Combined cognitive and vocational interventions after mild to moderate traumatic brain injury: study protocol for a randomized controlled trial

Background A considerable proportion of patients with mild to moderate traumatic brain injury (TBI) experience long-lasting somatic, cognitive, and emotional symptoms that may hamper their capacity to return to work (RTW). Although several studies have described medical, psychological, and work-related factors that predict RTW after TBI, well-controlled intervention studies regarding RTW are scarce. Furthermore, there has traditionally been weak collaboration among health-related rehabilitation services, the labor and welfare sector, and workplaces. Methods/design This study protocol describes an innovative randomized controlled trial in which we will explore the effect of combining manualized cognitive rehabilitation (Compensatory Cognitive Training [CCT]) and supported employment (SE) on RTW and related outcomes for patients with mild to moderate TBI in real-life competitive work settings. The study will be carried out in the southeastern region of Norway and thereby be performed within the Norwegian welfare system. Patients aged 18–60 years with mild to moderate TBI who are employed in a minimum 50% position at the time of injury and sick-listed 50% or more for postconcussive symptoms 2 months postinjury will be included in the study. A comprehensive assessment of neurocognitive function, self-reported symptoms, emotional distress, coping style, and quality of life will be performed at baseline, immediately after CCT (3 months after inclusion), following the end of SE (6 months after inclusion), and 12 months following study inclusion. The primary outcome measures are the proportion of participants who have returned to work at 12-month follow-up and length of time until RTW, in addition to work stability as well as work productivity over the first year following the intervention. Secondary outcomes include changes in self-reported symptoms, emotional and cognitive function, and quality of life. Additionally, a qualitative RTW process evaluation focused on organizational challenges at the workplace will be performed. Discussion The proposed study will combine cognitive and vocational rehabilitation and explore the efficacy of increased cross-sectoral collaboration between specialized health care services and the labor and welfare system. If the intervention proves effective, the project will describe the cost-effectiveness and utility of the program and thereby provide important information for policy makers. In addition, knowledge about the RTW process for persons with TBI and their workplaces will be provided. Trial registration ClinicalTrials.gov, NCT03092713. Registered on 10 March 2017

Cost-effectiveness analysis of combined cognitive and vocational rehabilitation in patients with mild-to-moderate TBI: results from a randomized controlled trial

Background: Traumatic brain injury (TBI) represents a fnancial burden to the healthcare system, patients, their families and society. Rehabilitation interventions with the potential for reducing costs associated with TBI are demanded. This study evaluated the cost-effectiveness of a randomized, controlled, parallel group trial that compared the effectiveness of a combined cognitive and vocational intervention to treatment as usual (TAU) on vocational outcomes. Methods: One-hundred sixteen participants with mild-to-moderate TBI were recruited from an outpatient clinic at Oslo University Hospital, Norway. They were randomized to a cognitive rehabilitation intervention (Compensatory Cognitive Training, CCT) and Supported Employment (SE) or TAU in a 1:1 ratio. Costs of CCT-SE and TAU, healthcare services, informal care and productivity loss were assessed 3, 6 and 12 months after study inclusion. Cost-effectiveness was evaluated from the difference in number of days until return to pre-injury work levels between CCT-SE and TAU and quality-adjusted life years (QALYs) derived from the EQ-5D-5L across 12 months follow-up. Cost-utility was expressed in incremental cost-effectiveness ratio (ICER). Results: The mean total costs of healthcare services was € 3,281 in the CCT-SE group and € 2,300 in TAU, informal care was € 2,761 in CCT-SE and € 3,591 in TAU, and productivity loss was € 30,738 in CCT-SE and € 33,401 in TAU. Costs related to productivity loss accounted for 84% of the total costs. From a healthcare perspective, the ICER was € 56 per day earlier back to work in the CCT-SE group. Given a threshold of € 27,500 per QALY gained, adjusting for baseline difference in EQ-5D-5L index values revealed a net monetary beneft (NMB) of € -561 (0.009*27,500–979) from the healthcare perspective, indicating higher incremental costs for the CCT-SE group. From the societal perspective, the NMB was € 1,566 (0.009*27,500-(-1,319)), indicating that the CCT-SE intervention was a cost-effective alternative to TAU. Conclusions: Costs associated with productivity loss accounted for the majority of costs in both groups and were lower in the CCT-SE group. The CCT-SE intervention was a cost-effective alternative to TAU when considering the societal perspective, but not from a healthcare perspective

