Sentinel Patients : Value of an Information System Collecting Patient's Own Report on His Healthcare Management. Application to the Detection of Adverse Events After Hospital Discharge.

Main lines of the study. Evolution of patient's health after hospital discharge is poorly documented. We hypothesize that information of good quality on this concern might be accessible at a relatively low cost from patients, further referred to as sentinel patients, who would voluntary report their health evolution on a dedicated website.

The SENTIPAT study presents as a proof of concept study. It will collect patient's health evolution during a post-hospital discharge period of 45 days. The study presents as a randomized trial comparing patients' reports issued from two different methods in patients returning home after hospital discharge and having at disposal an internet connection available at home (further referred to as "eligible patients"):

in the " Internet " arm, sentinel patients will be solicited to directly report their data on a web-site especially devoted for collecting these data while in the " Telephone " arm, the same data will be collected through a telephone interview 45 days after hospital discharge. Investigations will concern appearance/worsening of symptoms, healthcare resources utilization, quality of life, and patients' satisfaction.

Adverse events. An adverse event is defined as non-related to patient's disease but associated with a default or excess of care. A clinically significant event is defined as one of the following events: new symptom(s) appearing after hospital discharge or worsening for symptoms present at hospital discharge, unscheduled rehospitalization or consultation whatever the reason for it, death (patients lost to follow-up will be investigated for their vital status). A validated event is an event considered as adverse by a validation medical committee, blind in terms of the source declaration whatever the source (sentinel patients or telephone survey). In addition, the committee will classify each validated event according to a criterion of avoidability.

Design. The main hypothesis of the study is that the risk of clinically significant validated adverse event is at least as well reported by volunteer patients (sentinel patients: Internet arm) as by a specific cohort follow-up (Telephone survey arm). SENTIPAT presents as a multi-center (five departments within the same hospital) non-inferiority randomized trial comparing the internet and telephone arms. Enrollment of eligible patients will be performed on the basis of consecutive such patients being discharged from hospital in the participating departments. Internet/Telephone randomization of eligible patients is stratified per department.