Skip to content

A feasibility study of the effect of proactive diabetes specialist nurse reviews of patients with diabetes in hospital

Proactive review for people with diabetes in hospital: a cluster randomised feasibility study and process evaluation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN70402110
Enrollment
522
Registered
2022-02-21
Start date
2022-04-25
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Nutritional, Metabolic, Endocrine

Interventions

The Proactive Diabetes Review Model (PDRM) is a complex intervention delivered by diabetes inpatient specialist nurses for patients with diabetes admitted to hospital. PDRM consists of a patient centr

Sponsors

Cambridge University Hospitals NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The main trial will recruit both wards (clusters) and patients: 1. Wards: General adult medical and surgical wards are eligible. The specialist diabetes wards, day-case units, maternity wards and paediatric areas (age <16 years) are excluded. 2. Patients: Adult patients with a diagnosis of diabetes documented on their problem list admitted to one of the included wards will be eligible. Inpatients already under the care of the specialist diabetes team in hospital will be excluded. The process evaluation will include both a sub-sample of patients from the trial and health care professionals: 1. Patients: All patients with diabetes admitted to an included ward and taking part in the trial will be eligible. 2. Healthcare professionals: Nurses and Doctors that are permanent members of staff on an included ward will be eligible, along with all members of the diabetes inpatient specialist nurse team responsible for delivering the proactive diabetes review model (intervention). As key stakeholders, divisional leads with service development, budget assignment and strategic decision-making responsibilities will also be eligible and known as managers for the purpose of this protocol.

Exclusion criteria

Exclusion criteria: 1. Inpatients already under the care of the specialist diabetes team in the hospital 2. <16 years old

Design outcomes

Primary

MeasureTime frame
1. Evaluate and describe the feasibility of a cluster randomised design within an acute trust setting recorded as: 1.1. the proportion of eligible wards, healthcare professionals and patients who consent to take part in the study by 8 months 1.2. the completion of the randomisation process and review of the equilibrium between arms 1.3. the number of eligible diabetes specialist nurses undertaking the training and contributing to the delivery of the study by 8 months 2. Assess the extent to which the PDRM is delivered as intended 3. Assess acceptability of the PDRM intervention and trial processes, including recruitment and consent 4. Identify any potential sources of contamination in the usual care arm 5. Identify contextual barriers and facilitators of delivery 6. Identify outcomes that are important to patients For points 2-6 the methods used will include: • Direct non participatory observations at the point of intervention delivery followed by debrief interviews • Semi structured interviews with patient, healthcare professionals and managers

Secondary

MeasureTime frame
Evaluate availability and integrity of data relating to measures of glycaemic control through: 1. monthly ward level and individual patient admission incidence of hypoglycaemia defined as a glucose result15.0 mmol/L 3. monthly ward level and individual patient admission incidence of positive capillary ketones >1.5 mmol/L 4. monthly ward level and individual patient admission length of hospital stay 5. monthly ward level and individual patient admission incidence of hospital acquired foot ulceration

Countries

England, United Kingdom

Contacts

Public ContactAndrea Lake
a.lake@uea.ac.uk+44 7852353760

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 7, 2026