The Comquol Study MHRN SUNLOWS Research Seminar Friday 25 th January 2013

1. The Comquol StudyMHRN SUNLOWS Research SeminarFriday 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-0609-19107) 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 • 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. FORMAL CO LLABORATION INFORMAL COLLABORATION Flexibility Training Equality Clarity of Involvement Time Scale Information and Support Confidentiality Dissemination Access, Payment, Staff Liaison, Service Cooperation ADMINISTRATION Important Areas to Consider When Undertaking Collaborative Research

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. Overview • 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. 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 Up to10 nurses recruited per ward = 60 16 users in each unit = 48 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. 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

39. If anyone would like any further information please contact us:douglas.macinnes@canterbury.ac.ukcatherine.kinane@kmpt.nhs.ukjacqueline.mansfield@kmpt.nhs.uk