The effect of the Talking Diabetes consulting skills intervention on glycaemic control and quality of life in children with type 1 diabetes: cluster randomised controlled trial (DEPICTED study)BMJ 2012; 344 doi: https://doi.org/10.1136/bmj.e2359 (Published 26 April 2012) Cite this as: BMJ 2012;344:e2359
- Mike Robling, senior lecturer and associate director1,
- Rachel McNamara, senior trial manager1,
- Kristina Bennert, senior research fellow1,
- Christopher C Butler, professor of primary care medicine and head of department5,
- Sue Channon, consultant clinical psychologist2,
- David Cohen, professor of health economics3,
- Elizabeth Crowne, consultant in paediatric endocrinology and diabetes4,
- Helen Hambly, data manager1,
- Kamila Hawthorne, reader5,
- Kerenza Hood, professor of medical statistics and director1,
- Mirella Longo, health economist3,
- Lesley Lowes, reader and paediatric diabetes nurse6,
- Tim Pickles, junior statistician1,
- Rebecca Playle, senior statistician1,
- Stephen Rollnick, professor of healthcare communication5,
- Emma Thomas-Jones, senior trial manager1,
- John W Gregory, professor of paediatric endocrinology and honorary consultant2
- 1South East Wales Trials Unit, Department of Primary Care and Public Health, School of Medicine, Cardiff University, Cardiff CF14 4YS, UK
- 2Department of Child Health, School of Medicine, Cardiff University
- 3Faculty of Health, Sport and Science, University of Glamorgan, UK
- 4Bristol Royal Hospital for Children, University Hospital Bristol NHS Foundation Trust, UK
- 5Department of Primary Care and Public Health, School of Medicine, Cardiff University
- 6School of Nursing and Midwifery Studies, Cardiff University
- Correspondence to: M Robling
- Accepted 2 March 2012
Objective To evaluate the effectiveness on glycaemic control of a training programme in consultation skills for paediatric diabetes teams.
Design Pragmatic cluster randomised controlled trial.
Setting 26 UK secondary and tertiary care paediatric diabetes services.
Participants 79 healthcare practitioners (13 teams) trained in the intervention (359 young people with type 1 diabetes aged 4-15 years and their main carers) and 13 teams allocated to the control group (334 children and their main carers).
Intervention Talking Diabetes programme, which promotes shared agenda setting and guiding communication style, through flexible menu of consultation strategies to support patient led behaviour change.
Main outcome measures The primary outcome was glycated haemoglobin (HbA1c) level one year after training. Secondary outcomes were clinical measures (hypoglycaemic episodes, body mass index, insulin regimen), general and diabetes specific quality of life, self reported and proxy reported self care and enablement, perceptions of the diabetes team, self reported and carer reported importance of, and confidence in, undertaking diabetes self management measured over one year. Analysis was by intention to treat. An integrated process evaluation included audio recording a sample of 86 routine consultations to assess skills shortly after training (intervention group) and at one year follow-up (intervention and control group). Two key domains of skill assessment were use of the guiding communication style and shared agenda setting.
Results 660/693 patients (95.2%) provided blood samples at follow-up. Training diabetes care teams had no effect on HbA1c levels (intervention effect 0.01, 95% confidence interval −0.02 to 0.04, P=0.5), even after adjusting for age and sex of the participants. At follow-up, trained staff (n=29) were more capable than controls (n=29) in guiding (difference in means 1.14, P<0.001) and agenda setting (difference in proportions 0.45, 95% confidence interval 0.22 to 0.62). Although skills waned over time for the trained practitioners, the reduction was not significant for either guiding (difference in means −0.33, P=0.128) or use of agenda setting (difference in proportions −0.20, −0.42 to 0.05). 390 patients (56%) and 441 carers (64%) completed follow-up questionnaires. Some aspects of diabetes specific quality of life improved in controls: reduced problems with treatment barriers (mean difference −4.6, 95% confidence interval −8.5 to −0.6, P=0.03) and with treatment adherence (−3.1, −6.3 to −0.01, P=0.05). Short term ability to cope with diabetes increased in patients in intervention clinics (10.4, 0.5 to 20.4, P=0.04). Carers in the intervention arm reported greater excitement about clinic visits (1.9, 1.05 to 3.43, P=0.03) and improved continuity of care (0.2, 0.1 to 0.3, P=0.01).
Conclusions Improving glycaemic control in children attending specialist diabetes clinics may not be possible through brief, team-wide training in consultation skills.
Trial registration Current Controlled Trials ISRCTN61568050.
We thank the contribution of the following in the conduct and delivery of the DEPICTED study: Participating clinical centres and support groups: the local principal investigators, members of each clinical team, and local UKCRN research staff participating in the 26 trial centres, and to all the practitioners and families who contributed to the development and implementation of the Talking Diabetes intervention (particularly from clinics and support groups in South Wales and South West England). The local principal investigators and participating NHS Trusts were: Paul Langridge (children’s community specialist nurse) at Countess of Chester Hospital NHS Foundation Trust; Tracy Tinklin (consultant paediatrician) at Derby Hospitals NHS Foundation Trust; Francesca Annan (specialist paediatric dietitian) at Royal Liverpool Children’s NHS Trust; Timothy Barratt (professor of paediatrics) at Wellcome Trust Clinical Research Facility at Birmingham Children’s Hospital NHS Trust; Claire Smith (consultant paediatrician) at East Lancashire Hospitals NHS Trust; Fiona Regan (consultant paediatrician) at the Hillingdon Hospital NHS Trust; Rakesh Amin (consultant paediatric endocrinologist) at Central Manchester and Manchester Children’s University Hospitals NHS Foundation Trust; Mark Bone (paediatric diabetologist) at Central Manchester and Manchester Children’s University Hospitals NHS Trust; Loretta Davis-Reynolds (consultant paediatrician) and Sunil Bhimsaria (consultant paediatrician) at Barnsley Hospital NHS Foundation Trust; Marie Marshall (paediatric diabetes nurse) at Central Manchester and Manchester Children’s University Hospitals NHS Foundation Trust; Neil Hopper (consultant paediatrician) at City Hospitals Sunderland NHS Foundation Trust; Anuja Natarajan (consultant paediatrician) at Doncaster and Bassetlaw Hospitals NHS Foundation Trust; Peter Stutchfield (consultant paediatrician) at Conway and Denbighshire NHS Trust; Jerry Wales (senior lecturer in paediatric endocrinology) at Sheffield Children’s NHS Trust; Fran Ackland (consultant paediatrician) at Northampton General Hospital NHS Trust; Shailini Bahl (consultant paediatrician) at Ashford and St Peter’s Hospitals NHS Trust; Sue Courtman (diabetes nurse) at East and North Hertfordshire NHS Trust; Ivor Lewis (consultant paediatrician) at Surrey and Sussex Healthcare NHS Trust; Roma Romano-Morgan (paediatric diabetes nurse specialist) at the Whittington Hospital NHS Trust; Joanna Stanley (consultant paediatrician) at the Lewisham Hospital NHS Trust; Victoria Surrell (diabetes specialist nurse) at Hinchingbrooke Healthcare NHS Trust; Tim Taylor (consultant paediatrician) at Royal West Sussex NHS Trust; Nicola Trevelyan (consultant paediatrician) at Southampton University Hospitals NHS Trust; Tabitha Randell (consultant in paediatric endocrinology and diabetes) at Nottingham University Hospitals NHS Trust; Fiona Campbell (clinical director) at the Leeds Teaching Hospitals NHS Trust; Roby Mathew (consultant paediatrician) at Chesterfield Royal Hospital NHS Foundation Trust. Administrative, methodological, and technical support: Veronica Silva Dunning (trial administrator), Ian Russell (co-applicant), Helen Stanton, Tim Harris, Cathy Lisles, Neil Burt, Fasih Alam, Benedict Hodge, Karen Marsh (consultation rater), Nina Gobat (consultation rater), Carolyn Blake, and members of the administrative team at SEWTU. Members of the trial steering committee: Steve Greene (chair), Julie Edge, Tim Peters, Frank Snoek. Members of the Stakeholder Advisory Group: the young patients, parents, adult patients, and diabetes professionals participating in the SAG who critically helped design the trial intervention and Neil Frude who acted as SAG facilitator. User representative: We particularly thank the dedicated input of our parent and patient representative Charlotte Crawley (co-applicant) in particular during the development phase of the study. Other contributors to programme development: students and staff at Whitchurch High School (drama club), escape to Design (3T: TimeToTalk), the HealthCare Learning Company (Talking Diabetes online learning programme, in particular Pat Cannon, Valerie Dougall), Philippa Thomas and Dafydd Gape (learning programme actors). Institutional support: the South East Wales Trials Unit is funded by the Wales Assembly Government through the National Institute of Social Care and Health Research and the authors thank SEWTU’s contribution to study implementation.
Contributors: JWG and MR were coprincipal investigators and joint guarantors of the study in its entirety. JWG, MR, KeH, KB, SC, DC, EC, HH, KaH, ML, LL, RP, SR, CCB, and RMcN were responsible for developing the research question and study design and implementation of the study protocol. RMcN was responsible for trial management. RP led the main statistical analysis. TP led the analysis of consultation ratings. MR and JWG were responsible for drafting the manuscript. All those listed as authors were responsible for reading, commenting on, and approving the final manuscript. All contributors were independent from the study funders in conducting the research.
Funding: The UK National Institute for Health Research Health Technology Assessment Programme funded the intervention development and trial phases. An educational grant from Novo Nordisk UK partially funded the production of some study materials. This study was sponsored by Cardiff University.
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: all authors had financial support from the National Institute for Health Research Health Technology Assessment research funding scheme for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: The intervention development phase was approved by the South East Wales NHS research ethics committee. The trial phase was approved by the Thames Valley NHS (now South Central-Berkshire) research ethics committee (07/MRE12/9). Approval for the conduct of the study at each participating centre was provided through the corresponding NHS organisation (NHS R&D approval).
Data sharing: No additional data available.
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