Problem Solving Training for Care Partners of Adults With Traumatic Brain Injury (CP-PST)

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.

Study Overview

• Status: Completed
• Conditions: Care Partners of Patients With Traumatic Brain Injury (TBI)
• Intervention / Treatment: Behavioral: Problem Solving Training (PST); Behavioral: Education

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.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936
      • Kessler Foundation
    • Edison, New Jersey, United States, 08820
      • JFK Johnson Rehabilitation Institute
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center
    • Dallas, Texas, United States, 75246
      • Baylor Scott & White Institute for Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Problem Solving Training + Education; Participants in this arm will receive the TBI-specific education intervention and the Problem Solving Training (PST) intervention.	Behavioral: Problem Solving Training (PST); The PST intervention consists of six sessions that will follow a structured format based on the PST manual. In these sessions, the interventionist will first provide the TBI-specific education, introduce the participant to the PST steps, then help the care partner generate and select a problem to address first. Interventionist will facilitate the care partner's use of the ABCDEF steps of PST to develop a specific action plan to solve the problem. As problems are attempted or solved, the care partner will learn how to perform the steps on his/her own, thus acquiring self-management problem solving skills that will be applicable to future problems. The final session will include a review and generalization of the PST steps and progress made.; Behavioral: Education; Participants will receive TBI-specific education alone through a workbook. It consists of educational modules for self-study, common sequelae of TBI, issues encountered by care partners, work and school concerns for those with TBI, and on navigating the rehab system and accessing resources. The modules consist of a brief introduction, key definitions, examples, resources, and a summary. Some chapters also include self-directed activities, such as worksheets or checklists. The investigators will provide a brief orientation to the workbook and include open-ended questions about the participants' need for clarification or questions of the education material. The last session will consist of an open discussion about expected problems that may arise post-discharge.
Active Comparator: Education; Participants in this arm will only receive the TBI-specific education intervention.	Behavioral: Education; Participants will receive TBI-specific education alone through a workbook. It consists of educational modules for self-study, common sequelae of TBI, issues encountered by care partners, work and school concerns for those with TBI, and on navigating the rehab system and accessing resources. The modules consist of a brief introduction, key definitions, examples, resources, and a summary. Some chapters also include self-directed activities, such as worksheets or checklists. The investigators will provide a brief orientation to the workbook and include open-ended questions about the participants' need for clarification or questions of the education material. The last session will consist of an open discussion about expected problems that may arise post-discharge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from T1 to T2 in the Patient Health Questionnaire (PHQ9) Changes from T2 to T3 in the PHQ9 T3 in the PHQ9 to measure maintenance of change Group/Arm differences at T2 in the PHQ9	The PHQ-9 assesses the frequency over the past two weeks of each of the nine symptoms of DSM-IV-TR that define a major depressive episode. Total scores range from 0-27, with established interpretative symptom cut-off scores of 0-4 (none), 5-9 (mild), 10-14 (moderate), 15-19 (moderately severe), and >20 (severe).	Baseline (T1), 1-month (T2) and 6-month (T3) post-discharge between both arms
Changes T2 to T3 in the Zarit Burden Interview (ZBI) Group/Arm differences at T2 in the ZBI	The ZBI is a self-reported measure of perceived caregiver burden, including psychological health, well-being, social and family life, finances, and perceive control. There are multiple versions of the ZBI, but the investigators will use the 22-item version (each scored on a 5-pt Likert Scale), because it has been found to have good internal consistency reliability (α=.92) and established reference values for interpretation (mild: 2-20; mild to moderate: 21-40; moderate to severe:41-60; severe: 61-88).	1 month (T2) and 6 month (T3) post-discharge between both arms

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol Use Disorders Identification Test (AUDIT)	The AUDIT is a 10-item screening tool for alcohol use behaviors designed by the World Health Organization to screen for alcohol abuse.The AUDIT assesses consumption, drinking behaviors, and alcohol-related problems, with a score of >8 indicating harmful alcohol use.	Baseline, 1-month and 6-month post-discharge
Brief Coping Orientation to Problems Experienced	The Brief COPE is a shorter version of the COPE Inventory composed of 28-items rated on a 4-point ordinal scale that measure 14 subscales of coping style (2-items each).	Baseline, 1-month and 6-month post-discharge

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Hackensack Meridian Health; Kessler Institute for Rehabilitation; Baylor Health Care System
• Investigators: Principal Investigator: Shannon Juengst, PhD, UT Southwestern

