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Trial registered on ANZCTR


Registration number
ACTRN12616000265471
Ethics application status
Approved
Date submitted
24/02/2016
Date registered
26/02/2016
Date last updated
21/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A proactive Inpatient Diabetes Service to improve diabetes care in hospitalised patients.
Scientific title
Randomised study of a proactive Inpatient Diabetes Service on hospitalised patients with diabetes, evaluating its effect on adverse glycaemia and hospital complications.
Secondary ID [1] 288555 0
None
Universal Trial Number (UTN)
Trial acronym
RAPIDS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 297666 0
Condition category
Condition code
Metabolic and Endocrine 297878 297878 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A proactive inpatient diabetes service (IDS)

1) Consists of an endocrinology registrar & diabetes nurse practitioner, overseen by an endocrinologist. The IDS will also include diabetes nurse educators and a dietician.

2) Identifies inpatients with known diabetes or new hyperglycaemia without diabetes (fasting BGL > 7.0 mmol/L or random BGL > 11.1 mmol/L) using Connectivity Blood Glucose Meters (CBGM) and a central repository of point of care blood glucose levels (BGL).

3) Identifies inpatients with unstable BGL or altered clinical state via the Glucose Alert Pathway. Glucose alert pathway is a paper-based clinical escalation guideline for nursing and treating team medical staff in response to hypoglycaemia, hyperglycaemia or a change in diabetes-related clinical status.

4) Delivers a consult service on all patients with known diabetes or new hyperglycaemia, early in their admission (aim within 48 hours after admission) & without referral from the treating team (proactive care). The consultation includes:
a) Assessment of diabetes control prior to admission and during hospitalisation.
b) Appropriate adjustment of diabetes-related medications and insulin during hospitalisation
c) Provision of appropriate diabetes education and/or dietary advice
d) Optimisation of diabetes therapy at discharge from hospital
A typical consult may last 5 - 20 minutes depending on the clinical scenario. The IDS may provide a single or multiple consults depending on clinical status. (e.g. if regular insulin or diabetes medication dose titration is required, there may be daily or second-daily consults, until discharge).

5) Delivers individualised diabetes care in hospital using a variety of appropriate diabetes medication and insulin regimens depending on the clinical scenario.

6) Facilitate discharge by formulating diabetes regimen and follow up plans following discharge. These plans will be communicated to the patient's local medical officer by a discharge summary.

The IDS intervention will be in place for 3 months.
Intervention code [1] 293999 0
Treatment: Other
Comparator / control treatment
Usual care:
Inpatient diabetes care will be managed by the treating team. The treating team can refer to the endocrinology registrar for advice and consult on patients as required. (As per current practice)
Control group
Active

Outcomes
Primary outcome [1] 297447 0
Adverse glycaemic days (defined as any patient-day with BGL < 4.0 mmol/L or > 15.0 mmol/L) as a proportion of all patient-days.

(BGL values will be collected from point-of-care tests performed on connectivity blood glucose meters)
Timepoint [1] 297447 0
During hospitalisation
Secondary outcome [1] 321072 0
Adverse clinical outcomes: A composite of infections (wound, urinary, respiratory, bacteraemia), acute kidney injury, myocardial infarct, unplanned critical care admission and in-hospital mortality. Data will be collected from hospital notes.

Timepoint [1] 321072 0
During hospitalisation
Secondary outcome [2] 321212 0
Prescription of basal insulin during hospitalisation (data collected from inpatient medication chart)
Timepoint [2] 321212 0
during hospitalisation
Secondary outcome [3] 321220 0
Appropriate cessation of unsuitable anti-diabetic medications. (data obtained from inpatient medication chart)
Timepoint [3] 321220 0
during hospitalisation
Secondary outcome [4] 321221 0
Documented diabetes regimen and follow-up plan at discharge. (Data collected from patient discharge summary in patient notes)
Timepoint [4] 321221 0
At patient discharge
Secondary outcome [5] 321222 0
Patient-day weighted mean glucose
(Data collected from point-of-care BGL values from connectivity blood glucose meters)
Timepoint [5] 321222 0
during hospitalisation
Secondary outcome [6] 321223 0
Proportion of patient-days with hypoglycaemia (BGL < 4.0 mmol/L).
(data collected from point-of-care BGL values from connectivity blood glucose meters)
Timepoint [6] 321223 0
during hospitalisation
Secondary outcome [7] 321224 0
Proportion of patient-days with mean BGL > 10.0 mmol/L
(data collected from point-of-care BGL values from connectivity blood glucose meters)
Timepoint [7] 321224 0
during hospitalisation
Secondary outcome [8] 321225 0
Proportion of patient-days with mean BGL > 15.0 mmol/L
(data collected from point-of-care BGL values from connectivity blood glucose meters)
Timepoint [8] 321225 0
during hospitalisation
Secondary outcome [9] 321226 0
Hospital length of stay
(data collected from hospital inpatient administration database)
Timepoint [9] 321226 0
at patient discharge

Eligibility
Key inclusion criteria
Consecutive inpatients with
1) Known diabetes OR
2) New hyperglycaemia without known diabetes (fasting BGL > 7.0 mmol/L or random BGL > 11.1 mmol/L)
that are admitted to the 8 participating wards at the Royal Melbourne Hospital.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients admitted under the diabetes and endocrinology team as the treating team.
Patients admitted under palliative care team

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Cluster randomised design, based on participating wards.
8 participating wards are included (4 medical and 4 surgical).
The wards will be randomised to 4 control and 4 intervention arms in a stratified manner so that even number of surgical and medical wards will be in each arm.

