welcome to the rxeach investigators’ meeting inv me… · chronic kidney disease (egfr
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Welcome to the RxEACHInvestigators’ Meeting
October 8, 2013Calgary
RxEACH Meeting Agenda
Time TOPIC PRESENTER ACTION12:30-1:00 Registration/Lunch/informa
l NetworkingAll
1:00 -1:30 Welcome and Introductions Louise Morrin Welcome All
1:30 – 2:00 Introducing the study protocol (Study summary)
Dr. Ross Tsuyuki and Dr. Yazid Al Hamarneh Introduction & Presentation of VRR
RxEACH project
2:00 -2:20 Break All
2:20-4:00 How to case-find; obtaining consents from patients etc.
2 case studies on primary/secondary
prevention & Chronic Kidney Diseases
Dr. Charlotte Jones, Dr. Yazid Al Hamarneh, Craig Curtis and Carlee Balint
Education/training
4:00 -4:30 Q&A session (Online Educational Modules, Letter
of Award, Research Agreement letter, How to
engage primary care physicians etc.)
Yazid/Dunsi to facilitate Q&A
The Alberta Vascular Risk Reduction Community Pharmacy Project: RxEACH
Ross T. Tsuyuki, BSc(Pharm), PharmD, MSc, FCSHP, FACCCharlotte A. Jones, MD, PhD, FRCP(c)
Brenda Hemmelgarn, MD, PhD, FRCP(c)Yazid N. Al Hamarneh, BSc(Pharm), PhD
Dunsi Oladele, PhD
Background
• Cardiovascular disease (CVD) is the leading cause of death worldwide accounting for nearly one third of the total deaths
• The majority (90%) of CVD cases are caused by modifiable risk factors. These factors include tobacco smoking, hypertension, hyperlipidemia, diabetes, physical inactivity, high fat diet and obesity
Background
• In Canada CVD rates have decreased drastically over the last few decades, yet it is still one of the leading causes of death
• CVD also carries a financial burden on the Canadian economy with a cost of $ 21 billion every year divided between loss of productivity and healthcare costs
• Despite the risks associated with the major CVD risk factors and the treatment advancement, their prevalence is still substantial in Canada. – Still large treatment gaps: a recent evaluation of 5132
patients with Type 2 diabetes in 479 family practices, showed only 13% met the target of A1C, lipids and blood pressure
Leiter L, et al. Can J Diab 2013
Background
• Guidelines recommend using cardiovascular risk assessment equations to guide CVD prevention and management yet these equations have not been integrated in the clinicians’ daily routine
• Community pharmacists are frontline primary healthcare professionals who see patients with chronic diseases more frequently than physicians– are well positioned to identify patients at high risk for CVD,
determine their CVD risk and assist in their disease management.
Objectives
Primary objective• To evaluate the effect of a community
pharmacy-based case finding and intervention program in patients at high risk for cardiovascular events on reduction in risk for major cardiovascular events
Objectives
Secondary objectives– Improvements in individual risk factors:
LDL-cholesterol, blood pressure, HbA1c, and smoking cessation
– Achievement of recommended cholesterol, blood pressure and glycemic control targets
– Increase in proportion of patients receiving appropriate BP, cholesterol and diabetes medication
Other Objectives
– Increase in number of high risk patients screened for cardiovascular risk
– Assess the efficacy of various case-finding mechanisms
– Assure sustainability by exploring enabling and barrier forces
Methods
• Design: Multicentre randomized controlled trial with patients as the unit of randomization
• Setting: Community pharmacists in Alberta for recruitment and follow up, engaging both patients and family physicians
Inclusion Criteria
Adults (≥18 years of age) at high risk for cardiovascular events*, including those with:
• Diabetes• Chronic kidney disease (eGFR <60
ml/min/1.73m2)• Established atherosclerotic vascular disease
including cerebrovascular, cardiovascular or peripheral arterial disease
• Primary prevention patients with multiple risk factors and Framingham risk score >20%
* must have at least one uncontrolled risk factor (blood pressure, LDL-cholesterol, HbA1c, or current smoking)
Exclusion Criteria
• Unwilling to participate/sign consent form
• Unwilling or unable to participate in regular follow-up visits
• Pregnancy
Recruitment
Pharmacists and pharmacy staff will utilize various methods to recruit subjects:
• Proactive recruitment • Pharmacists will check the most recent lab results for those
patients in the course of routine care
• Blood pressure measurement• Measurement of point of care total cholesterol • Case-finding facilitators (trained pharmacy
technicians, assistants or students who focus on target prescriptions for oral hypoglycemic, anti-hypertensive and lipid lowering medications).
