Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000010392
Ethics application status
Approved
Date submitted
19/12/2007
Date registered
10/01/2008
Date last updated
25/08/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving glycaemic control of patients with type 2 diabetes mellitus (T2DM) through management by a community based, multidisciplinary, integrated primary care / specialist level care service.
Scientific title
Is glycaemic control of patients with type 2 diabetes mellitus (T2DM) improved through management by a community based, multidisciplinary, integrated primary care / specialist level care service relative to comparable patients receiving usual care at a specialist outpatient diabetes clinic.
Universal Trial Number (UTN)
Trial acronym
ICDMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes mellitus (T2DM)

Recognised complications of T2DM 2652 0
Condition category
Condition code
Metabolic and Endocrine 2767 2767 0 0
Diabetes
Public Health 2768 2768 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are 2 levels of the intervention: the patient level and the general practice level.

Patient level intervention: The Inala Chronic Disease Management Service (ICDMS) provides multidisciplinary, coordinated and comprehensive care appropriate to the needs of the individual patient based on a systematic assessment of glycaemic control, presence of recognised complications of T2DM, and lifestyle and behavioural considerations. Patients will attend the ICDMS for management of acute complications of T2DM. Once blood sugar levels and/or other complications have stabilised, the patient will be discharged back to their usual General Practitioner (GP). Patients will be followed up for 12 months for the ICDMS evaluation.

General practice / primary care level – an education and training program for GPs and general practice nurses.

The education and training program for GPs consists of a number of different, inter-related activities, and will continue for at least 12 months. Participation in any of the activities will enable the GPs to gain Professional Development points in the Royal Australian College of General Practitioners (RACGP) Quality Assurance and Continuing Professional Development (QA&CPD) program.

One activity are the monthly, one hour Case Based Discussions. The program for these discussions is relatively informal, and is adapted according to the needs of the attending GPs, the patients seen at the ICDMS, and any "hot topics" in diabetes care.

GPs can also participate in the more formal, eight week "clinical fellow" training. Each session is 1.5 hours. The clinical fellow training aims to provide GPs with advanced skills, knowledge and confidence in caring for patients with T2DM who have complex care needs eg. a number of co-morbidities.

GPs will also be able to undertake supervised clinical attachments. These will consist of observing an endocrinologist over 10 hours of consultation time, and keeping a reflective diary of the experience.

The practice nurse education and training program will consist of a series (approximately 3) of 2 hour seminars that are aimed at enabling the practice nurse take a more active role in providing comprehensive, coordinated care for patients with T2DM.
Intervention code [1] 2389 0
Lifestyle
Intervention code [2] 2390 0
Treatment: Other
Intervention code [3] 2391 0
Behaviour
Comparator / control treatment
Patient level intervention – comparable patients from a diffferent geographical region receiving usual care at a specialist diabetes outpatients clinic.

Primary care level – GPs and general practice nurses whose patients are cared for at the ICDMS but have been randomised to be waitlisted for the education and training program
Control group
Active