Feasibility of a cognitive rehabilitation program for individuals with mild-to-moderate traumatic brain injury: Participants’ engagement and satisfaction

Purpose: To assess the feasibility of recruitment procedures and delivery of a Norwegian adaptation of a manualized cognitive intervention to a civilian sample with traumatic brain injury (TBI). Materials and methods: Six individuals received a 10-week group-based intervention (Compensatory Cognitive Training, CCT) targeting post-concussive symptom management and cognitive symptoms. Participant engagement (i.e. attendance, level of participation, ability to learn and apply strategies, and homework completion) and satisfaction were assessed by the Therapist Checklist and CCT Feedback Form. Results: All participants had a diagnosis of concussion, were enrolled on average 4 months post-injury, and were sick-listed at a range of 70–100% at the time of inclusion. Attendance across CCT sessions was 97%. Eight out of nine topics in the CCT-intervention received a rating above 3.5 on a 5-point scale (i.e. towards very helpful). The items that received the highest mean ratings were information about TBI and post-concussive symptoms, and strategies targeting fatigue, prospective memory, and memory and learning. All participants were rated as participating fully (3/6) or moderately (3/6), and most participants (5/6) attempted to apply the trained skills to real-life situations. Conclusions: The results support the feasibility of a Norwegian adaptation of the intervention for a civilian sample with TBI

Cost-effectiveness analysis of combined cognitive and vocational rehabilitation in patients with mild-to-moderate TBI: results from a randomized controlled trial

Background Traumatic brain injury (TBI) represents a financial burden to the healthcare system, patients, their families and society. Rehabilitation interventions with the potential for reducing costs associated with TBI are demanded. This study evaluated the cost-effectiveness of a randomized, controlled, parallel group trial that compared the effectiveness of a combined cognitive and vocational intervention to treatment as usual (TAU) on vocational outcomes. Methods One-hundred sixteen participants with mild-to-moderate TBI were recruited from an outpatient clinic at Oslo University Hospital, Norway. They were randomized to a cognitive rehabilitation intervention (Compensatory Cognitive Training, CCT) and Supported Employment (SE) or TAU in a 1:1 ratio. Costs of CCT-SE and TAU, healthcare services, informal care and productivity loss were assessed 3, 6 and 12 months after study inclusion. Cost-effectiveness was evaluated from the difference in number of days until return to pre-injury work levels between CCT-SE and TAU and quality-adjusted life years (QALYs) derived from the EQ-5D-5L across 12 months follow-up. Cost-utility was expressed in incremental cost-effectiveness ratio (ICER). Results The mean total costs of healthcare services was € 3,281 in the CCT-SE group and € 2,300 in TAU, informal care was € 2,761 in CCT-SE and € 3,591 in TAU, and productivity loss was € 30,738 in CCT-SE and € 33,401 in TAU. Costs related to productivity loss accounted for 84% of the total costs. From a healthcare perspective, the ICER was € 56 per day earlier back to work in the CCT-SE group. Given a threshold of € 27,500 per QALY gained, adjusting for baseline difference in EQ-5D-5L index values revealed a net monetary benefit (NMB) of € -561 (0.009*27,500–979) from the healthcare perspective, indicating higher incremental costs for the CCT-SE group. From the societal perspective, the NMB was € 1,566 (0.009*27,500-(-1,319)), indicating that the CCT-SE intervention was a cost-effective alternative to TAU. Conclusions Costs associated with productivity loss accounted for the majority of costs in both groups and were lower in the CCT-SE group. The CCT-SE intervention was a cost-effective alternative to TAU when considering the societal perspective, but not from a healthcare perspective. Trial registration ClinicalTrails.gov NCT03092713

