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Evidence into practice: evaluating a child-centred intervention for diabetes medicine management

Evidence into practice: evaluating a child-centred intervention for diabetes medicine management Trial Registration: ISRCTN17551624 Principal Investigators: Professor Jane Noyes (1) Dr Lesley Lowes (2), Professor Anne Williams (retired) (2) EPIC Researchers

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Evidence into practice: evaluating a child-centred intervention for diabetes medicine management

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  1. Evidence into practice: evaluating a child-centred intervention for diabetes medicine management Trial Registration: ISRCTN17551624 Principal Investigators: Professor Jane Noyes (1)Dr Lesley Lowes (2), Professor Anne Williams (retired) (2) EPIC Researchers Dr Llinos Spencer (1) Deborah Edwards 1 Bangor University, Wales 2 Cardiff University, Wales This project was funded by the NIHR Health Services and Delivery Research programme (http://www.netscc.ac.uk/hsdr/projdetails.php?ref=08-1704-211)

  2. Background • People of all ages require high quality information promoting health, self care and medicine management to help facilitate them in making choices. • There is a lack of high quality, child-centred and effective health information to support development of self-care practices and expertise in children with acute and long-term conditions. • In type 1 diabetes, clinical guidelines indicate that high-quality, child-centred information underpins achievement of optimal glycaemic control with the aim of minimising acute readmissions and reducing the risk of complications in later life. (NICE Guidelines, 2004). • Tailored, child-centred information could equip children and young people with the knowledge to become expert in diabetes care (Waller et al., 2005; NICE, Guidelines, 2004).

  3. Child-centred health information • The development of self-care is dependent on information that is:- • age-appropriate • child-centred • Children’s National Service Framework (NSF). • Little evidence on provision of such age appropriate and child-centred information • Even less evidence about types and formats of information which could empower children and young people to make decisions and choices about aspects of their care. • Medicines for Children Research Network set up • Information Matters Project (a linked foundation study to EPIC) was funded by the National Institute for Health Research: Service Delivery and Organisation

  4. Research aims of the EPIC Project • To develop and evaluate an: • individually-tailored • age-appropriate diabetes diary and information pack • to support decision-making and self-care relating to insulin management and electronic blood glucose monitoring for children/young people aged 6-18 yrs with type 1 diabetes, compared with available resources (if any) in routine clinical practice. • The packs will be for children/young people aged: • 6-10 years • 11-15 years • 16-18 years

  5. EPIC Project: A four stage project • Stage 1: Review, and where appropriate, undertake further work to identify types/formats of information most likely to assist age-appropriate decision-making/choices related to children/young people with type 1 diabetes. • Stage 2: Construct age appropriate diabetes diaries and information packs, and consult with children as appropriate. • Stage 3: Conduct a pragmatic evaluation to assess utility, acceptability, effectiveness and cost effectiveness of the diabetes diaries and information pack. • Stage 4: Undertake data synthesis and comparative analysis of stages 1-3.

  6. Methods/Design • Published evidence • Qualitative research • Consultations with children and young people • Children’s diabetes diaries • Carbohydrate recording sheets • Age-appropriate diabetes information packs containing published information in a folder • Folder can be personalised by children and young people with pens and stickers. • Resources were designed for children and young people in the following age ranges – 6-10, 11-15 and 16-18. • RCT to assess the effectiveness • Cost effectiveness • And Implementation of the EPIC intervention packs in routine practice

  7. EPIC information intervention pack for children 6-10 years (customised)

  8. EPIC information intervention pack for children and young people 11-15 years (not customised)

  9. EPIC information intervention pack for young people 16-18 years

  10. Pump diary

  11. Recruitment sites for the EPIC Project Bangor University (Llinos) • Ysbyty Gwynedd, Betsi Cadwaladr University Health Board • Ysbyty Glan-Clwyd, Betsi Cadwaladr University Health Board • Wrexham Maelor Hospital, Betsi Cadwaladr University Health Board • Royal Bolton Hospital NHS Foundation Trust • Southport and Ormskirk NHS Trust - Ormskirk DGH • Blackpool and Fylde NHS Trust – Blackpool Victoria Hospital • Maidstone and Tunbridge Wells NHS Trust - Maidstone DGH • Hull and East Yorkshire NHS Trust - Hull DGH Cardiff University (Debs) • Abertawe Bro Morgannwg University NHS Trust - Singleton Hospital • Derby Hospitals NHS Foundation Trust - Derbyshire Royal Infirmary • Norfolk and Norwich University Hospital – Norwich DGH 11 EPIC Sites throughout England and Wales

