Title: Effective patient-clinician interaction to improve treatment outcomes for patients with psychosis
Funder: Department of Health (England)

Abstract: Alterations to the proposal In the developmental phase all participants will have experience of DIALOG, and CBT specialists will develop DIALOG+. The trial methodologist will be Wang instead of Ashby. There are no other major alterations. Aims and objectives The overall aim is to improve the effectiveness of community mental healthcare for patients with psychotic disorders. This will be done by refining a structured method to make patient-clinician interaction in routine meetings more effective. An evidence-based intervention, called DIALOG, will be optimised and tested in 2 variations. Specific objectives are to: 1. optimise the practical procedure and technology of DIALOG 2. identify elements of Cognitive Behaviour Therapy (CBT) to guide clinicians’ response to patients’ statements 3. establish in a multi-centre randomised controlled trial the most effective and cost effective way of delivering DIALOG, i.e. alone or combined with elements of CBT (ie DIALOG+). Background Schizophrenia and related disorders are disabling and generate high costs to the NHS and society. More than 100,000 patients with such disorders are in the care of Community Mental Health Teams (CMHTs) in England at any time. Key workers in CMHTs have regular meetings with patients, but their interactions are not guided by research evidence. Two trials showed positive effects of (1) structuring patient-clinician communication on clinical decisions and (2) regular assessment/feedback of outcomes on treatment costs, but not on long term clinical outcomes. DIALOG is the first intervention to directly structure patient-clinician interaction in routine meetings. Every 2 months key workers ask patients in a computer-mediated procedure about their satisfaction with life and treatment, and wishes for different treatment. In a European multi-centre trial, DIALOG led to better quality of life after one year. However, only one site was in the UK, and the study was not designed or powered to establish specifically the effectiveness in the NHS context. Also, DIALOG structured the interaction, but did not provide a guide for clinicians on how to respond to patients’ ratings. Before DIALOG is rolled out, there is a need to (a) make the practical procedures more user friendly and update the technology, (b) replicate the original findings in a pragmatic multi-centre trial in the NHS, and (c) test whether the effect can be enhanced by adding a guide for clinicians’ responses to patients’ ratings. The research team was in charge of the original DIALOG trial and published relevant conceptual and methodological research. Research Plans The programme will have a developmental phase and a trial phase. The developmental phase will have 2 modules, A and B: In module A, we will optimise the DIALOG procedure and develop an updated technology. Possible improvements will be identified in focus groups with key workers and patients with experience of using DIALOG. Existing tapes of in-depth interviews with key workers in the original DIALOG trial and videotapes of sessions will also be analysed to identify options for improvements. Technology experts will update and refine the DIALOG application. In module B, we will design DIALOG+ with CBT as the underpinning psychological model. Working with qualified CBT therapists in CMHTs, we will develop a guide for how to respond to patients’ statements in DIALOG and design and test a training programme. In the trial phase, we will test the effectiveness and cost effectiveness of DIALOG and DIALOG+ in a pragmatic multi-centre cluster randomised controlled trial. A total of 93 key workers and 651 patients will be randomly allocated to 3 groups: DIALOG, DIALOG+ or treatment as usual. Key workers in the two DIALOG arms will be trained, and the intervention will be administered every two months. Primary outcome will be subjective quality of life after a 1 year period. Secondary outcomes will be unmet needs, treatment satisfaction, symptom levels, social situation and costs. Research Team The team includes renowned experts in all aspects of the research. Research Environment The programme will be led by the Unit for Social and Community Psychiatry (Queen Mary University of London) which is supported by East London NHS Foundation Trust. All applicants are based at successful research units and will collaborate closely. The trial will be supported by a registered clinical trials unit. Anticipated Outcomes We will provide an updated DIALOG application, a manual and training programme for clinicians’ responses. We will establish evidence for the effectiveness and cost effectiveness of DIALOG and DIALOG+ in the NHS. If shown as effective, DIALOG can be rolled out at low cost. Small individual gains will amount to substantial public health benefits. Cost savings through reduced bed use may exceed £100m per year. Public Involvement There will be public involvement throughout all stages of the programme.


Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: MENTAL HEALTH