Cathy Linaker1,2, Simon Fraser3, Cathy Price4, Nick Maguire5, Paul Little6, Ira Madan7, Rafael Pinedo-Villanueva8, David Coggon1,2, Cyrus Cooper1,2, Georgia Ntani1,2, Karen Walker-Bone1,2. 1. MRC Versus Arthritis Centre for Musculoskeletal Health and Work, University of Southampton, Southampton General Hospital, Southampton, UK. 2. MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton, UK. 3. Academic Unit of Primary Care and Population Sciences, University of Southampton, Southampton General Hospital, Southampton, UK. 4. Solent NHS Trust, Southampton, UK. 5. Department of Psychology, University of Southampton, Southampton, UK. 6. Department of Primary Care and Population, Aldermoor Health Centre, Southampton, UK. 7. Guy's & St Thomas's NHS Foundation Trust, King's College London, Occupational Health Department, St Thomas' Hospital, London, UK. 8. Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.
Abstract
BACKGROUND: Chronic pain is a common cause of health-related incapacity for work among people in the UK. Individualised placement and support is a systematic approach to rehabilitation, with emphasis on early supported work placement. It is effective in helping people with severe mental illness to gain employment, but has not been tested for chronic pain. OBJECTIVE: To inform the design of a definitive randomised controlled trial to assess the clinical effectiveness of individualised placement and support for people unemployed because of chronic pain. METHODS: A mixed-methods feasibility study comprising qualitative interviews and focus groups with key stakeholders, alongside a pilot trial. STUDY PARTICIPANTS: Primary care-based health-care professionals, employment support workers, employers, clients who participated in an individualised placement and support programme, and individuals aged 18-64 years with chronic pain who were unemployed for at least 3 months. INTERVENTION: An individualised placement and support programme integrated with a personalised, responsive pain management plan, backed up by communication with a general practitioner and rapid access to community-based pain services. OUTCOMES: Outcomes included stakeholder views about a trial and methods of recruitment; the feasibility and acceptability of the individualised placement and support intervention; study processes (including methods to recruit participants from primary care, training and support needs of the employment support workers to integrate with pain services, acceptability of randomisation and the treatment-as-usual comparator); and scoping of outcome measures for a definitive trial. RESULTS: All stakeholders viewed a trial as feasible and important, and saw the relevance of employment interventions in this group. Using all suggested methods, recruitment was feasible through primary care, but it was slow and resource intensive. Recruitment through pain services was more efficient. Fifty people with chronic pain were recruited (37 from primary care and 13 from pain services). Randomisation was acceptable, and 22 participants were allocated to individualised placement and support, and 28 participants were allocated to treatment as usual. Treatment as usual was found acceptable. Retention of treatment-as-usual participants was acceptable throughout the 12 months. However, follow-up of individualised placement and support recipients using postal questionnaires proved challenging, especially when the participant started paid work, and new approaches would be needed for a trial. Clients, employment support workers, primary care-based health-care professionals and employers contributed to manualisation of the intervention. No adverse events were reported. CONCLUSION: Unless accurate and up-to-date employment status information can be collected in primary care health records, or linkage can be established with employment records, research such as this relating to employment will be impracticable in primary care. The trial may be possible through pain services; however, clients may differ. Retention of participants proved challenging and methods for achieving this would need to be developed. The intervention has been manualised. TRIAL REGISTRATION: Current Controlled Trials ISRCTN30094062. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 5. See the NIHR Journals Library website for further project information.
RCT Entities:
BACKGROUND:Chronic pain is a common cause of health-related incapacity for work among people in the UK. Individualised placement and support is a systematic approach to rehabilitation, with emphasis on early supported work placement. It is effective in helping people with severe mental illness to gain employment, but has not been tested for chronic pain. OBJECTIVE: To inform the design of a definitive randomised controlled trial to assess the clinical effectiveness of individualised placement and support for people unemployed because of chronic pain. METHODS: A mixed-methods feasibility study comprising qualitative interviews and focus groups with key stakeholders, alongside a pilot trial. STUDY PARTICIPANTS: Primary care-based health-care professionals, employment support workers, employers, clients who participated in an individualised placement and support programme, and individuals aged 18-64 years with chronic pain who were unemployed for at least 3 months. INTERVENTION: An individualised placement and support programme integrated with a personalised, responsive pain management plan, backed up by communication with a general practitioner and rapid access to community-based pain services. OUTCOMES: Outcomes included stakeholder views about a trial and methods of recruitment; the feasibility and acceptability of the individualised placement and support intervention; study processes (including methods to recruit participants from primary care, training and support needs of the employment support workers to integrate with pain services, acceptability of randomisation and the treatment-as-usual comparator); and scoping of outcome measures for a definitive trial. RESULTS: All stakeholders viewed a trial as feasible and important, and saw the relevance of employment interventions in this group. Using all suggested methods, recruitment was feasible through primary care, but it was slow and resource intensive. Recruitment through pain services was more efficient. Fifty people with chronic pain were recruited (37 from primary care and 13 from pain services). Randomisation was acceptable, and 22 participants were allocated to individualised placement and support, and 28 participants were allocated to treatment as usual. Treatment as usual was found acceptable. Retention of treatment-as-usual participants was acceptable throughout the 12 months. However, follow-up of individualised placement and support recipients using postal questionnaires proved challenging, especially when the participant started paid work, and new approaches would be needed for a trial. Clients, employment support workers, primary care-based health-care professionals and employers contributed to manualisation of the intervention. No adverse events were reported. CONCLUSION: Unless accurate and up-to-date employment status information can be collected in primary care health records, or linkage can be established with employment records, research such as this relating to employment will be impracticable in primary care. The trial may be possible through pain services; however, clients may differ. Retention of participants proved challenging and methods for achieving this would need to be developed. The intervention has been manualised. TRIAL REGISTRATION: Current Controlled Trials ISRCTN30094062. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 5. See the NIHR Journals Library website for further project information.
Entities:
Keywords:
CHRONIC PAIN; EMPLOYMENT; FEASIBILITY STUDIES; FOCUS GROUPS; FOLLOW-UP STUDIES; OUTCOME ASSESSMENT; PAIN MANAGEMENT; PILOT STUDIES; PRIMARY HEALTH CARE; QUALITY OF LIFE; REHABILITATION; REHABILITATION/VOCATIONAL; RETURN TO WORK; UNEMPLOYMENT; VOCATIONAL