Test & Learn: Outreach services with a health specialism for people rough sleeping
| ISRCTN | ISRCTN11572394 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11572394 |
- Submission date
- 05/12/2024
- Registration date
- 13/12/2024
- Last edited
- 24/06/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
People experiencing homelessness, particularly those rough sleeping, have poorer health outcomes than people who are housed. This study focuses on nurses working with outreach teams to support people rough sleeping who are living on the streets. The study aims to find out if the support given by outreach teams with nurses helps more people settle into housing and improves health.
Who can participate?
16 local authority (LA) areas in England are participating in the study. Eight are delivering outreach with a health specialism (intervention) and eight are continuing with usual practice (control). LAs estimate they will collect routine data from 640 people living on the streets during the baseline data collection period at the start of the study.
What does the study involve?
LAs will collect routine data for people rough sleeping and living on the streets at baseline, three, and six months. Cardiff University will interview some staff and service users in six LA sites (four intervention and two control), aimed at understanding the lived experience of those delivering and receiving the service. Some sessions will be observed on the street, and the cost of the intervention will be calculated and weighed up against any benefits.
What are the possible benefits and risks of participating?
There are no direct benefits for taking part in the study. By analysing routine data and hearing about the experiences of professionals and service users, we hope to fully understand outreach work with a health specialism. Taking part in an optional interview does require some time. Some people find it helpful to think or talk about their experiences, but some may find this upsetting. We cannot pay people to take part in this study, but as a thank you for participating in the individual interview, service users in intervention and control sites will be offered a £20 high street shopping voucher.
Where is the study run from?
The study is being organised and led by researchers at Cardiff University. The Chief Investigator is Professor Peter Mackie, School of Geography and Planning, Cardiff University.
When is the study starting and how long is it expected to run for?
April 2024 to April 2026
Who is funding the study?
This work is funded by the Ministry of Housing, Communities and Local Government (MHCLG)* via the Centre for Homelessness Impact (CHI) as part of the Test & Learn and Systems-Wide Evaluation Programme, a £15m programme of work to improve the evidence-base and understanding of what works to end rough sleeping. This was part of the 2022 ‘Ending Rough Sleeping for Good Strategy’.
*formerly known as the Department for Levelling Up, Housing and Communities (DLUHC)
Who is the main contact?
Dr Linda Adara, (Trial Manager, Centre for Trials Research, Cardiff University) TestandLearn@cardiff.ac.uk
Contact information
Principal Investigator
Cardiff University, Glamorgan Building, Room 2.70, King Edward VII Avenue
Cardiff
CF10 3WA
United Kingdom
 ORCID ID |
0000-0003-1494-0864 |
|---|---|
| Phone | +44 29208 76223 |
| MackieP@cardiff.ac.uk |
Scientific
Cardiff University, 7th Floor Neuadd Meirionnydd, Heath Park
Cardiff
CF14 4YS
United Kingdom
| ORCID ID |
0000-0001-8371-8453 |
|---|---|
| Phone | +44 29206 87054 |
| WhiteJ11@cardiff.ac.uk |
Public
Cardiff University, 7th Floor Neuadd Meirionnydd, Heath Park
Cardiff
CF14 4YS
United Kingdom
| ORCID ID |
0000-0002-0015-3942 |
|---|---|
| Phone | +44 29208 70535 |
| AdaraL@cardiff.ac.uk |
Study information
| Study design | Multisite interventional optimisation and pilot cluster randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Built environment/local authority, Community |
| Study type | Quality of life, Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet. |
| Scientific title | Test & Learn: Outreach services with a health specialism for people rough sleeping - optimisation and pilot cluster randomised controlled trial |
| Study acronym | Test & Learn |
| Study objectives | Cardiff University is leading the evaluation of homelessness outreach with a health specialism intervention, which will be optimised and then evaluated through a pilot cluster randomised controlled trial. The intervention will embed nurses into the outreach service, working directly on the streets. This will remove barriers to access as individuals will not have to attend a healthcare centre. The intervention aims to increase engagement of people living on the streets with outreach services and improve housing situation and health status. To date little is known about this method of delivery and if it is effective. |
