1. Clinicians and Services Users Working Collaboratively: The ComQuol Study

2. A Pilot Trial to Assess the Effect of a Structure Communication Approach on the Quality of Life of Service Users in Mental Health Settings (ComQuol)

3. The research is 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

4. 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
Dr Ian Marsh, Canterbury Christ Church University
Miss Jacqueline Mansfield, Canterbury Christ Church University
Professor Stefan Priebe, Queen Mary University, London

5. Presentation Overview
Five Presentations within Session
Background
The Role of a Mental Health Nurse in the ComQuol Project: Their Perspective and Involvement
Service User Perceptions of the ComQuol Approach: Focus Group Analysis
User Focused Outcomes
Ward and Service Focused Outcomes

6. A Pilot Trial to Assess the Effect of a Structure Communication Approach on the Quality of Life of Service Users in Mental Health Settings (ComQuol) – Background
Miss Jacqueline Mansfield, Forensic Researcher
Research Assistant/Trials Manager (ComQuol)
Canterbury Christ Church University

7. Background
Department of Health (2008) defines forensic mental health care as:
The provision of mental health services for people with mental disorder who are offenders or at risk of offending.
Services are provided in secure, community and criminal justice settings.
Department of Health defines forensic mental health care as the provision of mental health services for people with mental disorders who are offenders or at risk of offending. Services are provided in secure, community, NHS and criminal justice settings.
These patients include difficult, dangerous and/or extremely vulnerable people whose behaviour 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.

8. Background
NIMHE (2004) - Lack of a service user perspective and involvement in the service and a lack of research in forensic settings concerning therapeutic relationships
Paucity of published research regarding relational security in secure settings.
The Department of Health recommended developing patient involvement in all aspects of the service. This followed earlier guidance, that the interests of users should lead service development and that treatment be guided by their aspirations and experiences. However, a review by the National Institute of Mental Health in England of forensic mental services noted a lack of a patient perspective and involvement in the service. The report suggested future work should seek to build mechanisms and services that involve patients and respond to their views.
It has been found that significantly better clinical outcomes are reported with reductions in unmet needs, lower levels of psychopathology, higher global functioning, lower social disability, higher quality of life, and better satisfaction with services, when an agreed clinician-patient intervention strategy was in place.

9. How is this best measured and monitored?
Background
Walker & Gudjonsson (2000) - Quality of life assessments may represent the only way of measuring the totality of detained forensic patients' experience in secure environments
How is this best measured and monitored?
However there is a lack of research in forensic settings concerning therapeutic relationships and no published research regarding examining relational security in secure settings. It has been proposed that quality of life assessments may represent the only way of measuring the totality of detained forensic patients’ experience in secure environments to guide the development and improvement of patient care.

10. Structured Communication Approach
Priebe et al (2002) – developed intervention using a structured communication approach
The intervention consists of two elements:
A computer-mediated approach (DIALOG+) and
Non-directive counselling based on SFT
Priebe et al (2007) – Pan European study - the intervention recorded significantly higher quality of life scores, satisfaction with treatment, and reduced unmet needs
DIALOG+ has been found to be valid in rating subjective quality of life scores (Priebe et al, 2012)
Research in primary care settings indicates a patient-centred approach, including active participation of patients in the treatment process, is associated with better quality of life, increased adherence to treatment regimes and reduced misunderstanding between clinicians and users. A positive relationship with the primary worker is consistently found to predict a better outcome in relation to symptomatology, time in hospital, and quality of life.
Priebe and colleagues have developed an intervention using a structured communication approach placing the patients’ perspective of their care at the heart of the discussion between patients and clinicians. The intervention consists of two elements: a computer-mediated approach (DIALOG) used to conjunction with non-directive counselling, based on the principles of Solution Focused Brief Therapy (SFBT).
In a trial in six European countries, the intervention group has significantly higher quality of life scores, satisfaction with treatment, and less unmet needs, compared to the control group. A major strength of the study was the intervention was tested in routine clinical conditions.

11. Rationale For Our Research
By focusing on improving patients’ QoL through
their involvement in treatment planning and delivery;
building an alliance between staff and patients;
developing a valid therapeutic approach
Potential for producing clinical and economic benefits
The underling rationale of this approach is that providing patients and nurses with this information will lead to explicit negotiations about what each individual patient wants and what the nurse can help do about it.
The hypothesis presented is that this focus on the individual concerns of the patient will, in turn, lead to an improvement in subsequent care and the patient’s quality of life.
In a recent paper, it was found that the psychometric qualities of subjective qualities of life scores generated in DIALOG are strong. This indicates that DIALOG ratings can also be used for evaluating quality of life scores, adding the value of the approach. It has not been tested in a forensic environment so there is a need to pilot the intervention in this setting. It is proposed that using a structured user-clinician communication approach within a forensic mental health setting would improve users’ quality of life, level of satisfaction, engagement with services, and reduce disturbances.

12. Overview
ComQuol is a pilot trial of a structured communication approach
Proposed intervention comprises of six 1:1 sessions facilitated by primary nurses
During each session DIALOG+ and SFT are used to elicit patient’s perceptions of their QoL and care
It employs patient-centred approach promoting patient’s active participation in service provision and research
ComQuol is a pilot trial to evaluate a structured communication approach. The proposed intervention comprises of six 1:1 session that happen once a month for six months. The sessions combining the DIALOG computer software with principles of Solution Focused Therapy (SFT) to elicit patient’s perception on their quality of life and care in a medium secure setting. The intervention employs a patient-centred approach making the patient the centre of the conversation and allowing them to have an active participation in the service provision and research.

