FrailtyDISARMEDNCT07282379
Association Between Geriatric Frailty and Medication Related Problems in the Emergency Department to Help Clinical Pharmacists Prioritise Patients
An observational study of Frailty and Emergency Department Visit, run by Pharmacie des Hopitaux de l'Est Lemanique at 1 site in Switzerland.
Trial summary
The healthcare systems are under increasing pressure due to a rise in emergency consultations, staff shortages, an ageing population and rising costs. Emergency departments are seeing more vulnerable patients, including elderly people, who are often on multiple medications and at risk of medication errors. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Frailty, Emergency Department Visit, Elderly
- What is being tested?
- Pharmaceutical analysis based on the Electronic Patient Record
- How many people
- 300 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2026to Sep 2026
- 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 75 years and older
- All sexes
- Older adult
Study population: The study population will consist of all geriatric patients residing in the area of the Riviera-Chablais Hospital (Rennaz, Canton of Vaud, Switzerland). This hospital cares for nearly 200,000 people and its adult emergency department receives 35,000 patients per year (20% of whom are aged 75 and over).
Who may be able to join
- Patients aged ≥ 75 years admitted to the adult emergency department
- Patients able to give informed consent as documented by signature or a therapeutic representative, if applicable .
Who cannot join
- Patients initially admitted to the emergency resuscitation room.
- Patients admitted to the minor accidents and emergencies room.
- Patients admitted to the stroke unit, as they just pass through the emergency department to directly proceed to the CT-scanner.
- Missing data for proper file analysis (e.g., missing usual home medication)
- Patient's inability to sign consent and no therapeutic representative available
- Patient's refusal to sign consent
- Emergency physician's refusal to include patient for any reason.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Hôpital Riviera-Chablais (Vaud-Valais), service des urgences
Rennaz, Canton of Vaud, 1847
Ferdinand Le Bloc'h, PharmD, +41774879035, ferdinand.lebloch@unige.ch
About this study
Official title: DETECTION OF ISAR-FLAGGED AT-RISK MEDICATION IN THE EMERGENCY DEPARTMENT (DISARMED)
The healthcare systems are under increasing pressure due to a rise in emergency consultations, staff shortages, an ageing population and rising costs. Emergency departments are seeing more vulnerable patients, including elderly people, who are often on multiple medications and at risk of medication errors.
To improve safety, the integration of pharmacists specialising in emergency medicine has proven beneficial: their presence in the team improves the detection of medication-related problems, speeds up and optimises treatment, reduces rehospitalisations and lowers healthcare costs. However, in most countries, these pharmacists are still rarely found in emergency departments, mainly due to a lack of resources and clinical prioritisation criteria tailored for them and adapted to this environment.
Read more
Frailty screening tools and scores, such as ISAR, can be used to identify the elderly patients most at risk, predict adverse events such as fall or mortality, and thus adapt their care in the emergency department. Indeed, elderly frail patients often take many medications and consequently are at risk of medication errors, adverse events, inappropriate prescriptions or serious drug interactions. These patients may therefore require a specialised review on their medication by clinical pharmacists when they are admitted to the emergency department, but their high number make it impossible to care for all of them.
We aim thus to evaluate the association between frailty (according to the ISAR score) and medication-related problems among elderly patients admitted to the emergency department. Researchers will examine whether this score can predict the presence of inappropriate prescribing and high-risk drug interactions. If so, pharmacists would then have a quick and easy tool to prioritise patients who would benefit most from a specialised review of their medications when they visit the emergency department.
There will not be any intervention and this study will not influence patients care. Once patients agree to participate, researchers will prospectively collect medical data from elderly patients admitted to the emergency department and analyse their medical history, home medication, reason for admission, frailty score using ISAR, and perform a pharmaceutical analysis based on these data.
- Conditions
- Frailty, Emergency Department Visit, Elderly, Drug Drug Interaction, Inappropriate Drug Use
- Being tested
- Pharmaceutical analysis based on the Electronic Patient Record
- Keywords
- emergency department, clinical pharmacists, elderly, frailty, ISAR, inappropriate prescription, Drug interaction, drug-related problems
- Medical subject headings
- Frailty, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmaceutical analysis based on the Electronic Patient RecordOther
After inclusion, each patient's data will be collected and analysed by the investigator in the following 5 days. The said data will be:
- Independent variables (demographic data, laboratory results, comorbidities, home medication treatment, reason for admission)
- The ISAR score, using the electronic patients record
- The number of inappropriate prescriptions, using STOPP/START version 3 online tool.
