Clinical trial NCT03422276: Brain Injury Rehabilitation Improving the Transition Experience
Official title: Improving Transition From Acute to Post-Acute Care Following Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: Transition
Rehabilitation Discharge
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
name: Moss Rehabilitation Research Institute
name: Ohio State University
name: Baylor Institute for Rehabilitation
name: Indiana University School of Medicine
name: Craig Hospital
name: Patient-Centered Outcomes Research Institute
First posted: 2018-02-05
Enrollment: 1555
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Participation Assessment With Recombined Tools - Objective 17 (PART-O-17)
timeFrame: This outcome will be assessed via self-report instrument from the patient participant 6 months after discharge from inpatient rehabilitation care.
measure: Quality of Life After Brain Injury Scale (QoLIBRI)
timeFrame: This outcome will be assessed via self-report instrument from the patient participant 6 months after discharge from inpatient rehabilitation care.
Secondary outcomes:
measure: Cornell Services Index
timeFrame: 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.
measure: Bakas Caregiving Outcomes Scale
timeFrame: 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.
measure: Zarit Burden Interview
timeFrame: 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.
measure: Short Form 12-Item Measure (SF-12)
timeFrame: 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.
measure: PROMIS (Patient-Reported Outcomes Measurement Information System) Satisfaction With Social Roles and Activities 8a
timeFrame: 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.
measure: Time Spent Caregiving - Required Assistance
timeFrame: 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.
measure: Participation Assessment With Recombined Tools - Objective 17 (PART-O-17)
timeFrame: This outcome will be assessed longitudinally via self-report instrument from the patient participant 3,6, 9 and 12 months after discharge from inpatient rehabilitation care.
measure: Quality of Life After Brain Injury Scale (QoLIBRI)
timeFrame: 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.
measure: Satisfaction With Care
timeFrame: This outcome will be assessed via self-report instrument from the patient participant 6 and 12 months after discharge from inpatient rehabilitation care. 6-month outcomes are reported.
measure: RTP Satisfaction Survey
timeFrame: This outcome was 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 (if they consented to complete the survey).
measure: Time Spent Caregiving - Reason for Assistance
timeFrame: 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.
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Medicine/ Rehabilitation Hospital of Indiana
state: Indiana
city: New York
country: United States
facility: Mount Sinai Health System (NY)
state: New York
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center
state: Ohio
city: Elkins Park
country: United States
facility: Moss Rehab Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: Baylor Institute for Rehabilitation
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Jeanne Hoffman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Jesse Fann, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.