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Trial registered on ANZCTR


Registration number
ACTRN12612001028897
Ethics application status
Approved
Date submitted
20/09/2012
Date registered
25/09/2012
Date last updated
3/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Stepping Up Study: A Cluster Randomised Controlled Trial of team-based transition to insulin in primary care compared to usual care to improve HbA1c for patients with poorly controlled type 2 diabetes
Scientific title
Stepping Up To Insulin: A Cluster Randomised Controlled Trial of team-based transition to insulin in primary care compared to usual care to improve HbA1c for patients with poorly controlled type 2 diabetes
Secondary ID [1] 281242 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes (T2D) 287434 0
Condition category
Condition code
Metabolic and Endocrine 287770 287770 0 0
Diabetes
Public Health 287771 287771 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Stepping Up program involves two elements that address key factors that are important and influential in the way insulin is initiated and titrated in general practice:
a. Supportive education for GP and Practice Nurse (PN) that addresses inter-professional culture and clarifies roles particularly in enhanced role for PN
b. Practice systems change that is congruent with work practices of GP and PN and needs of patients to facilitate timely introduction and titration of insulin glargine and glulisine
The Stepping Up program training will be delivered by the study team during practice visit. The 1-2 hour training session covers evidence around insulin initiation, common barriers and how to deal with them, motivational interviewing and goal setting strategies, and hands on familiarisation with insulin delivery systems and insulin titration tools. Case studies derived from general practices patients are used as the basis of the training. Referrals to an endocrinologist, diabetes educators or other health professionals will be part of management options for GPs managing study patients.
GP and PN will be supported by Study Diabetes Nurse Educator (DNE) as required during 12-month follow-up period via practice visits, telephone and emails to individualise and embed the model of care to their in-practice systems.
Intervention code [1] 285709 0
Other interventions
Comparator / control treatment
Usual care by General Practitioners. This may involve referrals to an endocrinologist, diabetes educators or other health professionals.
Control group
Active

Outcomes
Primary outcome [1] 288000 0
an absolute HbA1c reduction of 0.5% in the intervention group compared with the control group
Timepoint [1] 288000 0
at 12 months post baseline
Secondary outcome [1] 299234 0
proportion of participants transferring to insulin
Timepoint [1] 299234 0
at 12 months post baseline
Secondary outcome [2] 299235 0
the level of HbA1c at which insulin initiation occurs
Timepoint [2] 299235 0
at 12 months post baseline
Secondary outcome [3] 299236 0
proportion of participants achieving adequate glycaemic control (HbA1c <7%)
Timepoint [3] 299236 0
at 12 months post baseline
Secondary outcome [4] 299237 0
proportion of participants achieving individualised HbA1c targets according to the Australian Diabetes Society guidelines
Timepoint [4] 299237 0
at 12 months post baseline
Secondary outcome [5] 299240 0
impact on psychometric scores as assessed using the Assessment of Quality of Life (AQoL-8D), Patient Health Questionnaire (PHQ-9) and Problem Areas in Diabetes (PAID)
Timepoint [5] 299240 0
at 12 months post baseline
Secondary outcome [6] 299313 0
reduction in net healthcare utilisation and costs as assessed using Medicare Benefits Scheme and Pharmaceutical Benefits Scheme and Victorian Department of Health data linkage (subject to approval)
Timepoint [6] 299313 0
at 12 months post baseline

Eligibility
Key inclusion criteria
1. T2D patients who are insulin naive.
2. At least 2 oral hypoglycaemic agents (OHA) (eg. metformin, sulphonylurea, TZDs, DPP-4 inhibitor) at maximal tolerated doses, or in the opinion of the responsible medical practitioner, insulin is deemed necessary.
3. Doses of the OHAs should be stable for at least 3 months prior to enrollment into the study (or medical practitioner discretion).
4. HbA1c>=7.5% in the last 6 months
5. T2D patients willing to monitor glucose levels at least twice daily.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Type 1 diabetes.
2. Previous or current treatment with insulin (excluding the short term (<2 weeks) use of insulin in acute illness or during hospitalization).
3. Non-English speaking.
4. Significant cognitive impairment.
5. Impaired vision or any other physical handicap precluding reliable glucose monitoring administration of insulin.
6. Significant renal impairment (eGFR < 20).
7. Any life-threatening illness.
8. Pregnancy or planned pregnancy.
9. Major psychiatric disorder.
10. Substance misuse (alcoholism, drug addiction, etc)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
General practices that employ a practice nurse will be recruited from the University of Melbourne database, the VicREN practice based Research Network and Victorian Medicare Local databases. The study will also be promoted through professional organisations such as RACGP and APNA. Practices will also be recruited using a snowballing method from key clinicians identified in the field.
General practices that express an interest to take part will be asked to obtain a comprehensive list of eligible patients. Practices will use a range of search methods including their own electronic medical records database, the PEN clinical data extraction tool, or a list of HbA1c results from their local pathology providers. The study team will assist GP and PN to screen their patients.
Each practice will be allocated a practice ID once signed consents (at least one from GP and one from PN) are received by the research team and the practice has identified one or more eligible patients. The unit of randomisation is the general practice. Randomisation will occur prior to patient baseline assessment.

