ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12612000380897

Ethics application status

Approved

Date submitted

2/04/2012

Date registered

3/04/2012

Date last updated

19/07/2016

Type of registration

Prospectively registered

Titles & IDs

Public title

A randomised trial of a novel model of diabetes care for adults in the community through multidisciplinary collaboration and integration across the primary and tertiary interface

Scientific title

Comparison of a novel model of community care versus usual care on glycaemic control in adults with type 2 diabetes: a randomised trial

Secondary ID [1]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Type 2 diabetes

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This intervention is based on a novel concept which incorporates the principle of General Practitioners (GPs) with special interests around a multidisciplinary and coordinated approach to diabetes care in the community. This model of care includes a specialist doctor (endocrinologist), who acts in a consulting capacity to the GP, to endorse the GPs patient management plan. The intervention is delivered face to face with their advanced GP as well as with a diabetes nurse educator. This intervention will include follow up appointments which will be approximately every 6 weeks and will continue until 12 months.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Usual care for patients with complex type 2 diabetes is in an endocrinology and diabetes outpatients settings at a secondary or tertiary hospital. Typically patient care is delivered prodominantly by a consultant doctor (an endocrinologist).

Control group

Active

Outcomes

Primary outcome [1]

glycaemic control (as measured by HbA1c)

Timepoint [1]

6 months
12 months

Secondary outcome [1]

blood pressure

Timepoint [1]

6 months
12 months

Secondary outcome [2]

cholesterol and cholesterol fractions

Timepoint [2]

6 months
12 months

Secondary outcome [3]

Body mass index

Timepoint [3]

6 months
12 months

Secondary outcome [4]

proportion of patients ceased smoking, collected by patient self-report on questionnaire

Timepoint [4]

6 months
12 months

Secondary outcome [5]

foot complications including presence of diabetic ulcers/sores, partial or total foot amputation, charcot joint, delayed healing times for injured skin, neuropathic symptoms, pulses present in right and left foot (determined by assessment from podiatrist)

Timepoint [5]

6 months
12 months

Secondary outcome [6]

retinopathy complications (determined by patient medical records data)

Timepoint [6]

6 months
12 months

Secondary outcome [7]

microalbuminuria (determined by urine analysis to calculate albumuria to creatinine ratio and compared to reference range)

Timepoint [7]

6 months
12 months

Secondary outcome [8]

serum creatinine

Timepoint [8]

6 months
12 months

Secondary outcome [9]

hospitalisations for diabetic related complications (determined by data linkage to external database Queensland Hospital Admitted Patients Data Collection (QHAPDC))

Timepoint [9]

6 months
12 months

Secondary outcome [10]

proportion of patients achieving clinical target for HbA1c (at less than or equal to 7%) measured by blood pathology testing

Timepoint [10]

6 months
12 months

Secondary outcome [11]

proportion of patients achieving clinical target for blood pressure (at less than or equal to 130/80 mm/Hg) measured in seated position with digital sphygmomanometer

Timepoint [11]

6 months
12 months

Secondary outcome [12]

proportion of patients achieving clinical target for low density lipoprotein (at less than or equal to 2.5 mmol/L) measured by blood pathology testing

Timepoint [12]

6 months
12 months

Eligibility

Key inclusion criteria

greater than 18 years
type 2 diabetes
referred to secondary/tertiary hospital diabetes outpatients for care
residing in the geographical area of interest in Brisbane, Australia
able to provide informed consent

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

patients without hypoglycaemic awareness
pregnancy
receiving haemodialysis
patients with terminal illness with life expectancy less than 2 years

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)

The person who determines if a patient is eligible to participate is unaware of the allocation group at the time of enrolment. Randomisation to group is conducted after eligibility is confirmed and consent has been provided from the patient.

