Proactive review for people with diabetes in hospital: a cluster randomised feasibility trial with process evaluation, protocol V3.1
- PMID: 38863071
- PMCID: PMC11165828
- DOI: 10.1186/s40814-024-01507-2
Proactive review for people with diabetes in hospital: a cluster randomised feasibility trial with process evaluation, protocol V3.1
Abstract
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 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.
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 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.
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.
Trial registration: UK Clinical Research Network, 51,167. ISRCTN, ISRCTN70402110. Registered on 21 February 2022.
Keywords: Diabetes mellitus; Diabetes specialist nurse; Hospitalised; Inpatient; Prevention; Proactive; Risk reduction; Service model.
© 2024. The Author(s).
Conflict of interest statement
The authors declare that they have no competing interests.
Figures
Similar articles
-
Development and evaluation of a de-escalation training intervention in adult acute and forensic units: the EDITION systematic review and feasibility trial.Health Technol Assess. 2024 Jan;28(3):1-120. doi: 10.3310/FGGW6874. Health Technol Assess. 2024. PMID: 38343036 Free PMC article.
-
Peer support for discharge from inpatient to community mental health care: the ENRICH research programme.Southampton (UK): National Institute for Health and Care Research; 2023 Nov. Southampton (UK): National Institute for Health and Care Research; 2023 Nov. PMID: 38127694 Free Books & Documents. Review.
-
Folic acid supplementation and malaria susceptibility and severity among people taking antifolate antimalarial drugs in endemic areas.Cochrane Database Syst Rev. 2022 Feb 1;2(2022):CD014217. doi: 10.1002/14651858.CD014217. Cochrane Database Syst Rev. 2022. PMID: 36321557 Free PMC article.
-
The Prevention of Delirium system of care for older patients admitted to hospital for emergency care: the POD research programme including feasibility RCT.Southampton (UK): NIHR Journals Library; 2021 Mar. Southampton (UK): NIHR Journals Library; 2021 Mar. PMID: 33819001 Free Books & Documents. Review.
-
The AMBER care bundle for hospital inpatients with uncertain recovery nearing the end of life: the ImproveCare feasibility cluster RCT.Health Technol Assess. 2019 Oct;23(55):1-150. doi: 10.3310/hta23550. Health Technol Assess. 2019. PMID: 31594555 Free PMC article. Clinical Trial.
References
-
- Baxter R, Murray J, O’Hara JK, Hewitt C, Richardson G, Cockayne S, Sheard L, Mills T, Lawton R, PACT research team Improving patient experience and safety at transition of care through the Your Care Needs You (YCNY) intervention: a study protocol for a cluster randomised controlled feasibility trial. Pilot Feasibil Stud. 2020;6:123. doi: 10.1186/s40814-020-00655-5. - DOI - PMC - PubMed
-
- Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77–101. doi: 10.1191/1478088706qp063oa. - DOI
-
- Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-JerićK Hróbjartsson A, Mann H, Dickersin K, Berlin JA, Doré CJ. SPIRIT 2013statement: defining standard protocol items for clinical trials. Ann InternMed. 2013;158(3):200–7. doi: 10.7326/0003-4819-158-3-201302050-00583. - DOI - PMC - PubMed
Grants and funding
LinkOut - more resources
Full Text Sources