Detection of Risk Behaviors: Pilot Observational Study With Bedridden and Agitated Patients.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Risk Behavior, Agitation, Hospitalization, Bedridden Patients. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Number of risk behaviors observed per one-hour period [Time frame: day 1]
- Number of risk behaviors observed per one-hour period [Time frame: day 2]
- Number of risk behaviors observed per one-hour period [Time frame: day 3]
- Number of risk behaviors observed per one-hour period [Time frame: day 4]
- Number of risk behaviors observed per one-hour period [Time frame: day 5]
- Number of risk behaviors observed per one-hour period [Time frame: day 6]
- Number of risk behaviors observed per one-hour period [Time frame: day 7]
- Number of risk behaviors observed per one-hour period [Time frame: day 8]
- Number of risk behaviors observed per one-hour period [Time frame: day 9]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- CHU clermont-ferrand — Clermont-Ferrand
Identifiers
NCT: NCT05522647 · RNI 2021 DUBOIS · 2021-A03099-32