Title: Proactive diabetes review in hospital: a cluster randomised feasibility study and process evaluation.
Funder: Health Education England

Abstract: Background Nationally inpatient diabetes management is sub-optimal. Contributing factors include low levels of confidence and knowledge of diabetes management among non-specialists. Currently referrals to diabetes specialists in hospitals are usually 'reactive' after a diabetes related adverse event, such as hypoglycaemia and hyperglycaemia, both of which are associated with increased risk and increased length of hospital stay. Proactive diabetes review model (PDRM) - intervention The Proactive Diabetes Review Model is a complex intervention of multiple factors. It aims to minimise potentially modifiable diabetes related harms rather than respond to them. All eligible patients will be reviewed by a diabetes specialist nurse within one working day of admission and any clinically indicated changes made. The PDRM differs from usual care in its focus on early prevention. Research questions Is the intervention delivered as intended? Is the new model of working acceptable to patients, primary teams and specialists? Is cluster randomisation by ward feasible and acceptable? What are the consequences and expectations of ward level cluster randomisation on patient consent? Is the outcome data routinely available and of adequate quality? What are the most relevant outcomes for patients?Methods A cluster randomised feasibility trial comparing Proactive Diabetes Review Model (PDRM) to usual care (reactive review). A total of eight medical and surgical wards will be randomised to receive PDRM or usual care. Adult patients on an included ward with a known diagnosis of diabetes, not under the diabetes specialist doctors will be eligible. Intensive care, theatres, day units, paediatrics and diabetes and endocrine specialty areas will be excluded. Data collection will be limited to that typically collected as part of usual care in both trial arms. Trial outcomes include hospital length of stay, rates of hypoglycaemia/hyperglycaemia and incidents of ketonemia >1.5 mmol/L. Feasibility outcomes will be the assessment of ward and participant recruitment and if ward level cluster randomisation is feasible. A process evaluation will be conducted in parallel to the trial. Doctors, nurses and managers will be recruited to take part in a semi-structured interview. The interviews will explore intervention acceptability and experience of diabetes care in hospital. An observation of the diabetes specialist nurses delivering the intervention and the patients receiving it will be completed, followed by debrief interviews to assess implementation fidelity. Observation notes and interview data will undergo content and thematic analysis. Process evaluation outcomes will be the implementation fidelity and acceptability of the PDRM intervention. Timelines for delivery Baseline data collection will be undertaken for eight-weeks in both arms and a 24-week intervention/ follow up period. Process evaluation will run in parallel throughout. Anticipated impact and dissemination This study is the first step within a wider research project plan. The aim is to explore the feasibility of a definitive trial. If a trial is feasible and PDRM is demonstrated to be effective this will inform the development and roll-out of inpatient diabetes services thus improving patient outcomes. Dissemination will be achieved through presentation at relevant conferences, lay and academic publications, attendance at stakeholder meetings and social media.

Lay abstract: The number of people diagnosed with diabetes has more than doubled in the last 20 years. This is a lifelong condition leading to high blood sugar levels. With an ageing population and people with diabetes living longer more people admitted to hospital will have diabetes. A recent audit in the UK demonstrated that one in every six NHS hospital beds is occupied by someone with diabetes. Most people admitted to hospital with diabetes are not admitted because of diabetes, meaning that they are typically under the care of health care professionals who are not specialised in diabetes management. Because activity levels, food intake and general well-being are different in hospital compared to home, diabetes management is challenging and often outside of the experience of those providing inpatient care. Many hospitals have inpatient diabetes specialist nurses, despite this, good blood sugar levels are achieved for less than half of the hospital inpatient days. Furthermore, 20% have an episode of dangerously low blood sugar, during hospital admission. Diabetes specialist nurses currently are only informed about diabetes inpatients after they have had dangerously low or high blood sugar levels. Inpatient specialist nurses are thus attempting to 'fix' rather than prevent diabetes complications. Diabetes specialist nurses could proactively assess the potential risk for these low or high blood sugar levels and recommend actions to help prevent them. This could mean that more specialist nurses would need to be employed, but money could also be saved as people with diabetes will have better glucose control, meaning their discharge is not delayed. My project aims to explore whether a proactive (rather than reactive) review of diabetes inpatients is possible in a large teaching hospital. I want to find out what staff and patients think of this approach and test whether a larger study could directly compare proactive reviews by diabetes nurses to what happens usually in hospital (reactive 'after an event' reviews). I will do this by allocating at random (e.g. through the toss of a coin) four wards to receive the proactive reviewing service while another four wards will continue to receive usual care. Patients will automatically be reviewed by a diabetes specialist nurse if they have diabetes and are admitted to a ward randomly allocated to proactive reviewing. If a patient has diabetes and is admitted to a ward randomly allocated to usual care, they will only receive the review if their doctors or nurses requests it (current practice). Patients will be included if they are adults, have diabetes and are not already being looked after by the diabetes doctors. Routinely available Information will be collected such as blood glucose test results and the length of time the patient spends in hospital. I will then compare the outcomes for the patients that received the proactive reviewing against the outcomes for patients on the wards that did not. While this initial study will not be big enough to test if proactive review is better than current clinical practice, it will help inform if a larger trial is possible. I am also interested in how well the diabetes specialist nurses deliver the proactive review and what staff and patients think of it. The inpatient diabetes specialist nurses will be observed delivering the proactive review to ensure that they all complete it to the same high standards. The patient and the diabetes nurse will then be invited to take part separately in a debrief interview. This will explore their experience of the review. Ward doctors, nurses and managers will also be interviewed.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: METABOLIC AND ENDOCRINE