Cognitive and vocational rehabilitation after mild-to-moderate traumatic brain injury: A randomised controlled trial

Background Returning to work is often a primary rehabilitation goal after traumatic brain injury (TBI). However, the evidence base for treatment options regarding return to work (RTW) and stable work maintenance remains scarce. Objective This study aimed to examine the effect of a combined cognitive and vocational intervention on work-related outcomes after mild-to-moderate TBI. Methods In this study, we compared 6 months of a combined compensatory cognitive training and supported employment (CCT-SE) intervention with 6 months of treatment as usual (TAU) in a randomised controlled trial to examine the effect on time to RTW, work percentage, hours worked per week and work stability. Eligible patients were those with mild-to-moderate TBI who were employed ≥ 50% at the time of injury, 18 to 60 years old and sick-listed ≥ 50% at 8 to 12 weeks after injury due to post-concussion symptoms, assessed by the Rivermead Post Concussion Symptoms Questionnaire. Both treatments were provided at the outpatient TBI department at Oslo University Hospital, and follow-ups were conducted at 3, 6 and 12 months after inclusion. Results We included 116 individuals, 60 randomised to CCT-SE and 56 to TAU. The groups did not differ in characteristics at the 12-month follow-up. Overall, a high proportion had returned to work at 12 months (CCT-SE, 90%; TAU, 84%, P = 0.40), and all except 3 were stably employed after the RTW. However, a significantly higher proportion of participants in the CCT-SE than TAU group had returned to stable employment at 3 months (81% vs. 60%, P = 0.02). Conclusion These results suggest that the CCT-SE intervention might help patients with mild-to-moderate TBI who are still sick-listed 8 to 12 weeks after injury in an earlier return to stable employment. However, the results should be replicated and a cost-benefit analysis performed before concluding

Cognitive and vocational rehabilitation after mild-to-moderate traumatic brain injury: A randomised controlled trial

Background: Returning to work is often a primary rehabilitation goal after traumatic brain injury (TBI). However, the evidence base for treatment options regarding return to work (RTW) and stable work maintenance remains scarce. Objective: This study aimed to examine the effect of a combined cognitive and vocational intervention on work-related outcomes after mild-to-moderate TBI. Methods: In this study, we compared 6 months of a combined compensatory cognitive training and supported employment (CCT-SE) intervention with 6 months of treatment as usual (TAU) in a randomised controlled trial to examine the effect on time to RTW, work percentage, hours worked per week and work stability. Eligible patients were those with mild-to-moderate TBI who were employed ≥ 50% at the time of injury, 18 to 60 years old and sick-listed ≥ 50% at 8 to 12 weeks after injury due to post-concussion symptoms, assessed by the Rivermead Post Concussion Symptoms Questionnaire. Both treatments were provided at the outpatient TBI department at Oslo University Hospital, and follow-ups were conducted at 3, 6 and 12 months after inclusion. Results: We included 116 individuals, 60 randomised to CCT-SE and 56 to TAU. The groups did not differ in characteristics at the 12-month follow-up. Overall, a high proportion had returned to work at 12 months (CCT-SE, 90%; TAU, 84%, P = 0.40), and all except 3 were stably employed after the RTW. However, a significantly higher proportion of participants in the CCT-SE than TAU group had returned to stable employment at 3 months (81% vs. 60%, P = 0.02). Conclusion: These results suggest that the CCT-SE intervention might help patients with mild-to-moderate TBI who are still sick-listed 8 to 12 weeks after injury in an earlier return to stable employment. However, the results should be replicated and a cost-benefit analysis performed before concluding

Combined cognitive and vocational interventions after mild to moderate traumatic brain injury: study protocol for a randomized controlled trial.

