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Trial registered on ANZCTR


Registration number
ACTRN12618001583235
Ethics application status
Approved
Date submitted
14/09/2018
Date registered
25/09/2018
Date last updated
29/08/2019
Date data sharing statement initially provided
29/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of Diabetes Teams on Health Outcomes of Patients Admitted in Hospitals in South Western Sydney
Scientific title
A Cluster Randomised Trial of Inpatient Diabetes Teams and the Impact on Health Outcomes in Patients Admitted to Hospitals in South Western Sydney
Secondary ID [1] 295073 0
Ni known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 309558 0
Condition category
Condition code
Metabolic and Endocrine 308380 308380 0 0
Diabetes
Public Health 308520 308520 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following randomisation, half of the wards (Intervention wards) will receive the Inpatient Diabetes Team (IPDT) model of care over a 24 week period. The model of care on the selected wards will involve a diabetes nurse educator (DNE) visiting the intervention wards every day (on weekdays). Blood glucose will be measured and monitored on the wards as part of routine care by the ward staff. Based on the assessment of the DNE, inpatients with DM will be stratified into 3 groups-
• low risk patients (BGL within 5-10, not insulin treated) - no further action
• intermediate risk patients (some BGL outside of 5-10 in past 24hr, hypos or on insulin therapy) - DNE reviews patient. Referral to endocrinologist or dietitian if considered required
• high risk patients (above 50% of BGL outside 5-10, BGL >15 or severe hypoglycaemia <3.0mmol/L) - DNE reviews patient AND referral to endocrinologist. Referral to dietitian if considered required
The trial investigators will meet at least once a month with the diabetes nurse educators to ensure the trial protocol is being followed.
Intervention code [1] 312364 0
Treatment: Other
Comparator / control treatment
Following randomisation, half of the wards (conventional wards) will continue with business as usual, with a referral only service. Ward staff can refer the patient for review by diabetes nurse educator (DNE), dietitian or endocrinologist if deemed necessary (as is the current practice).
Control group
Active

Outcomes
Primary outcome [1] 307360 0
Change in number of ‘good diabetes days’ during stay in hospital.
‘Good diabetes days’ are defined as days with no blood glucose readings <4.0 and one or less readings >10.0, as a proportion of seven days in hospital.
Timepoint [1] 307360 0
24 weeks from start of trial
Secondary outcome [1] 351596 0
Change in length of stay in hospital.
This data will be collected by linking into hospital admission and discharge records.
Timepoint [1] 351596 0
24 weeks from start of trial
Secondary outcome [2] 351597 0
Errors in relation to diabetes medication administration.
This data will be collected by a research assistant from the hospital medical records based on an pre-agreed proforma.
Timepoint [2] 351597 0
24 weeks from start of trial
Secondary outcome [3] 351598 0
Readmission rate within 12 weeks.
This data will be collected by linking into hospital admission and discharge records.
Timepoint [3] 351598 0
24 weeks from start of trial
Secondary outcome [4] 351599 0
Evidence of severe or persistent hyperglycaemia based upon glucose monitoring.
This data will be collected by a research assistant from the hospital medical records based on an pre-agreed proforma.
Timepoint [4] 351599 0
24 weeks from start of trial
Secondary outcome [5] 352120 0
Evidence of hypoglycaemia or severe hypoglycaemia based upon glucose monitoring.
This data will be collected by a research assistant from the hospital medical records based on an pre-agreed proforma.
Timepoint [5] 352120 0
24 weeks from start of trial

Eligibility
Key inclusion criteria
ALL patients admitted on the trial wards will be included in the study, unless they meet the exclusion criteria.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- patients directly managed by the endocrinology team
- those admitted for pancreatic surgery that develop diabetes
post-operatively during that admission

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Cluster randomisation of wards by simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)

Stratification was done by hospital site as well as medical/surgical ward type
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Wards were cluster randomised.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size:
We assume 5% significance level and an intra-cluster correlation coefficient of 0.015 [based on analyses of diabetes data from Liverpool, Campbelltown hospitals] as used to calculate the trial sample size. The calculation of total sample size was based on 80% power, 5% significance level for two-sided test and an effect size of 0.5 days difference in good diabetes days, with a standard deviation (SD) of 2.0 days. Taking into account 10% dropout at the end of the trial (i.e. inter-hospital transfer and death), and variation between cluster size of the medical and surgical wards, this results in a required sample of approximately 1340 participants (670 in each group). The sample size will enable us to be adequately powered to detect an effect in secondary outcomes and to undertake any subgroup analysis.

