Safe@Home: A Self-Management Program for Individuals With TBI and Their Families

Many persons who have sustained moderate to severe TBI and receive medical rehabilitation
transition to their home and community settings with impaired cognition, perceptual motor
skills, awareness of disability, self-regulation, and judgment that place them at risk for
subsequent unintentional injury or harm. Unintentional injuries often result from falls;
motor vehicle or pedestrian events; improper use of electrical equipment, fire, or sharp
objects; poisonings; and firearm-related incidents. Risk for harm to self or others also
results from victimization, loss of money or valuables, property damage, medication errors,
inappropriate responses to emergency or medical situations, and self-regulation problems.
Four TBI registry studies have shown that unintentional injury is a leading cause of death
(18%-20%) in the year following discharge. In one study, 32% of TBI participants (n=504) had
228 ER visits/hospitalizations from 3-months to several years following discharge due to
unintentional injuries.

In order to facilitate independent living and address the safety concerns for persons with
TBI in the home and community, a targeted, self-management approach that includes injury
prevention education and compensatory strategy training for instrumental activities of daily
living (IADLs) is recommended. Institute of Medicine (IOM) and Agency for Healthcare Research
and Quality (AHRQ) systematic reviews have recommended the need for TBI post-acute
rehabilitation research to find efficient and effective independent living treatments for
people with TBI. Rehabilitation investigators recommend evidence-based education that
includes integrated, consensus-based, prevention strategies from multidisciplinary
rehabilitation professionals to reduce unintentional injury and harm following TBI.
Interventions should set goals important to the person with TBI, help the person and family
to define roles/responsibilities and work as a team, and develop problem-solving skills and
strategies.

The Safe@Home self-management intervention program builds upon our previous research on
safety assessment and causes of unsafe events. This clinical trial will evaluate the
effectiveness of a person and family-centered intervention to reduce unsafe events and
increase self-managed activities and participation. The Safe@Home program is comprised of a
personalized assessment report, prevention education and goal-setting, and in-home activity
training with a life skills coach. The primary outcomes targeted for this intervention are
to: 1) decrease unintentional injury and harm, i.e., unsafe events, and 2) increase
independence in daily activities.

Participants will be assigned either to a usual care control group or the Safe@Home program
group. Family members of both groups will be asked to complete assessments and both groups of
participants and clients and family members will receive a personalized report on their
strengths and risks, and suggested strategies to improve independence and reduce risk. The
group receiving the Safe@Home Program will also receive in-home education on injury
prevention and training on self-selected activities of interest.

Persons with TBI in the Safe@Home program will also be asked to:

- Participate in 2 education sessions to understand their strengths and risks, set goals,
work as a team, reduce risks in their home, and problem-solve among themselves, their
family member, and personal transition coach

- Participate in 8 in-home visits in which training and supports are provided to help with
learning activity skills and compensatory strategies.

- Receive mobile phone and internet reminders to help work on goals and remember
strategies.

- Complete a brief questionnaire that should take no longer than 15 minutes before the
program, at the end of the program, and 3-months after the program ends.

The questionnaire will ask about:

- their current abilities

- their confidence in their ability to reach goals

- working with their family member on their activity goals and tasks

Family members play an important role in the transition from the hospital to home and have
firsthand knowledge of the safety issues that each person with TBI faces.

Family members will be asked to:

- Participate in 2 education sessions to understand the person who had a brain injury
strengths and risks, set goals, work as a team, reduce risks in the home, and
problem-solve among themselves, their family member who had a brain injury, and personal
transition coach

- Complete a questionnaire that should take no longer than 45 minutes to complete before
the program, at the end of the program, and 3-months after the program ends.

- Complete a very brief report about unsafe events that should take no longer than 1-2
minutes to complete every 2 weeks.

This questionnaire will ask:

- general background and health information about the family member and the person with
TBI

- the likelihood of certain unsafe situations occurring

- the supervision the person with TBI receives

- Mayo-Portland Participation subscale

Inclusion Criteria:

Persons with TBI and family members will be eligible if they meet all of the following
criteria:

1. Person with TBI aged 18 or older who sustained moderate to severe TBI defined as
externally caused damage to brain tissue as evidenced by one of the following (TBI
Model Systems Criteria):

- Post-traumatic Amnesia (PTA) > 24 hours

- Trauma related intracranial neuroimaging abnormalities

- Loss of consciousness exceeding 30 minutes (and not due to sedation or
intoxication)

- Glasgow Coma Scale (GCS) score in the emergency department of less than 13 (and
not due to intubation, sedation, or intoxication)

2. All participants must be capable of providing informed consent for research
participation.

3. Person with TBI has capacity to manage self-care as defined by a rehabilitation
specialist rating the patient on the Mayo-Portland Self-Care item ≤ 2, i.e., requires
a little assistance or supervision from others, ≤24% of the time.

4. An adult family member, e.g., parent, spouse, adult child, or committed, domestic
partner, aged 18 or older, living in the home environment is willing to participate.

5. Person-family resides within 75 miles of the enrollment site and willing to allow a
personal transition coach into the home.

6. Person-family willing to use the internet or a mobile phone as part of the
intervention.

7. Person-family are English speaking, either native or English as a second language.

Exclusion Criteria:

1. Person with brain injury primary diagnosis is hypoxic or hypoxic-ischemic (i.e.,
anoxic) brain injury; cerebral infarction (ischemic stroke) or cerebral hemorrhage
(i.e., hemorrhagic stroke); intracranial hemorrhage (i.e., aneurismal rupture,
subdural or epidural hematoma without TBI); inflammatory, toxic, or metabolic
encephalopathies which are not complications of head trauma; seizure disorders
(primary generalized epilepsy, partial epilepsies, status epilepticus, etc.); cerebral
neoplasm; intracranial surgery; or condition other than moderate or severe TBI as
defined above.

2. Person with TBI could not self-manage activities prior to their injury due to severe,
uncontrolled psychopathology (e.g., schizophrenia, bipolar disorder) or developmental
disability.

3. Person or family has current, severe, untreated/uncontrolled psychopathology (e.g.,
physically abusive, violent or sexual behavior) that places the personal transition
coach treating in the home at physical risk.

4. Person with TBI has severe, current physical or sensory impairment (e.g., tetraplegia,
legally blind) that prohibits participation in all activity modules and reflects
membership in a different population.