Professionals

Please see home page for the current progress of this study.

Scientific Summary
Little evidence exists concerning the effectiveness of the types and formats of information that could empower children to make decisions regarding medicines and self-care. For children with type-1 diabetes, intensive structured education programmes exist, however there is insufficient evidence about the effectiveness of information underpinning these programmes or routine clinical management.

Aim
The aim of the EPIC project was to develop and evaluate an individually-tailored, age-appropriate information resource to support decision-making and self-care relating to insulin management and electronic blood glucose monitoring for children aged 6-18yrs with type-1 diabetes, compared with available resources (if any) in routine clinical practice.

Objectives
* Review gold-standard clinical guidelines and currently available information including findings from completed Phase 1 of current SDO/145/2007 to identify best practice, and types/formats of information most likely to assist age-appropriate decision-making and choices concerning blood glucose monitoring and insulin management.

* Develop an age-appropriate child-centred information resource for children/young people, to support appropriate use of blood glucose meters to optimise management of and concordance with their insulin regime.

* Explore the utility of the resource within different contexts in which children manage their routine diabetes care (home, school, community) with and without support from parents or healthcare professionals, and in alternative settings.

* Explore how children, with and without their parents, teachers, nurses, doctors use (or not) the information resource to support decision-making; in particular how children/parents 'self-prescribe' the correct (or incorrect) dose of insulin.

* Identify similarities and differences between the resource developed for adolescents and those available within adult diabetes services.

* Evaluate the resource within the context of routine diabetes care in relation to patient outcomes (diabetes-specific, health-related quality-of-life concordance, acceptability, ease of use, and glycaemic control).

* Identify gaps in knowledge.

Methods

The investigation was a mixed-method study informed by the `Promoting Action on Research Implementation in Health Services' (PARIHS) framework which has been widely used to inform design and evaluation of evidence-into-practice initiatives. To meet our objectives which are aligned with the phases of the MRC framework for RCTs of complex interventions we designed a four-stage study:

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 an exemplar information resource, piloting for variations as necessary.

Stage 3. Conduct a pragamatic evaluation to assess utility, acceptability, effectiveness and cost effectiveness of the information resource.

Stage 4. Undertake data synthesis and comparative analysis.
Outcomes

Outcomes

Choice of outcomes is guided by HTA commissioned systematic reviews recommending that HbA1c (glycaemic control measure) is not the appropriate primary outcome on which to assess benefits of an intervention designed to more directly effect behaviour/self-management. Therefore, the primary outcome measure is diabetes self-efficacy and quality-of-life (Diabetes PedsQol). Secondary outcomes include: HbA1c, generic quality of life, routinely collected NHS/child-held data, costs, service use, acceptability/utility.