A pilot cluster randomised trial to assess the effect of a structured communication approach on quality of life in secure mental health settings: The Comquol Study.
BACKGROUND
There 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 intervention METHODS: A 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.


RESULTS
The 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.


CONCLUSIONS
The 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.


BACKGROUND
Current Controlled Trials ISRCTN34145189 . Retrospectively registered 22 June 2012.
Canterbury Christ Church University, Canterbury, UK. douglas.macinnes@canterbury.ac.uk.
Douglas
http://orcid.org/0000-0002-3723-7859
D
MacInnes
Kent and Medway NHS and Social Care Partnership Trust, Maidstone, UK.
Catherine
C
Kinane
Oxleas NHS Foundation Trust, Dartford, UK.
Janet
J
Parrott
Canterbury Christ Church University, Canterbury, UK.
Jacqueline
J
Mansfield
Institute of Psychiatry, Kings College London, London, UK.
Tom
T
Craig
Queen Mary University of London, London, UK.
Sandra
S
Eldridge
Canterbury Christ Church University, Canterbury, UK.
Ian
I
Marsh
Queen Mary University of London, London, UK.
Claire
C
Chan
Queen Mary University of London, London, UK.
Natalia
N
Hounsome
Canterbury Christ Church University, Canterbury, UK.
George
G
Harrison
Queen Mary University of London, London, UK.
Stefan
S
Priebe
Comquol; DIALOG; Forensic; Mental health; Quality of life; Service user collaboration; Solution focused brief therapy
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