Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000363886
Ethics application status
Approved
Date submitted
25/03/2012
Date registered
29/03/2012
Date last updated
4/09/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Diabetes Care Project - how does a specific primary care intervention focused on multidisciplinary teams affect clinical and overall health outcomes when compared to usual care?
Scientific title
For people with diabetes, how does a specific intervention focused on care coordination and multidisciplinary teams affect clinical and overall health outcomes when compared to usual care?
Secondary ID [1] 279904 0
Nil
Universal Trial Number (UTN)
U1111-1128-0481
Trial acronym
DCP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 285812 0
Condition category
Condition code
Metabolic and Endocrine 285989 285989 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Group 1:

- A new IT tool will be used by the patient and primary level care team (patient, general practitioner (GP), practice nurse (PN), allied health professionals (AHPs), specialists) to support care planning, share information with the patient and the team, and support a streamlined referrals process.

- An education and training program will ensure that people (both practitioners and people with diabetes) can navigate the resources available to them and improve people’s understanding of diabetes management and include four components:
1. Training specifically on how to implement the DCP for practitioners and will be conducted at the start of the DCP. Practitioners will the option to complete the training in-person or online, however, in-person training will be encouraged.
2. Forums for all enrolled practitioners which will be held once each quarter, in-person, to discuss how the project is progressing and hear from a guest speaker on diabetes.
3. Weekly to monthly (frequency depending on demand) phone access to a diabetes specialist for all practitioners to discuss specific concerns/questions
4. DCP website which includes information on what the DCP is about and links to multiple diabetes related resources for both practitioners and patients which can be accessed at any time during the trial.


Intervention Group 2:

- A new IT tool will be used by the patient and primary level care team (patient, GP, PN, AHPs, specialists) to support care planning, share information with the patient and the team, and support a streamlined referrals process.

- An education and training program will ensure that people (both practitioners and people with diabetes) can navigate the resources available to them and improve people’s understanding of diabetes management and include four components:
1. Training specifically on how to implement the DCP for practitioners and will be conducted at the start of the DCP. Practitioners will the option to complete the training in-person or online, however, in-person training will be encouraged.
2. Forums for all enrolled practitioners which will be held once each quarter, in-person, to discuss how the project is progressing and hear from a guest speaker on diabetes.
3. Weekly to monthly (frequency depending on demand) phone access to a diabetes specialist for all practitioners to discuss specific concerns/questions
4. DCP website which includes information on what the DCP is about and links to multiple diabetes related resources for both practitioners and patients which can be accessed at any time during the trial.

- A new funding model will make more funding available for the care of those with the greatest need ('need' is based on a pre-defined set of clinical metrics), and will reward practices for improving patient health outcomes, improving patient experience, and delivering best-practice standards of care (through quality improvement support payments). This funding model will replace care planning MBS items, those items associated with diabetes-related PIPs/SIPs and AHP funding tied to a patients care plan—typical GP consults continue to be claimed through Medicare.

- A new Care Facilitator role will be created. Care Facilitators, in collaboration with the general practice team and other members of the care team, will support the patient in finding the best available care options and proactively managing their care.

Both Intervention Group 1 and Intervention Group 2 will have a total duration of two years
Intervention code [1] 284228 0
Other interventions
Comparator / control treatment
The control group will continue to receive usual care from their care providers under current funding arrangements. No treatment will be prohibited, encouraged or required for control group patients.
Control group
Active

Outcomes
Primary outcome [1] 286480 0
Glycosylated haemoglobin as measured by HbA1c (%)
Timepoint [1] 286480 0
At the point of patient enrolment (mid-March to end-August 2012)
At the end of the trial (January to May 2014)

(Any measurement during the project recorded in the GP desktop software will also be recorded for evaluation purposes)
Secondary outcome [1] 295976 0
Cholesterol as measured by high density lipoprotein and low density lipoprotein (mmol/L)
Timepoint [1] 295976 0
At the point of patient enrolment (mid-March to end-August 2012)
At the end of the trial (January to May 2014)

(Any measurement during the project recorded in the GP desktop software will also be recorded for evaluation purposes)
Secondary outcome [2] 295977 0
Blood pressure, as measured by Systolic blood pressure (mmHg) over Diastolic blood pressure (mmHg)
Timepoint [2] 295977 0
At the point of patient enrolment (mid-March to end-August 2012)
At the end of the trial (January to May 2014)

