Cost/Utility Ratio in the Management of Patients With Acquired Severe Brain Injury
|ClinicalTrials.gov Identifier: NCT01743261|
Recruitment Status : Completed
First Posted : December 6, 2012
Last Update Posted : December 6, 2012
|Condition or disease||Intervention/treatment|
|Nervous System Diseases||Other: multidisciplinary intervention Other: usual care|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||249 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Cost/Utility Ratio in the Management of Patients With Acquired Severe Brain Injury: Comparison Between a Programme of In-hospital Graded Intensity Rehabilitation and Usual Care.|
|Study Start Date :||January 2007|
|Primary Completion Date :||January 2010|
|Study Completion Date :||January 2012|
Active Comparator: usual care
In this arm patients were managed according to the organization of the management model which took on the care of the patient. The organization of these models is characterized by one or two professional figures (physiatrists, neurologist), with hierarchical relationships, in spaces limited to a specific pathology; access is determined by clinical stability; the instruments of governance are guidelines and consensus and the rehabilitation programme is focused on functional and cognitive areas; the medical care process is governed by hierarchy. The technology in this model is limited to a specific specialty.
Other: usual care
specific pathology. access is determined by clinical stability. the instruments of governance are guidelines and consensus and the rehabilitation programme is focused on functional and cognitive areas.
the medical care process is governed by hierarchy. The technology in this model is limited to a specific specialty
Experimental: Graded intensive rehabilitation
Instruments of governance are the diagnostic-therapeutic rehabilitation. pathways (DTRP), the Quality system and product standards.
Medical care process with result-oriented autonomy. Technology support of vital signs. Multidisciplinary intervention
Other: multidisciplinary intervention
Multidisciplinary intervention Instruments of governance are the diagnostic-therapeutic rehabilitation pathways (DTRP), the Quality system and product standards; Medical care process with result-oriented autonomy Technology support of vital signs.
- cost/utility ratio [ Time Frame: up to 1 year ]
Management outcomes. The management outcomes considered were: access time, number of structures involved in the management of the patient, the healthcare path, the number of days spent in hospital, the type of management to which the patient was subsequently addressed.
Functional results. These included the number of devices at discharge, the Glasgow Outcome Scale (GOS) score, the Barthel Index score and any change in quality of life, assessed using the classification system based on the Health Utilities Index Mark 2 Survival. The patient's death related to the event index was considered as a hard event. In the survival analysis the two management models were considered as predictors of mortality. The association between independent predictors and outcome was assessed by comparing the follow-up data with a Cox proportional hazards regression model. The end-point of the study was event-related mortality
- quality of live [ Time Frame: up to 1 year ]quality of life, assessed using the classification system based on the Health Utilities Index Mark 2
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01743261
|Intenstive brain injury rehabilitation Unit of Polo Specialistico Riabilitativo|
|Sant'Angelo dei lombardi, Avellino, Italy, 83054|
|Principal Investigator:||Antonio S Capomolla, MD||Fondazione Don Carlo Gnocchi Onlus|