A Collaborative Approach to Medication Reviews for Older Patients With Polypharmacy
- Conditions
- Medication Therapy Management
- Interventions
- Other: Medication therapy management
- Registration Number
- NCT03909035
- Lead Sponsor
- University Hospital, Toulouse
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 697
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Medication therapy management Medication therapy management Medication therapy management by the community pharmacist in collaboration with the General Practitioners to the Optimizations of Prescriptions
- Primary Outcome Measures
Name Time Method Number of patients hospitalised 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 Outcome Measures
Name Time Method Girerd compliance test score Month 12 To evaluate the impact of medication therapy management on Medication adherence. From 0 to 6 Yes. 0 Yes: Best value. 6 Yes: worst value.
Number of patients hospitalised (only non-scheduled hospitalisations) Month 12 Number of non-scheduled hospitalisations (including emergency department transfers)
Mean number of medications per patient Month 12 Mean number of medications per patient
Medication regimen complexity index Month 12 Medication regimen complexity index
Quality of life measured with the EuroQol Group 5-level EQ-5D version Month 12 To evaluate the impact of medication therapy management on The patients' quality of life: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.Existence of at least one potentially inappropriate drug per patient Month 12 Evolution of potentially inappropriate prescribing
Differential cost ratio Month 12 To evaluate the impact of medication therapy management on The cost-utility and cost-efficacy ratios
Mean number of modifications made by the General Practitioner per patient, following the pharmacist's intervention Month 2 To evaluate the modifications made by the general practitioner due to the pharmacists' interventions
Trial Locations
- Locations (1)
Toulouse University Hospital
🇫🇷Toulouse, Occitanie, France