Ignite Creation Date:
2024-05-06 @ 12:19 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03739450
Status:
COMPLETED
Last Update Posted:
2023-01-30
First Post:
2018-11-01
Brief Title:
Problem Solving Training for Care Partners of Adults With Traumatic Brain Injury
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Problem Solving Training for Care Partners of Adults With Traumatic Brain Injury
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CP-PST
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 PSTEducaion 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
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 PSTEducaion 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 abuse12 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 life134 Care partner burden is largely predicted by the extent to which care partners perceived needs are met156 As the consequences of TBI continue to change over time so too do the perceived needs of care partners7-11 One study suggests that only 55 of care partner needs are perceived as being met12 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 rehabilitation13 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 home13 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 role13 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 home14 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 goal1516 A growing body of evidence indicates that PST post-discharge is associated with reduced distress among care partners of adults with TBI17-19 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 Cohens d40 α005 power80 and attrition10 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 contact19 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 telephone19-22 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 masters 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 YN and care partner satisfaction For Aim 2 the investigators will compare differences in PSTEducation 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 AUDIT23 Brief Coping Orientation to Problems Experienced Brief COPE24 Patient Health Questionnaire 9 PHQ925 Zarit Burden Interview ZBI26 and the Client Satisfaction Questionnaire CSQ827 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 eg 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 ANOVAANCOVA 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-discharge19 Care partners completed up to 10 sessions with 8 sessions as a target Of the 77 participants 41 532 completed 7-10 sessions 30 390 completed 1-6 sessions and 6 78 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
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 abuse12 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 life134 Care partner burden is largely predicted by the extent to which care partners perceived needs are met156 As the consequences of TBI continue to change over time so too do the perceived needs of care partners7-11 One study suggests that only 55 of care partner needs are perceived as being met12 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 rehabilitation13 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 home13 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 role13 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 home14 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 goal1516 A growing body of evidence indicates that PST post-discharge is associated with reduced distress among care partners of adults with TBI17-19 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 Cohens d40 α005 power80 and attrition10 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 contact19 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 telephone19-22 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 masters 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 YN and care partner satisfaction For Aim 2 the investigators will compare differences in PSTEducation 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 AUDIT23 Brief Coping Orientation to Problems Experienced Brief COPE24 Patient Health Questionnaire 9 PHQ925 Zarit Burden Interview ZBI26 and the Client Satisfaction Questionnaire CSQ827 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 eg 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 ANOVAANCOVA 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-discharge19 Care partners completed up to 10 sessions with 8 sessions as a target Of the 77 participants 41 532 completed 7-10 sessions 30 390 completed 1-6 sessions and 6 78 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None