The DETEcT Study - Delirium in Elderly paTiEnts Admitted to Trauma

Delirium Clinical Trial

— DETEcT  

Official title:

The DETEcT Study - Delirium in Elderly paTiEnts Admitted to Trauma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02086981
• Other study ID #: OSS.13.070
• Secondary ID: OSS.13.070
• Status: Completed
• Phase: N/A
• First received: February 22, 2014
• Last updated: December 25, 2015
• Start date: February 2014
• Est. completion date: January 2015

Study information

• Verified date: December 2015
• Source: Azienda Ospedaliero-Universitaria Careggi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 672
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Impossibility to give an informed consent; refusal

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bone Fractures
• Delirium
• Fractures, Bone
• Multiple Trauma
• Wounds and Injuries

Locations

Country	Name	City	State
Italy	C.T.O. Azienda Ospedaliero-Universitaria Careggi	Florence

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria Careggi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	Prevalence of Delirium, its association with risk factors and their prognostic value	Patients are evaluated on admission with: IqCode; Katz Index of Independence in Activities of Daily Living (ADL); The Lawton Instrumental Activities of Daily Living (IADL) Scale; The Barthel Index for Mobility; The Confusion Assessment Method (CAM); The 4AT Scale; Presence of Risk Factors	At hospital admission	No
Primary	Incidence of Delirium, its association with risk factors and their prognostic value	Detection of any change in clinical condition. Patients are evaluated with: The Confusion Assessment Method (CAM); The 4AT Scale	At hospital admission and for the next 48 hours	No
Primary	Incidence of Delirium, its association with risk factors and their prognostic value	Detection of any change in clinical condition. Patients are evaluated with: The Confusion Assessment Method (CAM); The 4AT Scale	After surgery and for the next 48 hours	No
Secondary	Mortality rates		In-Hospital	No
Secondary	Mortality rates		At 1,3 and 12 months follow-up	No
Secondary	Mean Hospital Stay		In-Hospital	No
Secondary	Clinical Complications		In-Hospital	No
Secondary	Changes in functional capabilities	Patients are evaluated with: Katz Index of Independence in Activities of Daily Living (ADL); The Lawton Instrumental Activities of Daily Living (IADL) Scale; The Barthel Index for Mobility	At 1, 3 and 12 months follow-up	No