File Analysis of Falling Patients: Are Drugs Frequently Involved

Fall Patients Clinical Trial

— ADOPAC  

Official title:

File Analysis of Falling Patients: Are Drugs Frequently Involved

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04787146
• Other study ID #: ADOPAC
• Status: Completed
• Start date: April 18, 2019
• Est. completion date: February 28, 2021

Study information

• Verified date: March 2021
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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:

1. Intrinsic:

• History of a fall,

• pathologies (Parkinson's or Alzheimer's disease),

• hearing and visual disturbances,

• urinary incontinence.

2. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 28, 2021
• Est. primary completion date: October 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fall Patients

Intervention

Other:
• No intervention
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.

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint-Joseph	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the prevalence of falls associated with one or more risk factors for drug iatrogenism within the Paris Saint-Joseph Hospital Group.	Percentage of falls involving one or more drugs at risk of falling	1 week
Secondary	List the drug treatments at risk taken by patients who fall	To list the drug treatments taken by the patients who fall: carrying out the patient's drug assessment	1 week
Secondary	Evaluate the relevance of drug prescriptions in patients who fall	Average number of inappropriate medication prescriptions per patient	1 week
Secondary	Evaluate the overall compliance of falling patients	Average compliance score in patients who fall	1 week