Condition category
Not Applicable
Date applied
24/03/2016
Date assigned
25/07/2016
Last edited
25/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Health and employment are linked, with good employment having a positive impact on health, and health having a significant impact on a patient’s ability to work. This is why the NHS is interested in the role it can play in supporting people back into employment. The aim of this study is is to test whether employment support based in primary care services (for example, GP surgeries) can help people who are out of work and with a long-term health condition or disabilities tor return to employment. This follows a well-established model of employment support called Individual Placement and Support. Individual Placement and Support has been shown to be very successful for people with severe mental health conditions. We wish to test if it is effective for a wider group of people with any long-term health condition or disability.

Who can participate?
People who live in Islington who are out of work and with a long-term condition

What does the study involve?
Participants are randomly allocated into two groups. Participants in the control group receive business-as-usual employment support from the NHS. This is signposting to sources of external advice and guidance. Participants in the treatment group receive one-to-one employment coaching from an employment specialist based within the GP practice. The support is ongoing and continues once the participant has returned to employment. The employment support is entirely voluntary and participants can opt-out at any time. We then follow the participants' progress towards employment, and any changes in their health, for a period of up to one year.

What are the possible benefits and risks of participating?
Possible benefits include improved health and employment chances. We do not anticipate any risks above what would be expected in daily life.

Where is the study run from?
Islington Clinical Commissioning Group (NHS)

When is the study starting and how long is it expected to run for?
June 2015 to December 2018

Who is funding the study?
1. NHS England (UK)
2. Islington Council (UK)

Who is the main contact?
Daniel Berry

Trial website

Contact information

Type

Public

Primary contact

Mr Daniel Berry

ORCID ID

Contact details

Strategy Group
NHS England
80 London Road
London
SE1 6LH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16/WM/0031

Study information

Scientific title

A randomised controlled trial to test the application of individual placement and support principles in primary and community care

Acronym

Study hypothesis

Does a particular type of employment support, called individual placement and support, help people to return to employment or improve their health?

Ethics approval

NHS Research Ethics Committee West Midlands (South Birmingham), 09/03/2016, REC ref: 16/WM/0031

Study design

Randomised controlled trial (individual level)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Common mental health conditions such as anxiety and depression; and common physical health conditions than may impact employment chances

Intervention

Patients randomly assigned to the control group will receive business as usual employment support from the NHS. This is signposting to sources of external advice and guidance.

Patients in the treatment group will receive one-to-one employment coaching from an employment specialist based within the GP practice. This follows a well-established model of employment support called Individual Placement and Support. The support is ongoing and continues once the person has returned to employment.

Intervention type

Other

Phase

Drug names

Primary outcome measures

The primary outcome measure is whether the person has returned to employment at 3, 6 and 12 months after starting the intervention. This will be collected by the patient reporting this to either the employment specialist (intervention group) or to a research assistant (control group).

Secondary outcome measures

Secondary outcome measures are to monitor changes to the patients health. These include three common questionnaires that measure: anxiety (GAD7), depression (PSQ9) and overall health status (EQ-5D). We will also measure indicators of being on the journey into employment, such as volunteering; and use of health services, such as attendances at GP surgeries. These will be collected 3, 6 and 12 months after the patient starts the intervention.

We will conduct subgroup analysis, for example of participants with higher levels of mental health difficulties, gender effects, and duration of unemployment.

Overall trial start date

01/06/2015

Overall trial end date

01/12/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participants will be required to be out of work
2. Participants will be required to have a long-term health condition or disability

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1000

Participant exclusion criteria

Patients who are already receiving employment support via another programme will not be enrolled onto this trial. These will be patients receiving support from services such as ‘Mental Health Working’, ‘Islington Aftercare’, ‘Work programme’, ‘Work Choice’, ‘Working Capital’ and ‘iWork’.

Recruitment start date

01/07/2016

Recruitment end date

31/12/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Islington Clinical Commissioning Group (NHS)
London
EC1V 7LQ

Sponsor information

Organisation

NHS England (UK)

Sponsor details

80 London Road
London
SE1 6LH
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

NHS England (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Islington Council (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We plan on publishing a policy report on our results in 2018 and a paper in a peer-reviewed journal.

Intention to publish date

01/12/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes