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Engaging community pharmacists in the primary prevention of cardiovascular disease: protocol for the Pharmacist Assessment of Adherence, Risk and Treatment in Cardiovascular Disease (PAART CVD) pilot study

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Engaging community pharmacists in the primary prevention of cardiovascular disease: protocol for the Pharmacist Assessment of Adherence, Risk and Treatment in Cardiovascular Disease (PAART CVD) pilot study
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  STUDY PROTOCOL Open Access Engaging community pharmacists in the primaryprevention of cardiovascular disease: protocol forthe Pharmacist Assessment of Adherence, Risk and Treatment in Cardiovascular Disease (PAART CVD) pilot study Kevin P Mc Namara 1,2* , Johnson George 1 , Sharleen L O ’ Reilly 3 , Shane L Jackson 4 , Gregory M Peterson 4 ,Helen Howarth 4 , Michael J Bailey 5 , Gregory Duncan 1,6 , Peta Trinder 1 , Elizabeth Morabito 1 , Jill Finch 4 ,Stephen Bunker 2 , Edward Janus 2,7 , Jon Emery 8 , James A Dunbar 2 Abstract Background:  Cardiovascular disease (CVD) is the leading cause of death globally. Community pharmacistintervention studies have demonstrated clinical effectiveness for improving several leading individual CVD risk factors. Primary prevention strategies increasingly emphasise the need for consideration of overall cardiovascularrisk and concurrent management of multiple risk factors. It is therefore important to demonstrate the feasibility of multiple risk factor management by community pharmacists to ensure continued currency of their role. Methods/Design:  This study will be a longitudinal pre- and post-test pilot study with a single cohort of up to 100patients in ten pharmacies. Patients aged 50-74 years with no history of heart disease or diabetes, and takingantihypertensive or lipid-lowering medicines, will be approached for participation. Assessment of cardiovascular risk,medicines use and health behaviours will be undertaken by a research assistant at baseline and following theintervention (6 months). Validated interview scales will be used where available. Baseline data will be used byaccredited medicines management pharmacists to generate a report for the treating community pharmacist. Thisreport will highlight individual patients ’  overall CVD risk and individual risk factors, as well as identifying modifiablehealth behaviours for risk improvement and suggesting treatment and behavioural goals. The treating communitypharmacist will use this information to finalise and implement a treatment plan in conjunction with the patientand their doctor. Community pharmacists will facilitate patient improvements in lifestyle, medicines adherence, andmedicines management over the course of five counselling sessions with monthly intervals. The primary outcomewill be the change to average overall cardiovascular risk, assessed using the Framingham risk equation. Discussion:  This study will assess the feasibility of implementing holistic primary CVD prevention programs intocommunity pharmacy, one of the most accessible health services in most developed countries. Trial registration:  Australia and New Zealand Clinical Trial Registry Number: ACTRN12609000677202 * Correspondence: kevin.p.mcnamara@monash.edu 1 Centre for Medicine Use and Safety, Department of Pharmacy Practice,Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, 381Royal Parade, Parkville, VIC 3052, AustraliaFull list of author information is available at the end of the article Mc Namara  et al  .  BMC Health Services Research  2010,  10 :264http://www.biomedcentral.com/1472-6963/10/264 © 2010 Mc Namara et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the CreativeCommons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, andreproduction in any medium, provided the srcinal work is properly cited.  Background Cardiovascular disease (CVD) is the leading cause of death globally, accounting for an estimated 17.1 milliondeaths per annum - 29% of all deaths [1]. The relativecontribution of CVD to the burden of disease remainshigh in countries with low-, middle-, and high incomes[1]. Despite significant gaps in research, there is suffi-cient evidence (particularly from developed nations suchas the United States and United Kingdom) to suggestthat the primary prevention of CVD represents a costeffective approach to reducing this burden [2].There is a cluster of highly prevalent CVD risk factorsin many developing and most developed countriesincluding Australia which can be controlled or avoided:tobacco