Medication AbuseOUTMEDIC-FRNCT05327634
Obstacles to Deprescribing Among French Patients Over 75 Years of Age Treated in the Geriatric Hospital Network
An observational study of Medication Abuse, run by Hôpital NOVO at 4 sites in France.
Trial summary
The aim of this study is to highlight action guidelines to encourage acceptance of deprescribing in people over 75 years of age: training, therapeutic education, post-prescription follow-up, specific patient pathways, specific consultations or even the integration of an advanced practice nurse in this process. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Medication Abuse
- What is being tested?
- self-questionnaire
- How many people
- 120 participants
- Where
- 4 sitesFrance
- Study dates
- 1 Apr 2022to 25 Jan 2023
- Phase
- Observational
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged 75 and over hospitalised in geriatric short stay or geriatric rehabilitation units
Who may be able to join
- Patients aged 75 years and over
- Hospitalized in geriatric short-stay or geriatric rehabilitation units
- Patients who did not object to participation in the study
Who cannot join
- Patient refusal
- Patients not able to understand and fill in the questionnaire: Cognitive disorders, Confusion, Unstable clinical state, Sensory disorders, not speaking French.
- Patient under protective supervision (guardianship or curatorship)
Trial locations and contacts
4 sites in 1 country.
France4 sites
Short stay Geriatric department - Hospital Simone Veil
Beauvais, 60021
SSR Geriatric department - Hospital Simone Veil
Beauvais, 60021
Short stay Geriatric department - Hospital René Dubos
Pontoise, 95300
SSR Geriatric department - Hospital René Dubos
Pontoise, 95300
About this study
Official title: Description of the Obstacles to Deprescribing Among French Patients Over 75 Years of Age Treated in the Geriatric Hospital Network
The aim of this study is to highlight action guidelines to encourage acceptance of deprescribing in people over 75 years of age: training, therapeutic education, post-prescription follow-up, specific patient pathways, specific consultations or even the integration of an advanced practice nurse in this process.
Read the detailed description
For several years now, the proportion of senior citizens in our country has been rising steadily. There are now 6.4 million people over the age of 75 in France.
It is therefore important to take into account the needs and specificities of this part of the population. One of its particularities is polypathology. Indeed, from the age of 70 onwards, 93% of elderly subjects have at least 2 diseases and 85% have at least 3. This polypathology will lead to a large number of different prescribers with an increased risk of having more than 5 molecules in their personal treatment. This is known as polypharmacy.
In the elderly, polypharmacy is harmful. It increases the risk of adverse effects and drug interactions. In France, 20% of patients over 75 years old and 25% of those over 85 years old consult the emergency room because of adverse drug reactions.
The literature shows that we can act on these adverse events by "deprescribing". De-prescribing is defined as intentionally stopping the prescription of an unnecessary or potentially dangerous drug for a patient.
The expected benefit for the patient is to reduce the iatrogenic risks induced by treatments that would no longer be useful for him/her or that have a negative benefit/risk balance. To achieve this objective, the patient must understand this risk, understand the benefit he or she can derive from it and be an actor in this process.
For carers, the expected benefit is greater involvement of the patient in the process, better adherence to the approach, which can be organised and carried out in a safer way.
- Conditions
- Medication Abuse
- Being tested
- self-questionnaire
- Keywords
- Elderly patient, Inappropriate drugs, Deprescribing, Obstacles, French
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-questionnaireOther
Prospective study on patients aged 75 and over, hospitalised in geriatric short stay or geriatric rehabilitation units
| Study group | Role | What they receive |
|---|---|---|
| Deprescribing | Prospective study on patients aged 75 and over, hospitalised in geriatric short stay or geriatric rehabilitation units Receives: Other: self-questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the obstacles to the withdrawal of medication in patients over 75 years of age in the geriatric sector
The main evaluation criterion will be measured using the self-questionnaire: a revised form of the 5-point Likert-type "Revised Patients' Attitude Toward Deprescribing" (rPATD), validated in French.
Discouragement will be assessed on the basis of the overall score of questions 1 to 20 of the self-questionnaire, with regard to questions 21 and 22.
Measured: Baseline
Secondary outcomes (5)
Assessment of the relationship between patient burden and acceptance (or refusal) of deprescribing.
They will be measured using the self-questionnaire given to patients. Responses to the burden (questions 1-5) and acceptance (question 21) questions will be measured using the revised 5-point Likert-type "Revised Patients' Attitude Toward Deprescribing" (rPATD) scale, validated in French. A correlation will be made between the two items.
They will be measured using the self-questionnaire given to patients. Responses to the burden (questions 1-5) and acceptance (question 21) questions will be measured using the revised 5-point Likert-type "Revised Patients' Attitude Toward Deprescribing" (rPATD) scale, validated in French. A correlation will be made between the two items.
Measured: Baseline
Assessment of the relationship between the benefit of the treatment experienced by the patient and the acceptance (or refusal) of the deprescribing
They will be measured using the self-questionnaire given to patients. Responses to the questions concerning the perceived benefit of treatment (questions 6 to 10) and acceptance (question 21) will be measured using the revised Patients' Attitude Toward Deprescribing (rPATD) 5-point Likert scale. A correlation will be made between the two items
Measured: Baseline
Assessment of the relationship between concern about possible negative effects of discontinuing treatment and acceptance (or refusal) of deprescribing
They will be measured using the self-questionnaire given to patients. Responses to questions concerning concern about possible negative effects of stopping treatment (questions 11 to 15) and acceptance (question 21) will be measured using the revised Patients' Attitude Toward Deprescribing (rPATD) 5-point Likert scale. A correlation will be made between the two items.
Measured: Baseline
Assessment of the relationship between the patient's good knowledge of their treatments and acceptance (or refusal) of the deprescribing.
They will be measured using the self-questionnaire given to patients. The answers to the questions concerning the patient's good knowledge of their treatments (questions 16 to 20) and acceptance (question 21) will be measured using the revised Patients' Attitude Toward Deprescribing (rPATD) 5-point Likert scale. A correlation will be made between the two items..
Measured: Baseline
Assessment of the relationship between certain families of treatments and acceptance (or refusal) of deprescribing
They will be measured using the self-questionnaire given to patients. Responses concerning the acceptance of deprescribing according to the different treatment families will be measured using simple questions 26 to 29 of the self-questionnaire
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start1 Apr 2022
- Primary completion25 Jan 2023
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Medication AbuseStudies of the same condition, open and under way.
- 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe Antoniazzi, Principal investigator, Hospital René Dubos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327634
- Sponsor's protocol ID
- CHRD2921
- Other IDs
- 2022-A00136-37
- Acronym
- OUTMEDIC-FR
- Status last verified
- Feb 2023
- First submitted
- 7 Apr 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roux B, Sirois C, Niquille A, Spinewine A, Ouellet N, Petein C, Sibille FX, Csajka C, Reeve E, Villeneuve C, Laroche ML. Cross-cultural adaptation and psychometric validation of the revised Patients' Attitudes Towards Deprescribing (rPATD) questionnaire in French. Res Social Adm Pharm. 2021 Aug;17(8):1453-1462. doi: 10.1016/j.sapharm.2020.11.004. Epub 2020 Nov 10.
PubMed 33317980Antoniazzi C, Cnockaert X, Michel P. Description of barriers to the deprescription of inappropriate drugs in French hospitalized geriatric services. Sci Rep. 2025 May 15;15(1):16837. doi: 10.1038/s41598-025-99752-9.
PubMed 40374894
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of the Obstacles to Deprescribing Among French Patients Over 75 Years of Age Treated in the Geriatric Hospital Network
- ClinicalTrials.gov ID
- NCT05327634
- Acronym / sponsor ID
- OUTMEDIC-FR / CHRD2921
- Conditions
- Medication Abuse
- Keywords
- Elderly patient, Inappropriate drugs, Deprescribing, Obstacles, French
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 25 Jan 2023 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 14 Apr 2022 (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.
The aim of this study is to highlight action guidelines to encourage acceptance of deprescribing in people over 75 years of age: training, therapeutic education, post-prescription follow-up, specific patient pathways, specific consultations or even the integration of an advanced practice nurse in this process.
Detailed description
For several years now, the proportion of senior citizens in our country has been rising steadily. There are now 6.4 million people over the age of 75 in France.