Publications and helpful links

General Publications

• Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. doi: 10.1207/s15327558ijbm0401_6.
• Rivera PA, Elliott TR, Berry JW, Grant JS. Problem-solving training for family caregivers of persons with traumatic brain injuries: a randomized controlled trial. Arch Phys Med Rehabil. 2008 May;89(5):931-41. doi: 10.1016/j.apmr.2007.12.032.
• Powell JM, Fraser R, Brockway JA, Temkin N, Bell KR. A Telehealth Approach to Caregiver Self-Management Following Traumatic Brain Injury: A Randomized Controlled Trial. J Head Trauma Rehabil. 2016 May-Jun;31(3):180-90. doi: 10.1097/HTR.0000000000000167.
• Malouff JM, Thorsteinsson EB, Schutte NS. The efficacy of problem solving therapy in reducing mental and physical health problems: a meta-analysis. Clin Psychol Rev. 2007 Jan;27(1):46-57. doi: 10.1016/j.cpr.2005.12.005. Epub 2006 Feb 9.
• Adelman RD, Tmanova LL, Delgado D, Dion S, Lachs MS. Caregiver burden: a clinical review. JAMA. 2014 Mar 12;311(10):1052-60. doi: 10.1001/jama.2014.304.
• Manskow US, Sigurdardottir S, Roe C, Andelic N, Skandsen T, Damsgard E, Elmstahl S, Anke A. Factors Affecting Caregiver Burden 1 Year After Severe Traumatic Brain Injury: A Prospective Nationwide Multicenter Study. J Head Trauma Rehabil. 2015 Nov-Dec;30(6):411-23. doi: 10.1097/HTR.0000000000000085.
• Bayen E, Jourdan C, Ghout I, Darnoux E, Azerad S, Vallat-Azouvi C, Weiss JJ, Aegerter P, Pradat-Diehl P, Joel ME, Azouvi P. Objective and Subjective Burden of Informal Caregivers 4 Years After a Severe Traumatic Brain Injury: Results From the PariS-TBI Study. J Head Trauma Rehabil. 2016 Sep-Oct;31(5):E59-67. doi: 10.1097/HTR.0000000000000079.
• Kreutzer JS, Gervasio AH, Camplair PS. Primary caregivers' psychological status and family functioning after traumatic brain injury. Brain Inj. 1994 Apr;8(3):197-210. doi: 10.3109/02699059409150973.
• Kolakowsky-Hayner SA, Miner KD, Kreutzer JS. Long-term life quality and family needs after traumatic brain injury. J Head Trauma Rehabil. 2001 Aug;16(4):374-85. doi: 10.1097/00001199-200108000-00007.
• Davis LC, Sander AM, Struchen MA, Sherer M, Nakase-Richardson R, Malec JF. Medical and psychosocial predictors of caregiver distress and perceived burden following traumatic brain injury. J Head Trauma Rehabil. 2009 May-Jun;24(3):145-54. doi: 10.1097/HTR.0b013e3181a0b291.
• Kreutzer JS, Gervasio AH, Camplair PS. Patient correlates of caregivers' distress and family functioning after traumatic brain injury. Brain Inj. 1994 Apr;8(3):211-30. doi: 10.3109/02699059409150974.
• Ponsford J, Olver J, Ponsford M, Nelms R. Long-term adjustment of families following traumatic brain injury where comprehensive rehabilitation has been provided. Brain Inj. 2003 Jun;17(6):453-68. doi: 10.1080/0269905031000070143.
• Nabors N, Seacat J, Rosenthal M. Predictors of caregiver burden following traumatic brain injury. Brain Inj. 2002 Dec;16(12):1039-50. doi: 10.1080/02699050210155285.
• Rotondi AJ, Sinkule J, Balzer K, Harris J, Moldovan R. A qualitative needs assessment of persons who have experienced traumatic brain injury and their primary family caregivers. J Head Trauma Rehabil. 2007 Jan-Feb;22(1):14-25. doi: 10.1097/00001199-200701000-00002.
• Murphy MP, Carmine H. Long-term health implications of individuals with TBI: a rehabilitation perspective. NeuroRehabilitation. 2012;31(1):85-94. doi: 10.3233/NRE-2012-0777.
• Lefebvre H, Levert MJ. The close relatives of people who have had a traumatic brain injury and their special needs. Brain Inj. 2012;26(9):1084-97. doi: 10.3109/02699052.2012.666364. Epub 2012 May 24.
• Luker J, Murray C, Lynch E, Bernhardsson S, Shannon M, Bernhardt J. Carers' Experiences, Needs, and Preferences During Inpatient Stroke Rehabilitation: A Systematic Review of Qualitative Studies. Arch Phys Med Rehabil. 2017 Sep;98(9):1852-1862.e13. doi: 10.1016/j.apmr.2017.02.024. Epub 2017 Mar 28.
• Gan C, Gargaro J, Brandys C, Gerber G, Boschen K. Family caregivers' support needs after brain injury: a synthesis of perspectives from caregivers, programs, and researchers. NeuroRehabilitation. 2010;27(1):5-18. doi: 10.3233/NRE-2010-0577.
• Grant JS, Elliott TR, Weaver M, Bartolucci AA, Giger JN. Telephone intervention with family caregivers of stroke survivors after rehabilitation. Stroke. 2002 Aug;33(8):2060-5. doi: 10.1161/01.str.0000020711.38824.e3.
• Bell KR, Brockway JA, Fann JR, Cole WR, St De Lore J, Bush N, Lang AJ, Hart T, Warren M, Dikmen S, Temkin N, Jain S, Raman R, Stein MB. Concussion treatment after combat trauma: development of a telephone based, problem solving intervention for service members. Contemp Clin Trials. 2015 Jan;40:54-62. doi: 10.1016/j.cct.2014.11.001. Epub 2014 Nov 8.
• Bell KR, Fann JR, Brockway JA, Cole WR, Bush NE, Dikmen S, Hart T, Lang AJ, Grant G, Gahm G, Reger MA, St De Lore J, Machamer J, Ernstrom K, Raman R, Jain S, Stein MB, Temkin N. Telephone Problem Solving for Service Members with Mild Traumatic Brain Injury: A Randomized, Clinical Trial. J Neurotrauma. 2017 Jan 15;34(2):313-321. doi: 10.1089/neu.2016.4444. Epub 2016 Oct 13.
• Bell KR, Brockway JA, Hart T, Whyte J, Sherer M, Fraser RT, Temkin NR, Dikmen SS. Scheduled telephone intervention for traumatic brain injury: a multicenter randomized controlled trial. Arch Phys Med Rehabil. 2011 Oct;92(10):1552-60. doi: 10.1016/j.apmr.2011.05.018.
• Bryce S, Spitz G, Ponsford J. Screening for Substance Use Disorders Following Traumatic Brain Injury: Examining the Validity of the AUDIT and the DAST. J Head Trauma Rehabil. 2015 Sep-Oct;30(5):E40-8. doi: 10.1097/HTR.0000000000000091.
• Fann JR, Bombardier CH, Dikmen S, Esselman P, Warms CA, Pelzer E, Rau H, Temkin N. Validity of the Patient Health Questionnaire-9 in assessing depression following traumatic brain injury. J Head Trauma Rehabil. 2005 Nov-Dec;20(6):501-11. doi: 10.1097/00001199-200511000-00003.
• Ballesteros J, Santos B, Gonzalez-Fraile E, Munoz-Hermoso P, Dominguez-Panchon AI, Martin-Carrasco M. Unidimensional 12-item Zarit Caregiver Burden Interview for the assessment of dementia caregivers' burden obtained by item response theory. Value Health. 2012 Dec;15(8):1141-7. doi: 10.1016/j.jval.2012.07.005. Epub 2012 Oct 4.
• Juengst SB, Silva V, Goldin Y, Cicerone K, Lengenfelder J, Chiaravalloti N, Driver S, Mellick D, Dart G, Kew CL, Nabasny A, Bell KR. Care partner problem solving training (CP-PST) for care partners of adults with traumatic brain injury during inpatient rehabilitation: Study protocol for a multisite, randomized, single-blind clinical feasibility trial. Contemp Clin Trials. 2019 May;80:9-15. doi: 10.1016/j.cct.2019.03.004. Epub 2019 Mar 16.

