Summary
This study investigated the impact of home or hospital management on biopsychosocial and economic outcomes of children with type 1 diabetes at the time of diagnosis. Children were randomised to receive treatment initiation at home or in hospital with a primary outcome of difference in HbA1c 24 months after commencing therapy, while personal outcomes such as anxiety and quality of life were also measured.
The study found that hospital management of type 1 diabetes in clinically-well children at diagnosis significantly increases NHS costs, with no difference in glycaemic control or quality of life over the first 24 months when compared to home management.
Results
This study involved the largest UK sample of children with diabetes ever recruited at diagnosis.
The primary outcome measure was glycosylated haemoglobin (HbA1c) at 24 months: findings showed no significant difference (p=0.865) in mean HbA1c between home and hospital.
Secondary outcome measures for patients included psychological assessment of quality of life. For parents, they included anxiety.
Parents showed no significant differences between trial arms. For children, there were some significant differences, and one differential effect over time between trial arms, self-esteem. Both staying in hospital and going home produced some stress, just different.
Initiation costs were significantly higher in the hospital arm due to the costs of in-patient care. Direct diabetes specific resource use was similar between arms.
Challenge
Before this study there was no high quality evidence on the differences in outcomes between hospital admissions and home management from diagnosis in children who are clinically-well.
If one or the other was found to reduce re-admissions and result in improved, sustained, glycaemic control, it could help reduce the risk of diabetes-related complications in later life. These issues needed to be examined, to determine the effect of home management and hospitalisation on patients’ long term health and wellbeing, and to assess cost-effectiveness. A randomised controlled trial (RCT) was needed.
The DECIDE multi-centred RCT was designed to provide high quality evidence on which to base decisions about the treatment environment (home or hospital) for children with newly diagnosed type 1 diabetes.
Objectives
The research aimed to determine whether, in children with newly diagnosed diabetes who were not acutely unwell, it was better to admit to hospital for initiation of insulin treatment, or whether results would be better if initial management was provided at home.
It investigated the effect of starting treatment at home and in hospital. The research looked at parents' and children's psychological adjustment, coping and adaptation to the diagnosis, diabetes knowledge and satisfaction with service provision, total health service resource use and patient borne costs including time off school/work.
It explored the experience of home management and hospitalisation from the perspective of parents, children with diabetes, and health professionals.
Solution
This was a multi-centre RCT. The sample comprised 203 children aged 0-17 years newly diagnosed with type 1 diabetes, and their parents. Participants were randomised to receive either hospital or home management. Eight UK paediatric diabetes centres participated - a DECIDE manual was developed to assist them.
Data concerning length of stay at diagnosis, glycaemic control, growth, re-admissions, adverse events, home and clinic visits, school attendance, self-care activity and parents' time off work (related to the child's diabetes) and travel costs were collected at clinic visits for 24 months after diagnosis. At months one, 12 and 24, a blood sample was taken for HbA1c assessment in a centralised laboratory. Parents and children completed questionnaires at these stages.
Twenty months after diagnosis, face-to-face interviews were undertaken with parents and children, in both the hospital and home arms of the test. Telephone interviews were undertaken with health professionals.
Learnings
One of the main outputs from the developmental work at the start of this study was the manualisation of key components underpinning home-based care from diagnosis. This was necessary to support participating units lacking previous experience of providing home-based care from diagnosis. It will facilitate the cascading of these clinical approaches to other NHS Trusts.
Interviews with participating healthcare professionals underlined the implications of introducing new models of care. The analyses of these interviews provided insights into the challenges of introducing a new management approach.
Qualitative interviews with children aged >8 years with diabetes and their parents provided important information concerning what patients and families value, which will inform teams considering changes to their care model.
Evaluation
It is too early to measure the impact of this intervention beyond the immediate study.
The programme for care at home from diagnosis has been designed in a pragmatic manner to be easily adapted in centres beyond the immediate trial.
Two of the eight centres participating discontinued this approach when DECIDE finished, citing resource issues as a primary reason. Two changed their practice from hospital to home management following the trial but only under specific circumstances – if the child is two under years of age and diagnosed within office hours. Others have adopted a ‘hybrid’ model of home management in which children stay in hospital for one night at diagnosis and are subsequently managed in the home environment.
