Health professionals' perspectives on delivering home and hospital management at diagnosis for children with type 1 diabetes: A qualitative study from the Delivering Early Care in Diabetes Evaluation trial.

OBJECTIVE: To explore the delivery of home and hospital management at diagnosis of type 1 diabetes in childhood and any impact this had on health professionals delivering care. METHODS: This qualitative study was undertaken as part of the Delivering Early Care in Diabetes Evaluation randomized controlled trial where participants were individually randomized to receive initiation of management at diagnosis, to home or hospital. Semi-structured telephone interviews were planned with a purposive sample of health professionals involved with the delivery of home and hospital management, to include consultants, diabetes and research nurses, and dieticians from the eight UK centres taking part. The interview schedule focused on their experiences of delivering the two models of care; preferences, impact, and future plans. Data were subject to thematic analysis. RESULTS: Twenty-two health professionals participated, represented by consultants, diabetes and research nurses, and dieticians. Overall, nurses preferred home management and perceived it to be beneficial in terms of facilitating a unique opportunity to understand family life and provide education to extended family members. Nurses described a special bond and lasting relationship that they developed with the home managed children and families. Consultants expressed concern that it jeopardized their relationship with families. Dieticians reported being unable to deliver short bursts of education to families in the home managed arm. All health professionals were equally divided over which was logistically easier to deliver. CONCLUSIONS: A hybrid approach, of a brief stay in hospital and early home management, offers a pragmatic solution to the advantages and challenges presented by both systems.

The experience of living with type 1 diabetes and attending clinic from the perception of children, adolescents and carers: analysis of qualitative data from the DEPICTED study.

Type 1 diabetes (T1D) is a complex, invasive childhood condition. Optimal glycemic control, essential to minimize risk of life-changing complications, is difficult to achieve. The DEPICTED trial evaluated a training program in consultation skills for pediatric diabetes teams. Qualitative descriptive analysis of questionnaire free-text comments from children, adolescents and carers participating in DEPICTED identified the emotional impact of living with T1D and how health professionals' communication skills in clinic influence the patient/carer experience. Healthcare professionals caring for children/adolescents with T1D and carers need training in patient-centered communication skills. Emotional needs of patients/carers need to be systematically assessed and addressed.

An ongoing struggle: a mixed-method systematic review of interventions, barriers and facilitators to achieving optimal self-care by children and young people with type 1 diabetes in educational settings.

BACKGROUND: Type 1 diabetes occurs more frequently in younger children who are often pre-school age and enter the education system with diabetes-related support needs that evolve over time. It is important that children are supported to optimally manage their diet, exercise, blood glucose monitoring and insulin regime at school. Young people self-manage at college/university. METHOD: Theory-informed mixed-method systematic review to determine intervention effectiveness and synthesise child/parent/professional views of barriers and facilitators to achieving optimal diabetes self-care and management for children and young people age 3-25 years in educational settings. RESULTS: Eleven intervention and 55 views studies were included. Meta-analysis was not possible. Study foci broadly matched school diabetes guidance. Intervention studies were limited to specific contexts with mostly high risk of bias. Views studies were mostly moderate quality with common transferrable findings.Health plans, and school nurse support (various types) were effective. Telemedicine in school was effective for individual case management. Most educational interventions to increase knowledge and confidence of children or school staff had significant short-term effects but longer follow-up is required. Children, parents and staff said they struggled with many common structural, organisational, educational and attitudinal school barriers. Aspects of school guidance had not been generally implemented (e.g. individual health plans). Children recognized and appreciated school staff who were trained and confident in supporting diabetes management.Research with college/university students was lacking. Campus-based college/university student support significantly improved knowledge, attitudes and diabetes self-care. Self-management was easier for students who juggled diabetes-management with student lifestyle, such as adopting strategies to manage alcohol consumption. CONCLUSION: This novel mixed-method systematic review is the first to integrate intervention effectiveness with views of children/parents/professionals mapped against school diabetes guidelines. Diabetes management could be generally improved by fully implementing and auditing guideline impact. Evidence is limited by quality and there are gaps in knowledge of what works. Telemedicine between healthcare providers and schools, and school nurse support for children is effective in specific contexts, but not all education systems employ onsite nurses. More innovative and sustainable solutions and robust evaluations are required. Comprehensive lifestyle approaches for college/university students warrant further development and evaluation.

Revisiting a non-significant findings study: a parent mentor intervention trial as exemplar.

The purpose of this paper is to describe an interactive process for revising a parent social support intervention study with non-significant quantitative findings but strong clinical significance. We will present the methodological challenges that were problematic in the original intervention that potentially contributed to the non-significant findings, and a revised plan of action for conducting a future parent social support intervention. Of note, we have reconsidered the theory used to frame the original study, the randomization process, the intervention clarity and fidelity plan, what measures would better capture the effect, and the development of a more robust analysis plan that considers intra-family correlation, mediation and moderation (mixed model analysis). We will present the revision for each of these methods supported by recent empirical literature. Although this process may not be appropriate for all non-significant interventions, it should be considered with any study that has clinical significance.

Involving lay and professional stakeholders in the development of a research intervention for the DEPICTED study.

AIM This paper focuses on stakeholders' active involvement at key stages of the research as members of a Stakeholder Action Group (SAG), particularly in the context of lay stakeholder involvement. Some challenges that can arise and wider issues (e.g. empowerment, the impact of user involvement) are identified and explored within the literature on service user involvement in health care research, reflecting on the implications for researchers. BACKGROUND In the DEPICTED study, lay and professional stakeholders were actively involved in developing a complex research intervention. Lay stakeholders comprised teenage and adult patients with diabetes, parents and patient organization representatives. Professional stakeholders were from a range of disciplines. METHODS Three 1-day research meetings were attended by 13-17 lay stakeholders and 10-11 professional stakeholders (plus researchers). The SAG was responsible for reviewing evidence, advising on developing ideas for the research intervention and guiding plans for evaluation of the intervention in a subsequent trial. Formal evaluations were completed by stakeholders following each SAG meeting. RESULTS Throughout the first (developmental) stage of this two-stage study, lay and professional stakeholders participated or were actively involved in activities that provided data to inform the research intervention. Lay stakeholders identified the need for and contributed to the design of a patient-held tool, strongly influenced the detailed design and content of the research intervention and outcome questionnaire, thus making a major contribution to the trial design. CONCLUSION Stakeholders, including teenagers, can be actively involved in designing a research intervention and impact significantly on study outcomes.

Delivering early care in diabetes evaluation (DECIDE): a protocol for a randomised controlled trial to assess hospital versus home management at diagnosis in childhood diabetes.

BACKGROUND: There is increased incidence of new cases of type 1 diabetes in children younger than 15 years. The debate concerning where best to manage newly diagnosed children continues. Some units routinely admit children to hospital whilst others routinely manage children at home. A Cochrane review identified the need for a large well-designed randomised controlled trial to investigate any significant differences in comprehensive short and long-term outcomes between the two approaches. The DECIDE study will address these knowledge gaps, providing high quality evidence to inform national and international policy and practice. METHODS/DESIGN: This is a multi-centre randomised controlled trial across eight UK paediatric diabetes centres. The study aims to recruit 240 children newly diagnosed with type 1 diabetes and their parents/carers. Eligible patients (aged 0-17 years) will be remotely randomised to either 'hospital' or 'home' management. Parents/carers of patients will also be recruited. Nursing management of participants and data collection will be co-ordinated by a project nurse at each centre. Data will be collected for 24 months after diagnosis; at follow up appointments at 3, 12 and 24 months and every 3-4 months at routine clinic visits.The primary outcome measure is patients' glycosylated haemoglobin (HbA1c) at 24 months after diagnosis. Additional measurements of HbA1c will be made at diagnosis and 3 and 12 months later. HbA1c concentrations will be analysed at a central laboratory.Secondary outcome measures include length of stay at diagnosis, growth, adverse events, quality of life, anxiety, coping with diabetes, diabetes knowledge, home/clinic visits, self-care activity, satisfaction and time off school/work. Questionnaires will be sent to participants at 1, 12 and 24 months and will include a questionnaire, developed and validated to measure impact of the diagnosis on social activity and independence. Additional qualitative outcome measures include the experience of both approaches by a subgroup of participants (n = 30) and health professionals. Total health service costs will be evaluated. A cost effectiveness analysis will assess direct and indirect health service costs against the primary outcome (HbA1c). DISCUSSION: This will be the first randomised controlled trial to evaluate hospital and home management of children newly diagnosed with type 1 diabetes and the findings should provide important evidence to inform practice and national guidelines. TRIAL REGISTRATION NUMBER: ISRCTN: ISRCTN78114042.

