Résumé
Although guidelines from professional societies recommend strategies for supporting the families of critically ill patients, evidence suggests that many families who might benefit from such support do not receive it. This study aims to evaluate communication interface software to improve patient-centered and individualized care for patients and families. Detailed description: the significant impact of serious illnesses on the family members of hospitalized persons has been widely proven. Twenty-five to 50% of family members of critically ill children or adults have proven psychological symptoms, including acute stress, post-traumatic stress, generalized anxiety, and depression during and after illness. The sum total of the family's exposure to serious illness can result in “post-intensive care syndrome”. The literature reiterates the importance of improving outcomes for family caregivers and that supporting family caregivers can improve outcomes for patients. Although open flexible family, presence, family participation in interdisciplinary visits and family support may include communication facilitators, the use of multi-functional software that would maintain easy, flexible and live access to the patient journey in USI has not been evaluated. INSEPARABLE aims to evaluate a technological innovation that would make it possible to follow seriously ill patients and their families up to 7 days after discharge or death from intensive care. INSEPARABLE is a randomized, multicenter, stepped-wedge trial that will compare communication in a control group (usual to the service) between healthcare workers, critically ill patients and caregivers to an intervention group in communication aided by the software. Primary endpoint: evaluation by a modified validated questionnaire (m-PPPC score) on the family-patient perception of the patient-centered nature of care (PPPC-R). Secondary results: ease of use of the software; efficiency; communication risks and errors; caregiver connection profiles. Eligibility criteria: -inclusion criteria: consecutive critically ill patients admitted within 72h in the present ICU, with an expected mechanical ventilation duration of at least 96h OR an admission SAPSII score of at least 40. The family contact need to be able to interact with an internet connected device -exclusion criteria: family opposition to participate, inability to use internet or not having a connected device. Arm label and arm type: control arm: standard communication vs intervention arm: standard communication AND the use of the software. Interventions: in the intervention arm, software with multiple functionalities will be added to the usual communication with the aim of permitting videoconferences, scheduled meetings, automated information flow etc... Number of subjects: with a pre-planned 3 clusters (6 centers combined by pairs), a stepped wedge design, an alpha risk of 5%, 350 patients will allow a 95% power to show a difference of 0.75 in mean m-PPPC score with an intra cluster variance of 100 and an inter cluster variance of 100 (package swCRTdesign and samplingDataCRT, R-software). Statistical analysis: intention to treat analysis. For the primary and secondary outcomes, we will use generalized linear mixed models, with ICU and time as random effects. We prespecify that all analyses will be adjusted for patient age, modified SAPS III, Elixhauser Comorbidity Index score, use or non use of mechanical ventilation, admission, source, and baseline patient and surrogate demographic characteristics that are associated with the outcome and will have a between-group difference (P≤0.20) in univariate analysis. Several post hoc sensitivity and restricted analyses will be conducted for heterogeneity of treatment effect across ICUs and across time. Conditions: intensive care, communication, patient centered care, family satisfaction.