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
This trial does not accept healthy volunteersQualifiers
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 population
patients in ICU and their primary caregivers
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
330 Participants
are grouped into 1 trial groupGroup A: Delirium Assessment Using FAM-CAM, ICDSC, and CAM-ICU
Trial outcomes
Primary outcomes
1
Overall Agreement Among Family FAM-CAM, Nurse ICDSC, and Professional Research Staff CAM-ICU Assessments
This outcome will measure the level of agreement among the three assessment methods in the same patient and within the same general time frame.During the ICU phase, paired assessment data will be created according to the pairing rules described for the primary outcome. The results of FAM-CAM, ICDSC, and CAM-ICU will be classified as either "positive" or "negative."Agreement will be evaluated using Cohen's kappa coefficient as the main measure. The overall agreement rate, positive agreement rate, and negative agreement rate will also be reported as additional measures, together with 95% confidence intervals.
Time frame
once daily between 3:30 PM and 4:30 PMSecondary outcomes
1
Effect of Older Age, Low Education Level, Language or Dialect Communication Barriers, and Family Members' Delirium Knowledge on Assessment Disagreement
This outcome measure will evaluate the effect of older age, defined as age 65 years or older; low education level, defined as primary school education or below; language or dialect communication barriers, recorded as present or absent; and family members' delirium knowledge questionnaire scores on disagreement among delirium assessments. Assessment disagreement is defined as inconsistent delirium classification among the family-completed FAM-CAM, nurse-completed ICDSC, and CAM-ICU completed by trained research staff in the same patient and within a similar assessment time frame. The study will compare the proportion of disagreement events across different subgroups and will use regression analysis to evaluate the strength of association between these factors and assessment disagreement. Results will be reported as odds ratios with 95% confidence intervals.
Time frame
once daily between 3:30 PM and 4:30 PMSponsors and contacts
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Source ClinicalTrials.gov