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Trial registered on ANZCTR


Registration number
ACTRN12605000788673
Ethics application status
Approved
Date submitted
6/12/2005
Date registered
12/12/2005
Date last updated
14/02/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
The Role of non-GP Staff in Chronic Disease Management in General Practice.
Scientific title
Trial of Structured Support to Enhance the Role of Non-GP Staff in the Management of Diabetes, Ischaemic Heart Disease and Hypertension in General Practice
Universal Trial Number (UTN)
Trial acronym
Teamwork
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus 946 0
Ischemic Heart Disease 947 0
Hypertension 948 0
Condition category
Condition code
Metabolic and Endocrine 1015 1015 0 0
Diabetes
Cardiovascular 1016 1016 0 0
Other cardiovascular diseases
Cardiovascular 1017 1017 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Study will recruit general practices within participating Divisions of General Practice. Participating practices will be randomly allocated to intervention group (30 practices) which will receive the intervention immediately following randomisation. Study staff collecting data will be blinded. Method: Six-month intervention driven by the practice with assistance from a facilitator (from the research team). The intervention will focus on establishing practice systems and defining roles and procedures for non-GP staff for the management of patients with type II diabetes or ischaemic heart disease, or hypertension to ensure: evidence based care is offered; patients return for follow-up; adequate access to appointments and length of consultations or group sessions is available; regular and comprehensive assessment and monitoring is carried out; multidisciplinary care needs are identified and plans to address them are implemented; access to structured patient education sessions and patient education resources is available; appropriate referral is made; financial stability of teamwork is optimised through use of Chronic Disease Management (CDM) Medicare items. Each practice in the intervention group will receive the core intervention, consisting of education sessions, practice visits and ongoing support, with additional customisation for each practice's specific circumstances. Located in the practice, the intervention will be conducted through and with the support of the division, who will support practices beyond the intervention period to maintain the effect of the intervention. At the completion of the study, the intervention will be offered to the control practices.
Intervention code [1] 785 0
None
Comparator / control treatment
The control group (50 practices) will receive the intervention at 12 months post randomisation.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1353 0
The study will evaluate the impact of the intervention on (i) quality of care
Timepoint [1] 1353 0
Data Collection: Measurements will be taken at 3 points in time. 1. Immediately before randomisation and before commencement of the intervention (0 month) to get a baseline measure. 2. At the completion of the training and support (6 months from randomisation) to measure the immediate effect of the intervention. 3. Six months after the completion of the intervention (12 months from randomisation) to measure maintenance of effect.
Primary outcome [2] 1354 0
The study will evaluate the impact of the intervention on (ii) patient's perceptions of access, continuity of care, interpersonal care and satisfaction with care
Timepoint [2] 1354 0
Data Collection: Measurements will be taken at 3 points in time. 1. Immediately before randomisation and before commencement of the intervention (0 month) to get a baseline measure. 2. At the completion of the training and support (6 months from randomisation) to measure the immediate effect of the intervention. 3. Six months after the completion of the intervention (12 months from randomisation) to measure maintenance of effect.
Primary outcome [3] 1355 0
The study will evaluate the impact of the intervention on (iii) health status of patients with diabetes and/or ischaemic heart disease and/or hypertension.
Timepoint [3] 1355 0
Data Collection: Measurements will be taken at 3 points in time. 1. Immediately before randomisation and before commencement of the intervention (0 month) to get a baseline measure. 2. At the completion of the training and support (6 months from randomisation) to measure the immediate effect of the intervention. 3. Six months after the completion of the intervention (12 months from randomisation) to measure maintenance of effect.
Primary outcome [4] 1356 0
Measures: (a) Clinical Care Interview: a GP self-report quality of care interview, which we have developed and validated in our ongoing research program, will be used. The instrument has good internal consistency and construct validity in relation to record audits.
Timepoint [4] 1356 0
Data Collection: Measurements will be taken at 3 points in time. 1. Immediately before randomisation and before commencement of the intervention (0 month) to get a baseline measure. 2. At the completion of the training and support (6 months from randomisation) to measure the immediate effect of the intervention. 3. Six months after the completion of the intervention (12 months from randomisation) to measure maintenance of effect.
Primary outcome [5] 1357 0
Measures: (b) Practice Claims of HIC Payment for long consultations (Levels C & D), care plans, completed cycles of care, investigations (HbAIc, urinary microalbumin) and eye referral for diabetes.
Timepoint [5] 1357 0
Data Collection: Measurements will be taken at 3 points in time. 1. Immediately before randomisation and before commencement of the intervention (0 month) to get a baseline measure. 2. At the completion of the training and support (6 months from randomisation) to measure the immediate effect of the intervention. 3. Six months after the completion of the intervention (12 months from randomisation) to measure maintenance of effect.
Primary outcome [6] 1358 0
The following measures will be taken on each of the 30 patients recruited in each practice: (c) An Audit of Medical Records to determine the recorded frequency and values of blood pressure, HbAIcm total cholesterol, HDL, LDL levels.
Timepoint [6] 1358 0
Audit of Medical Records at baseline and 12 months. Values of blood pressure, HbAIcm total cholesterol, HDL, LDL levels performed in the last 12 months.
Primary outcome [7] 1359 0
The following measures will be taken on each of the 30 patients recruited in each practice: (d) 20-item Patient Assessment of Chronic Illness Care (PACIC) developed and validated in the US that assesses patient's receipt of clinical services and the PACIC consists of 5 scales and an overall summary score.
Timepoint [7] 1359 0
Primary outcome [8] 1360 0
The following measures will be taken on each of the 30 patients recruited in each practice: (e) SF-12 (v2), a 7-item questionnaire measureing patients' health status.
Timepoint [8] 1360 0
Primary outcome [9] 1361 0
The following measures will be taken on each of the 30 patients recruited in each practice: (f) A 3-item questionnaire surveying whether patients have received i) education or patient education materials by the GP or other general practice staff in the past 12 months
Timepoint [9] 1361 0
Primary outcome [10] 1362 0
The following measures will be taken on each of the 30 patients recruited in each practice: (f) A 3-item questionnaire surveying whether patients have received ii) a referral in past 12 months for education, self help or support group, or allied health services (diabetes education, dietetics, podiatrist, cardiac rehabilitation)
Timepoint [10] 1362 0
Primary outcome [11] 1363 0
The following measures will be taken on each of the 30 patients recruited in each practice: (f) A 3-item questionnaire surveying whether patients have received iii) any recall or reminders from the practice.
Timepoint [11] 1363 0
Primary outcome [12] 1364 0
In addition, data will will be collected on practice and practice staff characteristics including: rurality of local area; number, age, gender, full time/part time status, training of GPs and practice staff; management of practice (e.g. solo, group, corporate).
Timepoint [12] 1364 0
These data will be collected at the time of recruitment. They will allow comparison between practices that elect to participate and those who decline.
Secondary outcome [1] 2416 0
Qualitative and quantitative data will also be collected about the roles of the GPs and practice staff in chronic disease management and team functioning at 3 points in time; Instruments being utilised by the investigators in our current research program will be used, including the 'Team Climate Inventory', the Staff Roles Interview, and a practice profiling survey of practice systems for chronic disease care, including appointment systems, information systems, procedures for recall, patient education materials and education sessions. The data will be used to ascertain which factors are associated with the adoption of a broader role for non-GP staff.
Timepoint [1] 2416 0
At the baseline before the commencement of intervention, at the completion of the intervention (6 months from baseline) and 6 months after competition of the intervention (12 months from baseline).