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2018
• Primary Completion (Actual): October 22, 2022
• Study Completion (Actual): October 22, 2022

Study Registration Dates

• First Submitted: November 1, 2018
• First Submitted That Met QC Criteria: November 9, 2018
• First Posted (Actual): November 13, 2018

Study Record Updates

• Last Update Posted (Estimate): January 30, 2023
• Last Update Submitted That Met QC Criteria: January 27, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: STU 042018-052

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The IPD that will be shared includes the study protocol, the statistical analysis plan and the clinical study report.
• IPD Sharing Time Frame: The research module data will remain under the control of the lead project team for one year after completion of data collection of the project. This will allow ample time for analyses and preparation of planned manuscripts. After the one-year period, any of the centers may request the data for additional analysis and dissemination. See SOP 6b for more details on internal procedures.

IPD Sharing Access Criteria

Both internal and external entities may request IPD through two separate procedures.

Internal Use:

Participating site in the TBI Model Systems may reference SOP 602b for further procedures.

External Use:

All staff, students, and other related personnel not involved in the NIDILRR-funded TBI Model Systems Centers or Follow-up Centers who wish to use data from the TBI Model Systems National Database or Modules may request access to the data set by completing a Data Request and Use Agreement Form available for download at www.tbindsc.org The Data Request and Use Agreement Form, once complete, can be emailed or faxed to the Project Director of the TBI Model Systems National Data and Statistical Center (see www.tbindsc.org and go to contacts).

Reference: SOP 602d

• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No