Clinical Research Directory

Patient Characterization Panel to Improve Satisfaction With the Intensive Care Unit Stay (CONNECT)

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.

Incidence and Factors Associated to the Development of PICS-F Among ICU Relatives: A Longitudinal Exploratory Study

The constellation of long-term psychological, physical, and cognitive impairments arising after a critical illness among family members of ICU survivors has been labeled as "Post Intensive Care Syndrome - Family" (PICS-F). Despite PICS-F awareness, the long-term issues faced by ICU family members remain poorly understood with several gaps in knowledge remaining such as the role of protective psychosocial factors, caregiver burden, or family satisfaction in the development of the syndrome. This single-center, longitudinal exploratory study, aims to determine the incidence of each PICS-F impairment (psychological, physical, and cognitive) and to identify factors (during ICU stay and after hospital discharge) associated with the development or prevention of the PICS-F impairments among family members of ICU survivors of a public hospital in Chile.