  12. EPIC Randomised Controlled Trial supported by NWORTH • Site selection was guided by co-applicant clinicians and the MCRN/NISCHR CRC Cymru Research Network. • N = 338 children/young people randomised into the EPIC RCT between 16th February 2010 and 11th August 2011. • Age categories: 6-10, 11-15 and 16-18. • 2/3 randomised into Pack arm • 1/3 randomised into Control arm

  13. Questionnaires • Baseline questionnaires • Children/young people • Parents • Healthcare professionals (CRF) • 3 month follow-up questionnaires • Children/young people • Parents • Healthcare professionals (CRF) • 6 month follow-up questionnaires • Children/young people • Parents • Healthcare professionals (CRF)

  14. Data management and Statistical Analysis • Questionnaire data cleaning by Shubha Sreenivas and Darren Baker at NWORTH, Bangor University • Statistical analysis for the RCT data by Yvonne Sylvestre and Rhiannon Whitaker at NWORTH, Bangor University • Statistical analysis of the Health Economics data by Seow Tien Yeo and Rhiannon Tudor-Edwards at the Health Economics Unit, Bangor University

  15. Process evaluation interviews • Process evaluation hypothesis: For implementation of evidence to be successful there needs to be clarity about the nature of the evidence being used, the quality of context, and the type of facilitation needed to ensure a successful process. • Conceptual framework: PARiHS • The hypothesis is based upon an understanding of the nature of the relationship between evidence, facilitation and context as core elements. These core elements have been conceptualised in a framework Promoting Action on Implementation of Research in Health Services (PARiHS) N = 60 children and young people and their families were interviewed. N = 41 children/young people from intervention arm N = 19 children/young people from control arm.

  16. Aims of the EPIC process evaluation • A) To evaluate the introduction of an evidence based information pack into children’s self-care regime and healthcare practice in order to improve blood glucose meter use and insulin management. • B) To focus on the key contextual variables mediating the implementation and use of the information pack. • C) To facilitate the gathering of individual (e.g. child/parent/practitioner) experiences as well as appreciating the fit with the broader context of care delivery. • D) To determine the acceptability and feasibility of the information pack.

  17. Healthcare professionals process evaluation questionnaires • Healthcare professionals associated with the care of children/young people recruited to the trial were also invited to complete a semi-structured questionnaires to determine acceptability and impact of the new diabetes diaries and information pack in practice. • Healthcare professionals questionnaire data will be analysed using descriptive statistics and open ended questions will be subject to content analysis. • This work is currently in progress.

  18. Programme logic • 1.  An age appropriate EPIC intervention information folder was to be handed to the child/young person by a diabetes specialist (Diabetes Nurse Specialist or Consultant). 2. The Diabetes Specialist was to integrate the EPIC information pack into their routine care of children and young people. 3. The Diabetes Specialists were to develop child centred ways of supporting children and young people, and their families to use and to continue using the EPIC information pack provided. 4. The Diabetes Specialists were to encourage the child/young person to use the EPIC age appropriate diaries to record their insulin management and blood glucose levels. 5. The Diabetes Specialists were to encourage children/young people on a basal bolus regime to use the EPIC Carbohydrate Counting Sheets to record their daily intake.

  19. References • Department of Health: Medicines for Children Standard. National Service Framework for Children/young people and Maternity Services. Department of Health, London; 2004. • MRC: Medical Research Council: Developing and Evaluating complex interventions. New guidance. MRC, London; 2008. • NICE. Type 1 diabetes: diagnosis and management of type 1 diabetes in children and young people. National Institute for Clinical Excellence. RCOG Press; 2004. • Waller, H., Eiser, C., Heller, S., Knowles, J., Price, K. Adolescents and their parents views on the acceptability and design of new diabetes education: a focus group analysis. Childcare Health and Development, 2005, 31 (3): 283-289.

  20. Contacting the EPIC Project Research Officers • If you have any queries, please contact: NORTH WALES AND NORTH ENGLAND Dr Llinos Spencer, EPIC Project Research Officer, Centre for Health-Related Research, School of Healthcare Sciences, Bangor University, Bangor, Gwynedd, Wales, LL57 2EF. • Tel: 01248 38 3171. E-mail: L.Spencer@bangor.ac.uk SOUTH WALES AND SOUTH ENGLAND Deborah Edwards, EPIC Project Research Officer, School of Nursing and Midwifery Studies, Cardiff University, Room 407, Eastgate House, 35-43 Newport Road, Cardiff, CF24 0AB • Tel: 02920 91 7810. E-mail: edwardsdj@cardiff.ac.uk www.epicproject.info

  21. Department of Health disclaimer: • 'The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HS&DR programme, NIHR, NHS or the Department of Health.’

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