NCT07282379

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress37%
Mar 2026Sep 2026

First Submitted

Initial submission to the registry

December 2, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 15, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

December 15, 2025

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

December 2, 2025

Last Update Submit

December 2, 2025

Conditions

Keywords

emergency departmentclinical pharmacistselderlyfrailtyISARinappropriate prescriptionDrug interactiondrug-related problems

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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.

    At the time of their admission to the emergency department.

Other Outcomes (2)

  • The number of drug-related problems (DRPs) in function to the ISAR score.

    At the time of their admission to the emergency department.

  • The likelihood of a medication-related emergency visit in function to the ISAR score.

    At the time of their admission to the emergency department.

Study Arms (1)

Elderly patients in the ED

Patients aged of 75 or more who are admitted to the emergency department

Other: Pharmaceutical analysis based on the Electronic Patient Record

Interventions

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.

Elderly patients in the ED

Eligibility Criteria

Age75 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • 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 .

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Riviera-Chablais (Vaud-Valais), service des urgences

Rennaz, Canton of Vaud, 1847, Switzerland

Location

Related Publications (6)

  • 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.

  • Abuzour 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.

  • 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.

Related Links

MeSH Terms

Conditions

FrailtyEmergencies

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Central Study Contacts

Ferdinand Le Bloc'h, PharmD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2025

First Posted

December 15, 2025

Study Start

March 1, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

December 15, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

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).

Shared Documents
STUDY PROTOCOL
Time Frame
IPD data will be available 6 months after publication of the first study results and for 10 years
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.
More information

Locations