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Clinical Trials/NCT03827031
NCT03827031
Recruiting
Not Applicable

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

Centre Hospitalier Universitaire de Nīmes8 sites in 1 country297 target enrollmentJuly 18, 2022
ConditionsChronic Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Disease
Sponsor
Centre Hospitalier Universitaire de Nīmes
Enrollment
297
Locations
8
Primary Endpoint
Change in iatrogenic drug risk in intervention groups versus control group
Status
Recruiting
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 18, 2022
End Date
July 1, 2027
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Change in iatrogenic drug risk in intervention groups versus control group

Time Frame: 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 Outcomes

  • Description of reason for non-transmission of multidisciplinary correspondence documents in the B2 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)
  • Time required for Multidisciplinary Medication Review in the interventional groups (B1 and B2)(Hospital discharge (maximum 30 days))
  • Time required for ransmitting multidisciplinary correspondence documents in 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)
  • Mortality rate in each group(3 months after hospital discharge)
  • Description of mode of diffusion of multidisciplinary correspondence documents in the B2 group(Hospital discharge (maximum 30 days))
  • Rate of patients with at least one rehospitalization in each group(3 months after hospital discharge)
  • patient satisfaction in all groups (A, B1, B2)(3 months after hospital discharge)
  • 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(3 months after hospital discharge)
  • Number of multidisciplinary correspondence documents sent to the community acotors in B2 group(Hospital discharge (maximum 30 days))
  • Number of multidisciplinary correspondence documents transmitted by community pharmacist in group B2(2 months post hospital discharge)
  • Healthcare team satisfaction in interventional groups (B1, B2)(3 months after hospital discharge)

Study Sites (8)

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