Problem Solving Training for Care Partners of Adults With Traumatic Brain Injury

North TX TBIMS Module Project: Problem Solving Training (PST) for Care Partners of Adults
with Traumatic Brain Injuries (TBI) during Inpatient Rehabilitation

Care partners of adults with TBI report substantial burden and emotional distress and a need
for more resources and skills training to manage the transition from hospital to home.

The investigators will assess the feasibility and efficacy of Problem Solving Training for
care partners during inpatient rehabilitation to reduce burden and depressive symptoms and
improve coping across the critical transition from inpatient rehabilitation to the community.

Statement of Problem: The chronic consequences of TBI are recognized, but ongoing support for
adults with TBI living in the community is limited. This puts undue burden on care partners,
particularly during the transition from hospital to home. It often leads to adverse
consequences among care partners, such as emotional distress and increased substance
abuse.1,2 Care partners of individuals with TBI often experience high levels of burden, which
may result in depression, anxiety, increased somatic symptoms, and reduced quality of
life.1,3,4 Care partner burden is largely predicted by the extent to which care partners'
perceived needs are met.1,5,6 As the consequences of TBI continue to change over time, so too
do the perceived needs of care partners.7-11 One study suggests that only 55% of care partner
needs are perceived as being met.12 A systematic review of qualitative studies for care
partners of adults with stroke revealed seven themes with regard to experiences, needs, and
preferences of care partners during inpatient rehabilitation.13 Care partners expressed a
desire to be included, informed, and recognized as a stakeholder in recovery, the need to
navigate an alien culture and environment, and the need to manage the transition home.13 The
authors concluded that "the investigators need to make deliberate efforts to provide a more
inclusive environment that better supports and prepares carers for their new role".13 Despite
this established need during inpatient rehabilitation, there are currently no evidence-based
interventions for care partners of adults with TBI to prepare them for their new role prior
to discharge of care recipients from inpatient rehabilitation. Hence, there is a critical
need to provide care partners of individuals with TBI with the necessary skills to navigate
this difficult transition from hospital to home.14 Self-management training for care partners
of adults with other chronic conditions demonstrates strong potential for application to care
partners of adults with TBI.

Proposed Solution: Problem-Solving Training (PST) is an evidence-based, self-management
approach that teaches a simple, systematic method for evaluating problems, generating and
selecting solutions, creating and implementing realistic goals and action plans, and
evaluating whether those plans effectively addressed the specific goal.15,16 A growing body
of evidence indicates that PST post-discharge is associated with reduced distress among care
partners of adults with TBI.17-19 Problems previously seen as overwhelming are regarded as
solvable and manageable when approached in a stepwise fashion using PST, thereby reducing
perceived burden and emotional distress. PST empowers care partners to be active participants
in directing health and rehabilitation services.

Specific Aims:

Specific Aim 1: To assess the feasibility (compliance, satisfaction) of delivering Problem
Solving Training (PST) to care partners of individuals with TBI during inpatient
rehabilitation.

Specific Aim 2: To assess the efficacy of PST plus TBI-specific education compared to
TBI-specific education alone for improving the outcomes of care partners of individuals with
TBI.

Method: The investigators will conduct a randomized control trial of PST + Education vs
Education alone during the inpatient rehabilitation stay of individuals with TBI. The
investigators will enroll 172 care partners across sites and conduct baseline assessment,
with follow-up assessment at 1 month and 6 months post-discharge.

Sample size: The investigators plan to enroll 172 care partners to achieve an effect size
(group differences in burden at 1 month) of Cohen's d=.40; α=0.05, power=80%, and
attrition=10%. With recruitment projected to occur for 27 months, this would require
recruiting 6-7 participants per month across participating sites.

Description of Intervention: Care partners in the intervention group will receive PST
training plus TBI-specific education (6 sessions). Participants in the Control group will
receive TBI-specific education alone (6 points of contact).19 Sessions will last ~30-60
minutes each. All sessions will occur in-person whenever possible, or over the telephone when
meeting is not feasible. PST has been successfully delivered via both modalities, with
similar effects. Our group has particular experience delivering PST via telephone.19-22
Control group points of contact for education will last ~15 minutes each, with the first and
last session conducted in person and other contacts by phone. Trained members of the research
team with master's level education or equivalent experience will provide both interventions
using a specific curriculum that has been validated in our previous research studies20. These
activities will take place before discharge from inpatient rehabilitation. A structured
database will be used to record the session delivery to ensure fidelity, including
completion, reasons for non-compliance, method of delivery, session length, and a brief
summary of the PST steps covered during session.

