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Cost/Utility Ratio in the Management of Patients With Acquired Severe Brain Injury

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Soccorso Capomolla, MD, Fondazione Don Carlo Gnocchi Onlus
ClinicalTrials.gov Identifier:
NCT01743261
First received: September 5, 2012
Last updated: December 5, 2012
Last verified: December 2012
History of Changes
  Purpose

The aim of this study was to compare the cost/utility ratio of a management model of integrated, graded, intensive rehabilitation (GIR) versus usual care (UC) for patients with acquired Severe Brain Injury (SBI).


Condition Intervention
Nervous System Diseases
 Other: multidisciplinary intervention
Other: usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fondazione Don Carlo Gnocchi Onlus:

Primary Outcome Measures:
  • cost/utility ratio [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • quality of live [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    quality of life, assessed using the classification system based on the Health Utilities Index Mark 2


Enrollment: 249
Study Start Date: January 2007
Study Completion Date: January 2012
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with acquired Severe brain injury
  • patients with Glasgow Coma Scale score <8
  • patients with Focal ischaemic lesion, cerebral contusion or hemorrhage on computed tomography or magnetic resonance imaging

Exclusion Criteria:

  • patient with age< 18 years
  • patients with previous degenerative nervous disease
  • oncological patients with reduce life expectancy
  • patients with impaired vital signs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01743261

Locations
Italy
Intenstive brain injury rehabilitation Unit of Polo Specialistico Riabilitativo
Sant'Angelo dei lombardi, Avellino, Italy, 83054
Sponsors and Collaborators
Fondazione Don Carlo Gnocchi Onlus
Investigators
Principal Investigator: Antonio S Capomolla, MD Fondazione Don Carlo Gnocchi Onlus
  More Information

No publications provided

Responsible Party: Soccorso Capomolla, MD, Director severe brain injury rehabilitation Unit, Fondazione Don Carlo Gnocchi Onlus
ClinicalTrials.gov Identifier: NCT01743261     History of Changes
Other Study ID Numbers: 270360, FDCGPLCPSR01012007
Study First Received: September 5, 2012
Last Updated: December 5, 2012
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Fondazione Don Carlo Gnocchi Onlus:
severe brain injury
graded intensive rehabilitation

Additional relevant MeSH terms:
Nervous System Diseases
Brain Injuries
Brain Diseases
Central Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 21, 2013