Impact of Mulstidisciplinary Medication Assessment Review in Surgery Departments

Chronic Disease Clinical Trial

— CHIROPMEV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03827031
• Other study ID #: NIMAO/2017-02/JMK-01
• Status: Recruiting
• Phase: N/A
• Start date: July 18, 2022
• Est. completion date: April 2024

Study information

• Verified date: July 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Jean-Marie Kinowski
• Phone: +33(0)4.66.68.31.04
• Email: jean.marie.kinowski[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 297
• Est. completion date: April 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease

Intervention

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
• 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.

Locations

Country	Name	City	State
France	Chu de Grenoble	Grenoble
France	CHU de Montpellier	Montpellier
France	Nimes University Hospital	Nîmes
France	CHU de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Number of potentially inappropriate medications per patient in each group		Hospital discharge (maximum 30 days)
Secondary	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
Secondary	Number of potentially inappropriate medications per patient in each group		3 months after hospital discharge
Secondary	Time required for Multidisciplinary Medication Review in the interventional groups (B1 and B2)	Hours	Hospital discharge (maximum 30 days)
Secondary	Time required for ransmitting multidisciplinary correspondence documents in B2 group	Hours	Hospital discharge (maximum 30 days)
Secondary	Number of multidisciplinary correspondence documents sent to the community acotors in B2 group		Hospital discharge (maximum 30 days)
Secondary	Description of mode of diffusion of multidisciplinary correspondence documents in the B2 group	email, fax or letter	Hospital discharge (maximum 30 days)
Secondary	Description of reason for non-transmission of multidisciplinary correspondence documents in the B2 group		Hospital discharge (maximum 30 days)
Secondary	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
Secondary	Number of multidisciplinary correspondence documents transmitted by community pharmacist in group B2		2 months post hospital discharge
Secondary	Rate of patients with at least one rehospitalization in each group		3 months after hospital discharge
Secondary	Mortality rate in each group		3 months after hospital discharge
Secondary	Healthcare team satisfaction in interventional groups (B1, B2)	Custom-built 7-part questionnaire	3 months after hospital discharge
Secondary	patient satisfaction in all groups (A, B1, B2)	questionnaire	3 months after hospital discharge