LEGS Cluster Randomized Trial: Liaison with Education and General Practices to Detect and Refine Referrals of People with At-Risk-Mental-States (ARMS)
| ISRCTN | ISRCTN70185866 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70185866 |
| Protocol serial number | 7036 |
| Sponsor | Cambridgeshire and Peterborough NHS Foundation Trust (UK) |
| Funder | National Institute for Health Research (NIHR) (UK) |
- Submission date
- 28/05/2010
- Registration date
- 28/05/2010
- Last edited
- 25/08/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Peter Jones
Scientific
Scientific
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
| pbj21@cam.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised interventional diagnosis, prevention and treatment trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | LEGS Cluster Randomized Trial: Liaison with Education and General Practices to Detect and Refine Referrals of People with At-Risk-Mental-States (ARMS) |
| Study acronym | LEGS Trial: Liaison with PCPs and HEIs to Refine Referrals of ARMS |
| Study objectives | In order to do really early intervention in psychosis we need to find people early, those with At-Risk-Mental-States (ARMS) of developing such illness. International efforts to decrease the stigma of psychosis and solicit self- and other referrals have exploited print and television media for public information campaigns, as well as educating members of relevant occupational groups. The Norwegian 'TIPS' projects and the Australian ORYGEN/PACE are exemplars regarding ARMS detection; neither of them was a randomised design for ARMS, nor did they use propensity or other appropriate methods to compare areas with and without the intervention. TIPS has no economic evaluation but is certainly very expensive. There was evidence that existing cases of psychosis (with long duration of untreated psychosis) were found, but it was less clear what worked in terms of finding ARMS. Influential work in Denmark and Australia has also taken this approach. |
| Ethics approval(s) | MREC approved (ref: 09/H0304/46) |
| Health condition(s) or problem(s) studied | Topic: Mental Health Research Network, Primary Care Research Network for England; Subtopic: Schizophrenia, Not Assigned, Psychosis, Service Delivery; Disease: Schizophrenia, Psychosis, All Diseases |
| Intervention | We are going to test whether a simple 'postal' campaign coordinated from an office is more effective and cost-effective than a more elaborate system of personal liaison by a health professional with the Primary Care Practices [PCPs] and the Higher Education Institutions [HEIs], as has been deployed in the international work cited above: a low versus high intensity strategy. Study entry: single randomisation only |
| Intervention type | Other |
| Primary outcome measure(s) |
Yield in terms of ARMS referrals |
| Key secondary outcome measure(s) |
Comparison of referral rates |
| Completion date | 06/05/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 90 |
| Key inclusion criteria | Liaison phase: 1. PCPs and HEIs in Cambridgeshire and Peterborough areas 2. Signed agreement form from PCPs Partners and HEIs Follow-up phase (at-risk-mental-states' data collection): 3. Patients confirmed as at-risk-mental-states for psychosis after being previously identified by PCPs and/or HEIs 4. Informed consent signed for data collection All: 5. Male and female, aged 16 years or older |
| Key exclusion criteria | Lack of mental capacity to provide informed consent |
| Date of first enrolment | 22/12/2009 |
| Date of final enrolment | 06/05/2013 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Addenbrooke's Hospital
Cambridge
CB2 0QQ
United Kingdom
CB2 0QQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2015 | Yes | No | |
| Protocol article | protocol | 17/07/2013 | Yes | No |
