Clinical trial NCT05991037: Relation Between Psychoactive Drugs Overdosage and Severity of Falls in Elderly People
Official title: Consequence of Plasma Concentrations of Psychoactive Drugs Located Beyond Therapeutic Ranges on Severity of Falls in Patients Over 75 Years Old
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fall
Keywords: fall
psychoactive drugs
old patients
prescription
plasmatic concentrations
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 400
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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%.
Primary purpose: PREVENTION

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.

Detailed description: Patients over the age of 75 with at least one psychoactive drugs in their usual treatment will be included in the study in order to assess the severity of their fall and to measure the concentrations of all psychoactive drugs identified in their blood samples.

This study must include 400 patients over the age of 75 hospitalized for a fall in geriatrics or another department after going to the emergency room.

Patients will be included in the study as soon as they go to the emergency room during which the blood samples will be taken and several data collected. The final inclusions and the consultations to collect the clinical and biological data essential to the achievement of the main and secondary objectives will then be carried out by a geriatrician in the patient's hospitalization department.

Qualitative research and plasma assays of psychoactive drugs will be carried out by liquid phase chromatography coupled with a tandem mass spectrometer.

The expected duration of the study will be 3 years.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patient not requiring hospitalization after going to the emergency room
* Patient having fallen for more than 12 hours before inclusion in the study (time of sampling) \[risk of excessive elimination of certain drugs with short half-lives\]
* 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

Primary outcomes:
measure: Comparison of the percentages of falls with serious traumatic consequences in each of the two "overdosed" and "non-overdosed" groups.
timeFrame: 3 years
Secondary outcomes:
measure: 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
timeFrame: 3 years
measure: 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.
timeFrame: 3 years
measure: 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).
timeFrame: 3 years
measure: Comparison between psychoactive drugs identified in the blood and expected prescriptions (entry prescription)
timeFrame: 3 years
measure: 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)
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Caen Normandie Universitary Hospital Center
name: Véronique Lelong-Boulouard, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.