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
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).


CONCLUSIONS
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.


BACKGROUND
ISRCTN: ISRCTN78114042.
South East Wales Trials Unit, Department of Primary Care & Public Health, School of Medicine, Cardiff University, 7th floor Neuadd Meirionnydd, Heath Park, Cardiff CF14 4YS, UK. townson@cf.ac.uk
Julia K
JK
Townson
John W
JW
Gregory
David
D
Cohen
Sue
S
Channon
Nicola
N
Harman
Justin H
JH
Davies
Justin
J
Warner
Nicola
N
Trevelyan
Rebecca
R
Playle
Michael
M
Robling
Kerenza
K
Hood
Lesley
L
Lowes
D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D002985:Clinical Protocols; D017281:Cost of Illness; D003362:Cost-Benefit Analysis; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000175:diagnosis / Q000191:economics / Q000451:nursing / Q000523:psychology / Q000628:therapy*; D019468:Disease Management; D042241:Early Diagnosis; D006442:Glycated Hemoglobin / Q000032:analysis; D007722:Health Knowledge, Attitudes, Practice; D006701:Home Nursing; D006760:Hospitalization; D006801:Humans; D007223:Infant; D007902:Length of Stay; D017063:Outcome Assessment, Health Care; D011788:Quality of Life; D006113:United Kingdom
D006442:Glycated Hemoglobin
N Engl J Med. 1993 Sep 30;329(14):977-86
8366922
Cochrane Database Syst Rev. 2003;(3):CD004099
12918002
J Consult Clin Psychol. 1990 Apr;58(2):189-95
2335636
Tex Med. 1992 Jul;88(7):64-8
1496490
Diabet Med. 2004 Jun;21(6):531-8
15154935
Diabetes Care. 2003 Mar;26(3):631-7
12610013
Arch Dis Child. 2004 Oct;89(10):934-7
15383437
Br J Clin Psychol. 1992 Sep;31(3):301-6
1393159
Nurs Health Sci. 1999 Mar;1(1):63-70
10894653
Diabetes Care. 1997 Apr;20(4):657-60
9096999
BMJ. 1993 Jul 10;307(6896):96-8
8343736
Med Care. 1998 Apr;36(4):586-98
9544598
J Adv Nurs. 2005 May;50(3):253-61
15811104
Clin Pediatr (Phila). 1992 Aug;31(8):450-6
1643761
J Pediatr Psychol. 2002 Oct-Nov;27(7):647-52
12228336
Lancet. 2009 Jun 13;373(9680):2027-33
19481249