Brain Injury Rehabilitation Improving the Transition Experience
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Hospital, Neurology |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/1/2018 |
| Start Date: | February 13, 2018 |
| End Date: | April 30, 2023 |
Improving Transition From Acute to Post-Acute Care Following Traumatic Brain Injury
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.
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.
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.
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.
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.
We found this trial at
6
sites
555 West 57th Street
New York, New York 10002
New York, New York 10002
Principal Investigator: Kristen Dams-O'Connor, PhD
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Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Jeanne M Hoffman, PhD
Phone: 206-616-8630
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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410 W 10th Ave
Columbus, Ohio 43210
Columbus, Ohio 43210
(614) 293-8652
Principal Investigator: Jennifer Bogner, PhD
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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60 Township Line Road
Elkins Park, Pennsylvania 19027
Elkins Park, Pennsylvania 19027
Principal Investigator: Tessa Hart, PhD
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340 West 10th Street
Indianapolis, Indiana 46254
Indianapolis, Indiana 46254
Principal Investigator: Flora Hammond, MD
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