Stroke Geriatrics Acute Coronary Syndrome OrthogeriatricCOD-AMAPNCT07133152
Medico-economic Analysis of Clinical Pharmacy Activities
An observational study of Stroke Geriatrics Acute Coronary Syndrome Orthogeriatric, run by Hospices Civils de Lyon at 6 sites in France.
Trial summary
In recent years, the deployment of clinical pharmacy activities in France has undergone rapid change as a result of the work carried out by the French Society of Clinical Pharmacy (SFPC), organisational innovations (iatrogenic day hospital, city-hospital pathway) and new regulations (adaptation and renewal of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Geriatrics Acute Coronary Syndrome Orthogeriatric
- What is being tested?
- Adverse events
- How many people
- 240 participants
- Where
- 6 sitesFrance
- Study dates
- 1 Feb 2025to 1 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatients, medical pathways (post-stroke, geriatrics, post-acute coronary syndrome, orthogeriatric).
Who may be able to join
- Adult patients
- Admitted to the hospital during the 2 months of recruitment
- Hospitalized in one of the following care pathways: post-stroke, geriatrics, post-acute coronary syndrome, orthogeriatric.
Who cannot join
- Patients who have expressed their opposition to the study;
- Patient under curatorship, guardianship or legal protection;
- Patients unable to express their non-opposition;
- Person deprived of liberty by a judicial or administrative decision;
- Person under compulsory psychiatric care.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Hospices Civils de Lyon - Hôpital Louis Pradel
Bron, France, 69500
Hospices Civils de Lyon - Hôpital Renée Sabran
Hyères, France, 83400
Hospices Civils de Lyon - Hôpital Edouard Herriot
Lyon, France, 69003
Hospices Civils de Lyon - Hôpital de la Croix-Rousse
Lyon, France, 69004
Hospices Civils de Lyon - Hôpital Lyon Sud
Oullins, France, 69495
Hospices Civils de Lyon - Hôpital des Charpennes
Villeurbanne, France, 69100
About this study
Official title: From Codification to Valorisation: a Medico-economic Analysis of Clinical Pharmacy Activities Integrated Into Patient Pathways.
In recent years, the deployment of clinical pharmacy activities in France has undergone rapid change as a result of the work carried out by the French Society of Clinical Pharmacy (SFPC), organisational innovations (iatrogenic day hospital, city-hospital pathway) and new regulations (adaptation and renewal of prescriptions by hospital pharmacies). This transformation is causing disparities between hospitals in the deployment of clinical pharmacy activities and a lack of clarity in the activities of each.
At the same time, the traceability of these clinical pharmacy activities is a major strategic challenge, as it meets regulatory requirements (pharmaceutical analysis linked to dispensing), safety requirements (pharmaceutical interventions, reconciliation of drug treatments), financial requirements (day hospital, medical and rehabilitation care, outpatient consultations) and quality requirements (reglutory indicators, mandatory certification).
Read more
Some healthcare institutions have launched local initiatives to code their clinical pharmacy activities themselves. These experiments have demonstrated the need to standardize coding across French healthcare institutions, in order to bring it into line with current guidelines (French Health Authority - HAS - guidelines, good clinical pharmacy practice, decree) and the coding rules of the common classification of medical acts. The ultimate aim of such coding is to qualify, in the long term, for financial recognition of clinical pharmacy activities via the Health Insurance System. To meet this need, in March 2023 OMEDIT PACA-Corse published a coding guide for clinical pharmacy activities, validated by the SFPC and deployed to date in a number of French establishments.
Based on national coding, the investigators propose to carry out a medico-economic analysis using observational data, in order to assess the efficiency of integrating clinical pharmacy activities into patient care pathways. The aim of this study is also to initiate a process of reflection to define the pharmaceutical costs associated with clinical pharmacy activities. The investigators hypothesize that the costs of implementing clinical pharmacy (hospital pharmacist salary) will be covered by the costs avoided in terms of adverse events.
A single-centre, prospective, non-interventional and comparative cohort study will be carried out in 4 different care pathways with 2 different sites targeted for each pathway: one site carrying out clinical pharmacy activities with patients as part of routine care (active group) and one site carrying out no clinical pharmacy activities with patients as part of routine care (comparator group).
The study takes place in the same way in each of the 4 pathways, with 3 distinct phases:
Phase 1: Collection of routine care data during hospitalisation:
- In the active group: no research-related procedures are carried out on the patient. The patient benefits from the clinical pharmacy activities offered as part of routine care. The pharmacist records the time spent with the patient for each clinical pharmacy activity performed during the hospital stay.
- In the comparator group: no research-related activities are performed on the patient. Patients benefit from the routine care pathway defined in their hospital ward.
