None listed
Conditions
Brief summary
This is a cluster randomized controlled trial, aiming to investigate both the feasibility of using this model and the impact of CVAR assessment and management on general practice clinical processes and patient care. This trial will be conducted in general practices in Sydney, involving GPs, other practice staff and patients aged 45-69 without existing CVD. 32 practices (40 GPs) and 1600 patients will be recruited. Randomization will be conducted at the practice level. The intervention group of GPs will be trained to use a CVAR implementation model while the control group of GPs will continue usual care. Study variables include clinical processes, patient risk, use of lifestyle intervention and prescribing of antihypertensive and lipid lowering medications. Data will be collected and analyzed using mixed methods. Study variables before and after the intervention will be compared, and the two groups be also compared after adjusting for baseline difference and clustering factors. Results of this study will help improve the primary prevention of CVD and inform guidelines for clinical practice and the implementation of other health initiatives.
Interventions
1. Before consultation:
One 3 hours' general practitioner (GP) training workshop: GPs will receive training in the use of CVAR assessment (an electronic calculator) and recommended treatment guidelines based on CVAR assessment. The workshop will use simulated patients (which we have used in previous studies) to develop effective communication and motivational interviewing skills in the GPs.
Two 2 hours' practice visits: After the workshop, two standardized practice visits will be conducted t
1. Before consultation: One 3 hours' general practitioner (GP) training workshop: GPs will receive training in the use of CVAR assessment (an electronic calculator) and recommended treatment guidelines based on CVAR assessment. The workshop will use simulated patients (which we have used in previous studies) to develop effective communication and motivational interviewing skills in the GPs. Two 2 hours' practice visits: After the workshop, two standardized practice visits will be conducted to set up software for CVAR assessment, educate non-GP staff (such as practice nurse, practice mangers) about the process of the study, ensure practice organization for the CVAR assessment visits, and provide patient education materials used in the waiting room and after the CVAR consultation. Patients will be sent a self assessment (SA) form to complete in about 10 minutes and a letter requesting them to bring the SA form to attend for a CVAR assessment with their GP. 2. During consultation: GPs will take about 15 minutes to review the SA form, assess the patient’s smoking, blood pressure, weight, waist circumference, blood lipids and glucose level if diabetic, and perform a CVAR assessment and discuss the results with patients. GP will use CVAR guideline to provide about management of patient’s CV risk where appropriate. This may include management of lifestyle risk factors in all patients and pharmacological interventions in patients at high risk. GP will use CVAR guideline to arrange referral to smoking quit line or allied health professionals (physiotherapist, nutritionist/dietician or diabetes educator) where appropriate. Patients will be provided educational materials 3. After consultation During the 12 months of the intervention period, continuous support will be provided to GPs and other practice staff via telephone (at least once month) or/and practice visit whenever needed. Duration of each call or visit is as required. Patients will be monitored and follow-up arranged for risk management as appropriate.
Sponsors
Centre for Primary Health Care and Equity,
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
45 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
Patients: Aged 45-69 (including 45 and 69) Attend the practice in the last 12 months Sufficient English to understand the invitation letter and complete the questionnaires.
Exclusion criteria
1. Aboriginal or Torres Strait Islander (not suitable for the calculator). 2. diagnosed or treated for: Angina, Myocardial infarction, Previous coronary revascularisation = angioplasty, coronary artery stent, coronary angiography +stent, coronary artery bypass graft, coronary artery surgery, Heart failure, Stroke, Transient ischaemic attack, cognitive impairment (eg dementia). 3. taking any of the following medications: Nitrates = glyceryl trinitrate, isosorbide mononitrate, isosorbide dinitrate, Clopidogrel.
Outcome results
None listed