Patient recruitment involves:
1. An invitation pack from the Practice inviting eligible patients to participate and
2. follow-up call(s) from the PN and/or GP.
Patients who agree to participate will also be asked to sign the consent form and return it with the baseline demographic questionnaire in a reply paid envelope. They will be asked to attend Melbourne Pathology to have HbA1c, lipids, U&E and spot urine albumin:creatinine ratio tests.
Patients who have HbA1c>=7.5% will be eligible to participate and will be mailed a baseline survey.
Patient identification and recruitment can be repeated at 3 month intervals allowing patients to enter the study sequentially and ensuring the initiation of insulin and patient management is easily embedded within routine clinical work. Each practice will ideally recruit four to five patients to the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be stratified by:
1. practice size (<=2 EFT GPs vs >2 EFT GPs) ,
2. practice type (Community Health Centres vs private/corporate); and
3. participation in the Australian Primary Care Collaboratives program (www.apcc.org.au).
Randomisation will be undertaken by a statistician independent of the research team. The statistician the will be blinded to practice stratification characteristics and random allocation. The Study Coordinator will assign codes specific to each practice stratification characteristics and group allocation. The statistician will generate a computerized random number in random block allocation. Practices will be randomised after consenting, prior to patient baseline data collection. The Study Coordinator will email stratification codes of consenting practice to the statistician who will inform the study team of practice random allocation codes by email within 24-48 hours. Stratification in random block randomisation method is required to minimize imbalances between study groups.
The research team will inform practices of their random allocation by phone call, fax or mail. Following randomisation, the research team will assist practices to identify and recruit more patients.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286031 0
Government body
Name [1] 286031 0
National Health and Medical Research Council
Address [1] 286031 0
GPO BOx 1421
Canberra ACT 2601
Country [1] 286031 0
Australia
Funding source category [2] 286043 0
Commercial sector/Industry
Name [2] 286043 0
Roche Diagnostics Australia Pty Ltd
Address [2] 286043 0
31 Victoria Avenue
Castle Hill NSW 2154
Country [2] 286043 0
Australia
Funding source category [3] 286044 0
Commercial sector/Industry
Name [3] 286044 0
Sanofi Australia and New Zealand
Address [3] 286044 0
Talavera Corporate Centre, Building D, 12-24 Talavera Road, Macquarie Park, NSW 2113
Country [3] 286044 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Primary Health Care and General Practice Academic Centre
200 Berkeley St
Carlton VIC 3053
Country
Australia
Secondary sponsor category [1] 284857 0
Individual
Name [1] 284857 0
Dr John Furler
Address [1] 284857 0
Primary Health Care and General Practice Academic Centre
The University of Melbourne
200 Berkeley St Carlton VIC 3053
Country [1] 284857 0
Australia
Other collaborator category [1] 277086 0
Charities/Societies/Foundations
Name [1] 277086 0
Diabetes Australia Victoria
Address [1] 277086 0
570 Elizabeth Street, Melbourne VIC 3000
Country [1] 277086 0
Australia
Other collaborator category [2] 277087 0
Hospital
Name [2] 277087 0
Melbourne EpiCentre
Address [2] 277087 0
c/o The Royal Melbourne Hospital
RMH VIC 3050
Country [2] 277087 0
Australia
Other collaborator category [3] 277088 0
Individual
Name [3] 277088 0
Prof Carl May
Address [3] 277088 0
Faculty of Health Sciences
Building 67 (Nightingale)
University of Southampton
Highfield Campus
University Road
Southampton SO17 1BJ
Country [3] 277088 0
United Kingdom
Other collaborator category [4] 277089 0
Individual
Name [4] 277089 0
Prof Leonie Segal
Address [4] 277089 0
School of Nursing and Midwifery
Division of Health Sciences
University of South Australia
Playford Building P4-26, City East Campus
CEA-24
North Terrace, Adelaide, SA 5000
Country [4] 277089 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288093 0
Human Research Ethics Committee, the University of Melbourne
Ethics committee address [1] 288093 0
Level 5, Alan Gilbert Building,
161 Barry St (corner Grattan St)
Carlton VIC 3053
Ethics committee country [1] 288093 0
Australia
Date submitted for ethics approval [1] 288093 0
Approval date [1] 288093 0
22/05/2012
Ethics approval number [1] 288093 0
HREC1237406

Summary
Brief summary
Stepping Up is a cluster randomised controlled trial that examines the effectiveness of the “Stepping Up” program in general practice to help patients with poorly controlled type 2 diabetes for whom insulin is indicated move onto insulin in a timely evidence-based manner.
The Stepping Up program involves two elements that address key factors we have found to be important and influential in the way insulin is or is not initiated in general practice. These elements are:
-supportive education for GP, Practice Nurse (PN) and Credentialed Diabetes Educator–Registered Nurse (CDE-RN) that addresses inter-professional culture and clarifies roles and
-practice systems change that is congruent with work practices of GP and PN and needs of patients to facilitate timely introduction and titration of insulin.
Trial website
http://www.gp.unimelb.edu.au/stepping_up
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34720 0
A/Prof John Furler
Address 34720 0
Dept General Practice
The University of Melbourne
200 Berkeley St Carlton VIC 3053
Country 34720 0
Australia
Phone 34720 0
+61383444747
Fax 34720 0
Email 34720 0
j.furler@unimelb.edu.au
Contact person for public queries
Name 17967 0
A/Prof John Furler
Address 17967 0
Primary Health Care and General Practice Academic Centre
The University of Melbourne
200 Berkeley St Carlton VIC 3053
Country 17967 0
Australia
Phone 17967 0
+61383444747
Fax 17967 0
+61 3 9347 6136
Email 17967 0
j.furler@unimelb.edu.au
Contact person for scientific queries
Name 8895 0
A/Prof Dr John Furler
Address 8895 0
Primary Health Care and General Practice Academic Centre
The University of Melbourne
200 Berkeley St Carlton VIC 3053
Country 8895 0
Australia
Phone 8895 0
+61 3 8344 4747
Fax 8895 0
+61 3 9347 6136
Email 8895 0
j.furler@unimelb.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary