Friday, 1 January 2016

EMPOWER: Early signs Monitoring to Prevent relapse and prOmote Wellbeing, Engagement and Recovery: a mixed methods study

EMPOWER: Early signs Monitoring to Prevent relapse and prOmote Wellbeing, Engagement and Recovery: a mixed methods study; March 2016 to September 2018; funded by National Institute for Health Research (UK) and National Health and Research Council (Australia)

Extracts:

"Study hypothesis

The overall objective of this study is to evaluate the novel EMPOWER intervention in terms of relapse prevention in individuals with chronic schizophrenia by:

1. Completing an evaluation of the system for a self-initiated and self-managed EWS using real time sampling methods
2. Examining the feasibility of EMPOWER through a 15-month pilot cluster randomised trial ..."

"Background and study aims

Schizophrenia is a serious mental health problem that affects how a person thinks, feels and behaves. Schizophrenia is usually treated with a combination of therapy and medication, which is able to control the symptoms, allowing the sufferer to function in their day-to-day life (remission). Relapse (reemergence of symptoms) in schizophrenia is a major cause of distress and disability amongst patients and their families. It can often be predicted by early warning signs (EWS) such as feelings of anxiety, depression and suspiciousness (paranoia).


Studies have shown that treatment programs focusing on addressing EWS when they appear can help to enhance recovery and lower the risks of relapse requiring hospitalisation. Currently, the quality of evidence for this is poor, and so it has not yet been possible to test whether programs such as these would work in routine practice. EMPOWER is a new program which uses digital smartphone technology for the monitoring of EWS, encouraging patients to seek help and minimizing the risk of “false alarms”. The aim of this study is to refine this approach in order to develop a practical program for use in the mental health services. ..."

"Intervention

Participating CMHTs will be randomized to the EMPOWER Relapse Prevention Intervention or to continue their Treatment as Usual approach to care.

EMPOWER Relapse Prevention involves Mental Health Staff, Service Users and their carers. Mental health staff will receive training and ongoing support to emphasise:

1. Therapeutic alliance
2. Barriers to help-seeking
3. Developing an individualised formulation of risk of relapse
4. Developing a collaborative relapse prevention plan. 

Service users will receive have access to the EMPOWER App for 12-months. A Peer Support Worker will meet with service users, carers and their key-workers to introduce the service users (and their nominated carers) to the App and the handset use. EMPOWER will be developed as a flexible user-led Early Warning Signs (EWS) monitoring tool that incorporates flexibility to tailor frequency of EWS monitoring, delivery of personalised self management messages directly to service users, flexibility to reduce numbers of items included in EWS, development of a user interface enabling service users to interact with and analyse their own data and ability for service users to send their data via email notification to their case coordinator and nominated carer.

Treatment as Usual will be delivered by adult Community Mental Health Teams, which largely involve regular, fortnightly, follow-up with a care coordinator and regular review by a psychiatrist. We will assess relevant policies governing delivery of routine care, service utilisation, documentation of care plans and crisis intervention plans (including advance statements, early signs indicator forms and relapse prevention plans). ..."

"Publication and dissemination plan

Our strategy for Knowledge Exchange and Impact means that we are ensuring service user and carer involvement from the outset of the study (for audit criteria see Ruppertsberg et al., 2014). This is reflected in a number of design features of the protocol. 

1. The Scottish Recovery Network (www.scottishrecovery.net/) are active collaborators on the project proposal and have actively been involved in the design of the EMPOWER Relapse Prevention Intervention (led by their Director Simon Bradstreet). A key impact of this early involvement has been to ensure that service users retain control of their data and can be empowered to make decisions to activate different stages of the relapse prevention pathway and share their data with carers and case coordinators. 

2. In addition, the SRN will employ the Research Assistant evaluating the outcomes of the C-RCT and a Peer Support Worker who will engage with and support service user participants randomized to the EMPOWER Relapse Prevention Intervention. The main beneficiaries of the intervention are service users with a diagnosis of schizophrenia and their carers. At the outset of the study we will involve these stakeholders in evaluating the acceptability and usability of ambulant symptom recording using mobile phones and identifying key of incentives and barriers to use. 

3. Our strategy for Knowledge Exchange and Impact also means that we are ensuring the involvement of professional care staff from the outset of the study. This is reflected in our work packages that explore the acceptability and usability of ambulant symptom recording using mobile phones amongst professional care staff, identify incentives and barriers to implementation by NHS Teams and identification existing relapse prevention pathways. 

4. In addition, our use of a Cluster Randomised Controlled Trial design maximises our ability to learn how to implement the EMPOWER Relapse Prevention Intervention into routine care. Our inclusion of sites spanning the United Kingdom and Australia maximises the portability of this intervention across different health systems. 

5. We will work with and seek feedback from a Trial Steering Group following each WP phase. This will enable us to report transparently achievement of milestones and inform the next step of project development. The Trial Steering Group will comprise stakeholders including clinical academic, health service managers and clinicians, and service user and carers.

6. We will organize a number of events for carers, service users and professional staff in Glasgow, Edinburgh, Manchester and Birmingham to identify and share key learning experiences arising from the study and to facilitate scoping and engagement of stakeholders participating in the main study. ..."


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