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Brain Injury Rehabilitation Improving the Transition Experience (BRITE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03422276
Recruitment Status : Enrolling by invitation
First Posted : February 5, 2018
Last Update Posted : September 9, 2019
Sponsor:
Collaborators:
Icahn School of Medicine at Mount Sinai
Moss Rehabilitation Research Institute
Ohio State University
Baylor Institute for Rehabilitation
Indiana University School of Medicine
Craig Hospital
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Jeanne Hoffman, University of Washington

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.


Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Other: Rehabilitation Discharge Plan Other: Rehabilitation Transition Plan Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1507 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Supportive Care
Official Title: Improving Transition From Acute to Post-Acute Care Following Traumatic Brain Injury
Actual Study Start Date : February 13, 2018
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Rehabilitation Discharge Plan
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

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.

Active Comparator: Rehabilitation Transition Plan
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

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.




Primary Outcome Measures :
  1. Participation Assessment with Recombined Tools - Objective 17 (PART-O-17) [ Time Frame: This outcome will be assessed via self-report instrument from the patient participant 6 months after discharge from inpatient rehabilitation care. ]
    Measure that assesses participation in usual roles and social activities.

  2. Quality of Life after Brain Injury Scale (QoLIBRI) [ Time Frame: This outcome will be assessed via self-report instrument from the patient participant 6 months after discharge from inpatient rehabilitation care. ]
    A patient-reported instrument specifically created to measure the patient's perception of their health-related quality of life following TBI


Secondary Outcome Measures :
  1. Cornell Services Index [ Time Frame: 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. ]
    A patient-reported instrument created to assess healthcare services utilization.

  2. Bakas Caregiving Outcomes Scale [ Time Frame: This outcome will be assessed via self-report instrument from the caregiver participant 3, 6, 9 and 12 months after the patient is discharged from inpatient rehabilitation care. ]
    A 15-item measure, each with a 7-point scale that assesses change in social functioning, emotional well-being, and physical health related to caregiving.

  3. Zarit Burden Interview [ Time Frame: This outcome will be assessed via self-report instrument from the caregiver participant 3, 6, 9 and 12 months after the patient participant is discharged from inpatient rehabilitation care. ]
    12 item version addresses the concerns that our stakeholders feel are most important and that we feel are most relevant to our study interventions.

  4. Short Form 12-Item Measure (SF-12) [ Time Frame: This outcome will be assessed via self-report instrument from the caregiver participant 3, 6, 9 and 12 months after the patient participant is discharged from inpatient rehabilitation care. ]
    The SF-12 is a measure of health-related quality of life (HRQOL) and allows for 2 component scores to be determined: physical health and mental health.

  5. PROMIS (Patient-Reported Outcomes Measurement Information System) Satisfaction with Social Roles and Activities [ Time Frame: This outcome will be assessed via self-report instrument from the caregiver participant 3, 6, 9 and 12 months after the patient participant is discharged from inpatient rehabilitation care. ]
    A measure that assesses engagement in roles and activities apart from those related to caregiving.

  6. Time Spent Caregiving [ Time Frame: This outcome will be assessed via self-report instrument from the caregiver participant 3, 6, 9 and 12 months after the patient participant is discharged from inpatient rehabilitation care. ]
    A measure developed by the study team to describe the use of caregivers for individuals with TBI.

  7. Participation Assessment with Recombined Tools - Objective 17 (PART-O-17) [ Time Frame: This outcome will be assessed via self-report instrument from the patient participant 3, 9 and 12 months after discharge from inpatient rehabilitation care. ]
    Measure that assesses participation in usual roles and social activities.

  8. Quality of Life after Brain Injury Scale (QoLIBRI) [ Time Frame: This outcome will be assessed via self-report instrument from the patient participant 3, 9 and 12 months after discharge from inpatient rehabilitation care. ]
    A patient-reported instrument specifically created to measure the patient's perception of their health-related quality of life following TBI.

  9. Satisfaction with Care [ Time Frame: This outcome will be assessed via self-report instrument from the patient participant 6 and 12 months after discharge from inpatient rehabilitation care. ]
    A measure developed by the study team to assess satisfaction with health care received by the patient participant.

  10. Satisfaction with RTP Group [ Time Frame: This outcome will be assessed via self-report instrument from both patient and caregiver participants (if applicable) randomized to the RTP group 6 months after discharge from inpatient rehabilitation care. ]
    A measure developed by the study team to assess satisfaction with participation in the RTP group.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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:

    1. PTA>24 hours;
    2. Trauma related intracranial neuroimaging abnormalities;
    3. Loss of consciousness exceeding 30 minutes (unless due to sedation or intoxication); or
    4. Glasgow Coma Scale in the emergency department of less than 13 (unless due to intubation, sedation, or intoxication).
  2. 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.);
  3. At least 18 years old;
  4. 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);
  5. 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);
  6. Able to provide informed consent, or if unable to provide consent have family or legal guardian to provide informed consent for the patient.

Inclusion Criteria- Caregiver Participants:

  1. Individuals who will have primary care giving responsibility post rehabilitation care discharge of enrolled patient participants;
  2. 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.);
  3. At least 18 years old;
  4. Able to provide informed consent.

Exclusion Criteria:

Exclusion criteria- Patient Participants:

  1. We will not enroll individuals who are in law enforcement custody at admission to the designated rehabilitation unit or who are taken into custody prior to discharge from the designated rehabilitation unit due to federal restrictions on inclusion of prisoners in research.
  2. We will not enroll individuals who do not have access to a phone.
  3. 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.

Exclusion criteria- Caregiver Participants:

  1. We will not enroll individuals who are in law enforcement custody due to federal restrictions on inclusion of prisoners in research.
  2. We will not enroll individuals who do not have access to a phone.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03422276


Locations
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United States, Indiana
Indiana University School of Medicine/ Rehabilitation Hospital of Indiana
Indianapolis, Indiana, United States, 46254
United States, New York
Mount Sinai Health System (NY)
New York, New York, United States, 10002
United States, Ohio
Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Moss Rehab Hospital
Elkins Park, Pennsylvania, United States, 19027
United States, Texas
Baylor Institute for Rehabilitation
Dallas, Texas, United States, 75246
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Icahn School of Medicine at Mount Sinai
Moss Rehabilitation Research Institute
Ohio State University
Baylor Institute for Rehabilitation
Indiana University School of Medicine
Craig Hospital
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Jeanne Hoffman, PhD University of Washington
Principal Investigator: Jesse Fann, MD, MPH University of Washington

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Responsible Party: Jeanne Hoffman, Professor, School of Medicine: Rehabilitation Medicine:Psychology, University of Washington
ClinicalTrials.gov Identifier: NCT03422276     History of Changes
Other Study ID Numbers: STUDY00002859
PCS-1604-35115 ( Other Grant/Funding Number: Patient Centered Outcomes Research Institute (PCORI) )
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jeanne Hoffman, University of Washington:
Transition
Rehabilitation Discharge
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System