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West Midlands Combined Authority health-led trial

West Midlands Combined Authority health-led trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17267942
Enrollment
5300
Registered
2019-10-28
Start date
2018-05-08
Completion date
Unknown
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health and employment support Not Applicable

Interventions

Sponsors

Department for Work and Pensions
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Registered with a GP practice in one of the following health geographies at the point of the initial meeting: Wolverhampton; Dudley; South and Central Birmingham; Sandwell and West. If a trial participant moves out of the area they will continue to receive the service, if feasible. If not feasible, they will be considered to have dropped out 2. 18 years or older 3. Have a self-defined health condition or disability which presents obstacles to them gaining work 4. Has been out of work for 4 or more weeks and have expressed an interest in finding paid employment Issues around informed consent and capacity are of course key gateways into the WM IPS service trial, but these are not part of the inclusion criteria, which are primarily aimed at referring professionals. Informed consent and capacity are essential, but are assessed by the Employment Specialist at the first meeting, if the individual meets other inclusion criteria. It was decided that the following would not feature as part of the inclusion criteria: having sufficient command of English to take part in the procedure (because this could possibly be discriminatory and a small proportion of those referred may have limited levels of English, given the local demographic); physically capable of undertaking the study procedures (the ‘spirit’ of IPS is not to discriminate or base assessment on any factors other than the individual’s perception of their own capability); likely to be available for the planned duration of the study (the WM IPS service would like to keep the criteria simple, this could be hard for a referring clinician to assess).

Exclusion criteria

Exclusion criteria: 1. Not registered with a GP in one of the outlined areas 2. Less than 18 years’ old 3. Not capable of undertaking/attending for the study procedures due to any long-standing condition (e.g. moderate to severe learning disability or presenting with late stage dementia) 4. People who are not out of work 5. People who have been out of work for less than 4 weeks 6. People in work but job in jeopardy (e.g. long-term sick leave) 7. People who have a job offer 8. People who are currently on a state-funded employment programme (apart from Job Centre Plus or programmes where employment is not the primary focus) or relevant research programme With regards to the exclusion criteria, consideration has been given as to whether individuals with a progressive condition (such as cancer, degenerative neurological disease etc.) or those with a condition likely to improve rapidly (e.g. currently temporarily impaired after successful treatment) should be included or excluded. It was decided not to include these factors in the inclusion/ exclusion criteria. In relation to the former, with medical treatment people with these conditions can make functional gains and may wish to return to work - and would need support to do so. In relation to the latter, the criteria for inclusion specifies long-term health conditions or disabilities, and it is unlikely that this criteria would be interpreted by a health professional as a brief stint of ill health.

Design outcomes

Primary

MeasureTime frame
Updated 31/03/2020: These are the primary outcome measures noted in the statistical analysis plan and thus are dated 20/12/2019: There are three primary outcomes at the interim report stage and four primary outcomes at the final report stage. The SAP gives a decision rule that will be used to define primary outcomes in the case of substantial treatment-control imbalance in the survey response rates. Interim report: 1. Employment: employed 4 months after randomisation 2. Health assessed using EQ-5D-5L scale on mobility, self-care, usual activities, pain/discomfort and anxiety/depression, at 4 months after randomisation 3. Well-being assessed using Short Warwick-Edinburgh Mental Well-being Scale (SWEMWB) at 4 months after randomisation Final report: 1. Sustained employment: 13 weeks or more in employment during the 12 months since randomisation 2. Earnings: total earnings in the 12 months since randomisation 3. Health assessed using EQ-5D-5L scale on mobility, self-care, usual activities, pain/discomfort and anxiety/depression, at 12 months after randomisation 4. Well-being assessed using Short Warwick-Edinburgh Mental Well-being Scale (SWEMWB) at 12 months after randomisation Previous primary outcome measures as of 18/11/2019: 1. Employment: employed 4 months after randomisation (interim report); 13 weeks or more employment 12 months after randomisation (final report) 2. Health assessed using EQ-5D-5L scale on mobility, self-care, usual activities, pain/discomfort and anxiety/depression, at 4 months and 12 months after randomisation 3. Well-being assessed using Short Warwick-Edinburgh Mental Well-being Scale (SWEMWB), 4 and 12 months after randomisation Previous primary outcome measures: 1. Employment: proportion spending 13 weeks or more in competitive employment at baseline, at +4 months after baseline, and at +12 months after baseline, at 31/07/2021 2. Health assessed using EQ-5D-5L scale on mobility, self-care, usual activities, pain/discomfort and anxiety/dep

Secondary

MeasureTime frame
Updated 31/03/2020: These are the secondary outcome measures noted in the statistical analysis plan and thus are dated 20/12/2019: Employment: 1. Percentage employed in each month since randomisation, measured using HMRC data on the start and end dates of employment spells, observed in each of the 12 months following randomisation 2. Number of months employed since randomisation, measured using HMRC data on the start and end dates of employment spells, observed over a period of 12 months following randomisation 3. Earnings by month since randomisation, measured using HMRC data on gross pay from employment and the start and end dates of employment spells, observed in each of the 12 months following randomisation 4. Total earnings since randomisation, measured using HMRC data on gross pay from employment, observed over a period of 12 months following randomisation 5. Receiving out of work benefits by month since randomisation, measured using DWP data on the start and end dates of benefit spells, observed in each of the 12 months following randomisation 6. Number of months receiving out of work benefits since randomisation, measured using DWP data on the start and end dates of benefit spells, observed over a period of 12 months following randomisation 7. Amount received in benefits by month over the 12 months following randomisation 8. Employed and receiving benefits by month over the 12 months following randomisation 9. Percentage employed or self-employed (any hours), measured using survey question on current employment status, observed 4 and 12 months after randomisation 10. Percentage employed or self-employed for 16 or more hours a week, measured using survey question on current employment status, observed 4 and 12 months after randomisation 11. Number of weeks in paid work (any hours) in the four or 12 months since randomisation, measured using survey question on number of weeks in paid work for those currently working, observed 4 and 12 months after randomisati

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026