(Any measurement during the project recorded in the GP desktop software will also be recorded for evaluation purposes)
Secondary outcome [3] 295978 0
Depression, as measured by PHQ-9 score (Patient Health Questionnaire - 9)
Timepoint [3] 295978 0
At the point of patient enrolment (mid-March to end-August 2012)
At the end of the trial (January to May 2014)
Secondary outcome [4] 295979 0
Diabetes distress, as measured by Problem Areas in Diabetes (PAID) questionnaire score
Timepoint [4] 295979 0
At the point of patient enrolment (mid-March to end-August 2012)
At the end of the trial (January to May 2014)
Secondary outcome [5] 295980 0
Health related quality of life, as measured by AQoL-4D score
Timepoint [5] 295980 0
At the point of patient enrolment (mid-March to end-August 2012)
At the end of the trial (January to May 2014)
Secondary outcome [6] 295981 0
Incidence of diabetes related complications as measured by 1. Hospital diagnosis and treatment codes
2. GP record entries

Incidence of peripheral neuropathy
Incidence of peripheral vascular disease
Incidence of foot ulcers
Incidence of amputation
Incidence of microalbuminuria
Incidence of macroalbuminuria
Incidence of renal failure
Incidence of proliferative diabetic retinopathy
Incidence of macula edema
Incidence of glaucoma
Incidence of serious vision loss
Incidence of hypoglycaemia
Incidence of myocardial infarction
Incidence of stable angina
Incidence of unstable angina
Incidence of stroke

(List not exhaustive)
Timepoint [6] 295981 0
For point 1 above:
Data will be available from 2 years prior to enrolment (January 2010) to the end of the trial (end-May 2014)
For point 2 above:
Data will be available for the full duration of the trial (mid-March 2012 to end-August 2014) and including all history available within GP desktop data.
Secondary outcome [7] 295982 0
Patient completion of a diabetes cycle of care, as measured by completion of the following activities as recorded in GP desktop

Patients receiving annual HbA1C test
Patients receiving annual retinopathy screen
Patients receiving BMI measurement at least 6 monthly
Patients receiving BP test at least 6 monthly
Patients receiving annual foot examination
Patients receiving annual cholesterol screen
Patients receiving annual urine micro albumin screen
Patients receiving annual influenza vaccine
Patients with completed care plan
Timepoint [7] 295982 0
Data will be collected throughout the trial (mid-March 2012 to end-May 2014)
Secondary outcome [8] 295983 0
Patient empowerment and satisfaction, as measure by scores for:
1. Patients' Evaluation of the Quality of Diabetes care (PEQD) - satifsaction survey
2. Partners In Health (PIH) - patient empowerment survey
3. Selection of questions from Experienced Continuity of Care in Diabetes Mellitus (ECC-DM) - continuity of care survey
Timepoint [8] 295983 0
At the point of patient enrolment (mid-March to end-August 2012)
At the end of the trial (January to May 2014)
Secondary outcome [9] 295984 0
Hospitalisations, as measured by:
1. Number of hospitalisations by patient
2. Length of hospitalisations by patient
Timepoint [9] 295984 0
Data will be collected throughout the trial (mid-March 2012 to end-May 2014)
Secondary outcome [10] 295985 0
MBS usage and cost data, as measured by claims submitted under MBS, by patient
Timepoint [10] 295985 0
Data will be available from 2 years prior to enrolment (January 2010) to the end of the trial (end-May 2014)
Secondary outcome [11] 295986 0
PBS usage and cost data, as measured by claims submitted under PBS, by patient
Timepoint [11] 295986 0
Data will be available from 2 years prior to enrolment (January 2010) to the end of the trial (end-May 2014)
Secondary outcome [12] 295987 0
National Diabetes Services Scheme (NDSS) usage and cost data, as measured by subsidy provided
Timepoint [12] 295987 0
Data will be available from 2 years prior to enrolment (January 2010) to the end of the trial (end-May 2014)
Secondary outcome [13] 295988 0
Hospital cost information, as measured by cost of each hospital stay recorded by Queensland Health, SA Health, Victorian Department of Health
Timepoint [13] 295988 0
Data will be available from 2 years prior to enrolment (January 2010) to the end of the trial (end-May 2014)
Secondary outcome [14] 295989 0
Patient out-of-pocket expenses as measures by:
1. MBS co-payment data by claim
2. PBS co-payment data by claim
3. Month long patient diary on other out-of-pocket expenses completed by a small portion of trial participants (600 participants, ~5% of trial participants)
Timepoint [14] 295989 0
Data on points 1 and 2 will be available from 2 years prior to enrolment (January 2010) to the end of the trial (end-May 2014)

