Harris et al. Implementation Science 2013, 8:8
http://www.implementationscience.com/content/8/1/8
Implementation
Science
STUDY PROTOCOL
Open Access
Preventive evidence into practice (PEP) study:
implementation of guidelines to prevent primary
vascular disease in general practice protocol for a
cluster randomised controlled trial
Mark F Harris1*, Jane Lloyd1, John Litt2, Mieke van Driel3, Danielle Mazza4, Grant Russell4, Jane Smith5,
Chris Del Mar5, Elizabeth Denney-Wilson6, Sharon Parker1, Yordanka Krastev7, Upali W Jayasinghe1, Richard Taylor8,
Nick Zwar8, Jinty Wilson9, Helen Bolger-Harris10 and Justine Waters11
Abstract
Background: There are significant gaps in the implementation and uptake of evidence-based guideline
recommendations for cardiovascular disease (CVD) and diabetes in Australian general practice. This study protocol
describes the methodology for a cluster randomised trial to evaluate the effectiveness of a model that aims to
improve the implementation of these guidelines in Australian general practice developed by a collaboration
between researchers, non-government organisations, and the profession.
Methods: We hypothesise that the intervention will alter the behaviour of clinicians and patients resulting in
improvements of recording of lifestyle and physiological risk factors (by 20%) and increased adherence to guideline
recommendations for: the management of CVD and diabetes risk factors (by 20%); and lifestyle and physiological
risk factors of patients at risk (by 5%). Thirty-two general practices will be randomised in a 1:1 allocation to receive
either the intervention or continue with usual care, after stratification by state. The intervention will be delivered
through: small group education; audit of patient records to determine preventive care; and practice facilitation visits
adapted to the needs of the practices. Outcome data will be extracted from electronic medical records and patient
questionnaires, and qualitative evaluation from provider and patient interviews.
Discussion: We plan to disseminate study findings widely and directly inform implementation strategies by
governments, professional bodies, and non-government organisations including the partner organisations.
Keywords: Primary care, Family medicine, Guidelines, Preventive care, Cardiovascular disease
Background
Cardiovascular disease (CVD) represents a substantial
and increasing portion of healthcare expenditure and
practitioner workload [1]. It is estimated that 9 in 10
adult Australians have at least one risk factor for CVD
[2]. Behavioural risk factors include smoking, nutrition,
alcohol, physical activity, and being overweight or obese.
The physiological risk factors include high blood pressure and dyslipidaemia [3].
* Correspondence: m.f.harris@unsw.edu.au
1
Centre for Primary Health Care and Equity, University of New South Wales,
Kensington, NSW 2052, Australia
Full list of author information is available at the end of the article
Primary care providers are well placed to help reduce
the incidence of CVD. General practitioners provide
clinical services to approximately 88% of Australians
each year and are in an ideal position to screen for risk
factors and provide brief interventions including advice
about behavioural risk factors as well as medications [1].
However, there are numerous barriers to implementation at the patient, practitioner, practice, and system
levels [4-7].
The Australian Government Department of Health
and Ageing, the National Health and Medical Research
Council, the National Heart Foundation of Australia,
The Royal Australian College of General Practitioners,
© 2013 Harris et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative
Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and
reproduction in any medium, provided the original work is properly cited.
Harris et al. Implementation Science 2013, 8:8
http://www.implementationscience.com/content/8/1/8
Page 2 of 10
The Cardiac Society of Australia and New Zealand and
the National Vascular Disease Prevention Alliance have
published guidelines that address the major behavioural
and physiological risk factors for vascular disease. These
guidelines synthesise the evidence for preventing CVD
and provide clear messages for primary care providers
on what targets to aim for and what strategies might be
best employed at the patient provider interaction.
A number of these guidelines refer to the 5As framework, which describes how general practice staff can
intervene to prevent CVD [8]. This framework describes
the pathway and informs the role of different providers
and services in preventive care (Figure 1).
The guidelines have been widely disseminated and well
received. However implementation requires more than
dissemination [9], it requires a tailored approach to
generate change in clinicians behaviour [10], and there
exists evidence of gaps between the guideline recommendations and their implementation in Australian
general practice [7,11,12]. Some of the reasons for the
failure to implement prevention guidelines are related to
the complexity of guideline recommendations and patient, practitioner, and practice barriers [7,13], including
lack of capacity to provide brief interventions or refer
for more intensive education and support [14,15].