Outcomes
Primary outcome [1] 3654 0
Reduction in glycosylated haemoglobin (HbA1c), measured by blood samples
Timepoint [1] 3654 0
measurement will occur at baseline and at 6 months post intervention
Primary outcome [2] 3655 0
Improved processes of care of patients with T2DM by the GPs (and practice nurses) participating in the education and training program measured by pre and post assessment of GPs' knowledge, attitudes and clinical practices associated with caring for patients with T2DM.
Timepoint [2] 3655 0
Only at 6 months after commencement of intervention
Secondary outcome [1] 6157 0
Cholesterol levels (total, high density lipoprotein (HDL), low density lipoprotein (LDL), triglycerides), measured by blood samples
Timepoint [1] 6157 0
Only at 6 months after commencement of intervention
Secondary outcome [2] 6158 0
Diastolic and systolic blood pressure
Timepoint [2] 6158 0
Only at 6 months after commencement of intervention
Secondary outcome [3] 6159 0
Smoking status, measured by patient self-report
Timepoint [3] 6159 0
Only at 6 months after commencement of intervention
Secondary outcome [4] 6160 0
Body mass index (BMI)
Timepoint [4] 6160 0
Only at 6 months after commencement of intervention
Secondary outcome [5] 6161 0
Level of physical activity, measured by patient self-report
Timepoint [5] 6161 0
Only at 6 months after commencement of intervention
Secondary outcome [6] 6162 0
Retinopathy, measured by interpretation of retinal photographs
Timepoint [6] 6162 0
Only at 6 months after commencement of intervention
Secondary outcome [7] 6163 0
Estimated Glomerular Filtration Rate (eGFR), measured by urine samples
Timepoint [7] 6163 0
Only at 6 months after commencement of intervention
Secondary outcome [8] 6164 0
Urinary albumin, measured by urine samples
Timepoint [8] 6164 0
Only at 6 months after commencement of intervention
Secondary outcome [9] 6165 0
Urinary albumin:creatinine ratio, measured by urine samples
Timepoint [9] 6165 0
Only at 6 months after commencement of intervention
Secondary outcome [10] 6166 0
Active foot ulcer
Timepoint [10] 6166 0
Only at 6 months after commencement of intervention
Secondary outcome [11] 6167 0
Lower limb amputation
Timepoint [11] 6167 0
Only at 6 months after commencement of intervention
Secondary outcome [12] 6168 0
Proportion of patients on appropriate medication for prevention or minimisation of complications, particulary, proportion of patients with microalbuminuria on Angiotensin-Converting Enzyme (ACE) inhibitors or angiotensin 2 receptor antagonists (A2RB); proportion of patients with dyslipideamia on statins or fibrates (if indicated and tolerated); and proportion of patients on prophylactic aspirin
Timepoint [12] 6168 0
Only at 6 months after commencement of intervention
Secondary outcome [13] 6169 0
Patient quality of life (assessed using EQ-5D measure)
Timepoint [13] 6169 0
Only at 6 months after commencement of intervention
Secondary outcome [14] 6170 0
Patient diabetes self efficacy (assessed using Diabetes Self-Efficacy Scale)
Timepoint [14] 6170 0
Only at 6 months after commencement of intervention
Secondary outcome [15] 6171 0
Depression (intervention group only, assessed using PHQ-9 measure)
Timepoint [15] 6171 0
Only at 6 months after commencement of intervention
Secondary outcome [16] 6172 0
Severe hypoglycaemic episodes requiring assistance, measured by patient self-report
Timepoint [16] 6172 0
Only at 6 months after commencement of intervention
Secondary outcome [17] 6173 0
Acceptability of the ICDMS to participating GPs (qualitative assessement)
Timepoint [17] 6173 0
Only at 6 months after commencement of intervention
Secondary outcome [18] 6174 0
Acceptability of the ICDMS to patients (qualitative assessment)
Timepoint [18] 6174 0
3 and 6 months after commencement of intervention
Secondary outcome [19] 6175 0
Participation, satisfaction and impact of patient participation in self-management education program, measured by attendance records and outcome evaluation using a questionnaire and patient feedback about perceived accomplishments as a result of participating in the program.
Timepoint [19] 6175 0
Only at 6 months after commencement of intervention
Secondary outcome [20] 6176 0
Relative cost and benefit of ICDMS, assessed by health economic modeling using comparative changes in quality of life, resource utilisation and clinical indicators.
Timepoint [20] 6176 0
Only at 6 months after commencement of intervention

Eligibility
Key inclusion criteria
1. patients with T2DM referred by GPs in the Inala catchment area for specialist management of their diabetes.
2. 18 yrs or older
3. willing to provide informed consent
4. have intact cognition
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. patients on haemodialysis or renal transplant patients
2. patients with insufficient hypoglycaemic awareness
3. patients who are pregnant

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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
Parallel
Other design features
The patient level intervention is an open controlled trial. A geographical control is being used to assess the impact of the intervention on a range of clinical and patient related outcomes (listed previously).

The general practice intervention is a clustered randomised control trial, only involving general practices from the intervention area who have patients receiving care at the ICDMS. General practices were stratified according to the number of GPs, and randomised to either immediate or waitlisted participation in the GP and practice nurse education program. Practices were divided into two strata (one or two GPs, and three or more GPs), coded, and randomly allocated to the two groups by a blinded assessor, using opaque sealed envelopes. The impact of this intervention will be assessed by reviewing processes of care within the general practice of non-referred patients.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 351 0
4110
Recruitment postcode(s) [2] 352 0
4108
Recruitment postcode(s) [3] 699 0
4300
Recruitment postcode(s) [4] 700 0
4075
Recruitment postcode(s) [5] 701 0
4068
Recruitment postcode(s) [6] 702 0
4076
Recruitment postcode(s) [7] 703 0
4077
Recruitment postcode(s) [8] 704 0
4078
Recruitment postcode(s) [9] 705 0
4074
Recruitment postcode(s) [10] 706 0
4106
Recruitment postcode(s) [11] 707 0
4073
Recruitment postcode(s) [12] 965 0
4107
Recruitment postcode(s) [13] 966 0
4109
Recruitment postcode(s) [14] 967 0
4113
Recruitment postcode(s) [15] 968 0
4115
Recruitment postcode(s) [16] 969 0
4116
Recruitment postcode(s) [17] 970 0
4301
Recruitment postcode(s) [18] 971 0
4303
Recruitment postcode(s) [19] 972 0
4304
Recruitment postcode(s) [20] 973 0
4305
Recruitment postcode(s) [21] 974 0
4306