| Ethics approval(s) |
1. Approved 18/07/2024, School of Medicine Research Ethics Committee at Cardiff University (Main Building, Heath Park, Cardiff, CF14 4XN, United Kingdom; +44 (0)29 2087 4000; Medic_REC@cardiff.ac.uk), ref: 24/38 (Phase 1) 2. Approved 17/10/2024, School of Medicine Research Ethics Committee Cardiff University (Main Building, Heath Park, Cardiff, CF14 4XN, United Kingdom; +44 (0)29 2087 4000; Medic_REC@cardiff.ac.uk), ref: 24/38 (Phase 2) |
| Health condition(s) or problem(s) studied | Increase engagement of people living on the streets with outreach services to improve housing situation and health status. |
| Intervention | Street outreach service with a nurse health specialism intervention for people rough sleeping. Nurses meet service users where they are rough sleeping which increases contact, they have a respected identity as health professionals that service users may trust to support them. This trust can be enhanced by nurses having professional knowledge to identify and deliver the correct service provision and the expertise and professional standing to secure service access. Nurses’ identification of health care needs can also ensure access to appropriate housing, as health care needs can result in an accommodation entitlement. Standard and bespoke training is a key component of the intervention. Standard nurse training modules (e.g. treating substance use) will be made available to outreach nurses through Change Grow Live (intervention delivery partner). This is a bespoke training package with a focus on supporting people who are rough sleeping and will be delivered by an expert professional. Training will include didactic learning and scenario-based interaction which has been informed by people with lived experience. There are four key intervention components: 1. Outreach nurse training: Includes standard and bespoke training. 2. Outreach with specialism shifts: Outreach nurses accompany outreach teams to deliver healthcare on the street and arrange access to healthcare and housing. 3. Outreach nurse supervision and quality assurance: Clinical supervision of nurses by a Lead Nurse. 4. Service follow-up and Multi-Disciplinary Team (MDT) meetings: Arrangement of follow-up healthcare and housing services after outreach sessions. Attendance at MDT meetings to advocate for the service user. An intervention programme theory will be a key output of the optimisation phase, developed through consultation of the extant literature on outreach services with a health specialism for people rough sleeping, stakeholder workshops, and individual stakeholder interviews. Eight Local Authority areas will deliver the outreach service with a nurse health specialism intervention for people rough sleeping and eight LAs will continue with their usual street outreach practice without a nurse (control). There can be significant heterogeneity across street outreach services. Details of outreach delivery in comparator sites will be assessed through the process evaluation. The intervention will run for 17 months, and routine data will be captured at baseline, 3 and 6 months follow-up in both intervention and control sites. Block randomisation of varying sizes will be used, stratified by the Rough Sleeping Initiative (RSI) funding allocation 2022-2025, per individual rough sleeping (£) of the 16 eligible LAs. Strata are created based on the median RSI funding allocation of the 16 LAs. A random allocation sequence will be generated in blocks using the ralloc program in Stata 17. |
| Intervention type | Mixed |
| Primary outcome measure | Housing situation measured using the housing outcomes listed in the centre for Homelessness Impact (CHI)-adapted version of the Residential Time-Line Follow-Back (RTLFB) inventory at baseline, 3 and 6 months |
| Secondary outcome measures | Health status measured using the EQ-5D-5L measure of health status and health service interactions at baseline, 3 and 6 months |
| Overall study start date | 01/04/2024 |
| Completion date | 30/04/2026 |
Eligibility
| Participant type(s) | Health professional, Service user, Other |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 16 clusters (Local Authorities). Target number of service users eligible for routine data capture: 640 (estimated 40 per cluster). Target number of interview participants: 40. |
