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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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
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

Other trials in France

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 groups in NCT07133152
Study groupRoleWhat they receive
Post-stroke - Active groupPatients hospitalised after a stroke and benefiting from clinical pharmacy activities on their inpatient unit.
Receives: Other: Adverse events
Post-stroke - Comparator groupPatients hospitalised after a stroke and without any clinical pharmacy activities during their hospitalisation.
Receives: Other: Adverse events
Geriatrics - Active groupPatients hospitalised in geriatric settings and benefiting from clinical pharmacy activities on their inpatient unit.
Receives: Other: Adverse events
Geriatrics - Comparator groupPatients hospitalised in geriatric settings and without any clinical pharmacy activities during their hospitalisation.
Receives: Other: Adverse events
Post-Acute Coronary Syndrome - Active groupPatients 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 groupPatients hospitalised after an Acute Coronary Syndrome and without any clinical pharmacy activities during their hospitalisation.
Receives: Other: Adverse events
Orthogeriatric - Active groupPatients hospitalised in an orthogeriatric pathway and benefiting from clinical pharmacy activities on their inpatient unit
Receives: Other: Adverse events
Orthogeriatric - Comparator groupPatients 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.

  1. 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.

  1. First posted20 Aug 2025
  2. Study start1 Feb 2025
  3. Primary completion1 Oct 2025 (estimated)
  4. Study completion1 Dec 2025 (estimated)

Resources

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)
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

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.

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