- The number of high-risk drug interactions (categories D "Consider therapy modification" and X "Avoid combination"), using Lexicomp™ Interact online tool.
- The number of drug-related problems, using the PCNE classification version 9.1, including usual home patient's treatment as well as treatment received in the ED.
- The likelihood of a medication-related emergency consultation, using AT-HARM 10 score.
| Study group | Role | What they receive |
|---|---|---|
| Elderly patients in the ED | Patients aged of 75 or more who are admitted to the emergency department Receives: Other: Pharmaceutical analysis based on the Electronic Patient Record |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of inappropriate prescription (PIP) as a function of their ISAR score.
The rate of inappropriate prescription (PIP) will be compared as a function of their ISAR score, using Poisson regression analysis. PIPs will be defined according to the STOPP/START online tool version 3, developed for geriatric patients.
Measured: At the time of their admission to the emergency department
The rate of high-risk drug-drug interactions (DDIs) as a function of their ISAR score.
The rate of high-risk drug-drug interactions (DDIs) will be compared as a function of their ISAR score, using Poisson regression analysis. High-risk DDIs will be detected with the Lexicomp™ Interact online tool and only categories D ("Consider therapy modification") and X ("Avoid combination") will be considered.
Measured: At the time of their admission to the emergency department
Secondary outcomes (1)
The predictive performance of the ISAR score for the detection of PIPs and high-risk DDIs.
Determining optimal ISAR threshold for predicting medication problems further improves its use in clinical settings. If possible, sensitivity, specificity, positive predictive value, negative predictive value, and Youden index will be calculated.
Measured: At the time of their admission to the emergency department.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start1 Mar 2026 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies 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
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmacie des Hopitaux de l'Est Lemanique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07282379
- Sponsor's protocol ID
- DISARMED2026
- Acronym
- DISARMED
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If patients give their consent for data re-utilisation (consent signature independent from their inclusion in the study), demographic data and all individual outcomes (ISAR score, inappropriate prescriptions, high-risk drug interactions, drug-related problems, AT-HARM10 score) will be shared. All data will be anonymised and shared in a secure format (CSV).
Publications
Kempen TGH, Hedstrom M, Olsson H, Johansson A, Ottosson S, Al-Sammak Y, Gillespie U. Assessment tool for hospital admissions related to medications: development and validation in older patients. Int J Clin Pharm. 2019 Feb;41(1):198-206. doi: 10.1007/s11096-018-0768-8. Epub 2018 Dec 26.
PubMed 30585296Abuzour AS, Hoad-Reddick G, Shahid M, Steinke DT, Tully MP, Williams SD, Lewis PJ. Patient prioritisation for hospital pharmacy services: current approaches in the UK. Eur J Hosp Pharm. 2021 Nov;28(Suppl 2):e102-e108. doi: 10.1136/ejhpharm-2020-002365. Epub 2020 Dec 1.
PubMed 33262131McCusker J, Bellavance F, Cardin S, Trepanier S, Verdon J, Ardman O. Detection of older people at increased risk of adverse health outcomes after an emergency visit: the ISAR screening tool. J Am Geriatr Soc. 1999 Oct;47(10):1229-37. doi: 10.1111/j.1532-5415.1999.tb05204.x.
PubMed 10522957Ellis B, Carpenter CR, Lowthian JA, Mooijaart SP, Nickel CH, Melady D. Statement on Minimum Standards for the Care of Older People in Emergency Departments by the Geriatric Emergency Medicine Special Interest Group of the International Federation for Emergency Medicine. CJEM. 2018 May;20(3):368-369. doi: 10.1017/cem.2017.426. Epub 2018 Jan 23. No abstract available.
PubMed 29357950Almarsdottir AB, Haq R, Norgaard JDSV. Prioritizing patients for medication review by emergency department pharmacists: a multi-method study. Int J Clin Pharm. 2023 Apr;45(2):387-396. doi: 10.1007/s11096-022-01515-3. Epub 2022 Dec 5.
PubMed 36469215Bamps J, Lelubre S, Cauchies AS, Devillez A, Almpanis C, Patris S. Identification of seniors at risk (ISAR) score and potentially inappropriate prescribing: a retrospective cohort study. Int J Clin Pharm. 2024 Dec;46(6):1345-1351. doi: 10.1007/s11096-024-01766-2. Epub 2024 Jul 2.
PubMed 38954078
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DETECTION OF ISAR-FLAGGED AT-RISK MEDICATION IN THE EMERGENCY DEPARTMENT (DISARMED)
- ClinicalTrials.gov ID
- NCT07282379
- Acronym / sponsor ID
- DISARMED / DISARMED2026
- Conditions
- Frailty, Emergency Department Visit, Elderly, Drug Drug Interaction, Inappropriate Drug Use
- Keywords
- emergency department, clinical pharmacists, elderly, frailty, ISAR, inappropriate prescription, Drug interaction, drug-related problems
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Pharmacie des Hopitaux de l'Est LemaniqueUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 15 Dec 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.
The healthcare systems are under increasing pressure due to a rise in emergency consultations, staff shortages, an ageing population and rising costs. Emergency departments are seeing more vulnerable patients, including elderly people, who are often on multiple medications and at risk of medication errors.
To improve safety, the integration of pharmacists specialising in emergency medicine has proven beneficial: their presence in the team improves the detection of medication-related problems, speeds up and optimises treatment, reduces rehospitalisations and lowers healthcare costs. However, in most countries, these pharmacists are still rarely found in emergency departments, mainly due to a lack of resources and clinical prioritisation criteria tailored for them and adapted to this environment.
Frailty screening tools and scores, such as ISAR, can be used to identify the elderly patients most at risk, predict adverse events such as fall or mortality, and thus adapt their care in the emergency department. Indeed, elderly frail patients often take many medications and consequently are at risk of medication errors, adverse events, inappropriate prescriptions or serious drug interactions. These patients may therefore require a specialised review on their medication by clinical pharmacists when they are admitted to the emergency department, but their high number make it impossible to care for all of them.
We aim thus to evaluate the association between frailty (according to the ISAR score) and medication-related problems among elderly patients admitted to the emergency department. Researchers will examine whether this score can predict the presence of inappropriate prescribing and high-risk drug interactions. If so, pharmacists would then have a quick and easy tool to prioritise patients who would benefit most from a specialised review of their medications when they visit the emergency department.
There will not be any intervention and this study will not influence patients care. Once patients agree to participate, researchers will prospectively collect medical data from elderly patients admitted to the emergency department and analyse their medical history, home medication, reason for admission, frailty score using ISAR, and perform a pharmaceutical analysis based on these data.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly patients in the ED | – | Other: Pharmaceutical analysis based on the Electronic Patient RecordPatients aged of 75 or more who are admitted to the emergency department |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- The study population will consist of all geriatric patients residing in the area of the Riviera-Chablais Hospital (Rennaz, Canton of Vaud, Switzerland). This hospital cares for nearly 200,000 people and its adult emergency department receives 35,000 patients per year (20% of whom are aged 75 and over).
Key inclusion criteria (2 listed)
- Patients aged ≥ 75 years admitted to the adult emergency department
- Patients able to give informed consent as documented by signature or a therapeutic representative, if applicable .
Key exclusion criteria (7 listed)
- Patients initially admitted to the emergency resuscitation room.
- Patients admitted to the minor accidents and emergencies room.
- Patients admitted to the stroke unit, as they just pass through the emergency department to directly proceed to the CT-scanner.
- Missing data for proper file analysis (e.g., missing usual home medication)
- Patient's inability to sign consent and no therapeutic representative available
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 |
|---|---|---|
| Pharmaceutical analysis based on the Electronic Patient RecordAfter inclusion, each patient's data will be collected and analysed by the investigator in the following 5 days. The said data will be: * Independent variables (demographic data, laboratory results, comorbidities, home medication treatment, reason for admission) * The ISAR score, using the electronic patients record * The number of inappropriate prescriptions, using STOPP/START version 3 online tool. * The number of high-risk drug interactions (categories D "Consider therapy modification" and X "Avoid combination"), using Lexicomp™ Interact online tool. * The number of drug-related problems, using the PCNE classification version 9.1, including usual home patient's treatment as well as treatment received in the ED. * The likelihood of a medication-related emergency consultation, using AT-HARM 10 score. | Other | Elderly patients in the ED |
Primary outcome
The rate of inappropriate prescription (PIP) as a function of their ISAR score.
Time frame: At the time of their admission to the emergency department
The rate of inappropriate prescription (PIP) will be compared as a function of their ISAR score, using Poisson regression analysis. PIPs will be defined according to the STOPP/START online tool version 3, developed for geriatric patients.
The rate of high-risk drug-drug interactions (DDIs) as a function of their ISAR score.
Time frame: At the time of their admission to the emergency department
The rate of high-risk drug-drug interactions (DDIs) will be compared as a function of their ISAR score, using Poisson regression analysis. High-risk DDIs will be detected with the Lexicomp™ Interact online tool and only categories D ("Consider therapy modification") and X ("Avoid combination") will be considered.
1 secondary outcome
The predictive performance of the ISAR score for the detection of PIPs and high-risk DDIs.
Time frame: At the time of their admission to the emergency department.
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 15 Dec 2025.
- Results publication: PubMed 30585296Kempen TGH, Hedstrom M, Olsson H, Johansson A, Ottosson S, Al-Sammak Y, Gillespie U. Assessment tool for hospital admissions related to medications: development and validation in older patients. Int J Clin Pharm. 2019 Feb;41(1):198-206. doi: 10.1007/s11096-018-0768-8. Epub 2018 Dec 26.
- Results publication: PubMed 33262131Abuzour AS, Hoad-Reddick G, Shahid M, Steinke DT, Tully MP, Williams SD, Lewis PJ. Patient prioritisation for hospital pharmacy services: current approaches in the UK. Eur J Hosp Pharm. 2021 Nov;28(Suppl 2):e102-e108. doi: 10.1136/ejhpharm-2020-002365. Epub 2020 Dec 1.
- Results publication: PubMed 10522957McCusker J, Bellavance F, Cardin S, Trepanier S, Verdon J, Ardman O. Detection of older people at increased risk of adverse health outcomes after an emergency visit: the ISAR screening tool. J Am Geriatr Soc. 1999 Oct;47(10):1229-37. doi: 10.1111/j.1532-5415.1999.tb05204.x.
- Results publication: PubMed 29357950Ellis B, Carpenter CR, Lowthian JA, Mooijaart SP, Nickel CH, Melady D. Statement on Minimum Standards for the Care of Older People in Emergency Departments by the Geriatric Emergency Medicine Special Interest Group of the International Federation for Emergency Medicine. CJEM. 2018 May;20(3):368-369. doi: 10.1017/cem.2017.426. Epub 2018 Jan 23. No abstract available.
- Results publication: PubMed 36469215Almarsdottir AB, Haq R, Norgaard JDSV. Prioritizing patients for medication review by emergency department pharmacists: a multi-method study. Int J Clin Pharm. 2023 Apr;45(2):387-396. doi: 10.1007/s11096-022-01515-3. Epub 2022 Dec 5.
- Results publication: PubMed 38954078Bamps J, Lelubre S, Cauchies AS, Devillez A, Almpanis C, Patris S. Identification of seniors at risk (ISAR) score and potentially inappropriate prescribing: a retrospective cohort study. Int J Clin Pharm. 2024 Dec;46(6):1345-1351. doi: 10.1007/s11096-024-01766-2. Epub 2024 Jul 2.
- Web page of the hospital pharmacy conducting the study (PHEL) and describing all current research projects summaries.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. If patients give their consent for data re-utilisation (consent signature independent from their inclusion in the study), demographic data and all individual outcomes (ISAR score, inappropriate prescriptions, high-risk drug interactions, drug-related problems, AT-HARM10 score) will be shared. All data will be anonymised and shared in a secure format (CSV).
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty and Emergency Department Visit, run by Pharmacie des Hopitaux de l'Est Lemanique at 1 site in Switzerland.
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 2 inclusion and 7 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: opening soon, as of the sponsor's last update on 15 Dec 2025. 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 Switzerland. 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?
Contact Ferdinand Le Bloc'h, PharmD (+41774879035, ferdinand.lebloch@unige.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of inappropriate prescription (PIP) as a function of their ISAR score. (time frame: At the time of their admission to the emergency department). The study lists 2 primary outcomes in all. 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 NCT07282379, which also lists 6 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 15 Dec 2025.