Eligibility
Key inclusion criteria
The research will take place in partnership with 10 Divisions of General Practice. All general practices that use computerised prescribing, have a minimum of 3 people working in the practice, have a practice manager and/or practice nurse role in the practice and the practice manager role is not carried out solely by a GP, are located in the participating Divisions of General Practice will be eligible for inclusion. Patients in participating practices will be eligible for inclusion in the study if they have type II diabetes and/or ischaemic heart disease and/or hypertension, and have attended the practice in the past 12 months and who have been prescribed medications commonly used to treat the above conditions.
Minimum age
18 Years
Maximum age
79 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
Allocation concealment will be achieved by Patient selection, patient consent and baseline data collection will occur before randomisation. Using a centralised randomisation scheme where a University of NSW statistician not involved in the study (not linked to practice or patient recruitment, or staff recruitment) and who is blinded to the identity of the participating practices will generate random numbers using computer generated random numbers. The outcome of the random allocation will be kept in sealed envelopes. Project staff who collect data are different from those who deliver the intervention. Data collection officers will be unaware of random practice allocation. The intervention research assistants will not be informed of the practices in the intervention group until they start delivering the intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block design will be used to randomise participating practices into intervention and control groups. Practices within each division of general practice will constitute one block. In each block, practices will be allocated to intervention or control groups using computer generated random numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/06/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1119 0
Government body
Name [1] 1119 0
The National Health and Medical Research Council
Country [1] 1119 0
Australia
Primary sponsor type
University
Name
Centre for GP Integration Studies, University of New South Wales.
Address
Country
Australia
Secondary sponsor category [1] 977 0
None
Name [1] 977 0
Address [1] 977 0
Country [1] 977 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2434 0
The Human Ethics Committee University of New South Wales
Ethics committee address [1] 2434 0
Ethics committee country [1] 2434 0
Australia
Date submitted for ethics approval [1] 2434 0
Approval date [1] 2434 0
Ethics approval number [1] 2434 0

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

Contacts
Principal investigator
Name 35751 0
Address 35751 0
Country 35751 0
Phone 35751 0
Fax 35751 0
Email 35751 0
Contact person for public queries
Name 9974 0
Professor Mark Harris
Address 9974 0
Centre for Primary Health Care and Equity, University of New South Wales, NSW 2052 Australia
Country 9974 0
Australia
Phone 9974 0
+61 2 93851547
Fax 9974 0
+61 2 93851513
Email 9974 0
m.f.harris@unsw.edu.au
Contact person for scientific queries
Name 902 0
Professor Mark Harris
Address 902 0
Centre for Primary Health Care and Equity, University of New South Wales, NSW 2052 Australia
Country 902 0
Australia
Phone 902 0
+61 2 93851547
Fax 902 0
+61 2 93851513
Email 902 0
m.f.harris@unsw.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
No additional documents have been identified.