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OpenTrials
Completed

NCT Number: NCT04787146

File Analysis of Falling Patients: Are Drugs Frequently Involved

The damage caused by patient falls is a major public health problem, due to the large and growing number of people concerned, the potentially serious consequences but also the financial cost generated by their care.

These consequences can be physical as well as psychological. Fractures and pain are the first consequences that come to mind, but many others should be mentioned: post-fall syndrome, loss of autonomy or even entering an institution, fear of falling, loss of confidence in itself.

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Key information

Conditions

Fall Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier Paris Saint-Joseph

Paris, Île-de-France Region, 75014, France

About this study

During 2018, 285 reports of falls were counted within the Paris Saint-Joseph Hospital Group (GhPSJ). Reducing these falls is one of the institutional goals. A dedicated working group has been created to put in place preventive and corrective measures.

These falls can be caused by many factors to the patient:

  • Intrinsic:
  • History of a fall,
  • pathologies (Parkinson's or Alzheimer's disease),
  • hearing and visual disturbances,
  • urinary incontinence.
  • extrinsic:
  • Unsuitable shoes
  • unsuitable habitat,
  • slippery floors (eg bathroom).

Among the intrinsic factors, polypharmacy is also found. It has been established that certain drug classes are at risk of falling, in particular psychotropic drugs (benzodiazepines, hypnotics, anxiolytics, antidepressants, neuroleptics) which promote sedation and dizziness, hypoglycemic drugs which cause hypoglycaemia in diabetic patients on -treated or antihypertensive drugs causing hypotension.

It is now clearly established that drug adherence to treatment is poor in cities, giving rise to omissions but also sometimes to overconsumption of certain drugs, including psychotropic drugs.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Major patient
  • French-speaking patient
  • Patient hospitalized within the Paris Saint-Joseph Hospital Group
  • Patient who fell during hospitalization and for whom a fall report has been completed

Exclusion criteria

  • Patients in the process of therapeutic limitation
  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient objecting to participation in the study
  • Patient under legal protection

Treatment and study plan

No intervention

Other

Once the patient is included, a drug assessment is carried out as part of the treatment and then an compliance questionnaire is submitted to him.

Primary outcomes

  1. To assess the prevalence of falls associated with one or more risk factors for drug iatrogenism within the Paris Saint-Joseph Hospital Group.

    Time frame: 1 week

    Percentage of falls involving one or more drugs at risk of falling

Secondary outcomes

  1. List the drug treatments at risk taken by patients who fall

    Time frame: 1 week

    To list the drug treatments taken by the patients who fall: carrying out the patient's drug assessment

  2. Evaluate the relevance of drug prescriptions in patients who fall

    Time frame: 1 week

    Average number of inappropriate medication prescriptions per patient

  3. Evaluate the overall compliance of falling patients

    Time frame: 1 week

    Average compliance score in patients who fall

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Registry information

Acronym: ADOPAC

Important dates

Study start
2019
Primary completion
2019
Study completion
2021
First posted
Mar 8, 2021
Registry last updated
Mar 8, 2021

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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