1. ComQuol: overview of the project
The Comquol Study MHRN SUNLOWS Research Seminar Friday 25th January 2013

2. A pilot trial to assess the effect of a structured COMmunication approach on QUality Of Life in secure 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. ComQuol: overview of the project
Research Team
Dr 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
George Harrison, Oxleas NHS Foundation Trust
Dr Ian Marsh, Canterbury Christ Church University
Jacqueline Mansfield, Kent and Medway Partnership Trust
Professor Stefan Priebe, Queen Mary University, London

5. Overview of User Involvement in Forensic Mental Health Research
Little user involvement
Barriers
Security
Access to individuals and information
Confidentiality
Prejudicial attitudes.
Researchers expertise threatened
Disinterest in research amongst service users
No identified service user priorities

6. Studies Informing Comquol
Development of Forensic Satisfaction Scale
Satisfaction levels on Medium Secure Units (MSUs)
Experiences of illicit drug use in MSUs
Types of support required by carers
Systematic review of carer outcomes
Introduction of carer support workers into MSUs

7. Important Areas to Consider When Undertaking Collaborative Research
FORMAL CO
LLABORATION INFORMAL COLLABORATION
ADMINISTRATION
Access, Payment, Staff Liaison, Service Cooperation
Training
Clarity of Involvement
Time Scale
Flexibility
Equality
Information and Support
Confidentiality
Dissemination

8. Access Difficulty in gaining access to service users Security
Many users do not want to be involved
Discussions with service managers
Working with service users to develop initial research question and project outline
Discussions with user councils/user groups
Expressions of interest from service users in becoming part of the research team
Is the service user representative
Working with service user members of research team to develop protocol

9. Payment
Fair remuneration for service users time and contribution to project.
Discussions with Trust finance department regarding whether payment will effect benefits.
Payment costs are included in any funding proposal.

10. Staff Liaison Having a specified liaison member of staff
Provides a clear line of communication between the project team, the service users, and the service
Roles include; booking rooms, transport, providing information and ensuring service users gain access to ward meetings and research sites

11. Service Co-operation
Allows project team access to potential service user members of the project team
Allows project team access to participants.
Supports their involvement in the project
Regular updates given to service regarding the progress of the study

12. Training Research methods Related specifically to project
Timing of session
Each session contains a brief theoretical overview and the development of practical skills

13. Satisfaction Study Training Sessions
Session One - Overview of research process.
Session Two - Focus groups.
Session Three - Analysis of focus group data.
Session Four - Development of questionnaires.
Session Five - Piloting of questionnaires.
Session Six - Questionnaire – Data analysis

14. Clarity of Involvement
All the team have a clear idea about their involvement in the project
Regular meetings
Training sessions
Formal job description
Description of roles in research protoco.
Use jargon-free language understandable to service users

15. Time Scale Takes longer to carry out than professional only research
Approximately 50% longer
Allows the project to proceed at a pace where all the research team are comfortable
Increases likelihood of full participation
Should be built into any project proposal

16. Equality
Each member of the team is able to have an equal say in the conduct of the research and each person’s view is equally valid
Disagreements resolved through discussing the divergent views and examining these differing viewpoints
If disagreement still unresolved, the issue is voted upon by the team with a simple majority view holding

17. Flexibility
Reasons:
Limited knowledge of research
Require training and support
Mental health problems may affect volition
Occasions when service users are unable (or unwilling) to attend meetings
Acknowledge at beginning of the project that this could happen
Agree that individuals can choose to be involved in as much (or as little) of the project
Give information on each stage of the project and encourage service user to have a level of involvement that is appropriate for them at that point in time

18. Information and Support
Regular meetings
Convenient times and locations
Transport
System in place for quick communication
Practical, emotional and research based support
At least two service users should be involved in any one project

19. Confidentiality
Concerns about confidentiality when service users are part of a research team
Discuss the importance of not disclosing information that could be considered sensitive at start of project
Judge issues regarding confidentiality on a project by project basis

20. Dissemination Service user involvement in any dissemination
All members of the team credited for every presentation, article and official report arising from the project

21. Comquol Background
Health Offender Partnerships (2007) - the key security measure in forensic healthcare settings is relational security; the formation of a therapeutic alliance between staff
NIMHE (2004) - lack of a service user perspective and involvement in the service and a lack of research in forensic settings concerning therapeutic relationships
Walker & Gudjonsson (2000) - Quality of life assessments may represent the only way of measuring the totality of detained forensic users' experience in secure environments

22. 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

23. ComQuol: overview of the project
ComQuol is a pilot trial of a structured communication approach.
Proposed intervention comprises of six 1:1 sessions facilitated by nurses
During each session DIALOG and SFT are used to elicit users perceptions of their QoL and care
The project focuses on improvement of users’ QoL through their involvement in treatment planning and delivery, building an alliance between staff and users and developing a valid therapeutic approach which has the potential for producing clinical and economic benefits
It employs user-centred approach promoting users active participation in service provision and research

24. Proposition
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

25. ComQuol: overview of the project
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

26. Scope of the project Six Medium Secure Units in Southern England
and London
Unit liaison worker
in each unit =6
Random allocation
Intervention group
3 units
Control group
3 units
16 users
in each unit
= 48
Up to10 nurses
recruited per ward
= 60
Up to10 nurses
recruited /trained in each ward
= 60
16 users
in each unit
= 48

27. Intervention
Service users complete a rating scale recording a degree of satisfaction in 11 life domains (MH, physical health, accommodation, job situation, leisure activities, friendships, relationships with family/partner, personal safety, medication, meetings)
All answers are presented in a fixed order on an iPad screen using DIALOG software
During the rating users identify domains in which they require extra help/support
User’s views on their situation and needs are the central point of discussion, their views are explicit

28. Intervention
DIALOG software

29. Comparison between DIALOG sessions

30. Intervention Solution Focused 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 changes towards that desired difference

31. Preparation and support
Each nurse is individually trained to use the DIALOG software
Nurses receive a three-day training in Solution Focused Brief Therapy
Monthly meetings are held between a researcher and each nurse to examine the intervention and monitor the needs of staff participating in the study

32. nurses working on these
Recruitment
Staff recruitment
2. users recruitment
Unit liaison & RT
Unit liaison & RT
Unit liaison & RT
Identify at least
2 male wards within
each medium secure
unit
Provide information
about the study to all
nurses working on these
wards
Obtain informed
consents from staff
MDT
Nursing staff & RT RT
Review all users
currently residing in
the participating
wards
Provide information
about the study to all
users eligible to
take part
Obtain informed
consents from users

33. Data collection Users 5 questionnaires (collected at 3 time points)
Primary outcome - Quality of Life
Secondary outcomes
Therapeutic Relationships
Social Climate of Ward
Service User Satisfaction
Recovery
Ratings completed during DIALOG session
Disturbance monitoring form (collected monthly for a period of 15 months)

34. Data Collection Nurses
Maslach Burnout Inventory (collected at 3 time points)
Intervention Group Only
Evaluation of participants' experiences through focus groups
Monthly interviews with key workers
Audio recording of DIALOG sessions

35. Analysis
The estimated treatment effect and corresponding confidence intervals for all outcomes measured at 6 and 12 months
Completion rates
Variability of the outcomes
Qualitative data – thematic analysis
Cost-effectiveness of the intervention vs standard treatment

36. Where are we now?
Accepted as portfolio study and adopted by Mental Health Research Network
Stage 1 units
Bracton Centre and Trevor Gibbens Unit
Completed: recruitment, TP 1 data collection, randomisation, staff training
Ongoing: intervention, 1: 1 interviews with staff
Stage 2 and 3 units
Ongoing: R&D governance procedures, preparation to recruitment

38. Thank you for listening
Any Questions

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