smoking, hypertension, overweight and obesity,physical inactivity, dyslipidaemia (high cholesterol), poornutrition and diabetes [1,3]. Significant evidence-treat-ment gaps remain in the management of each of these,culminating in substantially elevated incidences of CVDin most countries. Community pharmacists are highly accessible health professionals in most communities andhave demonstrated an effective role in the managementof several of these risk factors [4-7]. Guidelines on pri-mary CVD prevention now highlight the importance of overall CVD risk assessment rather than traditional indi- vidual risk factor assessment, resulting in a muchgreater emphasis on multiple risk factor management[8-13].The expertise of community pharmacists in medicinesmanagement including adherence screening and man-agement, and a growing role in health promotion hasresulted in several studies demonstrating effective phar-macist involvement with multiple CVD risk factor man-agement [14-16]. However, we are not aware of any multiple risk factor study specifically examining struc-tured, pharmacist-led disease state management pro-grams for primary CVD prevention in a non-diabeticpopulation. The  Pharmacist Assessment of Adherence, Risk and Treatment in Cardiovascular Disease (PAART CVD)  was developed as a pilot project to address thisevidence gap.This paper describes the research protocol developedfor the PAART CVD project, a community-pharmacy based CVD primary prevention pilot project in a non-diabetic, adult population. We also identify the theoreti-cal framework, local issues affecting implementationdecisions, and gaps in current knowledge experienced tofacilitate future adaptation. Goals of research 1. To assess the feasibility of implementing a pri-mary CVD prevention program in a community pharmacy setting2. To measure changes to cardiovascular health forpatients receiving the PAART CVD intervention. Methods and Design Study design and setting This is a longitudinal pre- and post-test study to beundertaken with a single cohort of patients. Ten phar-macies from two States (Victoria and Tasmania) will berecruited - five each from rural and metropolitan loca-tions. Each pharmacy will be asked to approach a conve-nience sample of patients meeting the inclusion criteria,with a goal of recruiting 10 participants per pharmacy.Local general practices and general practice organisa-tions will be informed about the project. Outcomes examined The primary outcome for the intervention will be theaverage change to estimated 5-year risk of primary onsetof CVD between baseline and six months calculatedusing the New Zealand CVD risk scores [11], a modified version of the Framingham-based risk equation [17].Secondary health outcomes include change to bloodpressure, lipid profile, random blood glucose, waist,body mass index (BMI), and depression score. Pharmacist training Over two consecutive days, pharmacists from recruitedpharmacies will attend training focussed on the follow-ing key topics: •  health promotion and behavioural change •  overall CVD risk and CVD risk assessment •  medicines adherence •  medicines management for cardiovascular riskfactors •  lifestyle modification (diet, physical activity, weightmanagement, alcohol consumption) •  antiplatelet use for primary CVD prevention •  smoking cessation •  managing patients who screen positively for dia-betes, alcohol abuse or depression; and •  General Practitioner (GP) and other health profes-sional engagement.All training, including training materials, will be con-sistent with relevant national guidelines and will be tai-lored to suit a generalist community pharmacistaudience. Emphasis will be placed on the need for phar-macists to act within their professional competenciesand take appropriate action if situations arise outsidetheir competencies (e.g. patient screens positive fordepression). Written guidelines will be provided to Mc Namara  et al  .  