A considerable proportion of patients with mild to moderate traumatic brain injury (TBI) experience long-lasting somatic, cognitive, and emotional symptoms that may hamper their capacity to return to work (RTW). Although several studies have described medical, psychological, and work-related factors that predict RTW after TBI, well-controlled intervention studies regarding RTW are scarce. Furthermore, there has traditionally been weak collaboration among health-related rehabilitation services, the labor and welfare sector, and workplaces. This study protocol describes an innovative randomized controlled trial in which we will explore the effect of combining manualized cognitive rehabilitation (Compensatory Cognitive Training [CCT]) and supported employment (SE) on RTW and related outcomes for patients with mild to moderate TBI in real-life competitive work settings. The study will be carried out in the southeastern region of Norway and thereby be performed within the Norwegian welfare system. Patients aged 18–60 years with mild to moderate TBI who are employed in a minimum 50% position at the time of injury and sick-listed 50% or more for postconcussive symptoms 2 months postinjury will be included in the study. A comprehensive assessment of neurocognitive function, self-reported symptoms, emotional distress, coping style, and quality of life will be performed at baseline, immediately after CCT (3 months after inclusion), following the end of SE (6 months after inclusion), and 12 months following study inclusion. The primary outcome measures are the proportion of participants who have returned to work at 12-month follow-up and length of time until RTW, in addition to work stability as well as work productivity over the first year following the intervention. Secondary outcomes include changes in self-reported symptoms, emotional and cognitive function, and quality of life. Additionally, a qualitative RTW process evaluation focused on organizational challenges at the workplace will be performed. he proposed study will combine cognitive and vocational rehabilitation and explore the efficacy of increased cross-sectoral collaboration between specialized health care services and the labor and welfare system. If the intervention proves effective, the project will describe the cost-effectiveness and utility of the program and thereby provide important information for policy makers. In addition, knowledge about the RTW process for persons with TBI and their workplaces will be provided

Combined cognitive and vocational interventions after mild to moderate traumatic brain injury: study protocol for a randomized controlled trial

Abstract Background A considerable proportion of patients with mild to moderate traumatic brain injury (TBI) experience long-lasting somatic, cognitive, and emotional symptoms that may hamper their capacity to return to work (RTW). Although several studies have described medical, psychological, and work-related factors that predict RTW after TBI, well-controlled intervention studies regarding RTW are scarce. Furthermore, there has traditionally been weak collaboration among health-related rehabilitation services, the labor and welfare sector, and workplaces. Methods/design This study protocol describes an innovative randomized controlled trial in which we will explore the effect of combining manualized cognitive rehabilitation (Compensatory Cognitive Training [CCT]) and supported employment (SE) on RTW and related outcomes for patients with mild to moderate TBI in real-life competitive work settings. The study will be carried out in the southeastern region of Norway and thereby be performed within the Norwegian welfare system. Patients aged 18–60 years with mild to moderate TBI who are employed in a minimum 50% position at the time of injury and sick-listed 50% or more for postconcussive symptoms 2 months postinjury will be included in the study. A comprehensive assessment of neurocognitive function, self-reported symptoms, emotional distress, coping style, and quality of life will be performed at baseline, immediately after CCT (3 months after inclusion), following the end of SE (6 months after inclusion), and 12 months following study inclusion. The primary outcome measures are the proportion of participants who have returned to work at 12-month follow-up and length of time until RTW, in addition to work stability as well as work productivity over the first year following the intervention. Secondary outcomes include changes in self-reported symptoms, emotional and cognitive function, and quality of life. Additionally, a qualitative RTW process evaluation focused on organizational challenges at the workplace will be performed. Discussion The proposed study will combine cognitive and vocational rehabilitation and explore the efficacy of increased cross-sectoral collaboration between specialized health care services and the labor and welfare system. If the intervention proves effective, the project will describe the cost-effectiveness and utility of the program and thereby provide important information for policy makers. In addition, knowledge about the RTW process for persons with TBI and their workplaces will be provided. Trial registration ClinicalTrials.gov, NCT03092713 . Registered on 10 March 2017

Additional file 1: of Combined cognitive and vocational interventions after mild to moderate traumatic brain injury: study protocol for a randomized controlled trial

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