Title: Manualising Individualised Placement Support for people with unemployment due to chronic pain and testing the feasibility of a randomised controlled trial
Funder: Department of Health and Social Care

Abstract: Before a definitive RCT of Individual Placement Support (IPS), we have a number of research questions that must be addressed around recruitment, the intervention, the comparator and the outcome measures, as well as needing to test the feasibility of delivery of IPS in the NHS. We propose that these questions can be addressed though qualitative and quantitative work in 6 iterative work packages (WPs): WP I: Qualitative work with a sample of patients who have experienced the City Deals IPS to explore assessment of motivation to enrol, outcomes most important to patients, and beliefs which may be barriers to change. WP2: Qualitative work with City vocational advisers (VAs) to understand their experiences of IPS, their knowledge of and attitudes to chronic pain and their training needs to implement IPS in practice. WP3: Focus groups with primary care teams to develop recruitment strategies and inform outcome measures and to assist with developing patient materials for WP4. WP4: A primary-care based longitudinal study involving the development of the RCT protocol in a sample of 80 patients. We will aim to recruit participants from primary care. A sample of GPs in Portsmouth and the Wessex Primary Care research network have agreed to use our proposed two-part search strategy to assess identification of appropriate patients in sufficient number. We will test the procedures for consent and randomisation in the sample of 80, “randomising” 40 to each arm (by pre-arranged algorithm known only to the researchers). All 80 will complete a baseline interview. ‘Cases’ will have assessment by the VAs and by a pain clinician to establish a pain management plan. The pain plan will be dynamic and responsive, can be reviewed at any time and can be supplemented by rapid access to the pain management clinic. Specialist pain psychology supervision will also be provided where pain is acting as a barrier to moving forwards with employment. The VAs will work with the 40 patients as per the City deals programme. Among participants, we will measure adherence to protocol and rates of drop-out. Questionnaires will be distributed and collected back, not to evaluate the main outcomes of the RCT but rather to assess whether people can and do complete the questionnaires as intended. The distribution of the outcome measures (employment, health-related and economic) will be assessed to inform a future power calculation. The 40 ‘control’ subjects will be surveyed and a sample interviewed to assess acceptability of randomisation and uptake of the ‘control’ booklet. WP5: Qualitative research with a sample of WP4 participants, their healthcare providers, and VAs to evaluate the study and lessons learned. WP6: manualise the integrated IPS /chronic pain and review fidelity principles if required, last refinement of study protocol and SOPs and data collection tools based on feedback from Phase V. We have allowed 6 months to set up WP4, including obtaining approvals. Once setup, we will complete WP4 over 18 months. WPs 1-3 will be initiated during the first 6 months. WPs 5 and 6 will take an additional 6 months timed towards the end of WP4 so that we can obtain maximum insight(total 27 months). Study team: Our team is multidisciplinary and includes expertise in chronic pain management, City Deals, epidemiology, occupational medicine, research methodology, primary care, public health, health economics, qualitative psychological research and employment locally.

Lay abstract: Chronic pain is pain that persists over months or years and fails to respond to usual pain care. It has many causes but is often musculoskeletal (e.g. back pain). Chronic pain negatively impacts on daily activities, relationships, mood, sleep, overall health and employment. In general, work is good for people: as well as financial wellbeing, it enhances self-worth and confidence and gives status and purpose in society. Unemployment is associated with poorer health and the children of workless adults in turn have poorer health and higher risk of long-term unemployment. Individualised Placement Support (IPS) has been shown to enhance employability of people with severe mental health conditions (such as schizophrenia). Trained vocational advisers (VAs) provide support to patients in finding and retaining a job using motivational interviewing techniques, problem-solving, identification of the skills and capabilities of the individual and using knowledge of local employers and workplaces. Support can be supplemented with skills training such as CV workshops or counselling to overcome low self-esteem. Vocational support is combined with healthcare. This research is to explore whether IPS could benefit people with chronic pain who have many problems similar to those with severe mental illness. Eventually, we would like to undertake a randomised controlled trial (comparing IPS with ‘usual care’) but before we can do so, there are gaps in our knowledge: 1) Can IPS transfer to people with chronic pain and what changes are needed to make it work? 2) If work is as important as we think for people’s health, can we justify using NHS resources to pay for IPS for its health benefits (rather than society’s costs). This application seeks funding to do the groundwork before a definitive trial. We plan to interview people who have recently completed IPS to understand what patients think the benefits are of IPS so that we can be certain to measure them. We will also interview VAs to identify what additional training they might need to provide IPS to pain patients and how to best integrate them with pain services. Through focus groups with GPs we will understand what ‘usual care’ is for unemployed people with chronic pain. From this qualitative work, and working with our patient and public engagement group, we will develop IPS for chronic pain patients and obtain permissions to carry out a small-scale dummy trial (n=80). In this trial we will randomise patients to IPS supported by community pain services. We will explore if we can identify and recruit patients through GP practices in sufficient number, whether they will stay in a trial and complete questionnaires for 12 months, and how they feel about being randomised particularly if they do not get the ‘active’ IPS. We propose to give ‘control’ patients a booklet which signposts them to employment and healthcare services but they will not get the support of the VAs integrated with the pain team. After the ‘dummy’ trial, we will interview a sample of the patients, the VAs and the GPs to evaluate their experiences and further develop our ideas about a possible full trial, what the standardised operating procedures and data collection tools should be, and what data should be collected that is important to patients as well as healthcare staff and will also allow us to find out if IPS is both effective and a cost-effective use of NHS resources for chronic pain patients.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: GENERIC HEALTH RELEVANCE