Clinical trial NCT03739450: Problem Solving Training for Care Partners of Adults With Traumatic Brain Injury
Official title: Problem Solving Training for Care Partners of Adults With Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Care Partners of Patients With Traumatic Brain Injury (TBI)
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Baylor Health Care System
name: Kessler Institute for Rehabilitation
name: Hackensack Meridian Health
First posted: 2018-11-13
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized and allocated after baseline assessment to PST + Education or Education only via stratified, blocked randomization. Randomization is stratified by participating center and then based on whether a single care partner or multiple care partners are participating for the same patient by participating TBIMS Center. The investigators used a block size of four to ensure equal numbers across groups and to account for potentially small numbers of participants at any given TBIMS Center. Randomization is computer-generated and maintained by the TBI Model Systems National and Statistical Data Center. Allocation assignments for each center are distributed to the site PI and maintained in a password-protected electronic file. Outcome assessors are blinded to intervention allocation.
Primary purpose: TREATMENT

Brief summary: Importance: The chronic consequences of TBI are established, 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. Currently, there are no evidence-based interventions for care partners of adults with TBI to prepare them for this role. Problem Solving Training (PST) is an evidence-based, self-management approach with demonstrated efficacy for care partners of individuals with disabilities, but it has not been delivered or evaluated during inpatient rehabilitation.

Aims: Aim 1): To assess the feasibility of providing PST to care partners of adults with TBI during the inpatient rehabilitation stay; Aim 2) To assess the efficacy of PST + education vs education alone for improving caregiver burden, depressive symptoms, and coping skills 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 and conduct baseline assessment, with follow-up assessment at 1 month and 6 months post-discharge. For Aim 1, the investigators will measure number of sessions of PST completed and care partner satisfaction. For Aim 2, the investigators will compare differences in PST+Educaion vs. Education alone in measures of caregiver burden, depressive symptoms, and coping skills at 1-month and 6-months post-discharge.

Conclusion: The investigators anticipate that care partners will be able to complete a minimum of 3 sessions during the inpatient rehabilitation stay and that PST + Education will be more effective than Education alone for reducing caregiver burden and depressive symptoms and improving positive coping among care partners. 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 during inpatient rehabilitation. The proposed project builds upon this foundation of evidence to address this critical gap in the literature. It will provide evidence for effective ways to support and improve outcomes for care partners during the transition from hospital to home.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes From T2 to T3 in the Patient Health Questionnaire (PHQ9)
timeFrame: 1-month (T2), 6-month (T3) post-discharge between both arms
measure: Changes T2 to T3 in the Zarit Burden Interview (ZBI) Group/Arm Differences at T2 in the ZBI
timeFrame: 1 month (T2) and 6 month (T3) post-discharge between both arms
Secondary outcomes:
measure: Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: Baseline and 6-month post-discharge
measure: Brief Coping Orientation to Problems Experienced
timeFrame: 1-month (T2) and 6-month (T3) post-discharge
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Kessler Foundation
state: New Jersey
city: Edison
country: United States
facility: JFK Johnson Rehabilitation Institute
state: New Jersey
city: Dallas
country: United States
facility: Baylor Scott & White Institute for Rehabilitation
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern
name: Shannon Juengst, PhD
role: PRINCIPAL_INVESTIGATOR
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