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

NCT01743261 | Completed

• 2 other identifiers: 270360FDCGPLCPSR01012007
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Nervous System Diseases

Keywords

severe brain injury; graded intensive rehabilitation

Outcome Measures

Primary Outcomes (1)

• cost/utility ratio

  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

  up to 1 year

Secondary Outcomes (1)

• quality of live

  up to 1 year

Study Arms (2)

usual care

ACTIVE COMPARATOR

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

Graded intensive rehabilitation

EXPERIMENTAL

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

Interventions

multidisciplinary intervention OTHER

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.

Graded intensive rehabilitation

usual care OTHER

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

usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• patient with age\< 18 years
• patients with previous degenerative nervous disease
• oncological patients with reduce life expectancy
• patients with impaired vital signs

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

Intenstive brain injury rehabilitation Unit of Polo Specialistico Riabilitativo

Sant'Angelo dei Lombardi, Avellino, 83054, Italy

Location

MeSH Terms

Conditions

Nervous System Diseases; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Antonio S Capomolla, MD

  Fondazione Don Carlo Gnocchi Onlus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director severe brain injury rehabilitation Unit

Study Record Dates

• First Submitted: September 5, 2012
• First Posted: December 6, 2012
• Study Start: January 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2012
• Last Updated: December 6, 2012

Record last verified: 2012-12

Locations

IT (1)