Davis Oliver, Dawson Jeremy, Degerdon Lizzie, Delgadillo Jaime, Kadam Umesh, Nielsen Karina, Sinclair Alice, Yarker Jo, Munir Fehmidah
Grounded Research Team, Rotherham Doncaster and South Humber NHS Trust, Doncaster, UK.
Sheffield University Management School, University of Sheffield, Sheffield, UK.
Pilot Feasibility Stud. 2024 Feb 3;10(1):23. doi: 10.1186/s40814-023-01439-3.
Long-term sickness costs businesses in the United Kingdom (UK) approximately £7 billion per annum. Most long-term sickness absences are attributed to common mental health conditions, which are also highly prevalent in people with acute or musculoskeletal health conditions. This study will pilot the IGLOo (Individual, Group, Leaders, Organisation, overarching context) intervention which aims to support workers in returning to and remaining in work following long-term sickness absence. The potential impact of the intervention is a timely return to work (main trial primary outcome) and prevention of a further episode of long-term sick leave. The intervention will be piloted in a randomised controlled trial (RCT) to examine the feasibility of the intervention (pilot trial primary outcome) and to inform a fully powered definitive trial to evaluate sustainable return to work (RTW) in people with primary or secondary mental ill-health who go on long-term sick leave.
A two-arm feasibility randomised controlled trial (with a 30-month study period including 12-month follow-up) of the IGLOo intervention will be conducted in large organisations (≥ 600 workers) from the Yorkshire and Humberside regions, in the UK. Eight consenting organisations will be recruited and randomised to the intervention or control arms of the study (1:1 ratio), with a minimum recruitment target of 13 workers eligible to participate from each. Organisations assigned to the control group will continue with their usual practice. Feasibility data will include data collected on recruitment, retention and attrition of participants; completion of research outcome measures; and intervention compliance. Measurements of mental health, RTW, work outcomes, quality-of-life, workplace support and communication and other demographic data will be taken at baseline, 3, 6, 9 and 12 months in all participants. Qualitative interviews and survey data with all participants will explore the experiences of participants, acceptability of the intervention components and evaluation measures. Exploratory economic evaluation will be conducted to further inform a definitive trial.
The findings from this pilot study will help to inform the development of a definitive cluster RCT designed to examine the efficacy of this intervention on health and work-related outcomes in UK workers on long-term sick leave.
ISRCTN11788559 (prospectively registered, date registered 6 October 2022).
长期病假给英国企业每年造成约70亿英镑的损失。大多数长期病假都归因于常见的心理健康问题，这些问题在患有急性或肌肉骨骼健康问题的人群中也非常普遍。本研究将试点IGLOo（个人、团体、领导者、组织、总体背景）干预措施，旨在支持长期病假后的员工重返工作岗位并继续工作。该干预措施的潜在影响是及时重返工作岗位（主要试验的主要结果）以及预防再次出现长期病假情况。该干预措施将在一项随机对照试验（RCT）中进行试点，以检验干预措施的可行性（试点试验的主要结果），并为一项充分有力的确定性试验提供信息，以评估患有原发性或继发性精神疾病且长期病假的人员可持续重返工作岗位（RTW）的情况。
将在英国约克郡和亨伯赛德地区的大型组织（≥600名员工）中进行一项双臂可行性随机对照试验（研究期为30个月，包括12个月的随访），对IGLOo干预措施进行研究。将招募8个同意参与的组织，并将其随机分配到研究的干预组或对照组（比例为1:1），每个组的最低招募目标是13名符合条件的员工。分配到对照组的组织将继续其常规做法。可行性数据将包括收集到的关于参与者招募、留存和流失的数据；研究结果测量的完成情况；以及干预措施的依从性。将在所有参与者的基线、3个月、6个月、9个月和12个月时对心理健康、RTW、工作成果、生活质量、工作场所支持与沟通以及其他人口统计学数据进行测量。将对所有参与者进行定性访谈和调查数据收集，以探索参与者的经历、干预措施组成部分的可接受性以及评估措施。将进行探索性经济评估，以进一步为确定性试验提供信息。
这项试点研究的结果将有助于为一项确定性整群随机对照试验的开展提供信息，该试验旨在检验这种干预措施对英国长期病假员工的健康和与工作相关的结果的疗效。
ISRCTN11788559（前瞻性注册，注册日期为2022年10月6日）。
