A Prospective Observational Study Using the FAM-CAM
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai Zhongshan Hospital
About this trial
The goal of this observational study is to learn whether family members can help identify signs of delirium in adult patients who are staying in the intensive care unit. Delirium is a sudden change in attention, thinking, or awareness that can happen during serious illness.
The main question it aims to answer is:
Can family members notice possible signs of delirium that may not be found during routine ICU delirium screening? Participants will receive their usual medical care. Family members who know the patient well will complete a short delirium assessment called the FAM-CAM after visiting the patient. Nurses will continue to perform routine ICU delirium screening using the ICDSC as part of usual care. The study team will compare the family member's assessment with the nurse's routine assessment to see whether family observations provide additional helpful information.
Family members may complete the assessment for up to 3 days while the patient is in the ICU.
Eligibility criteria
Qualifiers
Aged 18 years or older.
Admitted to the ICU for at least 24 hours.
Richmond Agitation-Sedation Scale (RASS) score ≥ -3 at the time of enrollment.
Provided written informed consent to participate. When patients were unable to provide consent, consent was obtained from their legal surrogates.
Disqualifiers
Persistent coma or deep sedation throughout the ICU stay, defined as Glasgow Coma Scale (GCS) score ≤ 8 or RASS score of -4 or -5.
A previously confirmed diagnosis of dementia, a severe psychiatric disorder, or an organic neurological disease.
Severe hearing impairment that prevented effective communication or study participation.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
330 Participants
are grouped into 1 trial groupSponsors and collaborators
Source ClinicalTrials.gov