Data on point 3 will be available for one month during the trial (specific dates TBC)

Eligibility
Key inclusion criteria
Type 1 or Type 2 diabetes
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People with diabetes are excluded from taking part if they:
- Are under 18 years of age
- Are pregnant
- Have been diagnosed with a terminal illness
- Have been diagnosed with dementia
- Have been diagnosed with Type 1 diabetes within the last 12 months
- Are a part of the Department of Veterans’ Affairs (DVA) Coordinated Veterans’ Care (CVC) program.

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 for patients

Patients will know which group they will be in (control, Intervention 1, Intervention 2) at the time of enrolment

Allocation is concealed for general practices through a central randomisation process run by UniSA and notified via the phone and mail.

This trial will be run as a pragmatic clustered randomized clustered trial.

The clusters are general practices, meaning general practices will be recruited and then patients will be recruited from participating general practices. Each general practice (and all enrolled patients connected to that practice) will be randomised into either the control group, Intervention Group 1 or Intervention Group 2

Our recruitment of general practices will focus on the Medicare Locals/Divisions of General Practice of our consortium partners in Queensland, South Australia and Victoria.

Each Medicare Local/ Division of General Practice will be allocated either to Intervention group 1 or Intervention group 2. This means that each Medicare Local/ Division of General Practice will have general practices in either Intervention 1 or Intervention 2 and general practices in the control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will use a block randomisation process which is applied separately for each Medicare Local /Division of General Practice and separately for urban (RA-1) and rural (RA-2-5) general practices.
Masking / blinding
Open (masking not 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
Recruiting
Date of first participant enrolment
Anticipated
2/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284674 0
Government body
Name [1] 284674 0
Australian Government Department of Health and Ageing
Country [1] 284674 0
Australia
Funding source category [2] 284675 0
Government body
Name [2] 284675 0
Department of Health, Victoria
Country [2] 284675 0
Australia
Primary sponsor type
Government body
Name
Australian Government Department of Health and Ageing
Address
Department of Health and Ageing
GPO Box 9848,
Canberra, 2601
ACT, Australia
Country
Australia
Secondary sponsor category [1] 283579 0
Individual
Name [1] 283579 0
Dr Tim Fountaine
Address [1] 283579 0
Level 34
88 Phillip Street
Sydney, 2000
NSW, Australia
Country [1] 283579 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286678 0
SA Aboriginal HREC
Ethics committee address [1] 286678 0
Ethics committee country [1] 286678 0
Date submitted for ethics approval [1] 286678 0
19/01/2012
Approval date [1] 286678 0
02/02/2012
Ethics approval number [1] 286678 0
4/11/0471
Ethics committee name [2] 286757 0
Toowoomba Darling Downs HREC
Ethics committee address [2] 286757 0
Ethics committee country [2] 286757 0
Australia
Date submitted for ethics approval [2] 286757 0
25/01/2012
Approval date [2] 286757 0
09/02/2012
Ethics approval number [2] 286757 0
HREC/11/QTDD/65

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

Contacts
Principal investigator
Name 33753 0
Address 33753 0
Country 33753 0
Phone 33753 0
Fax 33753 0
Email 33753 0
Contact person for public queries
Name 17000 0
Dr Tim Fountaine
Address 17000 0
Aurora Place, Level 35,
88 Phillip Street
Sydney
NSW
2000
Country 17000 0
Australia
Phone 17000 0
+61 2 8273 1600
Fax 17000 0
Email 17000 0
Tim_Fountaine@McKinsey.com
Contact person for scientific queries
Name 7928 0
Dr Tim Fountaine
Address 7928 0
Aurora Place, Level 35,
88 Phillip Street
Sydney
NSW
2000
Country 7928 0
Australia
Phone 7928 0
+61 2 8273 1600
Fax 7928 0
Email 7928 0
Tim_Fountaine@McKinsey.com

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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