BMC Health Services Research  2010,  10 :264http://www.biomedcentral.com/1472-6963/10/264Page 2 of 8  identify patients with complex or urgent clinical needsthat warrant referral to a GP or another health profes-sional (e.g. dietitian). Pharmacists will also be advised onoptions for referral (e.g. how to access specialist dietary or smoking cessation advice) when they might deem itappropriate. Subject eligibility criteria Inclusion criteriaTo be eligible for participation in the study, patientsneed to be •  aged 50-74 years •  currently taking one or more medicines for choles-terol and/or hypertension, and •  free from established cardiovascular disease, dia-betes or a cardiovascular event.Individuals will be excluded from the study in the fol-lowing instances: •  patients with a complex debilitating coexistingmedical condition •  target organ damage •  any cognitive impairment •  reliance on a carer or living in a residential agedcare facility  •  recent hospital inpatients who were medical admis-sions and discharged less than four weeks prior torecruitment •  non-English speaking •  living more than 40 km from a participatingpharmacy  •  patients who have received a Home MedicinesReview (HMR) in the past 12 months •  deemed inappropriate for the intervention by thepatient ’ s GP; or •  patients of GPs who express a desire not to haveany involvement with this project. Patient recruitment Pharmacists will initially be asked to conduct a simplepre-screening of potential participants based on theinclusion criteria outlined above. The informationrequired (CVD history, use of CVD medicines, and age)is quick and easy to obtain from dispensing records andpatient interview. Potential participants expressing inter-est will be provided with written patient informationand an Expression Of Interest (EOI) form to be com-pleted and returned to researchers.Upon receipt of EOIs or direct patient-initiated con-tact via a free telephone number, a formal assessment of all eligibility requirements will be undertaken by researchers and a provisional baseline assessment dateagreed. If eligible, consent must be obtained to contacttheir GP in writing and to provide the GP with anopportunity to comment on the appropriateness of par-ticipation. Written consent for participation and sharingof health information with relevant health professionalsis to be provided by patients prior to baselineassessment. Patient data collection Baseline and final (6 month) patient information will becollected by trained research assistants (RAs). This processwill take 60-90 minutes on both occasions and can takeplace in the patient ’ s home (preferred), or in a private areaat the pharmacy or their workplace. Assessment involvesanthropometric and Point Of Care (POC) biomedical test-ing, and an administered questionnaire using validatedscales where possible. Lipid profiles and fasting blood glu-cose levels will be obtained using Cholestech LDX® Analy-zers [18,19], in accordance with instructions provided by the manufacturer. This device uses finger-prick testingand provides results within 10 minutes. Quality controlsamples will be used to validate the machine prior to mea-surements. Patients will be advised that the most accurateresults for cholesterol and blood glucose levels would beobtained by fasting 12-16 hours prior to the initial assess-ment interview and testing, and to take their medicationsas normal on the day of clinical assessment. Fasting timewill be recorded to aid clinical interpretation.When the patient is rested, blood pressure (BP) will bemeasured using an Omron 1A1B® automated BP moni-tor in accordance with WHO MONICA Monitoring of Trends and Determinants of Cardiovascular Diseasesand the European Health Risk Monitoring protocols[20,21] amended for use with an automated monitor.The average of two measurements taken 2-3 minutesapart will be used, but if systolic BP measurements differby 10 mmHg or greater, or diastolic BP differ by 6mmHg or greater, a third reading will be taken. In thisinstance the average of the two closest systolic and twoclosest diastolic BP measurements will be used to definethe BP. The RA will advise patients to seek immediatemedical attention if systolic BP is 180 mmHg or greater,or if diastolic BP is 110 mmHg or greater. Weight,height, and waist and hip circumferences will be mea-sured in accordance with the EHRM protocol [21].The remainder of the assessment will consist of aresearcher-administered questionnaire (all interviewingresearchers have pharmacy qualifications). This ques-tionnaire, which includes several validated survey instru-ments, covers a range of health indicators: •  demographic and social information, includingsome questions based on the WHO MONICA Mc Namara  et al  .  