Relation Between Psychoactive Drugs Overdosage and Severity of Falls in Elderly People

NCT05991037 | Recruiting DMC

• 1 other identifier: 21-0177
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

There are many epidemiological data on the relationship between the number or nature of psychoactive medications used and the risk of falling in elderly, but very little on the relationship between the amount of psychoactive medication actually present in the blood and the severity of the fall. However, the inevitable drug-drug interactions related to polypharmacy and the pharmacokinetic modifications related to old age may lead plasma overdose situations which can potentiate the risk of falls but also aggravate these consequences. The investigators therefore propose a study with the objective of verifying whether the proportion of falls with serious traumatic consequences is more frequent in patients over 75 years old, presenting plasma overdoses of psychoactive drugs (plasma concentrations higher than the usual therapeutic concentrations) in regard to those between therapeutic ranges. The aim of this work is to verify if the falls present more severe characters when the psychoactive drug concentrations are beyond the usual therapeutic ranges.

Conditions

Fall

Keywords

fall; psychoactive drugs; old patients; prescription; plasmatic concentrations

Outcome Measures

Primary Outcomes (1)

• Comparison of the percentages of falls with serious traumatic consequences in each of the two "overdosed" and "non-overdosed" groups.

  To evaluate if serious traumatic consequences are more important in the group of elderly patients with plasma overdoses of psychoactive drugs than in the "non-overdosed" group.

  3 years

Secondary Outcomes (5)

• Relationship between the category of severity of the fall (according to the criteria of Schwenk et al, 2012) and the interactions highlighted in the prescription

  3 years

• Relationship between the blood concentrations of psychoactive drugs and the occurrence of confusional syndrome assessed by the Confusion Assessment Method and/or neurocognitive disorders assessed by the Mini Mental State Evaluation.

  3 years

• Relationship between drug blood concentrations and severity of the fall, various states and functions studied during the geriatric consultation (dependence, mood, nutritional state, renal and liver function, presence of drug-drug interactions).

  3 years

• Comparison between psychoactive drugs identified in the blood and expected prescriptions (entry prescription)

  3 years

• Evaluation of the severity of the fall (according to the criteria of Schwenk et al, 2012) with regard to a recent modification or not of the prescription (descriptive presentation of modification of dosage, addition ore deletion)

  3 years

Study Arms (2)

"overdosed" group

EXPERIMENTAL

The experimental group will be made up of falling patients recruited for whom at least one psychoactive drug has been measured in a concentration higher than the usual therapeutic ranges.

Biological: Blood sampling for psychoactive drugs dosage

"non-overdosed" group

OTHER

The control group will be made up of falling patients recruited for whom none of the psychoactive drugs have been measured in supra-therapeutic concentrations (therefore concentrations measured therapeutic or infra-therapeutic)

Biological: Blood sampling for psychoactive drugs dosage

Interventions

Blood sampling for psychoactive drugs dosage BIOLOGICAL

4 blood samples for psychoactive drugs identification and dosage will be taken on arrival at the emergency room during fall management

"non-overdosed" group; "overdosed" group

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patient (male, female) aged 75 and over admitted to the emergency room for a fall and for whom hospitalization (in geriatrics or not) after going to the emergency room is planned
• Patient consuming at least one psychoactive drug from the list provided in the protocol
• Patient able to move before hospitalization with or without technical assistance
• Patient who signed the consent
• Patient subject to the social security system

You may not qualify if:

• Patient not requiring hospitalization after going to the emergency room
• Parkinsonian patient or patient who has fallen following a convulsive attack
• Patient with a life-threatening prognosis in the very short term (state of shock, palliative care planned from the emergency room)
• Patient in wheelchair or bedridden
• Adult under legal protection, guardianship, curators
• Patient not understanding the French language

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Caen University Hospital

Caen, France

RECRUITING

Related Publications (3)

• Bloch F, Thibaud M, Dugue B, Breque C, Rigaud AS, Kemoun G. Psychotropic drugs and falls in the elderly people: updated literature review and meta-analysis. J Aging Health. 2011 Mar;23(2):329-46. doi: 10.1177/0898264310381277. Epub 2010 Oct 14.

  PMID: 20947876 BACKGROUND

• Han JH, Chen A, Vasilevskis EE, Schnelle JF, Ely EW, Chandrasekhar R, Morrison RD, Ryan TP, Daniels JS, Sutherland JJ, Simmons SF. Supratherapeutic Psychotropic Drug Levels in the Emergency Department and Their Association with Delirium Duration: A Preliminary Study. J Am Geriatr Soc. 2019 Nov;67(11):2387-2392. doi: 10.1111/jgs.16156. Epub 2019 Sep 10.

  PMID: 31503339 BACKGROUND

• Schwenk M, Lauenroth A, Stock C, Moreno RR, Oster P, McHugh G, Todd C, Hauer K. Definitions and methods of measuring and reporting on injurious falls in randomised controlled fall prevention trials: a systematic review. BMC Med Res Methodol. 2012 Apr 17;12:50. doi: 10.1186/1471-2288-12-50.

  PMID: 22510239 BACKGROUND

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Véronique Lelong-Boulouard, PhD

  Caen Normandie Universitary Hospital Center

  STUDY DIRECTOR

Central Study Contacts

Véronique Lelong-Boulouard, PhD

CONTACT

0231063341; lelongboulouard-v@chu-caen.fr

Cédric Villain, PhD

CONTACT

villain-c@chu-acen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: The groups will be constituted after the inclusions according to the results of the psychoactive drug blood concentration measures, so that Participants, Care Provider and Investigators will be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The severity of the fall will be assessed in the 400 patients included. The groups will be defined a posteriori, according to the results obtained for the psychoactive drug dosages. Approximately 80 patients expected in the "overdosed" group matched to the same number of subjects on gender, age and cognition from the 320 subjects in the "non-overdosed" group to meet the primary objective at risk α = 5% and a power = 80%.

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 14, 2023
• Study Start: May 22, 2024
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2028
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)