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| ID | Type | Description | Link |
|---|---|---|---|
| OSS.13.070 | Other Identifier | Local Ethical Committee |
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Primary objectives are to define incidence and prevalence of Delirium in an elderly population admitted to the Department of Orthopedics and Traumatology and, in the postoperative phase, in the high Dependency Unit as well as to determine the presence of risk factors. Secondary objectives are to determine mean hospital stay, rates of complications as well as in-hospital mortality and at 1-3 and 12 months after discharge, functional recovery and cognitive outcomes at 1, 3 and 12 moths follow-up.
The aging of population as well as the increased life expectancy put progressively urgent demands about the adequacy of the level of care provided in a hospital environment to ensure clinical pathways tailored on the needs of each individual patient. On the other hand, the gradual evolution of Health Care systems to care for the acute, with increasing levels of specialization often technologically driven, cannot and must not neglect these aspects of personalization of care protecting the elderly "frail" patient, because of its intrinsic characteristics. In such a context, evaluation of frailty undertakes not only the meaning of prevention and promotion of quality of life but it takes in account important issues for patient's safety and the economic weight it entails. Delirium (acute confusional state) is a complex syndrome which frequently occurs in the elderly hospitalized population. Development of Delirium is associated with negative outcomes such as a longer hospital stay, a higher rate of complications, cognitive and functional decline, loss of independence, institutionalization, and, ultimately, death. For skilled healthcare professionals, on the other hand, it represents a challenging condition because a prompt and accurate diagnosis with the introduction of all those prevention and non-pharmacological measures may reduce the incidence, severity and/or duration of Delirium and improve functional recovery. Therefore the meaning of conducting such an observational study is also to provide evidence of patients' needs and address the on-ground educational aspect for healthcare professionals in a daily practice. The purposes of the study are to determine the incidence and prevalence (before and after surgery) of Delirium in an elderly population admitted to the Department of Orthopedics and Traumatology and in the High Dependency Unit in the postoperative phase as well as to determine the risk factors for developing such a condition. Secondary objectives are mean hospital stay, rates of complications as well as in-hospital mortality and at 1, 3 and 12 months after discharge, functional recovery and cognitive outcomes at 1, 3 and 12 months follow-up.
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| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Delirium, its association with risk factors and their prognostic value | Patients are evaluated on admission with:
| At hospital admission |
| Incidence of Delirium, its association with risk factors and their prognostic value | Detection of any change in clinical condition. Patients are evaluated with:
| At hospital admission and for the next 48 hours |
| Incidence of Delirium, its association with risk factors and their prognostic value | Detection of any change in clinical condition. Patients are evaluated with:
| After surgery and for the next 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rates | In-Hospital | |
| Mortality rates | At 1,3 and 12 months follow-up | |
| Mean Hospital Stay |
| Measure | Description | Time Frame |
|---|---|---|
| Variations of serum cystatin C as a marker of glomerular filtration rate and its association with the development of Delirium | At hospital admission and on the fifth day of hospitalization |
Inclusion Criteria:
Exclusion Criteria:
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Patients admitted to the Department of Orthopedics and Traumatology and in the High Dependency Unit in the postoperative phase
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| Name | Affiliation | Role |
|---|---|---|
| Marco Mannucci, MD | Azienda Ospedaliero-Universitaria Careggi | Study Director |
| Alessandro Cartei, MD | Azienda Ospedaliero-Universitaria Careggi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| C.T.O. Azienda Ospedaliero-Universitaria Careggi | Florence | 50134 | Italy |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| D050723 | Fractures, Bone |
| D009104 | Multiple Trauma |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| In-Hospital |
| Clinical Complications | In-Hospital |
| Changes in functional capabilities | Patients are evaluated with:
| At 1, 3 and 12 months follow-up |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D014947 | Wounds and Injuries |