BMC Health Services Research  2010,  10 :264http://www.biomedcentral.com/1472-6963/10/264Page 3 of 8  (MONItoring of CArdiovascular events) protocol[21], as adapted for the Greater Green TriangleChronic Disease Risk Factor Studies [22] •  brief patient medical history and family history of CVD events •  details of current medicines •  details of recent testing for CVD risk factors priorto baseline •  adherence to current medications advice using theTool for Adherence Behaviour Screening (TABS)[23] and the Morisky scale [24] •  smoking, physical activity and weight managementstatus - including some screening questions from the ‘ Lifescripts ’  program [25] and questions from surveysused by the Greater Green Triangle Chronic DiseaseRisk Factor Studies [22] •  nutrition and adherence to national dietary guide-lines, based on Dietary Guidelines for AustralianAdults (2003) [26] and using a number of questionsfrom the National Nutrition Survey 1995 [27], andthe Cancer Council of Victoria Food Frequency Questionnaire [28] •  screening for excess alcohol consumption using theAUDIT C tool [29] •  screening for depression using the Center for Epi-demiological Study of Depression Scale (CES-D) [30] •  quality of life measure using the SF-12v2 HealthSurvey  ™  (Ware et al, 2007) [31].Pharmacists will be asked to supply medicines dispen-sing data for the six months ’  period prior to baselinedata collection and the six months prior to follow updata collection. To account for medicines collected else-where, patients will be asked during their interviews torecall any quantities of medicines obtained elsewhere forthe specified period. Intervention part one: accredited pharmacist review Using relevant national clinical guidelines as the bench-mark for management, pharmacists accredited to under-take collaborative, structured medicines managementreviews in community settings (known as  ‘ Home Medi-cines Reviews ’ ) will produce a written report for eachpatient highlighting the estimated 5-year CVD risk, sub-optimal CVD risk factors, and medication adherenceand other medicines use issues (see additional file 1 fortemplate). The report will also suggest patient treatmentgoals and opportunities for beneficial lifestyle changesand improved medicines management to achieve goals.This report will be provided to the patient ’ s community pharmacist with summaries for the patient and theirgeneral practitioner. Intervention part two: community pharmacist facilitatingpatient change Community pharmacists will be trained to deliver theirinterventions in accordance with the Health Action Pro-cess Approach (HAPA) [32] to behaviour change overfive counselling sessions conducted at monthly intervals.The emphasis in counselling progresses from changemotivation initially (via improved self-efficacy, belief inthe need for change and belief that change will generatepositive outcomes), through to change maintenance andrelapse prevention strategies. Written, achievable goalswill be encouraged.The first session with the patient will prioritise basichealth education regarding individual CVD risk and thebenefits of potential treatments. It also establishesacceptable goals for the treatment process throughpatient consultation, and how these might be achieved.Finally, the pharmacist will discuss with the patient any specific medication changes identified in the baselinereport that are recommended to improve adherence toCVD guidelines. Community pharmacists will not betrained or asked to make interventions related specifi-cally to diabetes or mental health issues, but will bealerted to any suboptimal assessment results in theseareas and asked to discuss with the patient the potentialneed for GP input. Such issues will also be identified inthe baseline assessment summary provided to the GP.If a patient ’ s overall 5-year CVD risk score is 5% orless (considered very low risk) they will be advised todiscuss with their pharmacist whether they are likely tobenefit from continuing with the intervention. The deci-sion to continue will be left to the pharmacist and thepatient. Pharmacists will be expected to assess anddocument patient motivation to undertake various med-ication and lifestyle changes. Following discussion witheach patient, the pharmacist will then forward the clini-cal summary to the patient ’ s GP with any additionalcomments considered relevant.Subsequent sessions will involve: ensuring necessary changes to medicines have been made; monitoring of medicines adherence especially for new medicines; link-ing patients with local health and other services thatprovide relevant patient support; initiating lifestylechange and supporting maintenance and relapse preven-tion. Throughout these sessions, patient progresstowards goals will be continually reassessed, as will bethe goals themselves. GP input to patient treatmentplans will also be invited. Primary outcomes The primary outcome for the PAART CVD interventionis the average change to overall estimated 5-year risk of  Mc Namara  et al  .  