1. Doug MacInnes Canterbury Christ Church University
The Comquol Study: A structured approach focused on quality of life in secure mental health settings
Doug MacInnes
Canterbury Christ Church University

2. The research was funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG ) The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health

3. Research Team
Professor Douglas MacInnes, Canterbury Christ Church University
Dr Catherine Kinane, Kent and Medway Partnership Trust
Dr Janet Parrott, Oxleas NHS Foundation Trust
Professor Tom Craig, Institute of Psychiatry, Kings College, London
Professor Sandra Eldridge, Queen Mary University, London
Mr George Harrison, Oxleas NHS Foundation Trust
Dr Ian Marsh, Canterbury Christ Church University
Miss Jacqueline Mansfield, Canterbury Christ Church University
Professor Stefan Priebe, Queen Mary University, London

4. Comquol Overview
A pilot trial of a structured communication approach in medium secure settings (Priebe et al, 2002)
Intervention comprised of six 1:1 sessions facilitated by primary nurses
The intervention consisted of two elements:
A computer-mediated approach (DIALOG+) and
Non-directive counselling based on SFT
It employed a user centred approach promoting service users active participation in the intervention
Solution Focus Approach
What difference a person wants to see in their life – their ‘preferred future’
What is working or going well right now
Finding out strengths and resources in the person and their wider context
Working out what small steps will bring about change towards that desired difference
Strategy emphasised importance for nurses spending time developing therapeutic relationships with patients as opposed to a more custodial or medically-based role
However, less attention spent training and improving skills for developing therapeutic alliance in forensic setting
More emphasis on work at ‘the ground level’ by training focused in policy and procedure;
Risk management has become the main area of focus with therapeutic processes being ignored

5. Aims and Objectives
To examine the proposed methodology and establish the feasibility of the research design for a full scale trial
To determine the variability of the outcomes of interest
To estimate the cost of the proposed intervention
Refine the intervention following the outcome of the study based upon the experiences of the participants
The aim of the study is to undertake a pilot trial to examine the proposed methodology of an intervention study based upon the structured communication approach developed by Priebe and colleagues (2007). The value of a pilot study lies in the understanding it generates concerning the study procedures in providing a thorough evaluation of the acceptance and feasibility of the proposed approach.
The specific objectives of the study are to:
a) Establish the feasibility of the trial as the basis for determining the viability of a large full-scale trial (the estimated treatment effect, study procedures, outcome measures, estimates of recruitment for a main trial, and follow up of participants).
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 cost of the intervention
d) Refine the intervention following the outcome of the study based upon the experiences of the nurses and patients.

6. Methods Design 36-Month pragmatic cluster randomised pilot trial
Six medium secure units
Units stratified:
First stratum:
Two units with one male ward and one female ward in each unit
Second stratum:
Four units with two male wards in each unit
A pragmatic cluster randomised trial has been designed avoiding any potential contamination between the intervention and control groups in clinical practice. Six medium secure units will be randomised. Far fewer women than men are resident in secure units. To enable the study to examine the intervention with both men and women in for the forensic mental health service, the units are stratified. The first stratum includes four medium secure units with two male wards in each unit participating in the study. The second stratum consists of two medium secure units with one male ward and one female ward in each unit participating in the study.
Within both groups there is a balanced design resulting in the same number of units in each of the intervention and control groups. A randomisation schedule has been drawn up by a statistician independent of the study. The study will include a population of in-patients in the six forensic medium secure wards, A six-month intervention approach is being used based on the work of Priebe et al (2002, 2007).

7. Data Collection For all quantitative data Three time points
Baseline
Six Months
Twelve Months
Disturbance – 15 months: 3 months pre- Comquol and 12 months post –Comquol

8. Outcomes Primary outcome - Quality of Life (MANSA, Priebe et al, 1999)
Secondary outcomes
Disturbance (disturbance monitoring form)
Therapeutic Relationships (HAS, Priebe & Gruyters, 1993)
Ward Climate (EssenCES, Schlast et al, 2008)
User Satisfaction (FSS, MacInnes et al, 2010)
Recovery (QPR, Neil et al, 2009)
Nurse Stress (MBI, Maslach et al, 1996)
Health economic data (self developed form)

9. Outcomes Intervention groups only
Evaluation of participants' experiences through focus groups
Monthly interviews with key workers
Audio recordings of some sessions

10. Units Assessed for Eligibility (N = 6)
Flow Chart
Units Assessed for Eligibility (N = 6)
Units excluded = 0
Nurses recruited (k = 92)
Users approached (n = 182)
Users excluded = 70
Units Randomised
(N = 6)
Ten nurses from each ward in the intervention units, will be trained in the structured communication approach to allow for some drop-outs. The trial will recruit 96 patients participants (48 in both intervention and control arms) to also allow for some drop-outs. The findings of this study will be used to estimate variability in outcomes for a later large study. As this is a pilot study, a formal sample size calculation is inappropriate.
Control group
Units (N = 3)
Nurses (k = 45)
Users (n = 57)
Intervention group
Units (N = 3)
Nurses (k = 47)
Users (n = 55)

11. Preparation and Support
Each nurse was individually trained to use the DIALOG+ software
Nurses received a three-day training in Solution Focused Brief Therapy
Monthly meetings were held between researcher-nurse

12. DIALOG+

13. DIALOG+ Sessions

14. Quality of Life Scores Domain Mean (range 1-7) (SD) Baseline 6-Months
Control
(N = 52)
4.2 (0.2)
4.3 (0.1)
4.3 (0.3)
Intervention
(N = 53)
4.4 (0.3)
4.5 (0.4)
4.7 (0.2)
Put in ICC and confidence interval

15. Treatment Effect Quality of Life Scores
Treatment Effect (intervention – control) and Confidence Interval
6-Month
12-Month
0.2 (-0.4 to 0.8)
0.4 (-0.3 to 1.1)
ICC (CI)
0.04 (0.00 to 0.17)
0.05 (0.00 to 0.18)
ICC = Intracluster Correlation Coefficient

16. Estimated Treatment Effects
Burnout - improvement in exhaustion and cynicism sub-scale scores
Recovery - increase intrapersonal scores and decrease in interpersonal scores
Therapeutic relationship - improvements in overall score
Satisfaction – little difference in scores
Social Climate – little difference in scores

17. Disturbance Monitoring
Intervention Group
Control Group
Disturbance (Number of )
Pre-
ComQuol
Post-
Seclusions 9 37
Hours of seclusion
231
150
328
758
Physical restraint 8 22 35
Suicide attempts 1 2 7 17
Self-harm attempts 18 47 10 93
Violent acts on others 21 50 23 96
Violent attacks on inanimate objects 48 81 15 76
Attempted absconding/escapes 3
Actual absconding/escapes 4 11
Abusive/racial language
201
427 94
313

18. Nurses’ Experiences Overall experience positive Arranging Sessions
Working with Intervention
Software (DIALOG+)
Solution Focused Therapy
Helpfulness of sessions

19. Focus Group Themes
Service User Involvement
Nature & benefits
Relationship between quality of life and perceptions of:
Fairness
Safety
Order
Humanity
Trust
‘We have to see them 24/7; we have to see them every day. We have to work with them and sometimes we are polite to them and they are not polite to us. Sometimes’.

20. Cost-Consequences Analysis
Resource use and costs
Intervention group
Control group
Total cost of intervention
£30,413 £0
Cost of intervention per user including nurse training £
Av no of days in the facility over 12 months, mean (SD)
341 (56)
338 (37)
Av cost of stay in the facility (bed-day cost) over 12 months
£166,064
£164,506
Total cost of incidents
£23,697 - £38,354
£51,222 - £92,340
Cost of incidents per user
£456 - £738
£985 - £1,776
Av treatment cost (intervention + stay + incidents)
£167,049 - £167,378
£165, ,282
Satisfaction – Little difference between intervention group vs. control group scores
Social Climate – Little difference in scores except higher therapeutic hold sub-scale scores for the control group
Disturbance – Much lower in most categories in intervention group
Economic Evaluation – Overall costs similar, incident costs much lower in intervention group

21. Conclusions
Establish the feasibility of the trial design as the basis for determining the viability of a large full-scale trial
The trial design appears viable.
The procedures seem to function well.
The response rates were good with low service user withdrawal rates.
Determine the variability of the outcomes of interest
The variability of the outcomes of interest was all within normal limits.
The estimated treatment effect of the primary outcome is within the range where it could be considered significant.
A full trial would be justified to estimate the effect with greater certainty.

22. Conclusions Estimate the costs of the intervention
Incidents are costly, as associated with significant use of NHS resources and police.
Real cost of incidents may be even higher when analysed using patient-level data.
Refine the intervention following the outcome of the study based upon the experiences of the participants
Responses suggest general satisfaction with the approach.
Number of nurses lost to follow up questions including nursing outcomes.
The reasons for higher dropout rates for women and whether to offer ongoing support.
Examining the incident costs for longer may give a better indication of on-going costs.

23. Thank you for you listening
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