Enrollment
• Once written informed consent is obtained, the patient will be randomized to either intervention or control groups
• The patient’s family physician will receive a letter from the pharmacist to inform him/her that the patient agreed to participate in this study
Intervention Group
• Comprehensive Annual Care Plan (CACP) or Standard Medication Management Assessment (SMMA)
• CV risk calculation and education• CV risk management
Intervention
• Complete a Comprehensive Annual Care Plan (CACP) or Standard Medication Management Assessment (SMMA)– Perform a patient assessment (blood pressure
measurement according to Canadian Hypertension Education Program (CHEP) guidelines, waist circumference, weight and height measurements)
– Arrange for laboratory assessment of HbA1c and lipids (if not done within 3 months)
Intervention
Intervention
• Individual assessment of CVD risk and discussion of this risk with the patient – Calculation of cardiovascular risk will be facilitated
by an online tool:• Pharmacist enters patient demographics such as age,
gender, cholesterol, blood pressure, diabetes, etc and the system will use the appropriate risk engine
– Customized printout for the patient explaining their individual cardiovascular risk and targets for intervention
Intervention
• Provide patient education on cardiovascular risk factors and healthy lifestyle options
• Provide treatment recommendations, prescription adaptation(s), and/or prescribe where necessary to meet lipid, blood pressure and glycemic control targets and smoking cessation– Pharmacists will practice to their FULL scope of practice
• Communicate regularly with the patient’s family physician
• Perform regular follow-up with all patients a minimum of every 3-4 weeks for 3 months
Control
• Usual pharmacy care with no specific interventions for 3 months
• At the end of 3 months of the control period, patients randomized to the control group will cross over to receive the intervention with 3 months of follow-up as outlined above– Schedule a 3 month visit at randomization
Primary Outcome
• Difference in change in cardiovascular risk between intervention and control groups– Cardiovascular risk will be calculated at
baseline and 3 months using validated risk engines*• UKPDS For patients with diabetes• International model to predict recurrent
cardiovascular disease for patients with established vascular disease
• Framingham Risk Score for patients with chronic kidney disease (CKD) and primary prevention patients
*In the case where a patient has more than one of these high risk conditions, the risk engine estimating the highest risk will be used.
Secondary Outcomes
• Difference in change in individual cardiovascular risk factors between intervention and control groups, including LDL-cholesterol, systolic and diastolic blood pressure, HbA1c and smoking cessation.
• Achievement of individual and the “triple target” of LDL-cholesterol ≤ 2.0 mmol/L, blood pressure control BP ≤140/90 mmHg (≤130/80 in those with diabetes) and glycemic control (HbA1c ≤ 7.0) in intervention compared to control group patients in those with diabetes.
Sample size
• 1180 patients total• Can detect a minimum 15% lower
cardiovascular risk between intervention and control groups
Study Status
• 87 pharmacies have signed up• Investigator training (online) ready
as of September 19th
• Launch meetings:– October 5 Edmonton– October 8 (Calgary)
Case Finding
Introduction
• Patient identification plays a vital role in any study
• This identification process can be time consuming and frustrating because of the poor yield when healthcare professionals use traditional screening methods
Introduction
• Screening methods include applying tests to entire populations to determine prevalence or probability that individual will have a disease regardless of the presence or absence of risk factors
• In order to improve the yield and the patient identification process as a whole case finding (a focused approach) was suggested. – This is a targeted approach using demographics, risk factors
and/or symptoms to decide whether to apply a test or proceed with further testing
Case Finding Strategy
2 major components should be taken into consideration when designing a case finding strategy:
– Prevalence: The proportion of patients who have the condition of interest.
