Medication Therapy ManagementBIMEDOCNCT03909035
A Collaborative Approach to Medication Reviews for Older Patients With Polypharmacy
A study testing Medication therapy management in people with Medication Therapy Management, run by University Hospital, Toulouse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Medication Therapy Management
- What is being tested?
- Medication therapy management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 697 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jun 2019to 25 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medication Reviews Performed for Elderly Patients: a Collaborative Approach Between Community Pharmacists, Patients and General Practitioners to the Optimizations of Prescriptions
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.
Read the 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.
- Conditions
- Medication Therapy Management
- Being tested
- Medication therapy management
- Keywords
- Medication review polypharmacy, clinical pharmacy, older people, inappropriate prescribing, collaboration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication therapy managementOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Medication therapy management | Experimental | Medication therapy management by the community pharmacist in collaboration with the General Practitioners to the Optimizations of Prescriptions Receives: Other: Medication therapy management |
| Usual pharmaceutical care | No intervention | Usual pharmaceutical care provided by the community pharmacist (first level pharmaceutical analysis of the prescriptions) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 12
Secondary outcomes (20)
Number of patients hospitalised (only non-scheduled hospitalisations)
Number of non-scheduled hospitalisations (including emergency department transfers)
Measured: Month 12
Existence of at least one potentially inappropriate drug per patient
Evolution of potentially inappropriate prescribing
Measured: Month 0
Existence of at least one potentially inappropriate drug per patient
Evolution of potentially inappropriate prescribing
Measured: Month 2
Existence of at least one potentially inappropriate drug per patient
Evolution of potentially inappropriate prescribing
Measured: Month 12
Mean number of medications per patient
Mean number of medications per patient
Measured: Month 0
Mean number of medications per patient
Mean number of medications per patient
Measured: Month 12
Medication regimen complexity index
Medication regimen complexity index
Measured: Month 0
Medication regimen complexity index
Medication regimen complexity index
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 12
Differential cost ratio
To evaluate the impact of medication therapy management on The cost-utility and cost-efficacy ratios
Measured: Month 4
Differential cost ratio
To evaluate the impact of medication therapy management on The cost-utility and cost-efficacy ratios
Measured: Month 8
Differential cost ratio
To evaluate the impact of medication therapy management on The cost-utility and cost-efficacy ratios
Measured: 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
Measured: Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start3 Jun 2019
- Primary completion25 Oct 2021
- Study completion25 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication Therapy ManagementStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 697 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cestac, Principal investigator, Toulouse University Hospital / Paul Sabatier University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909035
- Sponsor's protocol ID
- RC31/17/0454
- Other IDs
- 17-0277, 2018/A00213/52
- Acronym
- BIMEDOC
- Status last verified
- Nov 2023
- First submitted
- 19 Mar 2019
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Reviews Performed for Elderly Patients: a Collaborative Approach Between Community Pharmacists, Patients and General Practitioners to the Optimizations of Prescriptions
- ClinicalTrials.gov ID
- NCT03909035
- Acronym / sponsor ID
- BIMEDOC / RC31/17/0454
- Conditions
- Medication Therapy Management
- Keywords
- Medication review polypharmacy, clinical pharmacy, older people, inappropriate prescribing, collaboration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 697 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 25 Oct 2021 (actual)
- First posted
- 9 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medication therapy management | Experimental | Other: Medication therapy managementMedication 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) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medication therapy managementThe 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) | Other | Medication therapy management |
Primary outcome
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.
20 secondary outcomes
Number of patients hospitalised (only non-scheduled hospitalisations)
Time frame: Month 12
Existence of at least one potentially inappropriate drug per patient
Time frame: Month 0
Existence of at least one potentially inappropriate drug per patient
Time frame: Month 2
Existence of at least one potentially inappropriate drug per patient
Time frame: Month 12
Mean number of medications per patient
Time frame: Month 0
Mean number of medications per patient
Time frame: Month 12
Medication regimen complexity index
Time frame: Month 0
Medication regimen complexity index
Time frame: Month 12
Girerd compliance test score
Time frame: Month 0
Girerd compliance test score
Time frame: Month 4
Girerd compliance test score
Time frame: Month 8
Girerd compliance test score
Time frame: Month 12
Quality of life measured with the EuroQol Group 5-level EQ-5D version
Time frame: Month 0
Quality of life measured with the EuroQol Group 5-level EQ-5D version
Time frame: Month 4
Quality of life measured with the EuroQol Group 5-level EQ-5D version
Time frame: Month 8
Quality of life measured with the EuroQol Group 5-level EQ-5D version
Time frame: Month 12
Differential cost ratio
Time frame: Month 4
Differential cost ratio
Time frame: Month 8
Differential cost ratio
Time frame: Month 12
Mean number of modifications made by the General Practitioner per patient, following the pharmacist's intervention
Time frame: Month 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cestac principal investigator
Toulouse University Hospital / Paul Sabatier University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication therapy management in people with Medication Therapy Management, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients hospitalised (time frame: Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023; AzTrials last refreshed its copy on 6 Nov 2026.