Brain Injury Rehabilitation Improving the Transition Experience

NCT03422276 | Completed Results DMC

• 2 other identifiers: STUDY00002859PCS-1604-35115
• Study Type: interventional
• Target: 1,555
• Locations: 1 country
• Sites: 6

Brief Summary

Each year, about 2.8 million people sustain a traumatic brain injury (TBI) in the United States, and at least 25 percent of these injuries are classified as moderate to severe. Nearly half of those hospitalized for TBI have long-term disability. Most have psychological, physical, social, or work-related problems, which often become chronic. By talking with patients and family members, we found that returning to daily activities and regaining quality of life are major concerns. Outcomes are affected by the type and severity of the TBI, but the type of treatment someone with TBI receives is also important. What resources are available, whether providers are experienced with the problems associated with TBI, and how much treatment is available can affect outcomes as well. Currently, inpatient rehabilitation professionals are told to give people with TBI information, reassurance, advice, and referral resources. Some promising ways of helping people with TBI include using telephone and other mobile devices to reach patients after they leave the hospital, to regularly assess their individual needs and help them coordinate their health care, and to provide the information and resources that they need. These new strategies may lead to earlier return to activities and improved quality of life. No studies have compared the standard approach to discharge care with an approach that uses telecare to provide information and care coordination after discharge from inpatient rehabilitation for TBI. The main goal of this project is to find out how improving the transition from the hospital to outpatient care can improve the lives of people with moderate to severe TBI and achieve better results that are important to patients with TBI, their families, and healthcare providers. In this study, patients with TBI who are discharged from inpatient rehabilitation at one of six national TBI Model Systems sites (University of Washington, Indiana University, Ohio State University, Mount Sinai Hospital, Moss Rehabilitation, and Baylor Institute for Rehabilitation) will be randomized (like the flip of a coin) to either the standard discharge plan or the standard discharge plan with additional telephone follow up from a TBI care manager for the first 6 months after discharge. The project team will compare patient and caregiver functioning and quality of life at 3, 6, 9, and 12 months after hospital discharge in these two groups.

Conditions

Traumatic Brain Injury

Keywords

Transition; Rehabilitation Discharge

Outcome Measures

Primary Outcomes (2)

• Participation Assessment With Recombined Tools - Objective 17 (PART-O-17)

  The Participation Assessment with Recombined Tools - Objective 17 (PART-O-17) assesses participation in usual roles and social activities. There are 17 items with 0-5 response scales. Those items are combined and averaged into three domain subscale scores that range from 0-5: Productivity (3 items), Social Relations (7 items), and Out and About (7 items). The Averaged Total score, used here, is calculated by averaging the three domain scores. Higher values represent a better outcome.

  This outcome will be assessed via self-report instrument from the patient participant 6 months after discharge from inpatient rehabilitation care.

• Quality of Life After Brain Injury Scale (QoLIBRI)

  A patient-reported instrument specifically created to measure the patient's perception of their health-related quality of life following TBI. The QOLIBRI scores are reported on a 0-100 scale, where 0=worst possible quality of life and 100=best possible quality of life.

  This outcome will be assessed via self-report instrument from the patient participant 6 months after discharge from inpatient rehabilitation care.

Secondary Outcomes (11)

• Cornell Services Index

  This outcome will be assessed via self-report instrument from the patient participant 3, 6, 9 and 12 months after discharge from inpatient rehabilitation care.

• Bakas Caregiving Outcomes Scale

  This outcome was assessed via self-report instrument from the caregiver participant at 3, 6, 9 and 12 months after the patient is discharged from inpatient rehabilitation care. This is reporting the 6-month outcomes.

• Zarit Burden Interview

  This outcome was assessed via self-report instrument from the caregiver participant at 3, 6, 9 and 12 months after the patient is discharged from inpatient rehabilitation care. This is reporting the 6-month outcomes.

• Short Form 12-Item Measure (SF-12)

  This outcome was assessed via self-report instrument from the caregiver participant at 3, 6, 9 and 12 months after the patient is discharged from inpatient rehabilitation care. This is reporting the 6-month outcomes.

• PROMIS (Patient-Reported Outcomes Measurement Information System) Satisfaction With Social Roles and Activities 8a

  This outcome was assessed via self-report instrument from the caregiver participant at 3, 6, 9 and 12 months after the patient is discharged from inpatient rehabilitation care. This is reporting the 6-month outcomes.

Study Arms (2)

Rehabilitation Discharge Plan

ACTIVE COMPARATOR

Commission on Accreditation of Rehabilitation Facilities (CARF) standards for discharge following an inpatient rehabilitation stay for a traumatic brain injury, including patient and family education, written discharge care instructions, and telephone follow up from a clinical provider.

Other: Rehabilitation Discharge Plan

Rehabilitation Transition Plan

ACTIVE COMPARATOR

Approximately 12 scheduled contacts from a TBI care manager 6 months following discharge in addition to the CARF standards for discharge.

Other: Rehabilitation Transition Plan

Interventions

Rehabilitation Discharge Plan OTHER

CARF standards for discharge following an inpatient rehabilitation stay for a traumatic brain injury. This approach may include the following: 1. patient and family education about TBI, both general and individualized to each person's symptoms and level of function, as well as education on medications and symptoms to monitor following discharge; 2. written discharge care instructions, including recommended appointments with primary care, rehabilitation medicine and outpatient therapies, and medication list which are reviewed with the patient and family prior to discharge; and 3. a phone call from an inpatient care provider within a few days of discharge to address any immediate problems and ensure that equipment has arrived, medications are being taken, etc.