A random list of randomisation codes will be generated by a statistician and paired against a random medical or surgical ward in a stratified manner.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
In an initial 3-months baseline period, patient and glycaemic outcomes will be recorded from all 8 participating wards.
Following this, the wards will be cluster randomised into 4 intervention and 4 control wards.
A 3-month intervention period will then follow, where the 4 intervention wards will receive proactive IDS, and 4 control wards will continue usual care.

The initial 3 month baseline period will help evaluate the effect of intervention as a change from baseline for each ward.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Baseline adverse glycaemic days (from pilot study) = 30%
Expected recruitment during baseline phase = 600 (8 wards)
Expected recruitment during intervention phase = 600 (8 wards) or 300 patients in each arm (4 wards) totalling 1050 patient-days.
Using inter-cluster correlation coefficient of 0.05, and alpha of 0.05, there is > 80% power to detect a change of adverse glycaemic days from 30% to 20%.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
7/03/2016
Actual
7/03/2016
Date of last participant enrolment
Anticipated
4/09/2016
Actual
3/09/2017
Date of last data collection
Anticipated
31/12/2017
Actual
Sample size
Target
1200
Accrual to date
Final
1107
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5323 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 12785 0
3050 - Royal Melbourne Hospital

Funding & Sponsors
Funding source category [1] 292948 0
Charities/Societies/Foundations
Name [1] 292948 0
Australian Diabetes Society
Country [1] 292948 0
Australia
Funding source category [2] 292949 0
Hospital
Name [2] 292949 0
Royal Melbourne Hospital Home Lottery Grant
Country [2] 292949 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital
Address
Department of Diabetes and Endocrinology
Level 4 West
300 Grattan Street
Parkville, Victoria 3050
Country
Australia
Secondary sponsor category [1] 291720 0
None
Name [1] 291720 0
None
Address [1] 291720 0
None
Country [1] 291720 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294455 0
Melbourne Health, Human Research Ethics Committee
Ethics committee address [1] 294455 0
PO Box
Royal Melbourne Hospital
Parkville
Victoria 3050
Ethics committee country [1] 294455 0
Australia
Date submitted for ethics approval [1] 294455 0
27/05/2015
Approval date [1] 294455 0
24/06/2015
Ethics approval number [1] 294455 0
2015.126

Summary
Brief summary
Background:
The prevalence of diabetes in hospitalised patients is 25-30% in Australian hospitals. During hospitalisation for surgery or acute medical illness, diabetes management becomes more difficult. Resultantly, hypoglycaemia (low blood glucose) and hyperglycaemia (high blood glucose) frequently occur with associated complications including infections, longer length of stay and mortality.

The management of inpatient diabetes remains suboptimal due to multiple factors, including altered physiology, dynamic hospital processes and medication changes. There is inattention and clinical inertia to inpatient diabetes management due to numerous pressures on hospital beds, expediting acute care and the increasing prevalence of diabetes. This study seeks to investigate a novel, proactive model of inpatient diabetes care.

Methods:
This study is a cluster-randomised controlled trial of a proactive Inpatient Diabetes Service (IDS) model of care. The IDS will identify inpatients with known diabetes and inpatients with new-onset hyperglycaemia using connectivity blood glucose meters and a "glucose alert pathway". The IDS will deliver a proactive consult service to these patients without referral from the treating teams, early in their admission. The IDS will manage inpatient diabetes care and facilitate discharge for these patients with the aim of increasing safety, reducing adverse glycaemia and reducing diabetes related complications.

Consecutive inpatients with known diabetes or new-onset hyperglycaemia, admitted to the 8 participating wards will be included. The participating 8 wards will be cluster-randomised to 4 intervention and 4 control wards. The trial consists of a 3-months baseline period followed by a 3-months intervention period.

It is hypothesised that the proactive IDS will reduce adverse glycaemia (unsafe blood glucose levels), adverse clinical outcomes and reduce length of stay in hospitalised patients with diabetes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63598 0
Dr Spiros Fourlanos
Address 63598 0
Department of Diabetes and Endocrinology
Royal Melbourne Hospital
300 Grattan Street
Parkville, Victoria 3050
Country 63598 0
Australia
Phone 63598 0
+613 9342 7365
Fax 63598 0
Email 63598 0
[email protected]
Contact person for public queries
Name 63599 0
Mervyn Kyi
Address 63599 0
Department of Diabetes and Endocrinology
Royal Melbourne Hospital
300 Grattan Street
Parkville, Victoria 3050
Country 63599 0
Australia
Phone 63599 0
+613 9342 7365
Fax 63599 0
Email 63599 0
[email protected]
Contact person for scientific queries
Name 63600 0
Mervyn Kyi
Address 63600 0
Department of Diabetes and Endocrinology
Royal Melbourne Hospital
300 Grattan Street
Parkville, Victoria 3050
Country 63600 0
Australia
Phone 63600 0
+613 9342 7365
Fax 63600 0
Email 63600 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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