A pilot trial to assess the effect of a structured COMmunication approach on QUality Of Life in secure mental health settings (Comquol)

Forensic mental health services have largely ignored examining users’ views on the nature of the service offered to them. Priebe and colleagues have developed a structured communication approach placing the service users’ perspective of their care at the heart of the discussions between service users and clinicians. This approach was used as the basis of a pilot study to evaluate a structured six-month approach designed to increase the quality of life of service users in secure settings. The specific objectives of the study were to:

• Establish the feasibility of the trial design as the basis for determining the viability of a large full-scale trial
• Determine the variability of the outcomes of interest
• Estimate the costs of the intervention
• If necessary, to refine the intervention following the study based upon the experiences of the clinicians and service users.

A 36 month pilot trial was undertaken. Participants were recruited from 6 medium secure in–patient services with 55 patients in the intervention group and 57 in the control group as well as 92 nurses (47 in the intervention group and 45 in the control group). The intervention was based on the structured communication approach. Assessments took place prior to the intervention (baseline), at 6 months (post intervention) and at 12 months (follow-up).

A review of the trial design indicated this approach was viable as the basis for a large full-scale trial; no refinements were needed to the intervention. The variability of the outcomes can be used start thinking about how large a full scale trial needs to be. A full trial would be able to estimate the effect of the intervention whereas this small pilot study cannot. The total cost of the intervention was £29,100 (£529 per patient) when assuming the intervention was part of the nurses normal work. Disturbed behaviour was also found to be costly since it was associated with significant use of NHS resources and police.

Report number: PB-PG-0609-19107