouch@chu-grenoble.fr
Facility Name
CHU de Montpellier
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maxime Villiet
Phone
04 67 33 85 62
Email
m-villiet@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Maxime Villiet
First Name & Middle Initial & Last Name & Degree
François Canovas
First Name & Middle Initial & Last Name & Degree
Hubert Blain
Facility Name
Nimes University Hospital
City
Nîmes
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anissa Megzari
Phone
+33 (0)4.66.68.42.36
Email
drc@chu-nimes.fr
First Name & Middle Initial & Last Name & Degree
Géraldine LEGUELINEL-BLACHE, PharmaD
First Name & Middle Initial & Last Name & Degree
Jean-Marie KINOWSKI, PharmaD
First Name & Middle Initial & Last Name & Degree
Hélène RICHARD, PharmaD
First Name & Middle Initial & Last Name & Degree
Chloe CHOUKROUN, PharmaD
Facility Name
CHU de Toulouse
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien Jouglen
Phone
05 67 77 10 55
Email
jouglen.j@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Julien Jouglen
First Name & Middle Initial & Last Name & Degree
Pierre Mansat
First Name & Middle Initial & Last Name & Degree
Fatemeh Nourhashemi

12. IPD Sharing Statement

Learn more about this trial

Impact of Mulstidisciplinary Medication Assessment Review in Surgery Departments

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