Evidence into practice: evaluating a child-centred intervention for diabetes medicine management. The EPIC Project.

BACKGROUND: 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. This paper describes the development of a range of child-centred diabetes information resources and outlines the study design and protocol for a randomized controlled trial to evaluate the information resources in routine practice. The aim of the diabetes information intervention is to improve children and young people's quality of life by increasing self-efficacy in managing their type 1 diabetes. METHODS/DESIGN: We used published evidence, undertook qualitative research and consulted with children, young people and key stakeholders to design and produce a range of child-centred, age-appropriate children's diabetes diaries, carbohydrate recording sheets, and assembled child-centred, age-appropriate diabetes information packs containing published information in a folder that can be personalized by children and young people with pens and stickers. Resources have been designed for children/young people 6-10; 11-15; and 16-18 years.To evaluate the information resources, we designed a pragmatic randomized controlled trial to assess the effectiveness, cost effectiveness, and implementation in routine practice of individually tailored, age-appropriate diabetes diaries and information packs for children and young people age 6-18 years, compared with currently available standard practice.Children and young people will be stratified by gender, length of time since diagnosis (< 2 years and > 2 years) and age (6-10; 11-15; and 16-18 years). The following data will be collected at baseline, 3 and 6 months: PedsQL (generic, diabetes and parent versions), and EQ-5 D (parent and child); NHS resource use and process data (questionnaire and interview). Baseline and subsequent HbA1c measurements, blood glucose meter use, readings and insulin dose will be taken from routine test results and hand-held records when attending routine 3-4 monthly clinic visits.The primary outcome measure is diabetes self-efficacy and quality-of-life (Diabetes PedsQL). Secondary outcomes include: HbA1c, generic quality of life, routinely collected NHS/child-held data, costs, service use, acceptability and utility. TRIAL REGISTRATION: ISRCTN17551624.

Development and Evaluation of a Psychosocial Intervention for Children and Teenagers Experiencing Diabetes (DEPICTED): a protocol for a cluster randomised controlled trial of the effectiveness of a communication skills training programme for healthcare professionals working with young people with type 1 diabetes.

BACKGROUND: Diabetes is the third most common chronic condition in childhood and poor glycaemic control leads to serious short-term and life-limiting long-term complications. In addition to optimal medical management, it is widely recognised that psychosocial and educational factors play a key role in improving outcomes for young people with diabetes. Recent systematic reviews of psycho-educational interventions recognise the need for new methods to be developed in consultation with key stakeholders including patients, their families and the multidisciplinary diabetes healthcare team. METHODS/DESIGN: Following a development phase involving key stakeholders, a psychosocial intervention for use by paediatric diabetes staff and not requiring input from trained psychologists has been developed, incorporating a communication skills training programme for health professionals and a shared agenda-setting tool. The effectiveness of the intervention will be evaluated in a cluster-randomised controlled trial (RCT). The primary outcome, to be measured in children aged 4-15 years diagnosed with type 1 diabetes for at least one year, is the effect on glycaemic control (HbA1c) during the year after training of the healthcare team is completed. Secondary outcomes include quality of life for patients and carers and cost-effectiveness. Patient and carer preferences for service delivery will also be assessed. Twenty-six paediatric diabetes teams are participating in the trial, recruiting a total of 700 patients for evaluation of outcome measures. Half the participating teams will be randomised to receive the intervention at the beginning of the trial and remaining centres offered the training package at the end of the one year trial period. DISCUSSION: The primary aim of the trial is to determine whether a communication skills training intervention for specialist paediatric diabetes teams will improve clinical and psychological outcomes for young people with type 1 diabetes. Previous research indicates the effectiveness of specialist psychological interventions in achieving sustained improvements in glycaemic control. This trial will evaluate an intervention which does not require the involvement of trained psychologists, maximising the potential feasibility of delivery in a wider NHS context. TRIAL REGISTRATION: Current Controlled Trials ISRCTN61568050.

