A Prospective Observational Study Using the FAM-CAM
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: Patients in ICU, Delirium in the Intensive Care Unit, Family. 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
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Family Involvement in ICU Delirium Assessment: A Prospective Observational Study Using the FAM-CAM
Overview
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.
Primary outcome measures
- Overall Agreement Among Family FAM-CAM, Nurse ICDSC, and Professional Research Staff CAM-ICU Assessments [Time frame: once daily between 3:30 PM and 4:00 PM]
Secondary outcome measures (1)
- Effect of Older Age, Low Education Level, Language or Dialect Communication Barriers, and Family Members' Delirium Knowledge on Assessment Disagreement [Time frame: once daily between 3:30 PM and 4:00 PM]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07694687 · B2026-150