Protocol for a pilot cluster randomised controlled trial of a multicomponent sustainable return to work IGLOo intervention
Abstract Background 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 s...
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| Format: | Article |
| Language: | English |
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BMC
2024-02-01
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| Series: | Pilot and Feasibility Studies |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s40814-023-01439-3 |
| _version_ | 1797275853192691712 |
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| author | Oliver Davis Jeremy Dawson Lizzie Degerdon Jaime Delgadillo Umesh Kadam Karina Nielsen Alice Sinclair Jo Yarker Fehmidah Munir |
| author_facet | Oliver Davis Jeremy Dawson Lizzie Degerdon Jaime Delgadillo Umesh Kadam Karina Nielsen Alice Sinclair Jo Yarker Fehmidah Munir |
| author_sort | Oliver Davis |
| collection | DOAJ |
| description | Abstract Background 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. Methods and design 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. Discussion 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. Trial registration ISRCTN11788559 (prospectively registered, date registered 6 October 2022) |
| first_indexed | 2024-03-07T15:19:58Z |
| format | Article |
| id | doaj.art-6cd68090f9da45b2aa723a310c038964 |
| institution | Directory Open Access Journal |
| issn | 2055-5784 |
| language | English |
| last_indexed | 2024-03-07T15:19:58Z |
| publishDate | 2024-02-01 |
| publisher | BMC |
| record_format | Article |
| series | Pilot and Feasibility Studies |
| spelling | doaj.art-6cd68090f9da45b2aa723a310c0389642024-03-05T17:43:07ZengBMCPilot and Feasibility Studies2055-57842024-02-0110111610.1186/s40814-023-01439-3Protocol for a pilot cluster randomised controlled trial of a multicomponent sustainable return to work IGLOo interventionOliver Davis0Jeremy Dawson1Lizzie Degerdon2Jaime Delgadillo3Umesh Kadam4Karina Nielsen5Alice Sinclair6Jo Yarker7Fehmidah Munir8Grounded Research Team, Rotherham Doncaster and South Humber NHS TrustSheffield University Management School, University of SheffieldGrounded Research Team, Rotherham Doncaster and South Humber NHS TrustGrounded Research Team, Rotherham Doncaster and South Humber NHS TrustDepartment of Health and Community Sciences, University of ExeterInstitute of Work Psychology, University of SheffieldSchool of Sport, Health and Exercise Science, Loughborough UniversityAffinity Health at WorkSchool of Sport, Health and Exercise Science, Loughborough UniversityAbstract Background 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. Methods and design 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. Discussion 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. Trial registration ISRCTN11788559 (prospectively registered, date registered 6 October 2022)https://doi.org/10.1186/s40814-023-01439-3Return-to-workLong-term sick leaveMental healthInterventionWorkplaceEmployee |
| spellingShingle | Oliver Davis Jeremy Dawson Lizzie Degerdon Jaime Delgadillo Umesh Kadam Karina Nielsen Alice Sinclair Jo Yarker Fehmidah Munir Protocol for a pilot cluster randomised controlled trial of a multicomponent sustainable return to work IGLOo intervention Pilot and Feasibility Studies Return-to-work Long-term sick leave Mental health Intervention Workplace Employee |
| title | Protocol for a pilot cluster randomised controlled trial of a multicomponent sustainable return to work IGLOo intervention |
| title_full | Protocol for a pilot cluster randomised controlled trial of a multicomponent sustainable return to work IGLOo intervention |
| title_fullStr | Protocol for a pilot cluster randomised controlled trial of a multicomponent sustainable return to work IGLOo intervention |
| title_full_unstemmed | Protocol for a pilot cluster randomised controlled trial of a multicomponent sustainable return to work IGLOo intervention |
| title_short | Protocol for a pilot cluster randomised controlled trial of a multicomponent sustainable return to work IGLOo intervention |
| title_sort | protocol for a pilot cluster randomised controlled trial of a multicomponent sustainable return to work igloo intervention |
| topic | Return-to-work Long-term sick leave Mental health Intervention Workplace Employee |
| url | https://doi.org/10.1186/s40814-023-01439-3 |
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