Clinical trial NCT02086981: The DETEcT Study - Delirium in Elderly paTiEnts Admitted to Trauma
Official title: The DETEcT Study - Delirium in Elderly paTiEnts Admitted to Trauma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Bone Fractures
Multiple Trauma
Lead sponsor: Azienda Ospedaliero-Universitaria Careggi
Sponsor class: OTHER
First posted: 2014-03-14
Enrollment: 672
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the Department of Orthopedics and Traumatology and in the High Dependency Unit in the postoperative phase

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients with any medical condition with an age of 65 years and older

Exclusion Criteria:

* Impossibility to give an informed consent; refusal

Primary outcomes:
measure: Prevalence of Delirium, its association with risk factors and their prognostic value
timeFrame: At hospital admission
measure: Incidence of Delirium, its association with risk factors and their prognostic value
timeFrame: At hospital admission and for the next 48 hours
measure: Incidence of Delirium, its association with risk factors and their prognostic value
timeFrame: After surgery and for the next 48 hours
Secondary outcomes:
measure: Mortality rates
timeFrame: In-Hospital
measure: Mortality rates
timeFrame: At 1,3 and 12 months follow-up
measure: Mean Hospital Stay
timeFrame: In-Hospital
measure: Clinical Complications
timeFrame: In-Hospital
measure: Changes in functional capabilities
timeFrame: At 1, 3 and 12 months follow-up
Other outcomes:
measure: Variations of serum cystatin C as a marker of glomerular filtration rate and its association with the development of Delirium
timeFrame: At hospital admission and on the fifth day of hospitalization
Locations:
city: Florence
country: Italy
facility: C.T.O. Azienda Ospedaliero-Universitaria Careggi
Study officials:
affiliation: Azienda Ospedaliero-Universitaria Careggi
name: Marco Mannucci, MD
role: STUDY_DIRECTOR
affiliation: Azienda Ospedaliero-Universitaria Careggi
name: Alessandro Cartei, MD
role: PRINCIPAL_INVESTIGATOR
References: