Supported employment in primary and community care: a randomised controlled trial

ISRCTN	ISRCTN92404527
DOI	https://doi.org/10.1186/ISRCTN92404527
Secondary identifying numbers	16/WM/0031

Submission date: 24/03/2016
Registration date: 25/07/2016
Last edited: 01/11/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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 and Haringey 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?
1. Islington Clinical Commissioning Group (UK)
2. Bounds Green Group Practice (UK)
3. Somerset Gardens (UK)

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

Contact information

Mr Daniel Berry
Public

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

Study information

Study design	Randomised controlled trial (individual level)
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	A randomised controlled trial to test the application of individual placement and support principles in primary and community care
Study objectives	Does a particular type of employment support, called individual placement and support, help people to return to employment or improve their health?
Ethics approval(s)	NHS Research Ethics Committee West Midlands (South Birmingham), 09/03/2016, REC ref: 16/WM/0031
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/06/2015
Completion date	31/12/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	1000
Key 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
Key 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’.
Date of first enrolment	01/07/2016
Date of final enrolment	30/06/2018

Locations

Countries of recruitment

England
United Kingdom

Study participating centres

Islington Clinical Commissioning Group (NHS)

London
EC1V 7LQ
United Kingdom

Bounds Green Group Practice

Gordon Road
Southgate
London
N11 2PF
United Kingdom

Somerset Gardens

4 Creighton Road
Tottenham
London
N17 8NW
United Kingdom

Sponsor information

NHS England (UK)
Government

80 London Road
London
SE1 6LH
United Kingdom

"ROR"	https://ror.org/02wnqcb97

Funders

Funder type

Government

NHS England (UK)

No information available

Islington Council (UK)

No information available

Results and Publications

Intention to publish date	01/12/2018
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	We plan on publishing a policy report on our results in 2018 and a paper in a peer-reviewed journal.
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No

Editorial Notes

01/11/2019: Internal review.
27/03/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2017 to 30/06/2018.
2. The overall trial end date was changed from 01/12/2018 to 31/12/2018.
3. Bounds Green Group Practice and Somerset Gardens were added to the trial participating centres.