13. Hypothesis
Using a structured user-clinician communication approach within a forensic mental health setting will improve users quality of life, levels of satisfaction, engagement with services, ward atmosphere, and reduce disturbance

14. 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
To refine the intervention on the basis of study participants’ experiences
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.

15. 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).

16. Proposed Recruitment Process
Six Medium Secure Units
in Southern England
and London
Unit liaison worker in
each unit
= 6
Random allocation
Control group
3 units
Intervention group
3 units
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.
10 nurses
per unit
= 30
16 users
in each unit
= 48
16 users
in each unit
= 48
10 nurses
trained per unit
= 30

17. Methods Inclusion criteria for patients Residing on participating ward
History of 3 months of current treatment
Capable of giving informed consent
The participants are registered mental health nurses and in-patients at six medium secure units in Southern England and London. Nurses will be initially approached in two wards in each of the participating units (twelve wards overall). The inclusion criterion for the clinicians will be that they are registered mental health nurses working with in-patients within those wards. Each patient residing in the participating wards is eligible to participate as long as they following inclusion criteria are met; they have a history of at least 3 months of current in-patient treatment in the service and are capable of giving informed consent.
There is no time frame for the recruitment of participants. Recruitment will take place until a sufficient number of nurses and patients have agreed to participate. If there are insufficient numbers of participants from the two identified wards discussions will be held with the clinicians and management teams of the unit to consider whether other wards are able to be included.
To avoid bias, the allocation of a unit into either the intervention or control arm of the study is only undertaken following the identification and recruitment of a sufficient number of nurses and patients from each unit. The researchers are, therefore, blind to allocation status at the point of nurse and patient entry into the study. The allocation is performed by the randomisation service of the registered Pragmatic Clinical Trials Unit at Bart’s and the London School of Medicine and Dentistry (PCTU).

18. DIALOG+
Rated on a 1 (Couldn’t be worse) to 7 (Couldn’t be better) Likert scale across these domains
Patient’s view on their situation and needs are the central point of discussion; their views are explicit
Mental health
Physical health
Accommodation
Job situation
Leisure activities
Friendships
Medication
Personal safety
Relationship with family & friends
Practical help
Consultations
All answers are presented in a fixed order on an iPad screen using DIALOG software
During the rating patients identify domains in which they require extra help/support

19. DIALOG+

20. Comparison Between DIALOG Sessions

21. 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

22. Units Assessed for Eligibility (N = 6) Patients Approached (n = 182)
Retention Flow Chart
Units Assessed for Eligibility (N = 6)
Units excluded = 0
Nurses Recruited (k = 92)
Patients Approached (n = 182)
Patients excluded = 70
Units Random
(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)
Patients (n = 57)
Intervention group
Units (N = 3)
Nurses (k = 47)
Patients (n = 55)

23. Final Retention Numbers
Retention Flow Chart
Control group
Units (N = 3)
Nurses (k = 45)
Patients (n = 57)
Intervention group
Units (N = 3)
Nurses (k = 47)
Patients (n = 55)
Final Retention Numbers
Nurses:
Intervention = 24
Control = 18
Patients:
Intervention = 47
Control = 42
Lost to Follow-Up
Control Group
TP1: Nurse (k = 3)
Patients (n= 4)
TP2: Nurse (k = 13)
Patients (n= 7)
TP3: Nurse (k = 11)
Lost to Follow-Up
Intervention Group
TP1: Nurse (k = 4)
Patients (n= 3)
TP2: Nurse (k = 10)
Patients (n= 2)
TP3: Nurse (k = 9)
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.

24. Patient Demographics (Baseline)
Control = 57
Intervention =55
Age (Mean) 34 36
Gender (Total)
Males = 45
Females = 8
Males = 46
Ethnicity (Total)
White British = 16
White Other = 4
Black = 20
Asian = 3
Mixed = 10
All Other = 0
Missing = 4
White British = 24
White Other = 10
Black = 11
Asian = 4
Mixed = 4
All Other = 1
Missing = 1

25. Patient Forensic Demographics (Baseline)
Control = 57
Intervention =55
Clinical Diagnosis (Total)
Schizophrenia = 41
Mood Disorder = 1
Personality Disorder = 8
Neurotic Disorder = 2
Behavioural Syndromes = 0
Missing data = 5
Schizophrenia = 39
Mood Disorder = 2
Personality Disorder = 11
Neurotic Disorder = 0
Behavioural Syndromes = 1
Missing data = 2
Length of Current Admission
(Median)
554 days
(IQR = 188, 1127)
434 days
(IQR = 197, 869)

26. Patient Forensic Demographics (Baseline)
Control = 57
Intervention =55
Leave Status (Total)
Escorted Ground = 7
Unescorted Ground = 1
Escorted Community = 19
Unescorted Community = 8
No Leave = 17
Missing data = 5
Escorted Ground = 14
Unescorted Ground = 3
Escorted Community = 20
Unescorted Community = 5
No Leave = 12
Missing data = 1
Mental Health Status (Total)
Section 37 & 37/41 = 38
Section 47/49 & 48/49 = 9
Section 3 = 5
Other Section = 0
Section 37 & 37/41 = 41
Section 47/49 & 48/49 = 8
Section 3 = 3
Other Section = 1
Missing data= 1

27. Closing Remarks Implications
Trial design viable as basis for full-scale trial
Procedures functioned well
Recruitment numbers
Randomisation - Little differences in demographic features
Training/Delivery of intervention
Limitations
Lost to follow up (Female patients)