Intensive care units (ICUs) present unique challenges to humanized, person-centered care. The severity of illness and the demands of complex technical management can displace attention from patients as individuals, making it harder to build meaningful connections with patients and their families.
This trial tests a simple, low-cost bedside intervention: a structured panel. The "Patient as a Person" panel, placed near each patient's bed. The care team, together with the patient and family, records personal information about who the patient is outside the hospital: how they prefer to be addressed, their interests, and what matters most to them. Physicians, nurses, and physical therapists receive training on how to incorporate this information into daily care interactions.
The study follows a stepped-wedge cluster randomized design across six ICUs in Brazil: four at Clinical Hospital of the University of São Paulo Medical School (São Paulo); and two at Monte Klinikum Hospital (Fortaleza). All ICUs begin with a control period of standard care. Every two months, one ICU transitions to the intervention, until all six units have adopted the panel. The total study duration is 14 months. Each ICU serves as its own control together with the comparison between ICUs for periods with and without the intervention. Questionnaire administrators are blinded to whether a given hospitalization occurred during the control or intervention phase.
Eligible participants are adult patients (≥18 years) admitted to a participating ICU for more than 48 hours, and their family members or legal representatives (≥18 years). Pregnant women, incarcerated individuals, and non-Portuguese speakers are excluded. Informed consent is obtained from family members after 48 hours of admission, and from patients once they are alert and oriented.
The primary outcome is family satisfaction with the ICU stay, assessed using the Family Satisfaction with Care in the Intensive Care Unit Questionnaire (FS-ICU 24R questionnaire), a validated intrument adapted for use in Brazil. Secondary outcomes include patient-reported quality of communication, ICU staff perceptions of the panel, and symptoms of anxiety and depression in family members at three months. Estimated enrollment is 966 patients.
The intervention involves no physical procedures. Data are coded and de-identified. Results will be published regardless of outcome.
Patient admitted to a participating ICU for more than 48 hours.
Patient aged 18 years or older.
Patient's family member or legally designated surrogate aged 18 years or older, and identifiable at the time of enrollment.
Patient and/or family member/surrogate able to speak and understand Portuguese.
ICU stay of 48 hours or less.
No identifiable family member or legally designated surrogate.
Patient or family member/surrogate under 18 years of age.
Unable to speak or understand Portuguese.
Crossover
Patient-as-a-Person Characterization Panel with Staff Training
BehavioralThe Patient-as-a-Person Characterization Panel (PCPP) "Come to Know Me" is a structured 19-item instrument completed collaboratively by the multidisciplinary care team (medicine, nursing, and physical therapy) together with the patient and/or family members, and may include photographs. The panel documents the patient's identity, personal preferences, and biographical details, making this information visible to all members of the care team. It is displayed within the patient's private Intensive Care Unit (ICU) room in a location that preserves data privacy, and is completed as part of routine clinical care. Prior to each cluster's crossover, all relevant staff receive structured training on panel use; monthly retraining sessions and printed and online instructional materials are provided throughout the intervention period. Patients in the intervention arm also receive standard ICU care as practiced at each participating unit.
Standard ICU Care
Other interventionDuring the control period, each participating ICU maintains its routine standard of care without any study-related additions. The Patient-as-a-Person Characterization Panel is not used, and no related staff training is provided. Standard care practices vary by site and are not modified by the study.
Family/surrogate satisfaction with the ICU stay
Family or surrogate satisfaction is assessed using the Family Satisfaction with Care in the Intensive Care Unit 24R questionnaire (FS-ICU 24R), validated and culturally adapted for Brazil. Three summary scores are derived: Satisfaction with Care, Satisfaction with Decision Making, and Overall Satisfaction, each ranging from 0 to 100, with higher scores indicating greater satisfaction. The FS-ICU 24R is administered by a blinded assessor to all eligible family members or surrogates 15 days after ICU outcome (discharge or death), or 28 days after enrollment, whichever occurs first. The Informed Consent Form (ICF) is collected from the family member or surrogate 48 hours after ICU admission. Questionnaire administration is classified as a research procedure; the panel itself ("Come to Know me") is implemented as part of routine clinical care during the intervention period and does not require separate consent.
Patient-perceived quality of communication in the ICU
Patient-perceived quality of communication is assessed using the Quality of Communication Questionnaire (QOC), translated into Portuguese and validated for cultural use in Brazil. The score is calculated as the mean of the 13 items (items 1-6 for the General Communication subscale, and items 7-13 for the End-of-Life Communication subscale), ranging from 0 to 10 each, with higher scores indicating better perceived quality of communication. The QOC is administered by a blinded assessor 15 days after ICU discharge, or 28 days after enrollment, whichever occurs first, and only in patients assessed as conscious and oriented at the time of administration.
ICU staff perception following first completion of the Patient-as-a-Person Characterization Panel
Staff perception is assessed using a structured questionnaire developed by the study team, administered via REDCap (version 14.5.21). The questionnaire evaluates perceived difficulty in completing the panel, barriers to its use in clinical practice, its potential contribution to patient care, and open comments. It is made available via QR code posted in the ICU or via a link sent by the research team, and is completed only once, upon the staff member's first use of the panel.
Anxiety and depression in patients (where feasible) and family members/surrogates
Symptoms of anxiety and depression are assessed using the Hospital Anxiety and Depression Scale (HADS), validated and adapted for the Brazilian population. The HADS is administered 3 months after ICU outcome (discharge or death) to ICU survivors and to family members or surrogates of both surviving and deceased patients.
Bayesian analysis
A Bayesian re-analysis of the Family Satisfaction with Care in the Intensive Care Unit (FS-ICU 24R questionnarie) will be conducted as a sensitivity analysis.
Subgroup analyses of the primary outcome
The primary outcome will be evaluated in three pre-specified subgroups: (i) patient severity, as measured by the SAPS 3 score; (ii) ICU outcome (discharge vs. death); and (iii) presence or absence of terminal or advanced chronic illness. Subgroup effects will be assessed using an interaction term between the intervention and each subgroup of interest, within the same primary analysis model.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
