Study to assess the effect of a structured communication approach on quality of life in secure mental health settings (Comquol): study protocol for a pilot cluster randomized trial

Background
Forensic mental health services have largely ignored examining patients’ views on the nature of the service offered to them. A structured communication approach (DIALOG) has been developed with the aim of placing the patient’s perspective of their care at the heart of the discussions between patients and clinicians. The effectiveness of the structured communication approach in community mental health services has been demonstrated but no trial taken place in a secure psychiatric setting. This pilot study is evaluating a six-month intervention combining DIALOG with principles of Solution Focused Therapy (SFT) on quality of life in medium secure settings.

Methods/design
A cluster randomized controlled trial design is being employed to conduct a 36 months pilot study. Participants are recruited from six medium secure in–patient services with 48 patients in the intervention group and 48 in the control group. The intervention uses a structured communication approach. It comprises of six meetings between patient and nurse over held once a month a six month period. During each meeting patients rate their satisfaction with a range of life and treatment domains with responses displayed on a tablet. The rating is followed by a discussion on how to improve the current situation in those domains identified by the patient. Assessments take place prior to the intervention (baseline), at 6 months (post intervention) and at 12 months (follow-up). The primary outcome is self reported Quality of Life.

Discussion:
The study aims to a) establish the feasibility of the trial design as the basis for determining the viability of a large full-scale trial, b) determine the variability of the outcomes of interest (quality of life, levels of satisfaction, disturbance, ward climate, and engagement with services) c) estimate the costs of the intervention and d) refine the intervention following the outcome of the study based upon the experiences of the nurses and patients. The intervention allows patients to have a greater say in how they are treated and targets care on areas that patients identify as important to them. It is intended to establish systems that support meaningful patient (and carer) involvement and participation.

Trial registration: Current Controlled Trials ISRCTN34145189

Keywords: Comquol, DIALOG, Forensic, Mental Health, Quality of Life, Solution Focused Brief Therapy.