Lake Andrea K, Bansiya Vishakha, Davenport Katy, Murdoch Jamie, Murphy Helen R, Smith Toby, Clark Allan, Arthur Antony
The Wolfson Diabetes & Endocrine Clinic , Cambridge University Hospitals NHS Foundation Trust, Hills Road, Box 281, Cambridge, CB20QQ, UK.
School of Health Sciences, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, NR4 7TJ, UK.
Pilot Feasibility Stud. 2024 Jun 11;10(1):88. doi: 10.1186/s40814-024-01507-2.
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 have taken place, which are associated with an 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 result in a reduction in the risk of harm.
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 from usual care where patients are often only seen after diabetes-related harms have taken place. The trial duration will be approximately 32 weeks, with intervention delivery throughout. There will be an initial 8-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. The analysis aims to determine the fidelity and acceptability of the intervention and the feasibility of a future definitive trial. Whilst 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.
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.
UK Clinical Research Network, 51,167. ISRCTN, ISRCTN70402110. Registered on 21 February 2022.
糖尿病住院专科服务在全国范围内各不相同，指导服务提供的证据有限。目前，通常在糖尿病相关事件发生后才将患者转诊至糖尿病住院专科医生处，这些事件与发病/死亡风险增加及住院时间延长有关。我们提出，由糖尿病住院专科护士提供的主动式糖尿病评估护理模式，可能有助于预防此类糖尿病相关事件，并降低伤害风险。
我们将进行一项带有过程评估的整群随机可行性研究。主动式糖尿病评估模式（PDRM）是一项复杂干预措施，侧重于预防潜在可改变的糖尿病相关伤害。所有符合条件的患者都将接受全面、结构化的糖尿病评估，旨在通过使用标准化评估结构来识别和预防潜在可改变的糖尿病相关伤害。评估由糖尿病住院专科护士在患者入院后一个工作日内进行。这与常规护理不同，常规护理中患者通常在糖尿病相关伤害发生后才会得到诊治。试验持续时间约为32周，全程进行干预。将有一个为期8周的初始导入期，随后是一个为期24周的数据收集期。八个病房将被随机分为PDRM组或常规护理组。入住纳入病房且已知患有糖尿病的成年患者将符合条件。数据收集将限于常规护理通常收集的内容。收集的数据将包括病房和患者层面的描述性数据以及血糖测量值，如毛细血管血糖检测的频率和结果、酮血症和低血糖事件。分析旨在确定干预措施的保真度和可接受性以及未来确定性试验的可行性。虽然本研究主要关注试验可行性，但过程评估的结果可能会导致试验流程的改变以及干预措施的调整。将与试验并行进行定性过程评估。将通过直接非参与观察和半结构化访谈等方法，招募至少22名患者、护士、医生和管理人员。未来确定性试验的可行性将通过评估招募和随机化过程、人员资源以及可用数据的质量来评估。
这项带有过程评估的整群随机可行性试验的目的是探索确定性试验的可行性并确定合适的结局指标。如果试验可行且能评估PDRM的有效性，这可能为全国住院糖尿病服务的未来发展提供参考。
英国临床研究网络，51,167。国际标准随机对照试验编号，ISRCTN70402110。于2022年2月21日注册。