Patients’ understanding of prevention is variable: they
lack knowledge about what preventive care is what is
relevant to them, and there is a tendency for patients
with low health literacy and education attainment to be
less likely to ask for, and therefore to receive, preventive
care [16,17]. The culture of individual practices, their
openness to change, and the number and experience of
providers, all influence the ability to implement preventive guideline recommendations [18].
The Preventive Evidence into Practice (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 PEP study is a national, cluster randomised control trial of an intervention designed
to support general practices to implement the recommendations of evidence-based clinical management
Ask/
recall
guidelines for the prevention of CVD in general practice
among patients aged 40 to 69 years.
This study aims to evaluate the impact of the PEP
intervention on: The behaviour of doctors and nurses in
general practice in assessing and recording risk factors
and providing interventions to address these; and patient
behavioural and physiological risk factors.
We hypothesise that, for patients aged 40 to 69 years,
the PEP intervention measured at the practice level
over 12 months will improve: by 20% recording of behavioural and physiological risk factors; by 20% the
adherence to the recommendations of guidelines for
the management of these risk factors; and by 5% the lifestyle and physiological risk factors of patients with the
risk factors.
Methods
Study design
The study is a cluster randomised controlled trial conducted in general practices in four states. This design
was chosen because the primary intervention will be at
the practice level and outcomes will be measured at the
patient level.
Randomisation
Practices will be randomly assigned to intervention and
late intervention (control) groups after stratification into
blocks by state and practice size—i.e., the number of
general practictioners (GPs) in a practice—using a
computer-generated randomization list. Randomisation
will be conducted centrally, after completion of the baseline general practice and practice nurse (PN) surveys, by
one of the investigators, a statistician not involved in the
data collection or intervention (UJ). Results of the
randomisation will communicated to the project management committee prior to the commencement of the
intervention.
Setting
The study is being conducted in general practices in four
primary care organisations (Medicare Locals) in urban
areas during 2012 and 2013.
ASSESS
ADVISE
AGREE
ASSIST
ARRANGE
Risks
Readiness
to change
Motivational
counselling
and education
Collaborative
goal setting
Referral to
community-based
programs
&services
Phone and
follow up
Figure 1 The 5As conceptual model.
Harris et al. Implementation Science 2013, 8:8
http://www.implementationscience.com/content/8/1/8
The intervention
Intervention development
The process for intervention development broadly followed the framework for design of complex interventions [19]. In order to inform the development of the
PEP intervention we initially conducted a review of the
literature [20]. This identified effective strategies for
implementation of guidelines, including establishing
small group education sessions with patients, clinician
prompts and decision aids, audit and feedback, and external facilitation [21]. Educational interventions that are
interactive, provided feedback to participants, include an
objective assessment of education needs and involve
small groups are more likely to be effective [22,23].
Small group interventions are most effective because
they combine evidence-based material with peer influence [24]. Audit and feedback can be effective in providing more preventive care [25]. The variation of effect
can be explained by the different ways in which audits
are conducted and how feedback is provided. External
facilitation has been shown to be effective in improving
preventive care [26]. Facilitation is usually included as
part of a multifaceted intervention that includes auditing
medical records.
We then conducted a mixed method study involving
eight Sydney based general practices which included
qualitative interviews with eight staff from two divisions
of general practice, one allied health provider, eight GPs,
four PNs, three practice managers and 24 patients. We
also conducted a clinical audit of medical records in the
eight practices for CVD preventive activities (for 2,409
patients aged 40 to 69 years). The findings from this,
and the literature review, were discussed at a workshop
involving the investigators and partners and external
stakeholders including consumers, professional organisational representatives, and policy makers. The intervention was then piloted in three Sydney general practices
and evaluated through audio recording of facilitation
visits and interviews with practice staff before and after
the intervention. The analysis resulted in changes to the
audit feedback to practices, the program of practice visits, and the resources provided to practices. Following
the pilot a facilitator manual was developed and discussed among the investigators prior to finalisation.
Description of intervention
The intervention is at the practice level. It will be carried
out over a six-month period, and consists of a training
workshop, three practice visits by a facilitator in each
state based in the Medicare Local, and three follow-up
phone calls. The facilitators will be trained together
using the facilitator manual and case examples from the
pilot study.
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The training workshop for GPs and PNs in each state
on the prevention of CVD will be overseen and presented by a Chief or Associate Investigator, the Intervention Facilitator and a Division of General Practice/
Medicare Local staff member. GPs and PNs from each
of the intervention practices will attend the workshops.
The format of the workshop will include an introductory
presentation followed by case studies and role plays
using simulated patients. The workshop introduces the
5As for smoking, nutrition, alcohol, physical activity,
overweight, blood pressure, cholesterol, diabetes and absolute cardiovascular risk, and kidney disease. Guidelines
that provide unambiguous advice and require fewer
changes to practice are easier to implement. Thus,
guideline recommendations have been synthesised
across the 5As framework into a quick reference guide
on two sides of an A4 sheet (Figure 2). These will be
used as the basis for case discussion in the workshop.
A clinical audit will be provided to the GPs and PNs at
baseline and 12 months for patients aged 40 to 69 without heart or kidney disease, stroke, or diabetes. This will
focus on body mass index (BMI) and waist circumference, BP, lipids, fasting glucose, and absolute cardiovascular risk. This will include analysis of both the
recording of behavioural and physiological risk factors
and the risk factors themselves. Comparative data are
provided from other practices together with a commentary prepared by an investigator in each state asking
questions and suggesting areas for improvement.
The three practice visits will occur at regular intervals
within the six-month intervention period. Each practice
will be asked to identify a prevention coordinator who is
the key contact person for the research at the practice
level (preferably the PN). Each practice visit will be of
approximately 1 to 1.5 hours duration and include the
GP(s), the PN, and possibly the practice manager. The
practice visits will be conducted by the Intervention
Facilitator and are designed to occur at regular intervals
in order to build momentum and facilitate change at the
practice level. They will discuss the provision of preventive care for each of the behavioural and physiological
risk factors across the 5As (Figure 3).
Practice visit one will occur between one and four
weeks post the training workshop. At this visit, the baseline audit results will be reviewed and two to three goals
for improvement established. These goals might be to
improve recording of certain risk factors, and intensify
prescribing or advice given or referral to other services.
Resources and local referral links will be provided and
discussed at this initial visit as necessary.
Practice visit two will occur between three and four
weeks after visit number one. The purpose of this visit
will be to reflect on progress towards meeting the goals
for improvement. Any barriers will be discussed and
Harris et al. Implementation Science 2013, 8:8
http://www.implementationscience.com/content/8/1/8
5As
Page 4 of 10
Assess
Smoking status and
readiness to change if
smoker every visit
Smoking
Ask portions of
fruit and
vegetables per
day every 2 years
Nutrition
Consider pharmacotherapy
Measure BMI
(Wt/H 2) and Waist
circumference 2
yearly
Weight
5As
Individual including
both physical
activity and diet.
Refer high risk to a
dietitian or group
diet program.
Arrange follow up
Assess every 2 years
from age 45+ years
Diabetes
risk
Assess using
AUSDRISK from age
40+ year s (18 years
in ATSI) every 3
years
Risk score 15+
reduce weight &
improve diet and
physical activity
Measure every 5
years from 45
years
Renal
disease
<2
Standard
Drinks
30min
/day
5-10%
Wt
loss
Advise/Agree Assist/Arrange
Tailor lifestyle and
medication
management to
level of risk
Lipids
Arrange
follow up
Refer high risk to
exercise professional or
PA program. Arrange
follow up
Measure every 2
years
2 fruit
5 veg
Low fat
Arrange follow up
Advise 30min of
moderate activity
most days of the
week(>2.5 hrs wk)
Absolute
CVD risk
Blood
pressure
Refer high risk to a
dietitian or group
diet program
Advise <2 drinks per day and
no more than four drinks on
any one occasion
Assess
Stop
Arrange follow
up
Brief advice to reduce &and
increase fruit and vegetable
portions (2+5)
Ask (every 2 years)
about minutes of mod
physical activity per
day and days per
week
Physical
activity
Refer to
Quitline.
Advise to quit. Set quit date.
Ask about quantity
&frequency of alcohol
intake every 3-4 years
Alcohol
Assist/ Arrange
Advise/Agree
Low–Mod Absolute
risk Lifestyle
High risk Lifestyle +
pharmacotherapy
Low–Mod: risk
Lifestyle
High risk: Lifestyle +
pharmacotherapy
Urinalysis from age 50
years every 5 yr
Pharmacotherapy
(ACEi or ARB)
Creatinine/ eGFR
Microalbumin high risk*
Weight reduction if
obese.
