Clinical trial NCT03909035: A Collaborative Approach to Medication Reviews for Older Patients With Polypharmacy
Official title: Medication Reviews Performed for Elderly Patients: a Collaborative Approach Between Community Pharmacists, Patients and General Practitioners to the Optimizations of Prescriptions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Therapy Management
Keywords: Medication review polypharmacy
clinical pharmacy
older people
inappropriate prescribing
collaboration
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2019-04-09
Enrollment: 697
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of patients hospitalised
timeFrame: Month 12
Secondary outcomes:
measure: Number of patients hospitalised (only non-scheduled hospitalisations)
timeFrame: Month 12
measure: Existence of at least one potentially inappropriate drug per patient
timeFrame: Month 0
measure: Existence of at least one potentially inappropriate drug per patient
timeFrame: Month 2
measure: Existence of at least one potentially inappropriate drug per patient
timeFrame: Month 12
measure: Mean number of medications per patient
timeFrame: Month 0
measure: Mean number of medications per patient
timeFrame: Month 12
measure: Medication regimen complexity index
timeFrame: Month 0
measure: Medication regimen complexity index
timeFrame: Month 12
measure: Girerd compliance test score
timeFrame: Month 0
measure: Girerd compliance test score
timeFrame: Month 4
measure: Girerd compliance test score
timeFrame: Month 8
measure: Girerd compliance test score
timeFrame: Month 12
measure: Quality of life measured with the EuroQol Group 5-level EQ-5D version
timeFrame: Month 0
measure: Quality of life measured with the EuroQol Group 5-level EQ-5D version
timeFrame: Month 4
measure: Quality of life measured with the EuroQol Group 5-level EQ-5D version
timeFrame: Month 8
measure: Quality of life measured with the EuroQol Group 5-level EQ-5D version
timeFrame: Month 12
measure: Differential cost ratio
timeFrame: Month 4
measure: Differential cost ratio
timeFrame: Month 8
measure: Differential cost ratio
timeFrame: Month 12
measure: Mean number of modifications made by the General Practitioner per patient, following the pharmacist's intervention
timeFrame: Month 2
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Toulouse University Hospital
state: Occitanie
Study officials:
affiliation: Toulouse University Hospital / Paul Sabatier University
name: Cestac
role: PRINCIPAL_INVESTIGATOR
References: