A Feasibility Study on the Newly Developed Early Intervention for Families of Patients With Acquired Brain Injuries: SAFIR©

The aim of the study is to determine the feasibility of a newly developed intervention called SAFIR© to support families of Acquired Brain Injuries (ABI) patients, from the early phase (acute phase) of hospitalization. It will be conducted in the Department of Clinical Neurosciences (DNC) of Lausanne University Hospital. According to the study design, there will be no control group.

The intervention process engages all stakeholders, but is led by the trained clinical nurse specialist (CNS) of the care unit.

Screening for recruitment by the head nurse or the CNS will start from day 1 of patients' hospitalization at DNC. The CNS will meet the screened patients and their family with the medical team. This first contact will allow the CNS to introduce him/herself, to explain his/her role, to give all relevant information and forms, and to schedule a second appointment after 24 hours of reflection. In particular, he/she will explain to each participant the nature of the study, its purpose, the procedures involved, the expected duration, the potential risks and benefits and any discomfort it may entail. Information and Consent Forms will be provided to patients when relevant, or its Legal Representative, as well as to potential participants among family members. Each participant will be informed that the participation in the study is voluntary, he or she may withdraw from the study at any time, and withdrawal of consent without affecting the patient's subsequent medical care and treatment. A 24-hour reflection period for consent will be offered to the potential participants. The consent form will be signed and dated by the investigator or his designee at the same time as the participant sign. A copy of the signed informed consent will be given to the study participant. An "Independent physician consent form" will also be signed by the medical doctor in charge of the patient The consent form will be retained as part of the study records, as well as the "Independent physician consent form". The informed consent process will be documented in the research files and any discrepancy to the process described in the protocol will be explained, if necessary. Overall, the study will be conducted in compliance with the protocol, the current version of the Declaration of Helsinki.

If participant agrees to take part in the study (D0), the intervention will start. The intervention is organized in three main phases at day 3, day 5 and day 10, with a follow-up at day 30. Each phase include a preparation with the inter professional team for family interview, a structured family interview lead by CNS, and a feed-back with the inter professional team. Measures related to the ability to carry out the intervention (acceptability and integration of the intervention to the nursing care), the fidelity to the protocol, the recruitment and the retention will be collected throughout the process. At baseline, data collection will include socio-demographics data on the participants, Iceland-Expressive Family Functioning Questionnaire, Iceland-Family Perceived Support Questionnaire and Brief-Cope Questionnaire measures. These measures will be repeated at D10 and D30.

Both Investigator and Sponsor-Investigator will make a severity assessment of all adverse events as mild, moderate or severe. Mild means the complication is tolerable, moderate means it interferes with daily activities and severe means it renders daily activities impossible. All serious adverse event (SAE) will be documented and reported immediately (within a maximum of 24 hours) to the Sponsor-Investigator of the study. If it cannot be excluded that the SAE is attributable to the intervention under investigation, the Investigator will report it to the Ethics Committee within 15 days.