Refer moderate/high risk to
diet and physical activity
program or provider.
Arrange follow up
Refer at risk to a dietitian or
group diet program
<10% –
low
10-15%
- mod
>15% high
Arrange follow up
Reduce
Wt
5-10%
Arrange follow up
<140/90
Arrange follow up
LDL<2
HDL>1
TG<15
Refer eGFR<30
Arrange follow up
Maintain
GFR
*High risk: hypertension, diabetes, obesity, ATSI or family history every 1 year
Figure 2 Reference guide: summary of guideline recommendations across the 5As.
further resources and supports provided as needed. A
particular focus in this visit will be on ensuring that preventive care is available for all patients including disadvantaged patients who may have low health literacy.
Practice visit three occurs between three and four
weeks after visit number two. The purpose of this visit is
to monitor improvements, workshop ways to overcome
barriers and discuss how improvements might be maintained and incorporated as part of routine practice.
The Intervention Facilitator will conduct three followup and troubleshooting phone calls with the prevention
coordinator. Each of the practice visits will be
interspersed by a follow-up or trouble shooting phone
call initiated by the intervention facilitator. Additional
contact may be initiated by the prevention coordinator
as required.
Participants and recruitment
Eight practices have been recruited by a primary care organisation (Medicare Local) in each of the four states (a
total of 32 practices). Staff members from the Medicare
Locals approached practices that met the eligibility criteria, such as having computerised medical records to
enable an audit of medical records using the Pen Clinical
Harris et al. Implementation Science 2013, 8:8
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Clinical audit
Description of
practice roles and
organistion
Page 5 of 10
Review of clinical
audit
Identification of areas
of improvement and
barriers
Goals to improve
preventive care in
practice
Monitor andfollow
up
Plan for improvement
Problem solving
Ideas, resources, and
links to support
change
Maintenance of
changes
Figure 3 The intervention.
Audit Tool (Pen CAT) [27] and a PN. Of the 47 practices who expressed interest in the study and who were
subsequently visited, 32 agreed to participate, a response
rate of 68%. Figure 2 shows the selection and randomisation process.
In each practice, participants include practice staff and
patients. As a minimum, at least one GP, one PN and
one practice manager from each practice is involved in
the study. However, in some of the group practices, two
or more GPs are involved in the research. Of the 32
practices involved in the research, only seven are in solo
practices whereas 15 of the practices employ five or
more GPs and ten of the practices employ between two
and four GPs (Figure 4).
The patients of the practice will be involved in the
study in two ways. Firstly the records of all patients aged
between 40 to 69 years who are active patients of the
GPs who agree to participate in the study, and without
known cardiac disease, stroke, or diabetes will be
extracted in a de-identified audit at baseline and
12 months. In order to be seen as an active patient for
the purpose of this study, patients must have visited
their GP within the practice at least once in the last
12 months. Secondly, a random sample of 160 patients
from each practice who consent and meet the eligibility
criteria will be invited to complete the patient survey.
To be eligible to participate in the study patients must
have sufficient English and cognitive ability to understand the patient information letter, consent form, and
written questionnaire.
Data collection procedures
Data will be collected from the practices, the practitioners and the patients for all 32 practices involved in
the study (Figure 5). Data will be collected from practices by field research staff not involved in the conduct
of the intervention. However, it may not be possible to
fully blind them to allocation because practice staff may
incidentally inform them during their visits.
The practice manager or the principal GP from each
practice will be asked to complete a Practice Assessment
Survey that collects descriptive information about the
practice, including the location of the practice, number,
type, and roles of staff members and information systems used. This information will assist us in understanding how the practice operates and therefore in
identifying opportunities to facilitate preventive care.
During the analysis phase of the research, the collation
of practice information will enable us to examine
whether any patterns of preventive care improvements
Standards of Reporting Trials (CONSORT) 2010 statement
Enrollment
Assessed for eligibility (124)
Excluded (n= 92)
Not meeting inclusion criteria (n=8)
♦ Declined to participate (n=81)
♦ Other reasons (n=3)
♦
Randomized (32 practices)
Allocation
Allocated to intervention (n=16 practices)
Solo practice (n=3)
2-4 GPs (n=6)
More than 5 GPs (n=7)
Allocated to late intervention (n=16 practices)
Solo practice (n=4)
2-4 GPs (n=4)
More than 5 GPs (n=8)
Figure 4 Participant Flow Diagram for the PEP Study consistent with the Consolidated Standards of Reporting Trials (CONSORT) 2010
statement.