Funding & Sponsors
Funding source category [1] 2905 0
Government body
Name [1] 2905 0
Commonwealth Safety & Quality Team, Queensland Health
Country [1] 2905 0
Australia
Primary sponsor type
Government body
Name
Community & Primary Health Services, Queensland Health
Address
Mr Glenn Bradley, Executive Director, Community and Primary Health Services, Southside Health Service District.
Country
Australia
Secondary sponsor category [1] 2623 0
None
Name [1] 2623 0
Address [1] 2623 0
Country [1] 2623 0
Other collaborator category [1] 112 0
University
Name [1] 112 0
Discipline of General Practice, University of Queensland
Address [1] 112 0
Prof Claire Jackson
Discipline of General Practice
School of Medicine
University of Queensland
Herston Rd
Herston QLD 4006
Country [1] 112 0
Australia
Other collaborator category [2] 113 0
Hospital
Name [2] 113 0
Princess Alexandra Hospital
Address [2] 113 0
Dr Tony Russell
Diabetes and Endocrinology Department
Princess Alexandra Hospital
Ipswich Rd
Woolloongabba QLD 4102
Country [2] 113 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4846 0
Princess Alexandra Hospital Human Research Ethics Committee
Ethics committee address [1] 4846 0
Princess Alexandra Hospital
Ipswich Rd
Woolloongabba QLD 4102
Ethics committee country [1] 4846 0
Australia
Date submitted for ethics approval [1] 4846 0
Approval date [1] 4846 0
13/06/2007
Ethics approval number [1] 4846 0
2007/100

Summary
Brief summary
This research aims to improve quality of life in patients with type 2 diabetes by building the capacity of primary care and providing accessible, evidence based care in the community through multidisciplinary collaboration and integration across the primary and tertiary interface.

The primary objective of this research is to investigate if glycaemic control of patients with type 2 diabetes can be improved through management at the Inala Chronic Disease Management Service (ICDMS) relative to comparable patients receiving usual care at the PAH endocrinology outpatients clinic.
Other important objectives of the research include:
* To improve modifiable cardiovascular risk factors and microvascular complications of diabetes
* To increase the capacity and scope of primary care to manage patients with type 2 diabetes
* To restructure the organisation of care in order to improve the effectiveness of patient care
* To develop a sustainable model of care that is generalisable to other chronic diseases.
* To investigate the relative costs of the new model of care
* To assess the acceptability to GPs of the ICDMS caring for patients traditionally referred to the specialist outpatients clinic
* To assess the acceptability to patients of the ICDMS rather than usual care at a specialist outpatients clinic.

A key component of the ICDMS will be the staged devolution of diabetes services from tertiary care to primary care through increasing the capacity of primary care to meet the needs of patients who would otherwise use hospital outpatient clinic services. Initially, the tertiary level service providers (particularly the endocrinologist) will be heavily involved in training, support and service provision. Their involvement will gradually decrease to a virtual consultative function interspersed with limited patient contact.

The proposed research is a structured and rational approach to evaluating the efficaciousness and effectiveness of the ICDMS. To achieve this, an open controlled trial of patient care at the ICDMS compared with usual care at the PAH diabetes outpatient clinic is proposed. Additionally, a nested cluster randomized controlled trial is proposed to test the effectiveness of the upskilling component of the project – general practices will be randomised to either receive the upskilling immediately or to be a wait-listed control group.
Trial website
Trial related presentations / publications
Diabetes Self Management Education Program - it is making a difference? Presented at 2008 GP & PHC Research Conference. Hobart, Australia.

Enhancing patient and practitioner skills for chronic disease management in an integrated primary & specialist level diabetes service. National Health Care Reform Conference 2008. Sydney, Australia
Public notes

Contacts
Principal investigator
Name 28256 0
Address 28256 0
Country 28256 0
Phone 28256 0
Fax 28256 0
Email 28256 0
Contact person for public queries
Name 11413 0
Ms Deb Miller
Address 11413 0
Inala Chronic Disease Management Service
1st Floor
Inala Community Health Centre
64 Wirraway Pde
Inala QLD 4077
Country 11413 0
Australia
Phone 11413 0
0419 788 001
Fax 11413 0
Email 11413 0
[email protected]
Contact person for scientific queries
Name 2341 0
Dr Tony Russell
Address 2341 0
Department of Diabetes and Endocrinology, Princess Alexandra Hospital, Brisbane, Australia
b Diamantina Institute, University of Queensland
Country 2341 0
Australia
Phone 2341 0
+61 7 3240 2690
Fax 2341 0
Email 2341 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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