| Key inclusion criteria | Local Authority Inclusion: 1. Have sufficient numbers of people rough sleeping to potentially receive health outreach support (expect around 40 people rough sleeping to come through the service during the baseline period). 2. Have an outreach team. 3. Be within reasonable distance (defined by the Centre for Homelessness Impact (CHI)) to a CGL clinical service (to act as a clinical base to host the nurse). 4. Willingness to be involved and support data collection procedures. Routine Data Inclusion: 1. People living on the streets (defined as seen sleeping on the streets on at least 6 separate occasions over a period of up to 6-months) and included within CGL or Local Authority routine rough sleeping data collections. Interview Data Inclusion: Service Users 1. People living on the streets (defined as seen sleeping on the streets on at least 6 separate occasions over a period of up to 6-months). 2. Sufficient level of conversational English. Stakeholders and Professional Staff 1. Local Authority/Organisation with experience in designing or delivering outreach services with a health specialism to people rough sleeping. 2. Stakeholder, clinician, or professional staff. 3. Outreach team workers and nurse practitioners that have or will receive the Test and Learn with health specialism bespoke training package. 4. Outreach team workers and nurse practitioners delivering the outreach with a health specialism service in selected LAs. 5. Outreach team workers delivering usual practice in selected LAs. Local Authority Representative* ( *site withdrawals only) 1. LA site withdrawal confirmed in writing/notified via CHI. 2. LA site project lead or nominated staff representative. |
| Key exclusion criteria | Local Authority Exclusion: 1. Local Authority areas which already have an embedded health specialist who does shifts with the local outreach team. Routine Data Exclusion: 1. People rough sleeping who are not living on the streets and not included in LA or CGL routine data collections. Interview Data Exclusion: Service Users 1. People rough sleeping, not eligible to be included in routine data capture for the cRCT. 2. Incapable of giving informed consent. Stakeholders and Professional Staff 1. Based outside the UK. 2. Intervention staff that have not received the Test and Learn with health specialism bespoke training package (e.g. agency cover). 3. Agency cover staff. Local Authority Representative* ( *site withdrawals only) 1. LA staff/representative with no understanding or sufficient knowledge of reasons for withdrawal. |
| Date of first enrolment | 20/01/2025 |
| Date of final enrolment | 30/04/2026 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom
Sponsor information
University/education
Research and Innovation Services
McKenzie House, 7th Floor
30-36 Newport Road
Cardiff
CF24 9DE
Wales
United Kingdom
| Phone | +44 (0)2920875834 |
|---|---|
| resgov@cardiff.ac.uk | |
| Website | https://www.cardiff.ac.uk |
"ROR" |
https://ror.org/03kk7td41 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/03/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Open access Government report available online. Planned publication in a peer reviewed journal. |
| IPD sharing plan | The Ministry of Housing, Communities and Local Government (MHCLG) assumes the role of the data controller and holds the responsibility for determining the purpose and means of processing personal data within the scope of the cRCT. At the end of the evaluation, Cardiff University will securely transfer all data to the data controller. CLG will securely transfer the master dataset with key identifiers to the data controller. Once transferred, the data controller may keep data securely stored for up to five years after the completion of the study, after which this will be further reviewed. Data will be stored, processed and archived as per the MHCLG charter Personal Information charter - Ministry of Housing, Communities and Local Government - GOV.UK (www.gov.uk) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol (other) | V1.0 | 16/12/2024 | 04/04/2025 | No | No |
| Study website | 04/04/2025 | No | No | ||
| Protocol file | version 2.0 | 28/05/2025 | 24/06/2025 | No | No |
Additional files
Editorial Notes
24/06/2025: The following changes were made:
1. The overall study end date was changed from 31/01/2026 to 30/04/2026.
2. The recruitment end date was changed from 31/01/2026 to 30/04/2026.
3. The intention to publish date was changed from 31/12/2026 to 31/03/2027.
4. Protocol version 2.0 was added.
04/04/2025: Protocol and study website added.
06/12/2024: Study's existence confirmed by the School of Medicine Research Ethics Committee at Cardiff University.