Harris et al. Implementation Science 2013, 8:8
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Page 6 of 10
Step 1
Practice Recruitment
• General practices invited
• Interested practices sent Invitation Letter + Information
Sheet + Informed Consent/Revocation of Consent Form
• Practices recruited (n = 32)
Step 2
Baseline data collection Part
1 and Patient recruitment
• Practices complete Assessment Survey
• GPs and practice nurses complete GP+Practice Nurse
Survey
• Baseline Clinical Audit conducted
• Practices identify eligible patients (n=160). Patients
sent Invitation Letter + Information Sheet + Informed
Consent /Revocation of Consent Form + Survey
Step 3
Practice Randomisation
•
•
Baseline data collection
Part 2
• Clinical Audit reports prepared
• GP, practice nurse and practice manager interviews
held (only with the staff members from two Intervention
practices/State)
Step 4
Intervention
•
•
•
Training session for GPs and practice nurses
Telephone calls to practices
Intervention Practice Visits (n = 3)
Step 5
12-month Follow
-up data
collection
•
•
•
•
•
Clinical Audit
GP and practice nurse Survey
Patient Survey
GP, Practice Nurse and Practice Manager Interviews
Patient Interviews
Intervention group (n = 16)
Control group (n = 16)
Figure 5 Step by step description of the PEP study.
emerge according to practice location, size, and teamwork arrangements.
Information will then be collected from the practitioners at baseline and again at 12 months. The GPs and
PNs are asked to complete a survey that asks about their
demographic characteristics and years in practice, and
also how preventive care assessment and management is
provided including frequency of assessment and management of the behavioural and physiological risk factors. This survey is based on questions from the
Preventive Medicine Attitudes and Activities Questionnaire (PMAAQ) [28] used by us in previous research [29].
Patient information is also collected at baseline and
again at 12 months to enable us to identify changes in
the level of risk for CVD (Table 1). The medical record
audit is conducted by the field research staff using the
Pen CAT tool [27] The data extracted includes deidentified information on the recording and level of lifestyle and physiological risk factors, and the management
of hypertension, dyslipidemia, diabetes, and CVD risk
assessment. The patient survey is based on the NSW
Health Survey [30] and previous research [31]. The survey includes questions about practice attendance,
reported assessment and management of behavioural
risk factors—smoking, nutrition, alcohol, physical activity and weight (SNAPW)—in general practice [7], attendances at other services as a result of referral from the
practice or self-referral, self-reported fruit and vegetable
intake [32], smoking, physical activity [33] and alcohol
intake [34], and readiness for behaviour change (stage of
change) for each SNAPW risk factor [35].
Qualitative study
A purposive sample of eight intervention practices (two
in each state that includes a cross section of various
practice sizes) will be qualitatively studied. This study
will determine what individual and organisational factors
explain the success of the PEP intervention and explore
the role of the intervention facilitator in supporting
practices to make improvements. The qualitative study
is broadly informed by a variety of theories and frameworks that help us to understand the organizational routines and patterns of work [37,38], practice systems
[39-41], and the way in which change is enacted and
adapted in practices [42] and a framework for
organization of care activities (Chronic Care Model)
[43]. The study will include qualitative interviews conducted by the field researchers with practice staff
involved in the intervention early and late in the intervention process. Other qualitative data will be collected
from the intervention facilitators, including a diary of
meeting and contacts with the practice, their notes on
the implementation of the intervention, and an interview
towards the end of the intervention period. Analysis will
Harris et al. Implementation Science 2013, 8:8
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Page 7 of 10
Table 1 Outcome Variables
Category
Measures
Time Point
Proportion of eligible patients with the following recorded
0 and 12 months
Primary
Recorded risk factors
• In the previous 24 months:o Blood pressure (in patients without hypertension)
o Weight (with height for BMI)
o Waist circumference
o Fasting blood glucose
oFasting Lipids
• Ever:o Smoking status
o Alcohol intake
Recalled Advice
Proportion of eligible patients who were at risk who recalled being offered advice:
0 and 12 months
• Diet (fruit and vegetables, low saturated fat)
• Physical activity
• Weight control
Medication
Change in medications over previous 12 months
0 and 12 months
• lipid lowering,
• antihypertensive
Risk factors
Self assessed:
0 and 12 months
• Physical activity score*
• Diet score**
• Smoking Status
• Alcohol intake (standard drinks per week)
Measured
• BMI
• waist circumference
• blood pressure
• lipids (TC, LDL-C, HDL-C, TG).