Phase 2: Collection of routine care data at 3- and 6-months post-hospitalisation:
- In the active group and in the comparator group: consultation of the computerised patient record to collect adverse events related to drug management that occurred at 3- and 6-months post-hospitalisation (emergency room visits, hospitalisation, drug-related iatrogenicity);
Phase 3: Telephone call to the patient 3- and 6- months after hospitalisation:
- In the active group and in the comparator group: evaluation via a questionnaire of adverse events related to drug management which occurred in the 6 months post-hospitalisation (emergency room visits, hospitalisation, drug-related iatrogenicity, consultation with the treatment physician). The call at 3 months is optional.
- Being tested
- Adverse events
- Keywords
- Clinical Pharmacy, Medico-economic analysis, Iatrogenic, Codification, Valorisation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adverse eventsOther
During patient follow-up (hospitalisation + 6 months post-hospitalisation), adverse events will be collected from the patient's computerised medical record (available at the hospital) and by means of a questionnaire carried out by telephone with the patient at 3- and 6-months post-hospitalisation.
| Study group | Role | What they receive |
|---|---|---|
| Post-stroke - Active group | Patients hospitalised after a stroke and benefiting from clinical pharmacy activities on their inpatient unit. Receives: Other: Adverse events | |
| Post-stroke - Comparator group | Patients hospitalised after a stroke and without any clinical pharmacy activities during their hospitalisation. Receives: Other: Adverse events | |
| Geriatrics - Active group | Patients hospitalised in geriatric settings and benefiting from clinical pharmacy activities on their inpatient unit. Receives: Other: Adverse events | |
| Geriatrics - Comparator group | Patients hospitalised in geriatric settings and without any clinical pharmacy activities during their hospitalisation. Receives: Other: Adverse events | |
| Post-Acute Coronary Syndrome - Active group | Patients hospitalised after an Acute Coronary Syndrome and benefiting from clinical pharmacy activities on their inpatient unit. Receives: Other: Adverse events | |
| Post-Acute Coronary Syndrome - Comparator group | Patients hospitalised after an Acute Coronary Syndrome and without any clinical pharmacy activities during their hospitalisation. Receives: Other: Adverse events | |
| Orthogeriatric - Active group | Patients hospitalised in an orthogeriatric pathway and benefiting from clinical pharmacy activities on their inpatient unit Receives: Other: Adverse events | |
| Orthogeriatric - Comparator group | Patients hospitalised in an orthogeriatric pathway and without any clinical pharmacy activities during their hospitalisation. Receives: Other: Adverse events |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost/efficiency ratio
Numerator: production costs of clinical pharmacy activities per patient (expressed in Euro, from hospital pharmacist's salary) Denominator: adverse events avoided (expressed in adverse events number, difference in frequency per patient between the comparator group and the active group)
Measured: At 3-monts post-hospitalisation (facultative) At 6-months post-hospitalisation (mandatory)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start1 Feb 2025
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke Geriatrics Acute Coronary Syndrome OrthogeriatricStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07133152
- Sponsor's protocol ID
- 24-5534
- Acronym
- COD-AMAP
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Codification to Valorisation: a Medico-economic Analysis of Clinical Pharmacy Activities Integrated Into Patient Pathways.
- ClinicalTrials.gov ID
- NCT07133152
- Acronym / sponsor ID
- COD-AMAP / 24-5534
- Keywords
- Clinical Pharmacy, Medico-economic analysis, Iatrogenic, Codification, Valorisation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 20 Aug 2025 (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 recent years, the deployment of clinical pharmacy activities in France has undergone rapid change as a result of the work carried out by the French Society of Clinical Pharmacy (SFPC), organisational innovations (iatrogenic day hospital, city-hospital pathway) and new regulations (adaptation and renewal of prescriptions by hospital pharmacies). This transformation is causing disparities between hospitals in the deployment of clinical pharmacy activities and a lack of clarity in the activities of each.
At the same time, the traceability of these clinical pharmacy activities is a major strategic challenge, as it meets regulatory requirements (pharmaceutical analysis linked to dispensing), safety requirements (pharmaceutical interventions, reconciliation of drug treatments), financial requirements (day hospital, medical and rehabilitation care, outpatient consultations) and quality requirements (reglutory indicators, mandatory certification).
Some healthcare institutions have launched local initiatives to code their clinical pharmacy activities themselves. These experiments have demonstrated the need to standardize coding across French healthcare institutions, in order to bring it into line with current guidelines (French Health Authority - HAS - guidelines, good clinical pharmacy practice, decree) and the coding rules of the common classification of medical acts. The ultimate aim of such coding is to qualify, in the long term, for financial recognition of clinical pharmacy activities via the Health Insurance System. To meet this need, in March 2023 OMEDIT PACA-Corse published a coding guide for clinical pharmacy activities, validated by the SFPC and deployed to date in a number of French establishments.
Based on national coding, the investigators propose to carry out a medico-economic analysis using observational data, in order to assess the efficiency of integrating clinical pharmacy activities into patient care pathways. The aim of this study is also to initiate a process of reflection to define the pharmaceutical costs associated with clinical pharmacy activities. The investigators hypothesize that the costs of implementing clinical pharmacy (hospital pharmacist salary) will be covered by the costs avoided in terms of adverse events.
