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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "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. |
|
| "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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | To evaluate influence of prescribed medication on the nature of the fall.
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Véronique Lelong-Boulouard, PhD | Contact | 0231063341 | lelongboulouard-v@chu-caen.fr | |
| Cédric Villain, PhD | Contact | villain-c@chu-acen.fr |
| Name | Affiliation | Role |
|---|---|---|
| Véronique Lelong-Boulouard, PhD | Caen Normandie Universitary Hospital Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Caen University Hospital | Recruiting | Caen | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20947876 | Result | 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. | |
| 31503339 | Result | 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. |
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All study data is the exclusive property of the Promoter. Any publication relating to these can only be made after validation by the Promoter and the lead methodologist.
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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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%.
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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.
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| 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. | To evaluate influence of psychoactive drug overdosage on confusional and/or cognitive state
| 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). | To evaluate the influence of psychoactive drug blood concentrations on :
| 3 years |
| Comparison between psychoactive drugs identified in the blood and expected prescriptions (entry prescription) | To evaluate the level of adequacy between the prescription (expected prescriptions, verification of misuse, compliance, etc.) and the psychoactive drugs (nature and quantity evaluated as in outcome 3) found in the blood by chromatographic method. | 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) | To evaluate the influence of recent change in the prescription (taking into account any recent adjustments to it: modification of dosage, addition of prescription or deletion of prescription) on the severity of the fall (criteria of Schwenk et al, 2012: serious, moderate, minor or no injuries). | 3 years |
| 22510239 | Result | 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. |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |