- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03909035
A Collaborative Approach to Medication Reviews for Older Patients With Polypharmacy (BIMEDOC)
Medication Reviews Performed for Elderly Patients: a Collaborative Approach Between Community Pharmacists, Patients and General Practitioners to the Optimizations of Prescriptions
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Cestac
- Phone Number: +33 5 61 77 11 59
- Email: cestac.p@chu-toulouse.fr
Study Contact Backup
- Name: McCambridge
- Phone Number: +33 5 67 77 10 32
- Email: mccambridge.c@chu-toulouse.fr
Study Locations
-
-
Occitanie
-
Toulouse, Occitanie, France, 31059
- Toulouse University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Medication therapy management
Medication therapy management by the community pharmacist in collaboration with the General Practitioners to the Optimizations of Prescriptions
|
The intervention is in the form of a pharmacist-led medication review aimed at detecting potentially inappropriate prescribing. It includes:
|
No Intervention: Usual pharmaceutical care
Usual pharmaceutical care provided by the community pharmacist (first level pharmaceutical analysis of the prescriptions)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients hospitalised
Time Frame: Month 12
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients hospitalised (only non-scheduled hospitalisations)
Time Frame: Month 12
|
Number of non-scheduled hospitalisations (including emergency department transfers)
|
Month 12
|
Existence of at least one potentially inappropriate drug per patient
Time Frame: Month 0
|
Evolution of potentially inappropriate prescribing
|
Month 0
|
Existence of at least one potentially inappropriate drug per patient
Time Frame: Month 2
|
Evolution of potentially inappropriate prescribing
|
Month 2
|
Existence of at least one potentially inappropriate drug per patient
Time Frame: Month 12
|
Evolution of potentially inappropriate prescribing
|
Month 12
|
Mean number of medications per patient
Time Frame: Month 0
|
Mean number of medications per patient
|
Month 0
|
Mean number of medications per patient
Time Frame: Month 12
|
Mean number of medications per patient
|
Month 12
|
Medication regimen complexity index
Time Frame: Month 0
|
Medication regimen complexity index
|
Month 0
|
Medication regimen complexity index
Time Frame: Month 12
|
Medication regimen complexity index
|
Month 12
|
Girerd compliance test score
Time Frame: Month 0
|
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
Time Frame: Month 4
|
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
Time Frame: Month 8
|
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
Time Frame: 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.
|
Month 12
|
Quality of life measured with the EuroQol Group 5-level EQ-5D version
Time Frame: Month 0
|
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
Time Frame: Month 4
|
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
Time Frame: Month 8
|
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
Time Frame: 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. |
Month 12
|
Differential cost ratio
Time Frame: Month 4
|
To evaluate the impact of medication therapy management on The cost-utility and cost-efficacy ratios
|
Month 4
|
Differential cost ratio
Time Frame: Month 8
|
To evaluate the impact of medication therapy management on The cost-utility and cost-efficacy ratios
|
Month 8
|
Differential cost ratio
Time Frame: Month 12
|
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
Time Frame: Month 2
|
To evaluate the modifications made by the general practitioner due to the pharmacists' interventions
|
Month 2
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cestac, Toulouse University Hospital / Paul Sabatier University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- RC31/17/0454
- 17-0277 (Other Grant/Funding Number: French Ministry of Health, PREPS 2017)
- 2018/A00213/52 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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