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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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