Chronic sorrow in parents of children with type 1 diabetes.

AIM: This paper reports on a study exploring parents' longer-term experiences of having a child with type 1 diabetes. BACKGROUND: Parents of children with type 1 diabetes may experience a grief reaction at diagnosis similar to that normally associated with bereavement, but little is known about their long-term emotional adaptation. Chronic sorrow, a sustained but intermittent grief reaction, is identified in adults with diabetes but has not previously been explored in relation to parents. METHODOLOGY: In-depth interviews were conducted in 2007 with a convenience sample of 17 parents of children with type 1 diabetes 7-10 years after diagnosis. Data were explored within a theoretical framework of grief, loss, adaptation, and change. FINDINGS: Parents had adapted to the needs of diabetes management but most had not 'come to terms' with the diagnosis. They experienced a resurgence of grief at critical times during their child's development and some, particularly mothers, became upset during their interviews, even though these took place 7-10 years after their child's diagnosis. Mothers elaborated more on their emotions than fathers, but continuing feelings associated with grief, such as anger and guilt, were expressed by both fathers and mothers. CONCLUSION: Greater understanding of parents' long-term emotional responses and recognition that grief may never resolve in these parents may enable healthcare professionals to provide appropriate and timely support at critical times.

Decision-making: initiating insulin therapy for adults with diabetes.

AIM: This paper is a report of a study to describe nurses' perceptions of decision-making and the evidence base for the initiation of insulin therapy. BACKGROUND: Several theoretical perspectives and professional's attributes underpin decision-making to commence insulin therapy. The management of type 2 diabetes is moving from secondary to primary care and this affects how clinical decisions are made, by whom and the evidence base for these decisions. METHOD: A postal survey was conducted with a stratified sample of 3478 Diabetes Specialist Nurses and Practice Nurses with a special interest in diabetes across the four countries of the United Kingdom. A total of 1310 valid responses were returned, giving a response rate of 37.7%. The questionnaire was designed for the study and pilot-tested before use. Responses were given using Likert-type scales. Data were collected during 2005 and 2006, and one reminder was sent. RESULTS: People with diabetes are seen as having little influence in decision-making. Consultant physicians appear to be influential in most decisions, and the nursing groups held varying perceptions of who made clinical decisions. Nurses' identified different responsibilities for those working solely in secondary care from those working in both community and secondary care. Practice nurses were not as involved as anticipated. CONCLUSION: Nurses working with people with diabetes need to encourage them to become more active partners in care. Clinical guidelines can assist in decision-making where nurses are least experienced in initiating insulin therapy.

The kidney transplant failure experience: a longitudinal case study.

PURPOSE: To explore participants' experiences of kidney transplant failure. BACKGROUND: Kidney transplants are effective and efficient but not without complications. About 7% to 12% of kidney transplants fail within a year, and rates of failure increase over time. Graft failure can have profound effects, often resulting in depression and, occasionally, suicidal feelings. Despite these issues, the personal dimensions of graft failure have been poorly researched. METHODS: One donor-recipient couple experienced irreversible graft rejection immediately after a kidney transplant. This article is a longitudinal case study of this family's experiences. Data were collected through 3 semistructured interviews, conducted before the transplant and at 3 and 10 months after the transplant. Interviews were recorded, transcribed verbatim, and data coded into categories arising from the participants' accounts. RESULTS: Transplantation represented a significant source of hope. Fear of transplant failure was a major concern, but was dealt with by using emotion-focused coping mechanisms. Graft rejection was devastating, causing feelings of grief, loss, suicide, and depression. Depression improved as physical health and a sense of personal control improved. The recipient felt inadequately prepared for graft failure and poorly supported by health professionals. CONCLUSION: The primary source of grief and depression appeared to be related to the recipient's "loss of imagined future" (ie, the life that she anticipated after transplant). Study findings have potential implications for the provision of care, information, and support for patients and their families before and after transplantation and for future related research.

A UK wide survey of insulin initiation in children with type 1 diabetes and nurses' perceptions of associated decision-making.

AIM AND OBJECTIVES: The aim of this study was to examine insulin initiation practice across the UK in relation to children with newly diagnosed type 1 diabetes. Objectives of this study were to explore practices surrounding insulin initiation in children and nurses' perceptions of associated decision-making. BACKGROUND: There are comparative studies of insulin treatments and regimens for children but few that describe the insulin initiation process or associated decision-making. The literature suggests a heavy workload for nurses working in practice and insufficient resources for home initiation of insulin. DESIGN: A survey design. METHOD: A questionnaire regarding insulin initiation was distributed to 247 diabetes specialist nurses working with children from all four UK countries. RESULTS: One hundred and twelve responses (45%). Only 37 (33%) started clinically well, newly diagnosed children on insulin at home, but most would do so with adequate resources. The most common insulin regimen at diagnosis was twice daily injections, with 86% (n = 96) using re-usable pens to deliver the insulin. As expected, no one commenced children on pump therapy at diagnosis. Analogue insulin was seen as the drug of choice by over a quarter of the nurses (29%, n = 32). Doctors appeared to be the main decision-makers, supplemented by other members of the paediatric diabetes multi-disciplinary team and decision-making aids. CONCLUSION: Approaches to treatment at onset of type 1 diabetes in children remain relatively traditional. Nurses expressed a desire to stabilise clinically well children at home but were restricted by lack of resources. Decision-making in most domains was largely medically dominated. RELEVANCE TO CLINICAL PRACTICE: The study provides an insight into current insulin initiation practice in childhood diabetes and offers a useful comparator as practices change in the light of advances in treatment (medication and equipment), changes in professional roles (e.g. independent prescribing) and policy shifts (the move away from hospitals and resource constraints).

Effectiveness of home or hospital initiation of treatment at diagnosis for children with type 1 diabetes (DECIDE trial): a multicentre individually randomised controlled trial.

OBJECTIVE: To determine whether, in children with newly diagnosed type 1 diabetes who were not acutely unwell, management at home for initiation of insulin treatment and education of the child and family, would result in improved clinical and psychological outcomes at 2 years postdiagnosis. DESIGN: A multicentre randomised controlled trial (January 2008/October 2013). SETTING: Eight paediatric diabetes centres in England, Wales and Northern Ireland. PARTICIPANTS: 203 clinically well children aged under 17 years, with newly diagnosed type 1 diabetes and their carers. INTERVENTION: Management of the initiation period from diagnosis at home, for a minimum of 3 days, to include at least six supervised injections and delivery of pragmatic educational care. MAIN OUTCOME MEASURES: Primary outcome was glycosylated haemoglobin (HbA1c) concentration at 24 months postdiagnosis. Secondary outcomes included coping, anxiety, quality of life and use of NHS resources. RESULTS: 203 children, newly diagnosed, were randomised to commence management at home (n=101) or in hospital (n=102). At the 24 month primary end point, there was one withdrawal and a follow-up rate of 194/202 (96%). Mean HbA1c in the home treatment arm was 72.1 mmol/mol and in the hospital treated arm 72.6 mmol/mol. There was a negligible difference between the mean HbA1c levels in the two arms adjusted for baseline (1.01, 95% CI 0.93 to 1.09). There were mostly no differences in secondary outcomes at 24 months, apart from better child self-esteem in the home-arm. No home-arm children were admitted to hospital during initiation and there were no adverse events at that time. The number of investigations was higher in hospital patients during the follow-up period. There were no differences in insulin regimens between the two arms. CONCLUSIONS: There is no evidence of a difference between home-based and hospital-based initiation of care in children newly diagnosed with type 1 diabetes across relevant outcomes. TRIAL REGISTRATION NUMBER: ISRCTN78114042.