The Lambeth Early Onset (LEO) Team: randomised controlled trial of the effectiveness of specialised care for early psychosis

[As supplied by authors] Research ethics approval

The decision to allow randomisation prior to consent was made in consultation with the LREC and was approved after the following considerations were taken into account (a) patients cannot routinely choose between existing services but are allocated to the team that happens to cover their address (b) the new service would be distinctive in so far as it focuses on early psychosis but would not differ in terms of professional composition or range of treatments available. No new treatments were being tested nor treatments withheld. (c) Patients who were already known to an existing sector team were excluded from the study prior to any randomisation. In the event that a patient had been randomised to the LEO service before it was clear that they had some prior contact with a sector team, then the patient was to be offered the choice of continuing to receive care from the sector team (though for outcome purposes would be regarded as though they had remained in the LEO service). Throughout the trial this arose only once. (d) As patients were to be randomised as soon as possible after making initial contact with the psychiatric services (e.g. in emergency clinics or A&E departments) it was considered that some would lack the capacity to give informed consent at the point where a decision had to be made urgently about which treating service would be responsible for providing care (e) All patients were informed of the randomization and written consent was sought to collect outcome data from case notes and by interview.