BMC Health Services Research  2010,  10 :264http://www.biomedcentral.com/1472-6963/10/264Page 4 of 8  CVD onset, calculated using the New Zealand adapta-tion of the Framingham-based CVD risk score [11,17]. Secondary outcomes Other outcomes examined include: •  Changes to individual modifiable CVD risk factors(blood pressure, lipid profile, Body Mass Index, waistcircumference, smoking status, depression) •  changes in medicines adherence assessed usingMorisky [24] and TABS scales [23]; and •  changes in key health behaviours (physical activity,diet, alcohol intake, weight management).Additional outcomes to be assessed include stake-holder satisfaction (GP, pharmacist, patient) and processaudit based on community pharmacist documentationof counselling sessions. Sample size With 80 subjects this study would have a 90% power toshow an absolute reduction in risk of 1% based on astandard deviation in the change of risk of 2.7% with atwo sided p-value of 0.05. To account for potential sub- ject drop out and loss to follow-up of 20% we will aimto recruit 100 subjects. Statistical analysis Univariate comparisons between groups will be con-ducted using chi-square test for equal proportion (orFisher ’ s exact tests where numbers are small) andreported as numbers and percentages. Continuous nor-mally distributed variables will be compared using Stu-dent ’ s t-tests and reported as means (standard error)whilst non-parametric data will be compared using Wil-coxon rank-sum tests and reported as medians (inter-quartile range). Pairwise differences between pre andpost values will be calculated using paired t-tests fornormally distributed data and Wilcoxon sign rank testsfor non-normally distributed data. To account for thelarge number of comparisons being made, we willemploy a reduced 2-sided p-value of 0.01 to indicateclear statistical significance.If any parameter from POC finger prick testing isfound to be outside the measurable range for themachine, the value of the closest measurable limit willbe given to that patient.Health behaviours will largely be measured usingexisting scales associated with the survey instrumentsincorporated into baseline and follow-up assessment.For the dietary assessment, no validated tools are avail-able for use in an Australian population so a study-spe-cific tool has been devised. This tool is a 13-itemquestionnaire addressing dietary quality in this study population and using previously validated questionsfrom the National Nutrition Survey and Cancer Councilof Victoria Food Frequency Questionnaire relating tothe nutrients of concern for primary prevention of CVD[27,28]. Responses for each item will be scored betweenzero (least healthy response option) and 10 (healthiestoption) - consistent with the developing literature inthis area of nutrition research [33]. This scoring allowsfor an overall diet score to be generated ranging from 0to 130.The general quality of dietary intake will be inter-preted using the guidance provided in table 1.This score allows a good estimate of the level of adherence to key diet-related behaviours. Constituentelements of the 13-item questionnaire also alloweddevelopment of sub-scales for these areas of significantinfluence on cardiovascular health: •  fruit and vegetable intake (soluble fibre andantioxidants) •  saturated fat and total fat intake •  omega-3 fatty acid intake •  fibre intake (insoluble fibre); and •  salt intake.The sub-scales enable community pharmacists to deli- ver more tailored dietary advice to participants.The study protocol was approved by Monash Univer-sity Human Research Ethics Committee (HREC), Uni- versity of Tasmania HREC, Flinders University Socialand Behavioural Research Ethics Committee and theAustralia and New Zealand Clinical Trials Registry (Trial Number ACTRN12609000677202). Discussion The protocol and methods outlined above provide anintervention framework for managing multiple CVD riskfactors in community pharmacy or other primary caresettings. There is considerable incentive to demonstratefeasibility and effectiveness of such a service in commu-nity pharmacy, given the caution with which expandedroles for pharmacists in vascular care have been greetedby some [34]. While there is evidence of pharmacists ’ Table 1 Scoring mechanism used to assess overall qualityof dietary intake Diet score usingnutrition toolInterpretation 104-130 High level of compliance with CVD dietaryguidelines (80% or more)78-103 Medium level of compliance with CVD dietaryguidelines (60-79%)77 or less Low level of compliance with CVD dietaryguidelines (59% or less) Mc Namara  et al  .  BMC Health Services Research  2010,  10 :264http://www.biomedcentral.com/1472-6963/10/264Page 5 of 8
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