A Prospective Observational Study Using the FAM-CAM

Family Involvement in ICU Delirium Assessment: A Prospective Observational Study Using the FAM-CAM

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, or ICU. 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Patients in ICU; Family; Delirium in the Intensive Care Unit

• Study Type: Observational
• Enrollment (Estimated): 330

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

patients in ICU

Description

Inclusion Criteria

Patients:

• Age 18 years or older.
• Admitted to the ICU for at least 24 hours.
• Richmond Agitation-Sedation Scale (RASS) score ≥ -3.
• The patient or family member provides informed consent and voluntarily agrees to participate.

Family Members:

• Age 18 years or older.
• The patient's primary caregiver or main contact person, and familiar with the patient's usual cognition and behavior.
• The main visiting family member during the patient's ICU stay, with at least one ICU visit.
• Able to understand Chinese questionnaires.
• Provides informed consent and voluntarily agrees to participate.

Exclusion Criteria

Patients:

• Persistent coma or deep sedation throughout the ICU stay, defined as Glasgow Coma Scale (GCS) score ≤ 8 or RASS score of -4 or -5.
• Previous confirmed diagnosis of dementia, severe psychiatric disorder, or organic neurological disease.
• Language impairment or hearing impairment that prevents basic communication.

Family Members:

-Significant visual, hearing, or cognitive problems that prevent completion of the FAM-CAM assessment.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Delirium Assessment Using FAM-CAM, ICDSC, and CAM-ICU; In this observational study, participants will not receive any study treatment or experimental intervention. The study procedures include daily delirium assessments and routine clinical data collection. Family members will complete one FAM-CAM assessment each day as soon as possible after the ICU visiting period ends, usually between 15:30 and 16:00. The family member will fill out the assessment form, and study staff will check the form for completeness and accuracy and record the time the assessment is completed. Nurses will complete one ICDSC assessment each day as soon as possible after the ICU visiting period ends, usually between 15:30 and 16:00. The nurse will record the assessment result and the time the assessment is completed. Trained research staff will complete one CAM-ICU assessment within a prespecified time window, close to the time of the family FAM-CAM assessment and the nurse ICDSC assessment. The CAM-ICU result and assessment time will be recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	once daily between 3:30 PM and 4:00 PM

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	once daily between 3:30 PM and 4:00 PM

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 6, 2026
• First Posted (Actual): July 10, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 6, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: B2026-150

Drug and device information, study documents

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