Abstract
BackgroundThere is a lack of research in forensic settings examining therapeutic relationships. A structured communication approach, placing patients’ perspectives at the heart of discussions about their care, was used to improve patients’ quality of life in secure settings.The objectives were to:• Establish the feasibility of the trial design• Determine the variability of the outcomes of interest• Estimate the costs of the intervention• If necessary, refine the interventionMethodsA pilot cluster randomised controlled trial was conducted. Data was collected from July 2012 to January 2015 from participants in 6 medium secure in–patient services in London and Southern England. 55 patients and 47 nurses were in the intervention group with 57 patients and 45 nurses in the control group. The intervention comprised 6 nurse-patient meetings over a 6 month period. Patients rated their satisfaction with a range of domains followed by discussions on improving patient identified problems. Assessments took place at baseline, 6 months, and 12 months. Participants were not blind to their allocated group. The primary outcome was self-reported quality of life collected by a researcher blind to participants’ allocation status.ResultsThe randomisation procedures and intervention approach functioned well. The measures used were understood by the participants and gave relevant outcome information. The response rates were good with low patient withdrawal rates. The quality of life estimated treatment effect was 0.2 (95 % CI: −0.4 to 0.8) at 6 months and 0.4 (95 % CI: −0.3 to 1.1) indicating the likely extreme boundaries of effect in the main trial. The estimated treatment effect of the primary outcome is clinically important, and a positive effect of the intervention is not ruled out. The estimate of the ICC for the primary outcome at 6 and 12 months was 0.04 (0.00 to 0.17) and 0.05 (0.00 to 0.18). The cost of the intervention was £529 per patient.ConclusionsThe trial design was viable as the basis for a full-scale trial. A full trial is justified to estimate the effect of the intervention with greater certainty. The variability of the outcomes could be used to calculate numbers needed for a full-scale trial. Ratings of need for therapeutic security may be useful in any future study.Trial registrationCurrent Controlled Trials ISRCTN34145189. Retrospectively registered 22 June 2012.
Highlights
There is a lack of research in forensic settings examining therapeutic relationships
The trial design was viable as the basis for a full-scale trial
The variability of the outcomes could be used to calculate numbers needed for a full-scale trial
Summary
There is a lack of research in forensic settings examining therapeutic relationships. Services are provided in secure, community, NHS and criminal justice settings [1]. Many of these patients are managed in medium secure inpatient facilities. The number of beds in medium secure units has increased significantly over the last 20 years This has been partly due to rising demand, increased length of say, and the drive to reduce high secure hospital places. The patients include difficult, dangerous and/or extremely vulnerable people whose behaviours present a risk to themselves as well as others. They can be difficult to engage in assessment, treatment and research and staff must meet the therapeutic needs of patients whilst addressing legal, security and public safety issues
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