File Analysis of Falling Patients: Are Drugs Frequently Involved

NCT ID: NCT04787146

Last Updated: 2021-03-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 52 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-18
• Study Completion Date: 2021-02-28

Brief 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.

Detailed 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.

Conditions

Fall Patients

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients

From Monday to Friday, the study will be offered to patients selected consecutively and who have fallen within the previous 24 hours (between 7.55 a.m. the day before and 7.55 a.m. the next day).

After delivery of the written information note to the patient, the investigating physician answers the patient's questions and accepts his non-objection. The patient should be given sufficient time to think things through to make the decision to participate in the study.

Its non-opposition will be traced in the computerized medical file created on the day of its inclusion in the protocol. Each patient participating in the study retains the possibility of participating simultaneously in another research. No exclusion period is provided for in the protocol.

No intervention

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Hôpital Saint-Joseph

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elodie MENAGE

Role: PRINCIPAL_INVESTIGATOR

Fondation Hôpital Saint-Joseph

Locations

Groupe Hospitalier Paris Saint-Joseph

Paris, Île-de-France Region, France

Countries

France

Other Identifiers

ADOPAC

Identifier Type: -

Identifier Source: org_study_id