Assessments: For Aim 1, the investigators will measure number of PST sessions completed, if a
minimum of 3 sessions were completed (Y/N), and care partner satisfaction. For Aim 2, the
investigators will compare differences in PST+Education vs. Education alone in measures of
caregiver burden, depressive symptoms, and coping skills, including alcohol use, at 1-month
and 6-months post-discharge. The investigators will explore sustainability of the PST
intervention at 6-months, testing group by time interactions for caregiver burden, depressive
symptoms, and coping. Outcomes measures will include the Alcohol Use Disorders Identification
Test (AUDIT),23 Brief Coping Orientation to Problems Experienced (Brief COPE),24 Patient
Health Questionnaire 9 (PHQ9),25 Zarit Burden Interview (ZBI),26 and the Client Satisfaction
Questionnaire (CSQ8).27 Analysis Plan: The primary outcome to assess feasibility is the
completion of a minimum of 3 sessions of PST. The investigators will also report the number
of sessions completed prior to discharge, and method of completion (in person or via
telephone), to inform future intervention design. The investigators will descriptively
present reasons for non-compliance, captured through our intervention database. The
investigators will divide the participants into two groups, based upon completion of <3
sessions or >3 sessions. The investigators will then compare the two groups and explore
demographic or other baseline differences (e.g. in outcomes of interest, in inpatient length
of stay, etc.) to identify factors associated with compliance. The investigators will compare
the level of client satisfaction (CSQ-8) with the intervention in both groups. For all group
comparisons, the investigators will use t-tests, Mann-Whitney U test, or Chi Squared tests,
as appropriate.

The investigators will calculate measures of central tendency or numbers and percentages for
all demographic baseline variables and descriptively compare PST Intervention to Education
groups, to reduce the overall number of comparisons and the likelihood of a type I error. If
there are group differences, the investigators will conduct formal statistical testing
(t-tests, Mann Whitney U tests, or Chi Square tests, as appropriate) to determine potential
confounding variables resulting from initial group differences and adjust for these variables
accordingly. The investigators will use intent-to-treat analyses to measure the differences
in each outcome measure between PST Intervention vs. Education groups at 1-month follow-up
using t-tests or Mann Whitney U tests, as appropriate. If covariate adjustment is determined
to be necessary based on baseline differences between the two groups, the investigators will
conduct Analysis of Covariance (ANCOVA) for each outcome, adjusting for relevant factors. To
address our second hypothesis, the investigators will assess group by time interactions,
including baseline, 1-month, and 6-month time points, using repeated-measures ANOVA/ANCOVA.
For the coping skills outcome, the investigators will use baseline data from all participants
and conduct exploratory factor analysis to identify second-order factors in our sample as a
means of data reduction and analyze total scores within the second-order factors.

Implementation of research design is feasible given the time and resources: The investigators
have previously conducted a RCT delivering PST to 77 care partners of adults with TBI via
telephone beginning one week post-discharge.19 Care partners completed up to 10 sessions,
with 8 sessions as a target. Of the 77 participants, 41 (53.2%) completed 7-10 sessions, 30
(39.0%) completed 1-6 sessions, and 6 (7.8%) did not complete any sessions after
randomization. Dr. Juengst has experience as a treating therapist, trainer, and supervisor
for self-management interventions, including assessing treatment fidelity and navigating
intervention delivery during inpatient rehabilitation. She will train participating centers
in the conduct of this project via webinar and using a written manual. Interventionists will
demonstrate competency in the intervention before use. Assessments are self-reported, can be
completed by a research assistant (blinded to intervention allocation), and take 20-30
minutes to complete. Our timeline is feasible based on our past experience recruiting
participants, delivering self-management interventions, and participating in TBIMS modules
Addition to State-of-the-Art: The investigators anticipate that care partners will be able to
complete a minimum of 3 sessions during the inpatient rehabilitation stay, with the goal of
completing 6 sessions. The investigators also anticipate that PST + Education will be more
effective than Education alone for reducing caregiver burden and depressive symptoms and
improving positive coping among care partners. This study will provide evidence for effective
strategies to support and improve outcomes for care partners during the transition from
hospital to home. This will benefit the TBIMS as a whole by providing an evidence-based and
feasible intervention for care partners, upon whom the TBIMS relies heavily for participant
enrollment and data collection, in addition to the ongoing support that care partners provide
to the primary beneficiaries of TBIMS services, individuals with TBI. PST is an
evidence-based, self-management approach with a strong theoretical foundation that has
demonstrated efficacy for care partners of individuals with disabilities. Early work
indicates that it is also effective for care partners of adults with TBI. However, there are
no studies evaluating whether delivery of PST to care partners is feasible and effective
during inpatient rehabilitation. The proposed project builds upon this foundation of evidence
to address this critical gap in the literature.

Inclusion Criteria:

1. Identified as care partner of an individual with TBI admitted to inpatient
rehabilitation. A care partner is defined as an individual (spouse, partner, family
member, friends, or neighbor) involved in assisting the patient with activities of
daily living and/or medical tasks or responsible in any way for the patient's
well-being after discharge from inpatient rehabilitation.

2. >1-year relationship

3. Ability to communicate in English.

4. >18 years old

5. Capacity to self-consent

Exclusion Criteria:

Dispute over care partner's role in the care of patient.