CHIROPMEV: Impact of Mulstidisciplinary Medication Assessment Review in Surgery Departments

Sponsor

Centre Hospitalier Universitaire de Nīmes (Other)

Overall Status

Recruiting

CT.gov ID

NCT03827031

Collaborator

(none)

297

Enrollment

Locations

Arms

4.5

Anticipated Duration (Months)

Patients Per Site

22.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Disease	Other: Mutlidisciplinary medication Review (MMR) Other: Mutlidisciplinary medication Review (MMR) with community pharmacist follow-up	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

297 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jul 18, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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.

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)

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.

Outcome Measures

Primary Outcome Measures

Change in iatrogenic drug risk in intervention groups versus control group [3 months after hospitalization]
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 [Hospital discharge (maximum 30 days)]
Number of modifications accepted/number of modifications proposed
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 modifications accepted/number of modifications proposed
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)]
Hours
Time required for ransmitting multidisciplinary correspondence documents in B2 group [Hospital discharge (maximum 30 days)]
Hours
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 [Hospital discharge (maximum 30 days)]
email, fax or letter
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) [3 months after hospital discharge]
Custom-built 7-part questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts 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