File Analysis of Falling Patients: Are Drugs Frequently Involved (ADOPAC)

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.

Study Overview

• Status: Completed
• Conditions: Fall Patients
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• France
  • Ile De France
    • Paris, Ile De France, France, 75014
      • Groupe Hospitalier Paris Saint-Joseph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Evaluate the relevance of drug prescriptions in patients who fall	Average number of inappropriate medication prescriptions per patient	1 week
Evaluate the overall compliance of falling patients	Average compliance score in patients who fall	1 week

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Paris Saint Joseph
• Investigators: Principal Investigator: Elodie MENAGE, Groupe Hospitalier Paris Saint Joseph

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2019
• Primary Completion (Actual): October 15, 2019
• Study Completion (Actual): February 28, 2021

Study Registration Dates

• First Submitted: March 1, 2021
• First Submitted That Met QC Criteria: March 5, 2021
• First Posted (Actual): March 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 8, 2021
• Last Update Submitted That Met QC Criteria: March 5, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Drugs
• Other Study ID Numbers: ADOPAC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No