Clinical trial NCT06983314: Prescription Patterns of Antidepressants, Analgesics, and Antiepileptics Drugs in Adult With Acquired Brain Injury
Official title: Prescription Patterns of Antidepressants, Analgesics, and Antiepileptics Drugs in Adult Patients With Acquired Brain Injury Hospitalized in Rehabilitation Center Following Acute Care: a Bicentric Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acquired Brain Injury Including Stroke
Keywords: Acquired Brain Injury
Stroke
Traumatic Brain Injury
Rehabilitation
Prescription Patterns
Antidepressants
Antiepileptics
Analgesics
Drug Complications
Adverse Drug Reactions
Drug-Drug Interactions
Pharmacological Management
Post-acute Care
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of adult patients diagnosed with acquired brain injury (ABI) who were hospitalized in two rehabilitation centers in Normandy, France, between November 1, 2020, and October 31, 2023. Eligible patients were required to have passed through an acute care department before being admitted to the rehabilitation center. Only patients with ABI as the primary diagnosis, according to the PMSI (French medical information system), were included.

The study focused on patients who received new prescriptions for specific pharmacological classes (antidepressants, antiepileptics, and analgesics) either during acute care or within the first month of rehabilitation hospitalization. Patients were excluded if they had pre-existing prescriptions for these drugs prior to ABI, or if they did not receive new prescriptions for these drugs during the study period.

The final study population was selected based on these inclusion and exclusion criteria.

Brief summary: Acquired brain injury (ABI), primarily caused by stroke and traumatic brain injury (TBI), leads to severe disabilities and requires complex pharmacological management during post-acute rehabilitation. The lack of dedicated guidelines and regular treatment re-evaluation increases the risk of adverse drug reactions (ADRs).

Retrospective, bicentric study in two rehabilitation centers in Normandy, France, from November 1, 2020, to October 31, 2023, to describe prescription patterns of antidepressants, antiepileptics, and analgesics, as well as potential drug-related complications.


Eligibility criteria: Inclusion Criteria:

* Adults hospitalized in a rehabilitation center for acquired brain injury (ABI) after passing through an acute care department.
* ABI must be the primary diagnosis in the PMSI (French medical information system).
* The pharmacological classes of interest (antidepressants, antiepileptics, analgesics) must have been introduced during acute care or within the first month of hospitalization in the rehabilitation center.

Exclusion Criteria:

* Patients who did not receive new prescriptions for the pharmacological classes of interest during acute care or the first month of hospitalization in the rehabilitation center.
* Patients who were already prescribed these drugs prior to the ABI.
* Patients who were not hospitalized immediately after discharge from acute care (patients must have been transferred directly from acute care to the rehabilitation center, without spending time in another department or at home).
* Patients who were transferred to an emergency department during rehabilitation and did not return to the rehabilitation center.
* Patients who died during hospitalization or were discharged against medical advice.

Primary outcomes:
measure: Prescription Paterns and rates of antidepressants, antiepileptics and analgesics
timeFrame: From the date of admission to the rehabilitation center to the date of discharge from the rehabilitation center (median duration of stay approximately 100 days).
Secondary outcomes:
measure: Total number of drugs listed per prescription type
timeFrame: From the date of admission to the rehabilitation center to the date of discharge from the rehabilitation center (median duration of stay approximately 100 days).
measure: Most frequently prescribed drug classes per prescription type
timeFrame: From the date of admission to the rehabilitation center to the date of discharge from the rehabilitation center (median duration of stay approximately 100 days).
measure: Analysis of specific drugs, their indications, and therapeutic management
timeFrame: From the date of admission to the rehabilitation center to the date of discharge from the rehabilitation center (median duration of stay approximately 100 days)
measure: Number of potential drug-drug interactions identified
timeFrame: From the date of admission to the rehabilitation center to the date of discharge from the rehabilitation center (median duration of stay approximately 100 days).
measure: Rate of suspected Adverse Drug Reactions (ADRs) and therapeutic consequences
timeFrame: From the date of admission to the rehabilitation center to the date of discharge from the rehabilitation center (median duration of stay approximately 100 days).
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU de Caen (Centre Hospitalier Universitaire de Caen, France)
Study officials:
References: