PDF(Pubmed)
Abstract：
BACKGROUND: Moderately severe or major trauma (injury severity score (ISS) > 8) is common, often resulting in physical and psychological problems and leading to difficulties in returning to work. Vocational rehabilitation (VR) can improve return to work/education in some injuries (e.g. traumatic brain and spinal cord injury), but evidence is lacking for other moderately severe or major trauma.
METHODS: ROWTATE is an individually randomised controlled multicentre pragmatic trial of early VR and psychological support in trauma patients. It includes an internal pilot, economic evaluation, a process evaluation and an implementation study. Participants will be screened for eligibility and recruited within 12 weeks of admission to eight major trauma centres in England. A total of 722 participants with ISS > 8 will be randomised 1:1 to VR and psychological support (where needed, following psychological screening) plus usual care or to usual care alone. The ROWTATE VR intervention will be provided within 2 weeks of study recruitment by occupational therapists and where needed, by clinical psychologists. It will be individually tailored and provided for ≤ 12 months, dependent on participant need. Baseline assessment will collect data on demographics, injury details, work/education status, cognitive impairment, anxiety, depression, post-traumatic distress, disability, recovery expectations, financial stress and health-related quality of life. Participants will be followed up by postal/telephone/online questionnaires at 3, 6 and 12 months post-randomisation. The primary objective is to establish whether the ROWTATE VR intervention plus usual care is more effective than usual care alone for improving participants\' self-reported return to work/education for at least 80% of pre-injury hours at 12 months post-randomisation. Secondary outcomes include other work outcomes (e.g. hours of work/education, time to return to work/education, sickness absence), depression, anxiety, post-traumatic distress, work self-efficacy, financial stress, purpose in life, health-related quality of life and healthcare/personal resource use. The process evaluation and implementation study will be described elsewhere.
CONCLUSIONS: This trial will provide robust evidence regarding a VR intervention for a major trauma population. Evidence of a clinically and cost-effective VR intervention will be important for commissioners and providers to enable adoption of VR services for this large and important group of patients within the NHS.
BACKGROUND: ISRCTN: 43115471. Registered 27/07/2021.
METHODS: ROWTATE is an individually randomised controlled multicentre pragmatic trial of early VR and psychological support in trauma patients. It includes an internal pilot, economic evaluation, a process evaluation and an implementation study. Participants will be screened for eligibility and recruited within 12 weeks of admission to eight major trauma centres in England. A total of 722 participants with ISS > 8 will be randomised 1:1 to VR and psychological support (where needed, following psychological screening) plus usual care or to usual care alone. The ROWTATE VR intervention will be provided within 2 weeks of study recruitment by occupational therapists and where needed, by clinical psychologists. It will be individually tailored and provided for ≤ 12 months, dependent on participant need. Baseline assessment will collect data on demographics, injury details, work/education status, cognitive impairment, anxiety, depression, post-traumatic distress, disability, recovery expectations, financial stress and health-related quality of life. Participants will be followed up by postal/telephone/online questionnaires at 3, 6 and 12 months post-randomisation. The primary objective is to establish whether the ROWTATE VR intervention plus usual care is more effective than usual care alone for improving participants\' self-reported return to work/education for at least 80% of pre-injury hours at 12 months post-randomisation. Secondary outcomes include other work outcomes (e.g. hours of work/education, time to return to work/education, sickness absence), depression, anxiety, post-traumatic distress, work self-efficacy, financial stress, purpose in life, health-related quality of life and healthcare/personal resource use. The process evaluation and implementation study will be described elsewhere.
CONCLUSIONS: This trial will provide robust evidence regarding a VR intervention for a major trauma population. Evidence of a clinically and cost-effective VR intervention will be important for commissioners and providers to enable adoption of VR services for this large and important group of patients within the NHS.
BACKGROUND: ISRCTN: 43115471. Registered 27/07/2021.
摘要：
背景：中度或重度创伤（损伤严重程度评分（ISS）>8）很常见，经常导致身体和心理问题，并导致重返工作岗位的困难。职业康复（VR）可以改善某些受伤（例如创伤性脑和脊髓损伤）的工作/教育回报，但是缺乏其他中度严重或严重创伤的证据。
方法：ROWTATE是一项针对创伤患者早期VR和心理支持的独立随机对照多中心实用试验。它包括一个内部飞行员，经济评价,过程评估和实施研究。参与者将接受资格筛选，并在英格兰八个主要创伤中心入院后12周内招募。共有722名ISS>8的参与者将以1：1的比例随机分配给VR和心理支持（如有需要，在心理筛查之后)加上常规护理或单独进行常规护理。ROWTATEVR干预将在职业治疗师招募后的2周内提供，并在需要时提供。临床心理学家。它将单独定制并提供≤12个月，取决于参与者的需要。基线评估将收集人口统计数据，伤害细节,工作/教育状况，认知障碍，焦虑,抑郁症,创伤后的痛苦,残疾,复苏预期，经济压力和健康相关生活质量。参与者将在随机化后3、6和12个月通过邮政/电话/在线问卷进行随访。主要目标是确定ROWTATEVR干预加常规护理是否比仅常规护理更有效，以改善参与者自我报告的至少80％的受伤前工作/教育时间在随机化后12个月。次要成果包括其他工作成果(例如，工作/教育时间，回到工作/教育的时间，疾病缺席)，抑郁症,焦虑,创伤后的痛苦,工作自我效能感,财务压力，人生的目的，与健康相关的生活质量和医疗保健/个人资源使用。过程评估和实施研究将在别处描述。
结论：该试验将为主要创伤人群的VR干预提供有力的证据。临床和具有成本效益的VR干预措施的证据对于专员和提供者来说非常重要，以便为NHS内这一庞大而重要的患者群体采用VR服务。
背景：ISRCTN：43115471。注册27/07/2021。
方法：ROWTATE是一项针对创伤患者早期VR和心理支持的独立随机对照多中心实用试验。它包括一个内部飞行员，经济评价,过程评估和实施研究。参与者将接受资格筛选，并在英格兰八个主要创伤中心入院后12周内招募。共有722名ISS>8的参与者将以1：1的比例随机分配给VR和心理支持（如有需要，在心理筛查之后)加上常规护理或单独进行常规护理。ROWTATEVR干预将在职业治疗师招募后的2周内提供，并在需要时提供。临床心理学家。它将单独定制并提供≤12个月，取决于参与者的需要。基线评估将收集人口统计数据，伤害细节,工作/教育状况，认知障碍，焦虑,抑郁症,创伤后的痛苦,残疾,复苏预期，经济压力和健康相关生活质量。参与者将在随机化后3、6和12个月通过邮政/电话/在线问卷进行随访。主要目标是确定ROWTATEVR干预加常规护理是否比仅常规护理更有效，以改善参与者自我报告的至少80％的受伤前工作/教育时间在随机化后12个月。次要成果包括其他工作成果(例如，工作/教育时间，回到工作/教育的时间，疾病缺席)，抑郁症,焦虑,创伤后的痛苦,工作自我效能感,财务压力，人生的目的，与健康相关的生活质量和医疗保健/个人资源使用。过程评估和实施研究将在别处描述。
结论：该试验将为主要创伤人群的VR干预提供有力的证据。临床和具有成本效益的VR干预措施的证据对于专员和提供者来说非常重要，以便为NHS内这一庞大而重要的患者群体采用VR服务。
背景：ISRCTN：43115471。注册27/07/2021。
