Title: A pilot trial to assess the effect of a structured Communication approach on QUality Of Life in secure mental health settings (Comquol)
Funder: Department of Health (England)

Abstract: Background Forensic mental health is an important area of health care. However, it has a limited evidence base and there have been few studies examining the therapeutic relationship between clinicians and service users and these have been mainly small-scale case studies relating to individuals with personality disorder (1). Priebe and colleagues have developed an effective practical method of increasing users’ involvement in their treatment using a structured communication approach that places the service users’ perspective of their care at the heart of the discussions between service users and clinicians (2,3). A pilot study is proposed to evaluate this structured six month approach designed to increase the quality of life of service users receiving in-patient psychiatric care in secure settings.. Aims The aims are to; • Establish the feasibility of the trial design as the basis for determining the viability of a large full-scale cluster randomised trial (the estimated treatment effect, randomisation procedures, outcome measures, estimates of recruitment for a main trial, and follow up of participants). • Determine the variability of the outcomes of interest (quality of life, levels of disturbance, levels of satisfaction, disturbance, ward climate, and engagement with services) • Estimate the costs of the intervention. • To refine the intervention based upon the experiences of the clinicians and patients. Plan of Investigation It is proposed to undertake a 36 month pilot study using a randomised design. Participants will be recruited from six medium secure in–patient services with 48 in the intervention group and 48 in the control group. The intervention will be based on the structured communication approach (2,3). The service user will complete a simple checklist prior to their monthly meeting with their keyworker. This will be used as the basis for 1) assessing the user’s needs and 2) for focusing on changes to the service user’s care and treatment. The control group will receive standard care. Assessments will take place prior to the intervention (baseline), at 6 months (post intervention) and at 12 months (follow-up). Potential Impact Users of forensic mental health services include difficult, dangerous and/or extremely vulnerable people whose behaviours present a risk to themselves as well as others (4). The impact of a structured communication approach with service users in this area has not been previously studied. Any effective intervention will benefit this group and also reduce the demand on services. The value of a pilot trial lies in providing a thorough evaluation of the acceptance and feasibility of the proposed approach. This is necessary before large-scale prospective randomised trials can be conducted in an efficient and cost-effective manner (5). The study will also estimate the effect of the intervention on a range of outcomes giving an indication of its effect.


Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: MENTAL HEALTH