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Trial registered on ANZCTR


Registration number
ACTRN12612000578808
Ethics application status
Approved
Date submitted
24/05/2012
Date registered
29/05/2012
Date last updated
14/09/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Implementing guidelines to routinely prevent chronic disease in general practice (PEP study)
Scientific title
Guidelines for preventing primary vascular disease in general practice
Secondary ID [1] 280570 0
Nil
Universal Trial Number (UTN)
U1111-1130-9488
Trial acronym
PEP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Disease 286515 0
Stroke 286523 0
Condition category
Condition code
Cardiovascular 286777 286777 0 0
Other cardiovascular diseases
Cardiovascular 286784 286784 0 0
Coronary heart disease
Public Health 286813 286813 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of:-
1. A training workshop for General Practitioners (GPs) and Practice Nurses (PNs) on prevention of vascular disease. The workshop is of 3 hours duration and is overseen and presented by a Primary Health Care specialist and Clinical Investigator in each state, the Intervention Facilitator (IF) and a Division of General Practice/Medicare Local staff member. The workshop introduces the 5As (Assess, Advise/Agree, Assist/Arrange) for smoking, nutrition, alcohol, physical activity, weight, blood pressure, cholesterol, diabetes, absolute cardiovascular risk and kidney disease. The format of the workshop is an introductory presentation followed by case studies and role plays using simulated patients.
2. Three practice visits of approximately 1-1.5hours duration each over 4 months will be provided by an intervention facilitator. The practice visits are designed to occur at regular intervals during the intervention period
a) Practice visit 1 - 4 weeks post workshop
b) Practice visit 2- 3-4 weeks after visit no 1
c) Practice visit 3 - 3-4 weeks after visit no 2
During the 4 months period the IF will also conduct 3 follow-up and troubleshooting phone calls with a member of the practice staff identified at visit no 1 to act as the 'prevention coordinator'


This meeting with the practice staff is designed to:
a) Review the baseline clinical audit report and identify areas for improvement
b) Set some goals and plan for improvement
c) Provide resources, referral links or support to help the practice
d) Monitor improvements

The training for GPs and PNs is designed to highlight the guideline recommendations relating to preventive activities in general practice. The practice is given baseline data which allows them to identify deficits in meeting these guideline recommendations and guided to identify ways in which they can modify their practice to deliver appropriate preventive care to their patients. Patients will receive the usual care of their practitioner but we would envisage that this care will be modified reflecting guideline recommendations provided through the training and additional resources.
Intervention code [1] 284899 0
Prevention
Intervention code [2] 284901 0
Early detection / Screening
Intervention code [3] 284902 0
Lifestyle
Comparator / control treatment
Practices allocated to the control group will continue with Usual Care. Usual care refers to clinical practice usually offerred to patients by the general practitioner and the practice nurse
Control group
Active

Outcomes
Primary outcome [1] 287163 0
1.Changes in risk factor measurement (BP, BMI, smoking status, Diabetes and Lipids). This will be assessed via an audit of clinical records at baseline and post intervention using the Pen Clinical Audit Tool (CAT)
Timepoint [1] 287163 0
Baseline and 12 months
Primary outcome [2] 287165 0
2.Changes in prescribing and medication management (lipid lowering, antihypertensive). This will be assessed via an audit of clinical records at baseline and post intervention using the Pen Clinical Audit Tool (CAT
Timepoint [2] 287165 0
Baseline and 12 months
Primary outcome [3] 287166 0
3.Changes in patient self reported lifestyle risk factors (smoking, alcohol, diet, physical activity). This will be assessed via self-report on a patient survey sent to a random sample of 160 patients per practice.
Timepoint [3] 287166 0
Baseline and 12 months
Secondary outcome [1] 297530 0
1.Changes in GP/Practice nurse actions for risk management (referral to appropriate weight loss and exercise programs, smoking cessation programs, advice regarding smoking diet and exercise). This will be assessed by a GP/PN survey developed for this project
Timepoint [1] 297530 0
Baseline and 12 months
Secondary outcome [2] 297533 0
2. GP and Practice Nurse attitudes to preventive care in general practice. This will be assessed by a GP/PN survey developed for this project
Timepoint [2] 297533 0
Baseline and 12 months
Secondary outcome [3] 297534 0
3. Patient attitudes and perceptions of prevention and preventative activities by their GPs. This will be assessed by telephone interviews with a sample of patients who respond to the patient survey and indicate their willingness to participate in an interview
Timepoint [3] 297534 0
12 months

Eligibility
Key inclusion criteria
General Practices are required to be using electronic clinical software compatible with the Pen Clinical Audit Tool. Practices should employ at least one practice nurse and a proportion of the GPs within that practice need to be prepared to participate.

Patient inclusion criteria includes:
- Aged 40-69
- Active patient of the practice (3 visits in the last 2 years and one visit in the last 12 months)
- No diagnosis of diabetes, heart disease or renal impairment/failure
- Sufficient English to understand the invitation letter, provide consent and complete a written questionnaire
Minimum age
40 Years
Maximum age
69 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
General practices - Non computerised practices

Patients with the following diagnoses will be excluded:
- Angina
- Diabetes
- Coronary heart Disease
- Myocardial Infarction
- Previous coronary re-vascularisation
- Heart Failure
- Stroke
- Transient Ischaemic Attack
- Renal impairment
- Peripheral Vascular Disease
- Atrial Fibrillation
- Hyperlipidaemia
- Schizophrenia
- Bipolar Disorder
- Dementia
- Recent history of drug abuse (last 12 months)
- Pregnant

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
General practices are enrolled in each state by a Field Research Officer/Intervention Facilitator who obtain consent for participation. Consented practices are forwarded to a central administration site (University of NSW) where the randomisation is carried out (see below)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation is conducted at the level of the practice (cluster) using block randomisation, stratified according to practice size using a computer generated randomisation program. Randomisation is performed by a person independent of the data collection and intervention
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
NA
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)
NSW,QLD,SA,VIC
Recruitment postcode(s) [1] 5312 0
2570
Recruitment postcode(s) [2] 5313 0
2565
Recruitment postcode(s) [3] 5314 0
2560
Recruitment postcode(s) [4] 5315 0
2176
Recruitment postcode(s) [5] 5316 0
2165
Recruitment postcode(s) [6] 5317 0
2170
Recruitment postcode(s) [7] 5318 0
3151
Recruitment postcode(s) [8] 5319 0
3106
Recruitment postcode(s) [9] 5320 0
3103
Recruitment postcode(s) [10] 5321 0
3150
Recruitment postcode(s) [11] 5322 0
3148
Recruitment postcode(s) [12] 5323 0
3170
Recruitment postcode(s) [13] 5324 0
3149
Recruitment postcode(s) [14] 5325 0
4502
Recruitment postcode(s) [15] 5326 0
4508
Recruitment postcode(s) [16] 5327 0
4515
Recruitment postcode(s) [17] 5328 0
4067
Recruitment postcode(s) [18] 5329 0
4012
Recruitment postcode(s) [19] 5330 0
4053
Recruitment postcode(s) [20] 5331 0
4067
Recruitment postcode(s) [21] 5332 0
5042
Recruitment postcode(s) [22] 5333 0
5158
Recruitment postcode(s) [23] 5334 0
5162
Recruitment postcode(s) [24] 5335 0
5159

Funding & Sponsors
Funding source category [1] 285288 0
Government body
Name [1] 285288 0
National Health and Medical Research Council
Address [1] 285288 0
National Health and Medical Research Council (NHMRC)
GPO Box 1421
Canberra ACT 2601
Country [1] 285288 0
Australia
Funding source category [2] 285293 0
Charities/Societies/Foundations
Name [2] 285293 0
Heart Foundation
Address [2] 285293 0
Level 3, 80 William Street
Sydney NSW 2011
Country [2] 285293 0
Australia
Funding source category [3] 285294 0
Self funded/Unfunded
Name [3] 285294 0
Royal Australian College of General Practice
Address [3] 285294 0
1 Palmerston Crescent
South Melbourne, Victoria, 3205
Country [3] 285294 0
Australia
Funding source category [4] 285295 0
Charities/Societies/Foundations
Name [4] 285295 0
Bupa Health Foundation
Address [4] 285295 0
600 Glenferrie Road
HAWTHORN VIC 3122
Country [4] 285295 0
Australia
Primary sponsor type
University
Name
Centre for Primary Health Care and Equity, University of NSW
Address
Centre for Primary Health Care and Equity, School of Public Health and Community Medicine
University of New South Wales, NSW 2052
Country
Australia
Secondary sponsor category [1] 284155 0
None
Name [1] 284155 0
Address [1] 284155 0
Country [1] 284155 0
Other collaborator category [1] 260812 0
University
Name [1] 260812 0
Monash University
Address [1] 260812 0
270 Ferntree Gully Road
Notting Hill Vic, 3168
Country [1] 260812 0
Australia
Other collaborator category [2] 260813 0
University
Name [2] 260813 0
Flinders University
Address [2] 260813 0
Sturt Road
Bedford Park SA 5042
Country [2] 260813 0
Australia
Other collaborator category [3] 260814 0
University
Name [3] 260814 0
University of Queensland
Address [3] 260814 0
Brisbane QLD 4072 Australia
Country [3] 260814 0
Australia
Other collaborator category [4] 260815 0
University
Name [4] 260815 0
Bond University
Address [4] 260815 0
University Drive
Robina Queensland 4229
Country [4] 260815 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287307 0
RACGP National Research and Evaluation Ethics Committee
Ethics committee address [1] 287307 0
1 Palmerston Crescent
South Melbourne, Victoria 3205
Ethics committee country [1] 287307 0
Australia
Date submitted for ethics approval [1] 287307 0
Approval date [1] 287307 0
12/02/2010
Ethics approval number [1] 287307 0
NREEC 10/002
Ethics committee name [2] 287308 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [2] 287308 0
Ethics committee country [2] 287308 0
Australia
Date submitted for ethics approval [2] 287308 0
Approval date [2] 287308 0
12/10/2011
Ethics approval number [2] 287308 0
SAC HREC 397.11
Ethics committee name [3] 287309 0
The University of Queensland Medical Research Ethics Committee
Ethics committee address [3] 287309 0
Cumbrae-Stewart Building
Research Road
Brisbane Qld 4072
Ethics committee country [3] 287309 0
Australia
Date submitted for ethics approval [3] 287309 0
Approval date [3] 287309 0
06/12/2011
Ethics approval number [3] 287309 0
2011001326

Summary
Brief summary
The PEP study is a partnership between New South Wales, Flinders, Monash, Bond and Queensland Universities, the Royal Australian College of General Practitioners (RACGP), the National Heart Foundation of Australia (NHFA) and the BUPA Foundation.

The study is in response to the need to evaluate the uptake and effectiveness of current guidelines for the prevention of chronic disease in general practice, and to develop innovative and effective implementation strategies for the future.

The aims of this partnership are to design, trial and evaluate a framework to improve the implementation of the RACGP, the NHFA and NHMRC guidelines for prevention of chronic disease in general practice.
Trial website
Nil
Trial related presentations / publications
Harris, M. F., Lloyd, J. E., Litt, J., Van driel, M., Mazza, D., Russell, G., Smith, J., Del Mar, C. B., Denney-Wilson, E., Parker, S., Krastev, Y., Jayasinghe, U. W., Taylor, R. J., Zwar, N. A., Wilson, J., Bolger-Harris, H. and Waters, J. (2013). Preventive evidence into practice (PEP) study: implementation of guidelines to prevent primary vascular disease in general practice protocol for a cluster randomised controlled trial. Implementation Science, 8(8). doi: 10.1186/1748-5908-8-8

Harris MF,Parker SM, Litt J, et al. Implementing guidelines to routinely prevent chronic vascular disease in primary care: the Preventive Evidence into Practice cluster randomised controlled trial. BMJ Open 2015;5:e009397.
doi:10.1136/bmjopen-2015-009397
Public notes

Contacts
Principal investigator
Name 34203 0
Prof Mark Harris
Address 34203 0
Centre for Primary Health Care and Equity
The University of New South Wales
Level 3, AGSM
University of NSW Sydney NSW 2052
Country 34203 0
Australia
Phone 34203 0
+61 2 9385 1547
Fax 34203 0
Email 34203 0
m.f.harris@unsw.edu.au
Contact person for public queries
Name 17450 0
Prof Professor Mark Harris
Address 17450 0
Centre for Primary Health Care and Equity
The University of NSW
Level 3, AGSM
University of NSW
Sydney NSW 2052
Country 17450 0
Australia
Phone 17450 0
+61 2 9385 1547
Fax 17450 0
+61 2 9385 1513
Email 17450 0
m.f.harris@unsw.edu.au
Contact person for scientific queries
Name 8378 0
Prof Professor Mark Harris
Address 8378 0
Centre for Primary Health Care and Equity
The University of NSW
Level 3, AGSM
University of NSW
Sydney NSW 2052
Country 8378 0
Australia
Phone 8378 0
+61 2 9385 1547
Fax 8378 0
+61 2 9385 1513
Email 8378 0
m.f.harris@unsw.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