Mild to moderate mental health and/or physical health conditions Not Applicable
Conditions
Interventions
(iv) surveys of trial participants carried out in the course of the evaluation. The evaluation will use these data to reach assessments of the impact, benefits and costs of the
trial.
An RCT method w
Sponsors
Department for Work and Pensions
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Individuals giving informed consent to participate in the trial and share data for the evaluation 2. 18 years or older 3. Registered with a GP practice in one of the following areas: Barnsley; Bassetlaw; Doncaster; Rotherham; Sheffield (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) 4. Wants to participate in voluntary support to sustain paid work 5. May or may not be in receipt of DWP benefits and with a self-defined low/moderate mental health and/or physical health condition which is an obstacle to them finding or keeping work 6. Individuals in work but off sick or struggling in the workplace due to a self-defined low/moderate mental health and/or physical health condition 7. Individuals not currently receiving employment support other than from JobCentre Plus 8. Not on a Care Programme Approach, receiving Community Mental Health Team (CMHT) support or identified on a Serious Mental Illness (SMI) register 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 (in order to keep the criteria simple, this could be hard for a referring clinician to assess).
Exclusion criteria
Exclusion criteria: 1. Not giving informed consent to participate into the trial 2. Less than 18 years’ old 3. Not registered with a GP in one of the outlined areas 4. Does not want to participate in voluntary support to sustain paid work 5. People who are out of work but do not have a self-defined low/moderate mental health and/or physical health condition which is an obstacle to them finding or keeping work 6. Individuals in work but not off sick or struggling in the workplace due to a self-defined low/moderate mental health and/or physical health condition 7. Individuals currently receiving employment support other than JobCentre Plus 8. Individuals in the control group of the IPS Trial 9. On a Care Programme Approach, receiving Community Mental Health Team (CMHT) support or identified on a Serious Mental Illness (SMI) register 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.). The researchers decided not to include this as such individuals would not be likely to meet the inclusion criteria (the problem causing a person to be out of work, off sick or struggling at work must be a mild or moderate condition), but this would be assessed case-by-case and people with such conditions are not automatically excluded. Individuals taking part in another similar employment trial at the point of referral would not be eligible to continue to randomisation. This will be determined by a question to the service user at the initial meetings. Service users will be encouraged to let their Employment Specialist know if they are offered other similar interventions.
Design outcomes
Primary
| Measure | Time 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 Current primary outcome measures: 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 | — |
Secondary
| Measure | Time 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