Statistical Anaylsis:
The analysis will be by intention to treat (ITT) approach with supplementary per protocol analysis. The increase in good diabetes days in inpatient DM between intervention and control groups will be assessed using chi-square test, two independent samples t-test and regression analysis, adjusted for clustering. We will report the results for the primary trial outcome. Since multiple observations per participant are obtained, correlation between measurements in the same participant is expected and not independent of each other. For regression analysis of such multilevel data, random cluster and/or subject effects can be added into the regression model to account for the correlation of the data. The model will be able to test the relationship between diabetes and increase in good diabetes days, accounting for baseline characteristics and other variables. Subgroup analysis will be undertaken for within-intervention group. Model assumptions will be checked and appropriate adjustments to the analysis will be made where necessary. STATA® software version 14 (Stata Corporation, College Station, TX, USA) will be used for all analyses, with xtmixed command to fit linear mixed models and xtmelogit command to fit mixed-effects models for binary outcomes/responses. All tests will be two-sided, and p-value <0.05 will be considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/07/2018
Date of last participant enrolment
Anticipated
15/12/2018
Actual
15/12/2018
Date of last data collection
Anticipated
31/03/2019
Actual
28/08/2019
Sample size
Target
1340
Accrual to date
Final
1563
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11812 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [2] 11813 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 11814 0
Fairfield Hospital - Prairiewood
Recruitment postcode(s) [1] 23939 0
2560 - Campbelltown
Recruitment postcode(s) [2] 23940 0
2170 - Liverpool
Recruitment postcode(s) [3] 23941 0
2176 - Prairiewood

Funding & Sponsors
Funding source category [1] 299654 0
Government body
Name [1] 299654 0
South Western Sydney Local Health District
Country [1] 299654 0
Australia
Primary sponsor type
Government body
Name
South Western Sydney Local Health District
Address
South Western Sydney Local Health District
Liverpool Hospital Eastern Campus
Locked Bag 7279
LIVERPOOL BC NSW 1871
Country
Australia
Secondary sponsor category [1] 300257 0
None
Name [1] 300257 0
Address [1] 300257 0
Country [1] 300257 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300552 0
South Western Sydney Local Health District Human Research Ethics Committee (EC00136)
Ethics committee address [1] 300552 0
Ethics committee country [1] 300552 0
Australia
Date submitted for ethics approval [1] 300552 0
05/02/2018
Approval date [1] 300552 0
23/04/2018
Ethics approval number [1] 300552 0
HREC/18/LPOOL/38

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84038 0
Prof David Simmons
Address 84038 0
Macarthur Clinical School
School of Medicine,
Western Sydney University
Campbelltown Campus
Locked Bag 1797, Penrith, NSW 2751
Country 84038 0
Australia
Phone 84038 0
+61 2 46344028
Fax 84038 0
+61 2 46344045
Email 84038 0
da.simmons@westernsydney.edu.au
Contact person for public queries
Name 84039 0
Milan Kumar Piya
Address 84039 0
Senior Lecturer in Diabetes
Macarthur Clinical School
School of Medicine,
Western Sydney University
Campbelltown Campus
Locked Bag 1797, Penrith, NSW 2751
Country 84039 0
Australia
Phone 84039 0
+61 2 46344028
Fax 84039 0
+61 2 46344045
Email 84039 0
m.piya@westernsydney.edu.au
Contact person for scientific queries
Name 84040 0
Milan Kumar Piya
Address 84040 0
Senior Lecturer in Diabetes
Macarthur Clinical School
School of Medicine,
Western Sydney University
Campbelltown Campus
Locked Bag 1797, Penrith, NSW 2751
Country 84040 0
Australia
Phone 84040 0
+61 2 46344028
Fax 84040 0
+61 2 46344045
Email 84040 0
m.piya@westernsydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4388Study protocol  m.piya@westernsydney.edu.au
4389Ethical approval  m.piya@westernsydney.edu.au



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.