Allocation to treatment group is done off site by the study statistician who is removed from the screening of participants.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomisation will use a weighted control of 3 intervention to 1 control. The randomisation will be done via web based computer randomisation, which is set up by the study statistician remotely.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

multi site

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/06/2012

Actual

27/11/2012

Date of last participant enrolment

Anticipated

Actual

14/07/2015

Date of last data collection

Anticipated

Actual

31/12/2016

Sample size

Target

400

Accrual to date

Final

352

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

Individual

Name

Professor Claire Jackson

Address

Discipline of General Practice
School of Medicine
The University of Queensland
Level 8, Health Science Building
Royal Brisbane and Women's Hospital
Herston QLD 4029

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Associate Professor Anthony Russell

Address [1]

Department of Diabetes and Endocrinology
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba QLD 4102

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Metro South Human Research Ethics Committee

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

12/04/2012

Approval date [1]

31/05/2012

Ethics approval number [1]

Summary

Brief summary

Diabetes is a chronic disease where the primary care physician has a central role to play. Historically, evidence has supported the role of diabetes teams in hospital settings being able to provide better care compared with primary care but it has been argued whether this relates to improved systematic and organised care, compared to increased expert knowledge. With appropriate support and recall systems, delivery of diabetes care in general practice can be as good as hospital outpatient care. Recognising this, the United Kingdom has seen the introduction of diabetes clinics conducted by general practitioners with special interests (GPSIs) with demonstrated favourable improvements in HbA1c, cholesterol and blood pressure. To date, Australia has not adopted GPSIs into clinical practice. However, the Australian health care system is facing significant reform aimed at shifting the focus from tertiary and secondary hospital health care to primary health care, including the move towards GP superclinics.

This research project focusses on the care of patients with complex T2DM who have been referred by their GPs for specialist diabetes care. This research is based on a novel concept which incorporates the principle of GPs with special interests around a multidisciplinary and coordinated approach to diabetes care in the community. Important to this model is the role of the specialist Endocrinologist in a consulting capacity to review and endorse the advanced skill GPs (GP Clinical Fellows) management plan. Few studies have investigated the staged devolution of diabetes services from secondary/tertiary care to primary care through increasing the capacity of primary care to meet the needs of patients who would otherwise use hospital outpatient services.

Trial website

Trial related presentations / publications

Askew DA, Jackson CL, Ware RS, Russell A. Protocol and baseline data from The Inala Chronic Disease
Management Service evaluation study: a health services intervention study for diabetes care. BMC Health Services
Research 2010;10:134.

Jackson, Claire, Tsai, Jane, Brown, Cathy, Askew, Deborah and Russell, Anthony (2010) GPs with special
interests impacting on complex diabetes care. Australian Family Physician, 39 12: 972974.

Public notes

Contacts

Principal investigator

Name

Prof Claire Jackson

Address

Discipline of General Practice The School of Medicine The University of Queensland Level8, Health Sciences Building Royal Brisbane and Women's Hospital Herston 4029 QLD

Country

Australia

Phone

+61 7 3365 5381

Fax

c.jackson@uq.edu.au

Contact person for public queries

Name

Dr Maria Donald

Address

Discipline of General Practice
The School of Medicine
The University of Queensland
Level8, Health Sciences Building
Royal Brisbane and Women's Hospital
Herston 4029 QLD

Country

Australia

Phone

+61 7 3346 5135

Fax

+61 7 3346 5178

m.donald@uq.edu.au

Contact person for scientific queries

Name

Professor Claire Jackson

Address

Discipline of General Practice
The School of Medicine
The University of Queensland
Level8, Health Sciences Building
Royal Brisbane and Women's Hospital
Herston 4029 QLD

Country

Australia

Phone

+61 7 3365 5381

Fax

+61 7 3346 5178

c.jackson@uq.edu.au

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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Clinical outcomes of an integrated primary-secondary model of care for individuals with complex type 2 diabetes: a non-inferiority randomised controlled trial.	2019	https://dx.doi.org/10.1007/s00125-018-4740-x

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically