Prescription Patterns of Antidepressants, Analgesics, and Antiepileptics Drugs in Adult With Acquired Brain Injury

NCT06983314 | Completed

• 1 other identifier: 4726
• Study Type: observational
• Target: 201
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Prescription Paterns and rates of antidepressants, antiepileptics and analgesics

  Proportion of patients with at least one prescription of antidepressants, antiepileptics, or analgesics retrieved from medical records, described at three time points: (1) pre-existing usual prescriptions prior to acute care hospitalization, (2) prescriptions at discharge from acute care, and (3) prescriptions at discharge from rehabilitation. This outcome is purely descriptive. No clinical events are measured. No measurement tools are used. Data are extracted retrospectively from medical records.

  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 (5)

• Total number of drugs listed per prescription type

  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).

• Most frequently prescribed drug classes per prescription type

  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).

• Analysis of specific drugs, their indications, and therapeutic management

  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)

• Number of potential drug-drug interactions identified

  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).

• Rate of suspected Adverse Drug Reactions (ADRs) and therapeutic consequences

  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).

Study Arms (1)

Group

Patients with Acquired Brain Injury (ABI) receiving prescribed antidepressants, antiepileptics, and analgesics during hospitalization.

Other: Observation

Interventions

Observation OTHER

Observation of pharmacological prescriptions in patients with ABI

Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

CHU de Caen (Centre Hospitalier Universitaire de Caen, France)

Caen, 14000, France

Location

MeSH Terms

Conditions

Brain Injuries; Stroke; Brain Injuries, Traumatic; Drug-Related Side Effects and Adverse Reactions

Interventions

Observation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

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

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: May 21, 2025
• Study Start: November 1, 2020
• Primary Completion: October 31, 2023
• Study Completion: July 1, 2024
• Last Updated: May 21, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)