A single-centre, prospective, non-interventional and comparative cohort study will be carried out in 4 different care pathways with 2 different sites targeted for each pathway: one site carrying out clinical pharmacy activities with patients as part of routine care (active group) and one site carrying out no clinical pharmacy activities with patients as part of routine care (comparator group).
The study takes place in the same way in each of the 4 pathways, with 3 distinct phases:
Phase 1: Collection of routine care data during hospitalisation:
- In the active group: no research-related procedures are carried out on the patient. The patient benefits from the clinical pharmacy activities offered as part of routine care. The pharmacist records the time spent with the patient for each clinical pharmacy activity performed during the hospital stay.
- In the comparator group: no research-related activities are performed on the patient. Patients benefit from the routine care pathway defined in their hospital ward.
Phase 2: Collection of routine care data at 3- and 6-months post-hospitalisation:
- In the active group and in the comparator group: consultation of the computerised patient record to collect adverse events related to drug management that occurred at 3- and 6-months post-hospitalisation (emergency room visits, hospitalisation, drug-related iatrogenicity);
Phase 3: Telephone call to the patient 3- and 6- months after hospitalisation:
- In the active group and in the comparator group: evaluation via a questionnaire of adverse events related to drug management which occurred in the 6 months post-hospitalisation (emergency room visits, hospitalisation, drug-related iatrogenicity, consultation with the treatment physician). The call at 3 months is optional.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Post-stroke - Active group | – | Other: Adverse eventsPatients hospitalised after a stroke and benefiting from clinical pharmacy activities on their inpatient unit. |
| Post-stroke - Comparator group | – | Other: Adverse eventsPatients hospitalised after a stroke and without any clinical pharmacy activities during their hospitalisation. |
| Geriatrics - Active group | – | Other: Adverse eventsPatients hospitalised in geriatric settings and benefiting from clinical pharmacy activities on their inpatient unit. |
| Geriatrics - Comparator group | – | Other: Adverse eventsPatients hospitalised in geriatric settings and without any clinical pharmacy activities during their hospitalisation. |
| Post-Acute Coronary Syndrome - Active group | – | Other: Adverse eventsPatients hospitalised after an Acute Coronary Syndrome and benefiting from clinical pharmacy activities on their inpatient unit. |
| Post-Acute Coronary Syndrome - Comparator group | – | Other: Adverse eventsPatients hospitalised after an Acute Coronary Syndrome and without any clinical pharmacy activities during their hospitalisation. |
| Orthogeriatric - Active group | – | Other: Adverse eventsPatients hospitalised in an orthogeriatric pathway and benefiting from clinical pharmacy activities on their inpatient unit |
| Orthogeriatric - Comparator group | – | Other: Adverse eventsPatients hospitalised in an orthogeriatric pathway and without any clinical pharmacy activities during their hospitalisation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients, medical pathways (post-stroke, geriatrics, post-acute coronary syndrome, orthogeriatric).
Key inclusion criteria (3 listed)
- Adult patients
- Admitted to the hospital during the 2 months of recruitment
- Hospitalized in one of the following care pathways: post-stroke, geriatrics, post-acute coronary syndrome, orthogeriatric.
Key exclusion criteria (5 listed)
- Patients who have expressed their opposition to the study;
- Patient under curatorship, guardianship or legal protection;
- Patients unable to express their non-opposition;
- Person deprived of liberty by a judicial or administrative decision;
- Person under compulsory psychiatric care.
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 |
|---|---|---|
| Adverse eventsDuring patient follow-up (hospitalisation + 6 months post-hospitalisation), adverse events will be collected from the patient's computerised medical record (available at the hospital) and by means of a questionnaire carried out by telephone with the patient at 3- and 6-months post-hospitalisation. | Other | Geriatrics - Active group, Geriatrics - Comparator group, Orthogeriatric - Active group, Orthogeriatric - Comparator group, Post-Acute Coronary Syndrome - Active group, Post-Acute Coronary Syndrome - Comparator group, Post-stroke - Active group, Post-stroke - Comparator group |
Primary outcome
Cost/efficiency ratio
Time frame: At 3-monts post-hospitalisation (facultative) At 6-months post-hospitalisation (mandatory)
Numerator: production costs of clinical pharmacy activities per patient (expressed in Euro, from hospital pharmacist's salary) Denominator: adverse events avoided (expressed in adverse events number, difference in frequency per patient between the comparator group and the active group)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke Geriatrics Acute Coronary Syndrome Orthogeriatric, run by Hospices Civils de Lyon at 6 sites 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 3 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Cost/efficiency ratio (time frame: At 3-monts post-hospitalisation (facultative) At 6-months post-hospitalisation (mandatory)). 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 20 Aug 2025.