– Risk factors: Factors that may indicate the presence of disease, poor disease control or suboptimal treatment
Case Finding Strategy
• CVD prevalence in Alberta:– More than 120,000 Albertans are currently living
with cardiovascular disease (CVD) and many more are at risk of having CVD
Case Finding Strategy
• CVD risk factors include:– Diabetes– Hypertension– Hyperlipidemia– Chronic kidney disease (CKD)– Smoking– Elevated body mass index– Sedentary lifestyle– Unhealthy diet– Old age– Family history and race (e.g. First Nation and East Indian
origins) – Excessive alcohol consumption
Finding patients with CVD or at risk of developing CVD
• Pharmacy electronic records represent a source to obtain reports about individuals with CVD or at high risk of having CVD
Condition Medication
Coronary revascularization, MI, Stroke
Anti-platelet therapy (especially Clopidogrel), ACE inhibitors, ARBs,
Statin
Diabetes Oral hypoglycemics (Metformin, insulin secretagogues), Insulin,
supplies (needles, strips)
CKD ARBs, ACE inhibitors, Statin, oral hypoglycemics, insulin
Finding patients with CVD or at risk of developing CVD
Condition Medication
Hypertension ARBs, ACE inhibitors, Beta blockers, CCBs, diuretics
Dyslipidemia Statins, Fibrates, Ezetimibe
Smoking Nicotine replacement therapy (patches, gums, Varenicline)
Elevated BMI Weight reduction medications (Orlistat)
• Consider adding a pop-up alert to these medication files to prompt you to assess the patients’ CVD risk
Remember
• Write your case finding strategy and keep it posted in the pharmacy
• Proactively seek patients
• Remember that pharmacists see their patients more often than physicians and this gives pharmacists a chance to apply their knowledge and expertise in promoting patient-centered care services
RxEACH: Case Studies
Assess: qualify ?
Randomize
Advanced care
3 Month Intervention
Assess: FRS
“Usual care”
Usual Care
3 month recall
Assess: FRS3 M intervention
Assess: FRS
Website
55 yo male on Atorvastatin
• No diabetes, Non-smoker, no CVD, no CKD, no PAD
• Positive family history of premature CVD• Not on any blood pressure medication• BMI 36, Waist circumference (123cm)• BP: 135/85• BMI-FRS = 21.7% but have to double
because of family history 43.4%
https://redcap.med.ualberta.ca/
Obtainverbal
consent
Interview/physical assessment
BMI 36Waist circumference
(123cm)No diabetesNon-smoker
Positive family history of premature CVDNot on any blood
pressure medicationsBP 135/85 mmHg
Complete the physical activity and diet questionnaires
Last lipid panel done 1 year ago
No current labs do BMI-based Framingham
BMI-FRS = 21.7% but have
to double because of
family history 43.4%
SEND to lab: and arrange
follow up ASAP after
TC 5.4 HDL 0.8
LDL ~ 4.5 mmol/L
Calculate Framingham using total
cholesterol and HDL
FRS = 21.6% but have to double
because of family history 43.2%
55 YO male on 10 mg Atorvastatin
Eligible as high risk
Eligible
Consent then enrol
Randomize:
Advanced Care
Add or increase dose of statinGive lab req
Follow-up in 4 weeks
(side effects, etc)
Usual Care
Give lab requisition for
lipids
Follow up appointment for 3 months for inclusion in the intervention group
(provided patient still eligible)
Dyslipidemia treatment algorithm
At completion of 3 month
advanced care
WebsiteCase report
form
Interview/physical assessment
BMIWaist circumference
Blood pressure
Lab: make sure done
prior to appointment
Complete the physical activity
and diet questionnaires
Calculate Framingham using total
cholesterol and HDL
Case #2
• SG is a 64 year old male– Type 2 diabetes for 20 years and long-standing
hypertension
• In preparation for his retirement, he decided to finally have a check-up after avoiding seeing his physician for several years.
• Does SG qualify for a CACP?– Diabetes, hypertension
Interview
• 110 kg • 5 foot 5 inches• SG does not smoke and does not drink any
alcohol• One cup of coffee every morning before work• Blood pressure was 145/85 mmHg at his GP’s
office
Interview
• Medications:– Amlodipine 5 mg PO daily – Metformin 1000 mg PO twice daily– Centrum multivitamin 1 tablet PO daily – Naproxen sodium 220 mg PO Q12H PRN back pain
(uses approximately 10 doses/ month)
• SG had a full panel of blood work done
Laboratory test results
SCr 350 Urea 7 TChol 5.4eGFR 28 Albumin 39 HDL 3
Sodium 142 PTH 98 LDL 2.2Potassium 4.5 HgB 110 Trig 2.1
Chloride 108 Iron 14 HbA1C 8.1%
CO2 23 TIBC 38 ACR 5Calcium 2.21 TSAT 21%
Phosphate 1.4 Ferritin 200
Risk calculator
• BMI = 40.4
• CKD, diabetes• Use UKPDS
• Risk = 25% in 10 years• He qualifies for the study and is randomized
to the intervention arm.