Secondary
GP or nurse preventive care
• Self reported assessment
0 and 12 months
• Self reported advice
GP or nurse
• attitudes to preventive care in general practice
0 and 12 months
* Physical activity level which combines assessment of duration of vigorous and moderate physical activity (scored 0-8, <4 considered at risk) [36].
** Serves of fruit and vegetables per day.
be conducted with the aid of NVivo using an approach
previously trialed by Cohen et al. [44]. This will characterise narratives of the intervention at each study site
looking for variation of key components, focus at each
practice, and identifying factors which influence (or are
perceived as influencing) the intervention.
Study size
The trial is being conducted in 32 practices. We estimate
that the number of GPs and PNs recruited to the study
will be 80.
We estimate that the records of at least 500 patients
will be audited in each practice (i.e., 8,000 total). Assuming a design effect due to clustering of 1.8 based on previous studies [45], a sample of 188 patients in each
group would have sufficient power (β = 0.8 and α = 0.05)
to detect a 20% difference in the proportion of patients
whose lifestyle and physiological risk factors are
recorded. A sample size of 500 would have sufficient
power to detect an effect size if 0.3 in recorded BMI
(based on ICC = 0.047), LDL-Cholesterol (ICC 0.059),
and systolic blood pressure after adjusting for clustering
(ICC 0.062) [29,46,47].
Harris et al. Implementation Science 2013, 8:8
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It is estimated that at least 40 patients will be recruited
to participate in the patient survey per practice or 640
patients in each arm of the trial. Allowing for 10% loss
to follow up at 12 months, this will leave 36 patients per
practice (576 in each group). Assuming a design effect
due to clustering of two based on previous studies, a
sample of 500 patients in each group would have sufficient power (β = 0.8 and α = 0.05) to detect a 15% difference in the proportion of patients offered education for
diet or physical activity after adjusting for clustering
(ICCs 0.051 and 0.035) and a 10% difference referral
(ICCs 0.026 and 0.011). This sample size would have sufficient power to detect an effect size of 0.3 in serves of
fruit and vegetables consumed (ICC 0.001) and physical
activity scores (ICC 0.018) [33].
Statistical methods
We will examine the change of study variables within
the intervention and control practices before and after
interventions and compare the difference of outcomes
between the two groups after adjusting for baseline differences. Primary analyses will be by intention to treat
(patients and practices will be analysed as randomised,
rather than by intervention actually received). We will
analyse patient variables (risk behaviour, health service
use, blood pressure, total cholesterol, HDL, LDL,
General Practice Assessment Survey (GPAS) for within
and between group differences using multilevel regression techniques adjusted for clustering of patients (level
one) within practices (level two). The pre-randomisation
value of each outcome will be used as lag covariates.
Interactions as well as main effects will be tested. Secondary analysis will compare patients who were referred
against those who were not, and defined as at risk. For
cases lost to follow up at 12 months, we will conduct
sensitivity analyses of the primary and secondary outcomes to determine the effect of their inclusion assuming no change in the outcome variables.
Ethics
The study has been approved by the Royal Australian
College of General Practitioners Human Research Ethics
Committee and the Southern Adelaide Clinical Human
Research Ethics Committee. This approval has been
endorsed by the Human Research Ethics Committees at
the University of New South Wales, Monash University,
Bond and Queensland Universities. We obtained full
informed written consent from participants.
Project management
The study is led by a project management committee
that comprises the investigators and the project coordinator, which meets bimonthly. Intervention- and data collection subcommittees meet as required. There are Chief
Page 8 of 10
Investigators (CIs) from each of the four states participating in the study who implement the study in each
state together with the Field Research Officers and the
Intervention Facilitators. The Field Research Officers are
responsible for the data collection. Their roles include
conducting the clinical audit and administering surveys
and interviewing practice staff and patients. The Field
Research Officers are based at the local University and
do not interact directly with the intervention facilitators.
The Intervention Facilitators are responsible for working
with practices to facilitate improvements in preventive
activities. Their roles include working with practices to
set appropriate targets and goals, provide resources to
assist the practices in meeting their goals, monitoring
improvements, and identifying how changes and
improvements can be maintained. It is necessary that
the data collection and the facilitation roles are carried
out by different staff members so as not to contaminate
the results. The Intervention Facilitators are based in the
local Division of General Practice or Medicare Local.
Trial status
The trial is registered with the Australian Clinical Trials
Registry ACTRN12612000578808.
The trial is underway with baseline data collection
complete and the intervention commenced.
Discussion
The PEP study aims to evaluate the effectiveness of an
implementation strategy for cardiovascular preventive
care guidelines in Australian general practice. This has
the potential to address a significant evidence to practice
gap. Although there is self-reported use of guidelines by
most GPs, this does not mean that the guideline recommendations are routinely followed [48]. There are significant barriers to be overcome, and considerable
variation exists between practices and practitioners in
their readiness to implement evidence based care [49].
Effective practice interventions need to be tailored to
the barriers and local context [50], be multifaceted [10],
and involve the entire primary care team [51]. Thus, the
implementation strategy has been designed to take into
the context of individual practices and their staff with a
flexible approach based on small group education, medical record audit, and practice facilitation. This is a
unique approach in the Australian context and one that
is also being explored overseas [52].
The complexities of applied research have led us to
shift our focus from examining what works in preventing CVD generally, to focus more specifically on how
primary care practices can be best supported in different
contexts. By working with practices across four states in
Australia, we hope to identify important characteristics
and processes that can help generate and sustain a
Harris et al. Implementation Science 2013, 8:8
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collaborative approach to preventing CVD. A key function of this partnership project is to ensure that the findings emerging from the research are communicated to a
range of government and non-government organisations.
Space has been allocated into the timeframe to enable
potential implementation strategies and operational
changes to be considered as part of the project dissemination process.
Abbreviations
CVD: Cardiovascular disease; GP: General practitioner; NHMRC: National
health and medical research council; PEP: Preventive evidence into practice
(project); Pen CAT: Pen clinical audit tool; SNAPW: Smoking nutrition, alcohol,
physical activity and weight.
Page 9 of 10
7.
8.
9.
10.
11.
Competing interests
The authors declare that we have no competing interests.
12.
Authors’ contributions
MH, conceived of the study. All authors (except SP and YK) were involved in
the design of the study and development of the proposal for funding. SP is
the study coordinator. MH and JL wrote the initial draft. All authors have
been involved in reviewing and editing the manuscript and read and
approved the final draft.
13.
Acknowledgements
This study is funded by an Australian National Health and Medical Research
Council (NHMRC) Partnership grant (ID 568978) together with the Australian
National Heart Foundation, Royal Australian College of General Practitioners,
and the BUPA Foundation. MH is supported by a NHMRC Senior Principle
Research Fellowship. We gratefully acknowledge the involvement and
support of the South West Sydney, Southern Adelaide, Metro North Brisbane
and Inner East Melbourne Medicare Locals and their general practices
involved in this study.
Author details
1
Centre for Primary Health Care and Equity, University of New South Wales,
Kensington, NSW 2052, Australia. 2Discipline of General Practice, Flinders
University, Adelaide, Australia. 3Discipline of General Practice, University of
Queensland, St Lucia, QLD, Australia. 4School of Primary Health Care, Monash
University, Melbourne, Australia. 5Faculty of Health Sciences and Medicine,
Bond University, Robina, QLD, Australia. 6Faculty of Health, University of
Technology Sydney, Ultimo, NSW 2007, Australia. 7Ethics Secretariate,
University of Technology Sydney, Ultimo, NSW 2007, Australia. 8School of
Public Health and Community Medicine, University of New South Wales,
Kensington, NSW 2052, Australia. 9National Heart Foundation of Australia,
Melbourne, Australia. 10Royal Australian College of General Practitioners,
Melbourne, Australia. 11BUPA Foundation, Sydney, Australia.
Received: 23 November 2012 Accepted: 11 January 2013
Published: 18 January 2013
14.
15.
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24.
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doi:10.1186/1748-5908-8-8
Cite this article as: Harris et al.: 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 2013 8:8.
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