Title: Diabetes Intervention for Agenda Trial (DIAT)
Funder: Department of Health (England)

Abstract: Background People with diabetes have identified that, during outpatient clinic appointments, doctors can overlook issues that are worrying patients, and patients can feel inhibited from raising concerns. The National Service Framework for Diabetes (DoH 2003) defined standards for diabetes provision in England to improve quality of care (DoH 2002), and evaluations have highlighted that patients must be actively involved in their care (DoH 2008) with structured information key to effective self-management (DoH 2010). Cegala et al (2001) identified that effective patient communication involves patients: P resenting detailed information about how they are feeling; A sking questions if desired information is not provided; C hecking understanding of information that is given to them; E xpressing any concerns about the recommended treatment (PACE; http://patcom.jcomm.ohio-state.edu/). Aims The aim of this pilot study is to inform the planning of a future definitive trial, which would assess the clinical and cost effectiveness of a pre-clinic intervention for diabetes, based on the existing PACE intervention. Our hypothesis is that the intervention will enable the patient to identify their agenda for discussion with the Diabetologist, improving communication and empowering the patient to be more pro-active at managing their diabetes, leading to improved clinical and quality of life outcomes. The pilot trial will provide essential information for the successful planning and delivery of the intended larger trial. Plan 120 adults will be recruited from the diabetes register in Exeter and Plymouth, before their first or next planned diabetes outpatient clinic appointment. Patients will be asked to make contact with the research team if interested in the study and potential participants will be sent the study information sheet. A nurse will then telephone to discuss details, answer questions, confirm eligibility and (if willing) obtain verbal consent. Participants will be randomised to attend a clinic session using the intervention or a clinic run in the usual way (control). On attending, written consent will be obtained and baseline measures provided. Those in the intervention group will have a pre-clinic appointment with a Diabetes Specialist Nurse (DSN) who will facilitate the completion of the computer-based ‘PACE’ questionnaire (Cegala et al 2001). The DSN will support the patient to provide details of: their reasons for their appointment, their symptoms and concerns, and what they hope can be done to help them. The patient will then proceed to the clinical consultation, where the completed questionnaire will act as an agenda for the consultation. With the patient’s consent, the consultation will be audio-recorded. Outcome measures will be recorded at baseline, three and six months after the consultation. These will include: glycosylated haemoglobin (Perry et al 2001), enablement (Howie et al 1998); use of medication (Greenfield et al 1985, 1988); self-management (Toobert et al 2000), and quality of life (Bradley 1999). At follow-up they will also include patient report of communication (Bylund et al 2010). Experiences of both trial participation and use of the intervention will be captured through qualitative interviews with a purposive sample of trial participants and health professionals, and the resulting data will be thematically analysed. The findings of the study will be disseminated locally and nationally and will inform a definitive trial of the intervention. Potential benefits We hypothesise that the intervention will enable patients to discuss their own agenda for consultations with a Diabetologist, and that this will improve self-management and glycaemic control to the benefit of those patients and the wider NHS. The pilot study will assess the feasibility and inform the planning of a future definitive trial of the intervention, hence providing the benefit of ensuring that trial can be delivered successfully.


Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: METABOLIC AND ENDOCRINE