Evaluation of a primary care based collaborative care model (PARTNERS2) for people with diagnoses of schizophrenia, bipolar or other psychoses: Study protocol for a cluster randomised controlled trial.

Background Current NHS policy encourages an integrated approach to provision of mental and physical care for individuals with long term mental health problems. The ‘PARTNERS2’ complex intervention is designed to support individuals with psychosis in a primary care setting. Aims The trial will evaluate the clinical and cost-effectiveness of the PARTNERS2 intervention. Design & setting This is a cluster randomised controlled superiority trial comparing collaborative care (PARTNERS2) with care as usual, with an internal pilot to assess feasibility. The setting will be primary care within four trial recruitment areas: Birmingham & Solihull, Cornwall, Plymouth and Somerset. GP practices are randomised 1:1 to either (a) the PARTNERS2 intervention plus modified standard care (intervention) or (b) standard care only (control). Methods and analysis PARTNERS2 is a flexible general practice based person-centred coaching based intervention aimed at addressing mental health, physical health and social care needs. Two hundred eligible individuals from 39 GP practices are taking part. They were recruited through identification from secondary and primary care databases. The primary hypothesis is quality of life. Secondary outcomes include: mental wellbeing, time use, recovery and process of physical care. A process evaluation will assess fidelity of intervention delivery, test hypothesised mechanisms of action and look for unintended consequences. An economic evaluation will estimate the cost-effectiveness. Intervention delivery and follow up have been modified during the COVID-19 pandemic. Conclusion The overarching aim is to establish the clinical and cost effectiveness of the model for adults with a diagnosis of schizophrenia, bipolar, or other types of psychosis.