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| ID | Type | Description | Link |
|---|---|---|---|
| 17-0277 | Other Grant/Funding Number | French Ministry of Health, PREPS 2017 | |
| 2018/A00213/52 | Other Identifier | ANSM |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medication therapy management | Experimental | Medication therapy management by the community pharmacist in collaboration with the General Practitioners to the Optimizations of Prescriptions |
|
| Usual pharmaceutical care | No Intervention | Usual pharmaceutical care provided by the community pharmacist (first level pharmaceutical analysis of the prescriptions) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medication therapy management | Other | The intervention is in the form of a pharmacist-led medication review aimed at detecting potentially inappropriate prescribing. It includes:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients hospitalised (only non-scheduled hospitalisations) | Number of non-scheduled hospitalisations (including emergency department transfers) | Month 12 |
| Existence of at least one potentially inappropriate drug per patient |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cestac | Toulouse University Hospital / Paul Sabatier University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toulouse University Hospital | Toulouse | Occitanie | 31059 | France |
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| ID | Term |
|---|---|
| D054539 | Medication Therapy Management |
| ID | Term |
|---|---|
| D010593 | Pharmaceutical Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D054524 | Medicare Part D |
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|
Evolution of potentially inappropriate prescribing
| Month 0 |
| Existence of at least one potentially inappropriate drug per patient | Evolution of potentially inappropriate prescribing | Month 2 |
| Existence of at least one potentially inappropriate drug per patient | Evolution of potentially inappropriate prescribing | Month 12 |
| Mean number of medications per patient | Mean number of medications per patient | Month 0 |
| Mean number of medications per patient | Mean number of medications per patient | Month 12 |
| Medication regimen complexity index | Medication regimen complexity index | Month 0 |
| Medication regimen complexity index | Medication regimen complexity index | Month 12 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Differential cost ratio | To evaluate the impact of medication therapy management on The cost-utility and cost-efficacy ratios | Month 4 |
| Differential cost ratio | To evaluate the impact of medication therapy management on The cost-utility and cost-efficacy ratios | Month 8 |
| Differential cost ratio | To evaluate the impact of medication therapy management on The cost-utility and cost-efficacy ratios | Month 12 |
| 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 |
| D007356 | Insurance, Pharmaceutical Services |
| D007348 | Insurance, Health |
| D007341 | Insurance |
| D005381 | Financing, Organized |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D006278 | Medicare |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |