Proactive review for people with diabetes in hospital: a cluster randomised feasibility trial with process evaluation, protocol V3.1

Andrea K. Lake, Vishakha Bansiya, Katy Davenport, Jamie Murdoch, Helen R. Murphy, Toby O. Smith, Allan Clark, Antony Arthur

Research output: Contribution to journalArticlepeer-review


Background: Diabetes inpatient specialist services vary across the country, with limited evidence to guide service delivery. Currently referrals to diabetes inpatient specialists are usually ‘reactive’ after diabetes related events which are associated with increased risk of morbidity/mortality and increased length of hospital stay. We propose that a proactive diabetes review model of care, delivered by diabetes inpatient specialist nurses may contribute to the prevention of such diabetes related events and resulting increased risk of harm.

Method: We will conduct a cluster randomised feasibility study with process evaluation. The Proactive Diabetes Review Model (PDRM) is a complex intervention that focuses on the prevention of potentially modifiable diabetes related harms. All eligible patients will receive a comprehensive, structured diabetes review that aims to identify and prevent potentially modifiable diabetes related harms through utilising a standardised review structure. Reviews are undertaken by a diabetes inpatient specialist nurse within one working day of admission. This differs to usual care where patients are often only seen after diabetes related harms have taken place.

Trial duration will be approximately 32-weeks, with intervention delivery throughout. There will be an initial eight-week run-in phase, followed by a 24-week data collection phase. Eight wards will be equally randomised to either PDRM or usual care. Adult patients with a known diagnosis of diabetes admitted to an included ward will be eligible. Data collection will be limited to that typically collected as part of usual care. Data collected will include descriptive data at both the ward and patient level and glucose measures, such as frequency and results of capillary glucose testing, ketonaemia and hypoglycaemic events. Analysis aims to determine fidelity and acceptability of the intervention and the feasibility of a future definitive trial. While this study is primarily about trial feasibility, the findings of the process evaluation may lead to changes to both trial processes and modifications to the intervention. A qualitative process evaluation will be conducted in parallel to the trial. A minimum of 22 patients, nurses, doctors, and managers will be recruited with methods including direct non-participant observation and semi-structured interviews. The feasibility of a future definitive trial will be assessed by evaluating recruitment and randomisation processes, staffing resources, and quality of available data.

Discussion: The aim of this cluster randomised feasibility trial with a process evaluation is to explore the feasibility of a definitive trial and identify appropriate outcome measures. If a trial is feasible and the effectiveness of PDRM can be evaluated, this could inform the future development of inpatient diabetes services nationally.
Original languageEnglish
Article number88
JournalPilot and Feasibility Studies
Publication statusPublished - 11 Jun 2024


  • Diabetes Mellitus
  • Hospitalised
  • Inpatient
  • Diabetes Specialist Nurse
  • Proactive
  • Prevention
  • Risk reduction
  • Service model

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