Open Dialogue compared to usual care for adults experiencing a mental health crisis: A feasibility study for the ODDESSI trial

Abstract Background Open Dialogue is a complex mental health intervention which places strong emphasis on working with service users’ social network in conjunction with provision of crisis and community care. It is both an organisational intervention of the mental health team and a clinical intervention at the individual level. This study examines the feasibility of conducting a cluster randomised controlled trial to evaluate the clinical and cost-effectiveness of Open Dialogue compared to Usual Care in the English National Health Service. Methods Coterminous GP practice clusters were randomised to Open Dialogue or Usual Care in preparation for a future evaluation trial. The cluster randomisation approach used restricted randomisation to balance intervention groups for catchment area of the community mental health team, GP practice size and deprivation. Out of these clusters, four clusters were selected for inclusion in a pilot study to assess the feasibility of recruitment, retention and outcome measurement. Feasibility parameters were assessed against stop-go criteria to inform progression to the full cluster randomised trial. Future trial outcome measures were collected at baseline and 3-month follow-up including review of medical records to assess the acceptability and ability of obtaining outcome data in a future evaluation trial. Results We randomised 32 clusters from 9 catchment areas in 6 NHS Trusts to set up a future multicentre study. We screened 362 people who presented to NHS mental health crisis services in the four identified clusters. A total of 174 service users were identified as potentially eligible for the study with 63 assessed as eligible by the research team. The feasibility study aimed to recruit at least 66% of those deemed eligible, at least 80% of participants retained for interview at 3-month follow-up, and at least 85% retained for the suggested primary outcome obtained from medical records at 3 months. All these criteria were met. Conclusions A full cluster-randomised controlled effectiveness trial of Open Dialogue within the NHS is feasible in terms of cluster randomisation, participant recruitment and retention, outcome collection, and appropriate delivery of care. Key messages regarding feasibility Whether a cluster randomised controlled trial (cRCT) of OD might be feasibly undertaken within NHS mental health services. Feasibility criteria were met with high levels of recruitment and retention Large numbers of participants need to be pre-screened in order to reach recruitment targets