Brain Injury Rehabilitation Improving the Transition Experience

NCT03422276 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1555

Last updated 2025-03-12

Study results available
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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

Interventions

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.

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.

Sponsors & Collaborators

  • Icahn School of Medicine at Mount Sinai

    collaborator OTHER
  • Moss Rehabilitation Research Institute

    collaborator OTHER
  • Ohio State University

    collaborator OTHER
  • Baylor Institute for Rehabilitation

    collaborator OTHER
  • Indiana University School of Medicine

    collaborator OTHER
  • Craig Hospital

    collaborator OTHER
  • Patient-Centered Outcomes Research Institute

    collaborator OTHER
  • University of Washington

    lead OTHER

Principal Investigators

  • Jeanne Hoffman, PhD · University of Washington

  • Jesse Fann, MD, MPH · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-13
Primary Completion
2022-04-30
Completion
2022-11-10

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03422276 on ClinicalTrials.gov