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

Completed

• Conditions: Acquired Brain Injury Including Stroke

• Registration Number: NCT06983314
• Lead Sponsor: University Hospital, Caen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-01
• Primary Completion: 2023-10-31
• Study Completion: 2024-07-01
• Status Verified: 2025-01
• Study First Submitted: 2025-02-03
• Study First Submitted QC: 2025-05-13
• Last Update Submitted: 2025-05-13
• Study First Posted: 2025-05-21
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prescription Paterns and rates of antidepressants, antiepileptics and analgesics	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).	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.

Secondary Outcome Measures

Name	Time	Method
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).	To analyze the average number of drugs per prescription, categorized into three types: usual prescription, discharge from acute care, and discharge from rehabilitation.; Unit of Measure: Number of drugs per prescription Retrieval of prescriptions of interest from the medical file, analysis and data collection. No use of measurement tool. Just description of prescriptions.
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).	To identify the top prescribed pharmacological classes (e.g., using ATC classification) within usual prescriptions, acute discharge prescriptions, and rehabilitation discharge prescriptions.; Unit of Measure: Number of prescriptions per drug class Retrieval of prescriptions of interest from the medical file, analysis and data collection. No use of measurement tool. Just description of prescriptions.
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)	To describe the most frequently prescribed drugs in the three target classes, assess whether their indications comply with official labelling, and detail any therapeutic adjustments during the rehabilitation stay (e.g., dosage changes, discontinuation).; Unit of Measure: Number of prescriptions assessed for compliance and change Retrieval of prescriptions of interest from the medical file, analysis and data collection. No use of measurement tool. Just description of prescriptions.
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).	To identify and count potential pharmacokinetic or pharmacodynamic drug-drug interactions involving antidepressants, antiepileptics, or analgesics, in the context of all prescribed medications.; Unit of Measure: Number of potential drug-drug interactions per patient Retrieval of prescriptions of interest from the medical file, analysis and data collection. No use of measurement tool. Just description of prescriptions.
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).	To identify suspected Adverse Drug Reactions (ADRs) reported in medical records and describe the related clinical decisions (e.g., discontinuation, switch, dose adjustment).; Unit of Measure: Number of ADRs reported and management decisions documented Retrieval of prescriptions of interest from the medical file, analysis and data collection. No use of measurement tool. Just description of prescriptions.

Trial Locations

Locations (1)

CHU de Caen (Centre Hospitalier Universitaire de Caen, France); 🇫🇷 Caen, France