- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07282379
Association Between Geriatric Frailty and Medication Related Problems in the Emergency Department to Help Clinical Pharmacists Prioritise Patients (DISARMED)
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.
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ferdinand Le Bloc'h, PharmD
- Phone Number: +41774879035
- Email: ferdinand.lebloch@unige.ch
Study Locations
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Canton of Vaud
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Rennaz, Canton of Vaud, Switzerland, 1847
- Hôpital Riviera-Chablais (Vaud-Valais), service des urgences
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Contact:
- Ferdinand Le Bloc'h, PharmD
- Phone Number: +41774879035
- Email: ferdinand.lebloch@unige.ch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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 .
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Elderly patients in the ED
Patients aged of 75 or more who are admitted to the emergency department
|
After inclusion, each patient's data will be collected and analysed by the investigator in the following 5 days. The said data will be:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
At the time of their admission to the emergency department
|
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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.
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At the time of their admission to the emergency department
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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.
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At the time of their admission to the emergency department.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The number of drug-related problems (DRPs) in function to the ISAR score.
Time Frame: At the time of their admission to the emergency department.
|
After pharmaceutical analysis of the electronic patient file, DRPs will be classified according to the Pharmaceutical Care Network Europe Association (PCNE) V9.
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At the time of their admission to the emergency department.
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The likelihood of a medication-related emergency visit in function to the ISAR score.
Time Frame: At the time of their admission to the emergency department.
|
The likelihood of a medication-related emergency visit will be measured with the AT-HARM 10 score.
This score gives a binary result ("possibly" or "unlikely" medication-related visit) and is a useful tool to exclude patients who are unlikely to be admitted due to a medication issue.
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At the time of their admission to the emergency department.
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Zautra A, Hempel A. Subjective well-being and physical health: a narrative literature review with suggestions for future research. Int J Aging Hum Dev. 1984;19(2):91-110. doi: 10.2190/a9rb-7d02-g77k-m3n6.
- Mowri HO, Patsch JR, Gotto AM Jr, Patsch W. Apolipoprotein A-II influences the substrate properties of human HDL2 and HDL3 for hepatic lipase. Arterioscler Thromb Vasc Biol. 1996 Jun;16(6):755-62. doi: 10.1161/01.atv.16.6.755.
- McCusker 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.
- Ellis 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.
- Almarsdottir 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.
- Bamps 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DISARMED2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Data will be accessible to external researchers, regulatory bodies, and authorized entities under the following conditions:
Formal request submission detailing the project and data usage. Access granted if the request meets ethical, scientific, and confidentiality criteria.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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