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Clinical Trials/NCT03909035
NCT03909035
Completed
N/A

Medication Reviews Performed for Elderly Patients: a Collaborative Approach Between Community Pharmacists, Patients and General Practitioners to the Optimizations of Prescriptions

University Hospital, Toulouse1 site in 1 country697 target enrollmentJune 3, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Medication Therapy Management
Sponsor
University Hospital, Toulouse
Enrollment
697
Locations
1
Primary Endpoint
Number of patients hospitalised
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

In patients aged 65 years and older, polypathology is frequent and often associated with polypharmacy. This polypharmacy may be a source of iatrogeny due to pharmacokinetic interactions, enhanced sensitivity of older people to medication, or failure to adhere to the therapy. Since January 2018, French community pharmacists have been allowed by the Health ministry to perform medication reviews for people aged 65 years and over, who are being treated with more than 5 medications a day. the present hypothesis is that medication therapy management performed in collaboration with patients, general practitioners, and community pharmacists will lead to a reduction in medical events and inappropriate prescriptions.

Detailed Description

This is a stepped-wedge cluster randomised controlled trial conducted in 9 regions of France. Each region represents one cluster with 7 community pharmacies located around the University Hospital associated with that cluster. In total, 63 community pharmacies will be enrolled, with each pharmacy including 20 patients over a 10 month-period. Over the life-time of the project, a total of 1260 patients will benefit from either the intervention or from a controlled pharmaceutical care according to the period of time they will be enrolled.

Registry
clinicaltrials.gov
Start Date
June 3, 2019
End Date
October 25, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patient aged 65 or older suffering from long-term illness
  • Patient aged 75 or older
  • Living at home
  • Having 5 medications or more per day for more than 6 months
  • Being a regular patient of the community pharmacy involved in the study
  • General practitioner of the patient agrees to participate to the study
  • Patient being mentally and physically able to decide on his own to participate in the study
  • Patient available by phone throughout the study

Exclusion Criteria

  • Patient refuses to participate
  • Patient without a family doctor
  • Patient whose family doctor refuses to participate in the study
  • Patient who does not understand French, or dependant on someone else to manage his medication
  • Resident of a nursing home
  • Patient placed under guardianship
  • Uncertainty of the pharmacist about patient reliability
  • Patient having benefited from a medication review in the previous 12 months
  • Patient already included in another study

Outcomes

Primary Outcomes

Number of patients hospitalised

Time Frame: Month 12

Number of patients hospitalised for more or less than 24 hours, including emergency department transfers during a 12 month-period follow-up.

Secondary Outcomes

  • Girerd compliance test score(Month 12)
  • Number of patients hospitalised (only non-scheduled hospitalisations)(Month 12)
  • Mean number of medications per patient(Month 12)
  • Medication regimen complexity index(Month 12)
  • Quality of life measured with the EuroQol Group 5-level EQ-5D version(Month 12)
  • Existence of at least one potentially inappropriate drug per patient(Month 12)
  • Differential cost ratio(Month 12)
  • Mean number of modifications made by the General Practitioner per patient, following the pharmacist's intervention(Month 2)

Study Sites (1)

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