It is therefore important to take into account the needs and specificities of this part of the population. One of its particularities is polypathology. Indeed, from the age of 70 onwards, 93% of elderly subjects have at least 2 diseases and 85% have at least 3. This polypathology will lead to a large number of different prescribers with an increased risk of having more than 5 molecules in their personal treatment. This is known as polypharmacy.
In the elderly, polypharmacy is harmful. It increases the risk of adverse effects and drug interactions. In France, 20% of patients over 75 years old and 25% of those over 85 years old consult the emergency room because of adverse drug reactions.
The literature shows that we can act on these adverse events by "deprescribing". De-prescribing is defined as intentionally stopping the prescription of an unnecessary or potentially dangerous drug for a patient.
The expected benefit for the patient is to reduce the iatrogenic risks induced by treatments that would no longer be useful for him/her or that have a negative benefit/risk balance. To achieve this objective, the patient must understand this risk, understand the benefit he or she can derive from it and be an actor in this process.
For carers, the expected benefit is greater involvement of the patient in the process, better adherence to the approach, which can be organised and carried out in a safer way.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deprescribing | – | Other: self-questionnaireProspective study on patients aged 75 and over, hospitalised in geriatric short stay or geriatric rehabilitation units |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged 75 and over hospitalised in geriatric short stay or geriatric rehabilitation units
Key inclusion criteria (3 listed)
- Patients aged 75 years and over
- Hospitalized in geriatric short-stay or geriatric rehabilitation units
- Patients who did not object to participation in the study
Key exclusion criteria (3 listed)
- Patient refusal
- Patients not able to understand and fill in the questionnaire: Cognitive disorders, Confusion, Unstable clinical state, Sensory disorders, not speaking French.
- Patient under protective supervision (guardianship or curatorship)
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 |
|---|---|---|
| self-questionnaireProspective study on patients aged 75 and over, hospitalised in geriatric short stay or geriatric rehabilitation units | Other | Deprescribing |
Primary outcome
Description of the obstacles to the withdrawal of medication in patients over 75 years of age in the geriatric sector
Time frame: Baseline
The main evaluation criterion will be measured using the self-questionnaire: a revised form of the 5-point Likert-type "Revised Patients' Attitude Toward Deprescribing" (rPATD), validated in French. Discouragement will be assessed on the basis of the overall score of questions 1 to 20 of the self-questionnaire, with regard to questions 21 and 22.
5 secondary outcomes
Assessment of the relationship between patient burden and acceptance (or refusal) of deprescribing.
Time frame: Baseline
Assessment of the relationship between the benefit of the treatment experienced by the patient and the acceptance (or refusal) of the deprescribing
Time frame: Baseline
Assessment of the relationship between concern about possible negative effects of discontinuing treatment and acceptance (or refusal) of deprescribing
Time frame: Baseline
Assessment of the relationship between the patient's good knowledge of their treatments and acceptance (or refusal) of the deprescribing.
Time frame: Baseline
Assessment of the relationship between certain families of treatments and acceptance (or refusal) of deprescribing
Time frame: Baseline
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 19 Sep 2024.
- Background: PubMed 33317980Roux B, Sirois C, Niquille A, Spinewine A, Ouellet N, Petein C, Sibille FX, Csajka C, Reeve E, Villeneuve C, Laroche ML. Cross-cultural adaptation and psychometric validation of the revised Patients' Attitudes Towards Deprescribing (rPATD) questionnaire in French. Res Social Adm Pharm. 2021 Aug;17(8):1453-1462. doi: 10.1016/j.sapharm.2020.11.004. Epub 2020 Nov 10.
- Derived from this study: PubMed 40374894Antoniazzi C, Cnockaert X, Michel P. Description of barriers to the deprescription of inappropriate drugs in French hospitalized geriatric services. Sci Rep. 2025 May 15;15(1):16837. doi: 10.1038/s41598-025-99752-9.
- Individual participant dataSharing planned: No
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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.
Christophe Antoniazzi principal investigator
Hospital René Dubos
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medication Abuse, run by Hôpital NOVO at 4 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 3 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
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?
Description of the obstacles to the withdrawal of medication in patients over 75 years of age in the geriatric sector (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05327634, which also lists 2 linked publications.
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 19 Sep 2024.