Drug therapy problem #1
• SG is at risk of worsening CKD and had a very high vascular risk due to high BMI and requires lifestyle interventions to reduce his risk– Exercise (150 minutes/week)– Healthy diet– Low salt diet (less than 1.5 g)– Weight loss strategies – possible dietician consult?
Drug therapy problem #2
• SG is at risk of worsening CKD and increased vascular risk due to elevated BP above target for a diabetic patient with CKD– Target BP is less than 130/80 mmHg– Initiate an ACEi or ARB to prevent microvascular
and macrovascular complications of diabetes– Ramipril 5 mg PO daily– Continue amlodipine 5 mg PO daily
Drug therapy problem #2
• Follow up in 2 weeks after ACEi started:– SCr/eGFR– Potassium– Electrolytes– BP trend
Drug therapy problem #3
• SG is at elevated vascular risk since he has CKD and is not on a statin– Atorvastatin 20mg PO at bedtime, or rosuvastatin
10mg PO at bedtime
• Follow-up in 2 weeks– Side effects such as myalgias– Liver function tests (LFTs) & creatinine kinase (CK)
at baseline(?), not repeated unless experiencing symptoms
Drug therapy problem #4
• SG is at risk of progression of CKD while taking nephrotoxic NSAID (naproxen)– Stop naproxen– Use acetaminophen for pain– WHO analgesic ladder (opioids)
• Avoid morphine and codeine in CKD patients• DO NOT use meperidine
Drug therapy problem #5
• SG is at risk of progression of CKD and worsening vascular risk due to elevated HbA1C– Continue metformin 1000 mg PO twice daily– Add repaglinide 0.5 mg PO three times daily
• Follow-up– SCr/eGFR, electrolytes monthly to monitor for
worsening renal function – CO2 to monitor for lactic acidosis– HbA1C every 3 months – Encourage patient to self monitor once daily
Follow-up
• 1 week – Home BP trend
• Symptoms of hypotension
– Home blood glucose readings
• 2 weeks (blood work for ACEi)– Symptoms of hypotension– SCr/eGFR– Electrolytes, CO2– Statin side effects
Follow-up visit
• SG returns to the pharmacy two weeks later and his blood pressure has been 125/80 mmHg and his fasting blood glucose has been 5.2 mmol/L for the past week!
• SG does not have any symptoms of hypotension
• His lab results are as follows:SCr 321 K 4.7eGFR 32 Cl 108Na 142 CO2 21
Drug therapy problem #5
• SG is at risk of lactic acidosis secondary to CKD and receiving metformin and would benefit from close monitoring of his bicarbonate levels– SCr improved – don’t just rely on a single lab
value– Continue metformin since it is working!
• Follow-up– Continue to monitor bicarbonate and renal function
monthly
Project Timeline
• March – June 2013: Finalize study protocol, implementation planning, meeting with partners, agreements signed
• May – August 2013: preparation of study materials, training of pharmacists and technicians
• June 2013: research ethics board submission• September 2013: Study launch meetings, first patient enrolled • May 2014: End of recruitment.• August 2014: Last advanced care patients followed up.• November 2014: Final follow-up of usual care group patients crossed
over to receive the intervention• August - November, 2014: Data analysis and report writing• December 2014: Wrap-up investigators’ meeting, • March 2015: presentation at the American College of Cardiology
meeting, Media release of result
Next Steps
• Awaiting ethics and zonal approvals (expected in 2-3 weeks)
• Final recruitment website and data forms• We will be in touch when you can start
• Letter of Award and Research Agreement Letter• Complete education program
• Physician communications• Start case finding and lining up patients to be
enrolled.
What This Study Adds
• Largest pharmacist-led trial of cardiovascular risk reduction
• “Done in the real world, applies in the real world”• Incorporates expanded scope of practice• Incorporates remuneration opportunities through
CACP/SMMA and follow-ups– Can expand remunerable opportunities
• Can improve access and quality healthcare services to Albertans
• Unique partnership with other healthcare providers, health policymakers and opinion leaders
Study Team Contacts
Ross T. Tsuyuki: [email protected]
Charlotte A. Jones: [email protected]
Brenda Hemmelgarn: [email protected]
Yazid N. Al Hamarneh: [email protected]
Dunsi Oladele: [email protected]
Carlee Balint: [email protected]
Craig Curtis: [email protected]
Q & A Session
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