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Completed

NCT Number: NCT06983314

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

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.

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Key information

Conditions

Acquired Brain Injury Including Stroke Brain Diseases Brain Injuries Brain Injuries, Traumatic Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chemically-Induced Disorders Craniocerebral Trauma Drug-Related Side Effects and Adverse Reactions Nervous System Diseases Stroke Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Caen, 14000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

observation

Other

Observation of pharmacological prescriptions in patients with ABI

Primary outcomes

  1. Prescription Paterns and rates of antidepressants, antiepileptics and analgesics

    Time frame: 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 outcomes

  1. Total number of drugs listed per prescription type

    Time frame: 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.

  2. Most frequently prescribed drug classes per prescription type

    Time frame: 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.

  3. Analysis of specific drugs, their indications, and therapeutic management

    Time frame: 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.

  4. Number of potential drug-drug interactions identified

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study 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

Acronym: PRES'SMR

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
May 21, 2025
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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