Brain Injury Rehabilitation Improving the Transition Experience — BRITE  

Traumatic Brain Injury Clinical Trial

Official title: Improving Transition From Acute to Post-Acute Care Following Traumatic Brain Injury

Status Completed

Clinical Trial 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.

Clinical Trial Description

Screening

The screening process involves a review of medical records by our research staff for patients with a diagnosis of TBI, or suspected TBI, (see inclusion/exclusion for further detail) who are admitted to the inpatient rehabilitation unit at the study sites.

Recruitment

Patient Participants: If a potential participant meets eligibility criteria based on medical record review, research staff will approach him/her on the inpatient rehabilitation unit to determine whether the patient is cognitively capable of providing consent by administering a measure of orientation/ emergence from PTA. If the patient is deemed oriented, the research staff will introduce the study using a talking points script, and if the potential participant is interested, provide him/her with a brochure and a consent form.

Research staff will initiate the informed consent process if: a) the patient is deemed oriented per definition above, and b) the patient expresses interest in participating. Research staff will visit the patient on a subsequent day and re-administer the orientation test prior to consent if needed.

If the patient is not deemed oriented as per the outline above, the patient is deemed not yet oriented and unable at that time to provide informed consent. Research staff may administer the orientation test multiple times to determine capacity to consent. Research staff may talk with a Legally Authorized Representative (LAR) if one is willing and available to attempt to obtain their consent if a patient is not deemed oriented prior to discharge.

The investigators plan to enroll a total of 900 patient participants.

Caregiver Participants:

Caregiver participants will be those individuals who will have primary care giving responsibility following rehabilitation care discharge of patients with moderate to severe TBI. Caregivers may be recruited while the patient is in the hospital or by telephone, if not available during hospitalization. Research staff may enroll more than one individual as a caregiver following subject enrollment should a different individual assume the role of caregiver at a later time point.

The investigators plan to enroll a total of 607 caregiver participants.

Basic Demographic Information: All Potential Patient Participants

Basic demographic information including age, sex, and race will be collected via medical record review without consent from all patients including those who do not enroll to determine differences between enrolled patients participants and those who do not enroll.

Consent

For patient participants, the informed consent process will take place during the participants inpatient rehabilitation stay with our research staff while they are inpatients.

Potential participants will be fully informed of all risks and benefits prior to giving their written informed consent and prior to enrollment in the study. Participants may take time to think about participating and render a decision in a subsequent visit. Potential participants will be asked to repeat back understanding of this material as necessary.

Research staff will also review a HIPAA authorization form with the participant that permits research staff to collect data from his/her medical records regarding injury and medical history.

Caregiver Participants: Caregiver participants may be initially recruited by telephone or in person. Caregivers will provide written consent if enrolled in person.

All participants approached for possible enrollment in this study will be clearly informed that if they choose not to participate in this project, they and/or their loved one will still be able to receive any of the routine medical and rehabilitation services available to them. They will be informed that their participation is voluntary and that they may withdraw their consent and discontinue participation in the study at any time. Any new information developed during the course of the study that might affect a participant's understanding of the research and willingness to continue to participate will be brought to their attention by study staff.

Baseline Assessment

Contact Information Sheet Research staff will collect the following information from both caregiver and patient participants: (1) contact information; (2) best way to reach an individual if they have more than one line; best times/days to reach participant; and (3) names and contact information of people staff are allowed to contact if participant is lost to follow-up or otherwise cannot be contacted (i.e. collateral contacts).

Baseline Information: Demographic and injury related data will be collected from the electronic medical record, and additional demographic and clinical history will be collected in interview format. A cognitive assessment focused on memory, concentration, and problem solving will be given. These data will be entered in de-identified form into the NDSC centralized database by research staff.

Discharge Information: Research staff will collect information from a patient participant's medical record regarding the presence/absence of recommended and/or scheduled appointments to different medical disciplines/services. Specific information regarding the recommended/scheduled appointments (e.g. name, phone number, email address, date of scheduled appointment, etc.) of patient participants randomized to the rehabilitation transition phase (RTP) group will be stored locally in a database used by the TBI care managers for referential purposes.

The investigators will collect information regarding the nature of the caregiver's relationship to the patient participant, as well as basic demographic information. These data will be entered in de-identified form into the NDSC centralized database by research staff.

Randomization/ Post-Discharge Transition Phase

After the patient participant has been discharged, s/he will be randomly assigned 1:1 into one of two study arms: Rehabilitation Discharge Plan (RDP) group or the Rehabilitation Transition Plan (RTP) group.

The investigators will stratify randomization on study site and discharge destination (another facility vs. home/ community). Once randomization occurs, their random assignment will be communicated to the TBI Care Manager (TCM). The TCM will then send out a letter to the patient participant and caregiver (if applicable).

RTP Process Variables

Individual elements of the RTP will be measured as they are administered to each patient/ caregiver or other recipient in the form of a treatment note as captured in a secure database, incorporating documentation elements used in the field. Measures will include the clock time devoted to each contact, the recipient of each contact, total number of attempts/contacts, the type of need or issue discussed, and actions planned and implemented.

Follow Up Data Collection

3, 6, 9 and 12 Months Post Hospital Discharge: Patient Participant The 3, 6, 9 and 12 month post-hospital discharge questionnaire will take approximately 45-60 minutes to complete, and will be completed by phone or in person. This questionnaire includes both the primary and secondary outcomes described below. ;

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

• NCT number: NCT03422276
• Study type: Interventional
• Source: University of Washington
• Status: Completed
• Phase: N/A
• Start date: February 13, 2018
• Completion date: November 10, 2022