A Collaborative Approach to Medication Reviews for Older Patients With Polypharmacy

Medication Therapy Management Clinical Trial

— BIMEDOC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03909035
• Other study ID #: RC31/17/0454
• Secondary ID: 17-02772018/A002
• Status: Completed
• Phase: N/A
• Start date: June 3, 2019
• Est. completion date: October 25, 2021

Study information

• Verified date: November 2023
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 697
• Est. completion date: October 25, 2021
• Est. primary completion date: October 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Medication Therapy Management

Intervention

Other:
• Medication therapy management
The intervention is in the form of a pharmacist-led medication review aimed at detecting potentially inappropriate prescribing. It includes: A patient-pharmacist interview to collect comorbidities, medication, laboratory results, self-medication, adherence, medication patient's knowledge. A pharmacist's evaluation of the prescriptions based on the patient's conditions and on the current recommendations for clinical practice. Detailed feedback to the general practitioner. An appointment with the patient to explain the modifications made by the general practitioner (GP)

Locations

Country	Name	City	State
France	Toulouse University Hospital	Toulouse	Occitanie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients hospitalised	Number of patients hospitalised for more or less than 24 hours, including emergency department transfers during a 12 month-period follow-up.	Month 12
Secondary	Number of patients hospitalised (only non-scheduled hospitalisations)	Number of non-scheduled hospitalisations (including emergency department transfers)	Month 12
Secondary	Existence of at least one potentially inappropriate drug per patient	Evolution of potentially inappropriate prescribing	Month 0
Secondary	Existence of at least one potentially inappropriate drug per patient	Evolution of potentially inappropriate prescribing	Month 2
Secondary	Existence of at least one potentially inappropriate drug per patient	Evolution of potentially inappropriate prescribing	Month 12
Secondary	Mean number of medications per patient	Mean number of medications per patient	Month 0
Secondary	Mean number of medications per patient	Mean number of medications per patient	Month 12
Secondary	Medication regimen complexity index	Medication regimen complexity index	Month 0
Secondary	Medication regimen complexity index	Medication regimen complexity index	Month 12
Secondary	Girerd compliance test score	To evaluate the impact of medication therapy management on Medication adherence. From 0 to 6 Yes. 0 Yes: Best value. 6 Yes: worst value.	Month 0
Secondary	Girerd compliance test score	To evaluate the impact of medication therapy management on Medication adherence.From 0 to 6 Yes. 0 Yes: Best value. 6 Yes: worst value.; From 0 to 6 Yes. 0 Yes: Best value. 6 Yes: worst value.	Month 4
Secondary	Girerd compliance test score	To evaluate the impact of medication therapy management on Medication adherence. From 0 to 6 Yes. 0 Yes: Best value. 6 Yes: worst value.	Month 8
Secondary	Girerd compliance test score	To evaluate the impact of medication therapy management on Medication adherence. From 0 to 6 Yes. 0 Yes: Best value. 6 Yes: worst value.	Month 12
Secondary	Quality of life measured with the EuroQol Group 5-level EQ-5D version	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.	Month 0
Secondary	Quality of life measured with the EuroQol Group 5-level EQ-5D version	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.	Month 4
Secondary	Quality of life measured with the EuroQol Group 5-level EQ-5D version	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.	Month 8
Secondary	Quality of life measured with the EuroQol Group 5-level EQ-5D version	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.	Month 12
Secondary	Differential cost ratio	To evaluate the impact of medication therapy management on The cost-utility and cost-efficacy ratios	Month 4
Secondary	Differential cost ratio	To evaluate the impact of medication therapy management on The cost-utility and cost-efficacy ratios	Month 8
Secondary	Differential cost ratio	To evaluate the impact of medication therapy management on The cost-utility and cost-efficacy ratios	Month 12
Secondary	Mean number of modifications made by the General Practitioner per patient, following the pharmacist's intervention	To evaluate the modifications made by the general practitioner due to the pharmacists' interventions	Month 2