Detection of Risk Behaviors: Pilot Observational Study With Bedridden and Agitated Patients. (DECORIPAA)

There is a risk of falls and injuries in bedridden hospitalized patients, increased in agitated or confused patients. In neurosurgery departments, brain damaged patients can present a loss of consciousness of risky behaviors and be in a state of agitation which frequently leads to their endangerment. The repercussions of this endangerment are multiple. For the patients, there may be a feeling of insecurity, with physical or chemical restraint solutions which deprive them of their freedom without a total guarantee of safety. For the caregivers, there is an emotional distress in front of this endangerment, and a professional guilt. Finally, there are economic repercussions due to the costs of complementary examinations and the lengthening of hospitalization.

The objective of the present study is to determine the nature and frequency of occurrence of risk behaviours, through the observation of bedridden and agitated hospitalized patients. These risk behaviours are defined as potentially dangerous and are warning signs for the caregiver. A better understanding of these behaviours could help to better anticipate falls and injuries and to implement preventive measures more quickly.

Study Overview

• Status: Not yet recruiting
• Conditions: Risk Behavior; Agitation; Hospitalization; Bedridden Patients

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France
    • CHU Clermont-Ferrand
    • Principal Investigator: Charlène DUBOIS

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

Bedridden and agitated patients hospitalized in a neurosurgery department

Description

Inclusion Criteria:

• Hospitalized in the Neurosurgery Department of the Clermont-Ferrand University Hospital
• Suffering from neurological and/or cognitive disorders leading to agitation and/or confusion
• Affiliation to a social security system
• Hospitalization in the department for at least 9 days
• Acceptance by the patient and/or trusted person capable of giving informed consent to participate in the research

Exclusion Criteria:

• Acute or transient agitation phase of somatic origin (bladder globe, pain, ionic disorder...)
• Patient under guardianship, curatorship or safeguard of justice
• Pregnant and breastfeeding women
• Refusal to participate

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of risk behaviors observed per one-hour period	Each patient will be observed for 9 one-hour time slots, each distributed over a two-hour period between 6:00 am and midnight. The number of risk behaviors will be recorded for each one-hour observation period. Observation will be for one hour per day, with the order of the time slots randomly selected.	day 1
Number of risk behaviors observed per one-hour period	Each patient will be observed for 9 one-hour time slots, each distributed over a two-hour period between 6:00 am and midnight. The number of risk behaviors will be recorded for each one-hour observation period. Observation will be for one hour per day, with the order of the time slots randomly selected.	day 2
Number of risk behaviors observed per one-hour period	Each patient will be observed for 9 one-hour time slots, each distributed over a two-hour period between 6:00 am and midnight. The number of risk behaviors will be recorded for each one-hour observation period. Observation will be for one hour per day, with the order of the time slots randomly selected.	day 3
Number of risk behaviors observed per one-hour period	Each patient will be observed for 9 one-hour time slots, each distributed over a two-hour period between 6:00 am and midnight. The number of risk behaviors will be recorded for each one-hour observation period. Observation will be for one hour per day, with the order of the time slots randomly selected.	day 4
Number of risk behaviors observed per one-hour period	Each patient will be observed for 9 one-hour time slots, each distributed over a two-hour period between 6:00 am and midnight. The number of risk behaviors will be recorded for each one-hour observation period. Observation will be for one hour per day, with the order of the time slots randomly selected.	day 5
Number of risk behaviors observed per one-hour period	Each patient will be observed for 9 one-hour time slots, each distributed over a two-hour period between 6:00 am and midnight. The number of risk behaviors will be recorded for each one-hour observation period. Observation will be for one hour per day, with the order of the time slots randomly selected.	day 6
Number of risk behaviors observed per one-hour period	Each patient will be observed for 9 one-hour time slots, each distributed over a two-hour period between 6:00 am and midnight. The number of risk behaviors will be recorded for each one-hour observation period. Observation will be for one hour per day, with the order of the time slots randomly selected.	day 7
Number of risk behaviors observed per one-hour period	Each patient will be observed for 9 one-hour time slots, each distributed over a two-hour period between 6:00 am and midnight. The number of risk behaviors will be recorded for each one-hour observation period. Observation will be for one hour per day, with the order of the time slots randomly selected.	day 8
Number of risk behaviors observed per one-hour period	Each patient will be observed for 9 one-hour time slots, each distributed over a two-hour period between 6:00 am and midnight. The number of risk behaviors will be recorded for each one-hour observation period. Observation will be for one hour per day, with the order of the time slots randomly selected.	day 9

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Charlène DUBOIS, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): August 31, 2023
• Study Completion (Anticipated): August 31, 2023

Study Registration Dates

• First Submitted: August 18, 2022
• First Submitted That Met QC Criteria: August 30, 2022
• First Posted (Actual): August 31, 2022

Study Record Updates

• Last Update Posted (Actual): August 31, 2022
• Last Update Submitted That Met QC Criteria: August 30, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Dyskinesias; Psychomotor Disorders; Psychomotor Agitation
• Other Study ID Numbers: RNI 2021 DUBOIS; 2021-A03099-32 (Other Identifier: 2021-A03099-32)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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