Rehabilitation Discharge Plan

Rehabilitation Transition Plan OTHER

Participants and their caregivers (if applicable) randomized to the Rehabilitation Transition Plan group will receive up to 12 scheduled contacts 6 months post-discharge from a TBI care manager familiar with the care and resource networks at the respective sites. The contacts will at minimum be by telephone, although a HIPAA-compliant video conferencing option will also be available. The content of these contacts will include: 1. Particularly in the first few calls, review of discharge plans and assistance and/or directive problem-solving around any obstacles to following discharge plans; 2. Assessment of unmet needs, developed into a standard checklist of areas of need that are relevant to TBI, culled from literature on need fulfillment in this population.

Rehabilitation Transition Plan

Eligibility Criteria

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

You may qualify if:

• Hospitalized with a moderate-to-severe TBI defined by TBIMS and this study as damage to brain tissue caused by an external mechanical force as evidenced by medically documented loss of consciousness or post-traumatic amnesia (PTA) due to brain trauma or by objective neurological findings that can be reasonably attributed to TBI on physical examination or mental status examination. Potential participants must meet at least one of the following criteria to be considered experiencing a moderate-to-severe TBI:
• PTA\>24 hours;
• Trauma related intracranial neuroimaging abnormalities;
• Loss of consciousness exceeding 30 minutes (unless due to sedation or intoxication); or
• Glasgow Coma Scale in the emergency department of less than 13 (unless due to intubation, sedation, or intoxication).
• English speaking (we will track non-enrollment due to other language to determine common languages and have consumer dissemination materials translated for more broad use if time and resources permit.);
• At least 18 years old;
• Will be discharged from inpatient rehabilitation to community (private residence, adult home, hotel, homeless) or facility (nursing home, subacute care i.e. skilled nursing facility);
• Current admission to inpatient rehabilitation considered their first comprehensive rehabilitation experience, or extension thereof for most recent TBI (e.g. admitted to inpatient rehabilitation, discharged to acute care, then returns to inpatient rehabilitation to complete their initial stay);
• Able to provide informed consent, or if unable to provide consent have family or legal guardian to provide informed consent for the patient.
• Individuals who will have primary care giving responsibility post rehabilitation care discharge of enrolled patient participants;
• English speaking (we will track non-enrollment due to other language to determine common languages and have consumer dissemination materials translated for more broad use if time and resources permit.);
• At least 18 years old;
• Able to provide informed consent.

You may not qualify if:

• We will not enroll individuals who do not have access to a phone.
• We will not enroll individuals who are unable to complete study procedures due to cognitive/verbal limitations AND do not have a proxy to assist with study procedures.
• We will not enroll individuals who do not have access to a phone.

Sponsors & Collaborators

• University of Washington: lead
• Icahn School of Medicine at Mount Sinai: collaborator
• Moss Rehabilitation Research Institute: collaborator
• Ohio State University: collaborator
• Baylor Institute for Rehabilitation: collaborator
• Indiana University School of Medicine: collaborator
• Craig Hospital: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (6)

Indiana University School of Medicine/ Rehabilitation Hospital of Indiana

Indianapolis, Indiana, 46254, United States

Location

Mount Sinai Health System (NY)

New York, New York, 10002, United States

Location

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Moss Rehab Hospital

Elkins Park, Pennsylvania, 19027, United States

Location

Baylor Institute for Rehabilitation

Dallas, Texas, 75246, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (2)

• Fann JR, Hart T, Ciol MA, Moore M, Bogner J, Corrigan JD, Dams-O'Connor K, Driver S, Dubiel R, Hammond FM, Kajankova M, Watanabe TK, Hoffman JM. Improving transition from inpatient rehabilitation following traumatic brain injury: Protocol for the BRITE pragmatic comparative effectiveness trial. Contemp Clin Trials. 2021 May;104:106332. doi: 10.1016/j.cct.2021.106332. Epub 2021 Feb 27.

  PMID: 33652127 BACKGROUND

• Moore M, Kempthorne L, Fann JR, Shulein O, Dams-O'Connor K, Kajankova M, Conrick KM, Seeliger J, Hoffman JM. Patient and Caregiver Satisfaction With the Brain Injury Rehabilitation: Improving the Transition Experience (BRITE) Intervention. J Head Trauma Rehabil. 2024 Nov-Dec 01;39(6):E550-E563. doi: 10.1097/HTR.0000000000000949. Epub 2024 May 13.

  PMID: 38758094 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Jeanne Hoffman
• Organization: University of Washington

jeanneh@uw.edu

(206) 221-6511

Study Officials

• Jeanne Hoffman, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Jesse Fann, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study uses masked outcome assessment, which means study researchers will make every effort to ensure that staff members who collect outcomes data from both patient and caregiver participants at 3-, 6-, 9- and 12 months are unaware of patient participants' treatment group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine: Rehabilitation Medicine:Psychology

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 5, 2018
• Study Start: February 13, 2018
• Primary Completion: April 30, 2022
• Study Completion: November 10, 2022
• Last Updated: March 12, 2025
• Results First Posted: March 12, 2025

Record last verified: 2025-02

Locations

US (6)