Comparative Effectiveness of Rehabilitation Interventions for Traumatic Brain Injury

NCT02646176 | Completed

• 1 other identifier: OhioU
• Study Type: observational
• Target: 2,130
• Locations: 0 countries
• Sites: N/A

Brief Summary

Traumatic brain injury (TBI) is increasingly recognized as a significant public health issue, but the most effective rehabilitation methods have yet to be identified. The Institute of Medicine and the Agency for Healthcare Quality and Research sponsored systematic reviews of evidence for comparative effectiveness of rehabilitation interventions for TBI. Both reviews concluded that substantially more research is needed to identify interventions best suited for different individuals. The practice-based evidence (PBE) approach employed to create the data used in the proposed study was a research method recommended to provide greater clarity, along with use of patient-centered outcomes obtained over a longer period of time than used in previous studies. The following specific aims will be addressed in the proposed study:

1. 1.Determine the comparative effectiveness of different therapeutic approaches used in inpatient TBI rehabilitation after statistically adjusting for patient need and ability to benefit from various approaches.
2. 2.Determine the comparative effectiveness of difference in the delivery of inpatient rehabilitation therapies, after statistically adjusting for patient need and ability to benefit.

Conditions

Brain Injuries

Outcome Measures

Primary Outcomes (2)

• Participation

  Participation as measured by the Participation Assessment with Recombined Tools-Objective

  9 months post-discharge from inpatient rehabilitation

• Participation

  Participation as measured by the Participation Assessment with Recombined Tools-Objective

  3 months post-discharge from inpatient rehabilitation

Secondary Outcomes (11)

• Functional independence-Cognitive

  Upon completion of inpatient rehabilitation (discharge score), an average of 1 month

• Functional independence-Cognitive

  3 months after discharge from inpatient rehabilitation

• Functional independence-Cognitive

  9 months after discharge from inpatient rehabilitation

• Functional independence-Motor

  Upon completion of inpatient rehabilitation (discharge score), an average of 1 month

• Functional independence-Motor

  3 months post-discharge from inpatient rehabilitation

Interventions

Inpatient rehabilitation BEHAVIORAL

Inpatient rehabilitation includes activities and interventions provided by occupational, physical, therapeutic recreation and speech therapists, and psychologists.

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study sample was drawn from the population of persons who received inpatient rehabilitation for TBI in North America.

You may qualify if:

• Sustained a TBI, defined as damage to brain tissue caused by external force and evidenced by loss of consciousness, post-traumatic amnesia, skull fracture, or objective neurological findings
• Diagnosed with an International Classification of Diseases (ICD-9-CM) code consistent with the CDC Guidelines for Surveillance of Central Nervous System Injury
• Receiving inpatient care on a designated brain injury rehabilitation unit of one of the participating rehabilitation facilities
• Incurred a TBI severe enough to warrant inpatient rehabilitation regardless of other injuries, with TBI being the predominant reason for rehabilitation admission

You may not qualify if:

• \. None

Sponsors & Collaborators

• Jennifer Bogner, PhD, ABPP: lead
• Patient-Centered Outcomes Research Institute: collaborator
• University of Utah: collaborator

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Jennifer A Bogner, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 30, 2015
• First Posted: January 5, 2016
• Study Start: October 1, 2008
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: October 28, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share