Clinical trial NCT03827031: Impact of Mulstidisciplinary Medication Assessment Review in Surgery Departments
Official title: Implementation and Impact of Multidisciplinary Medication Review in Surgery Departments on Medication Management of Elderly Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Disease
Keywords: Drug Safety
Clinical Pharmacy
General Practice
Surgery
Geriatrics
Medication Review
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2019-02-01
Enrollment: 297
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Change in iatrogenic drug risk in intervention groups versus control group
timeFrame: 3 months after hospitalization
Secondary outcomes:
measure: Proportion of proposed medication modifications made by the clinical pharmacist accepted by the clinical doctor during the Multidisciplinary Medication Review in the experimental groups
timeFrame: Hospital discharge (maximum 30 days)
measure: Number of potentially inappropriate medications per patient in each group
timeFrame: Hospital discharge (maximum 30 days)
measure: Proportion of proposed medication modifications made by the collaborative team accepted and/or made permanent
timeFrame: 3 months after hospital discharge
measure: Number of potentially inappropriate medications per patient in each group
timeFrame: 3 months after hospital discharge
measure: Time required for Multidisciplinary Medication Review in the interventional groups (B1 and B2)
timeFrame: Hospital discharge (maximum 30 days)
measure: Time required for ransmitting multidisciplinary correspondence documents in B2 group
timeFrame: Hospital discharge (maximum 30 days)
measure: Number of multidisciplinary correspondence documents sent to the community acotors in B2 group
timeFrame: Hospital discharge (maximum 30 days)
measure: Description of mode of diffusion of multidisciplinary correspondence documents in the B2 group
timeFrame: Hospital discharge (maximum 30 days)
measure: Description of reason for non-transmission of multidisciplinary correspondence documents in the B2 group
timeFrame: Hospital discharge (maximum 30 days)
measure: Rate of patients for whom a follow-up review of proposed medication changes has been performed by the pharmacist in the B2 group
timeFrame: 2 months post discharge
measure: Number of multidisciplinary correspondence documents transmitted by community pharmacist in group B2
timeFrame: 2 months post hospital discharge
measure: Rate of patients with at least one rehospitalization in each group
timeFrame: 3 months after hospital discharge
measure: Mortality rate in each group
timeFrame: 3 months after hospital discharge
measure: Healthcare team satisfaction in interventional groups (B1, B2)
timeFrame: 3 months after hospital discharge
measure: patient satisfaction in all groups (A, B1, B2)
timeFrame: 3 months after hospital discharge
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Chu de Grenoble
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nîmes
country: France
facility: Nimes University Hospital
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: Nîmes University Hospital
name: Jean-Marie Kinowski
role: PRINCIPAL_INVESTIGATOR
References: