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Cardiovascular Health Awareness Program (CHAP): A community cluster-randomised trial among elderly Canadians
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Preventive Medicine 46 (2008) 537 – 544 www.elsevier.com/locate/ypmed
Cardiovascular Health Awareness Program (CHAP): A community cluster-randomised trial among elderly Canadians Janusz Kaczorowski a,b,g,i,⁎,1 , Larry W. Chambers c,d,e,f,1 , Tina Karwalajtys g , Lisa Dolovich g,h,i , Barbara Farrell c , Beatrice McDonough j , Rolf Sebaldt h,i , Cheryl Levitt g , William Hogg c,e , Lehana Thabane h,i , Karen Tu k , Ron Goeree h , J. Michael Paterson g,i,k , Mamdouh Shubair h,j , Tracy Gierman c , Shannon Sullivan c , Megan Carter c b
a Department of Family Practice, University of British Columbia, Canada Primary Care and Community Research, Child and Family Research Institute (CFRI), Vancouver (BC), Canada c Élisabeth Bruyère Research Institute, Ottawa (ON), Canada d Department of Epidemiology and Community Medicine, University of Ottawa, Canada e Department of Family Medicine, University of Ottawa, Canada f School of Nursing, University of Ottawa, Canada g Department of Family Medicine, McMaster University, Canada h Department of Clinical Epidemiology and Biostatistics, McMaster University, Canada i Centre for Evaluation of Medicines, St. Joseph's Healthcare, Hamilton (ON), Canada j City of Hamilton Public Health Services, Hamilton (ON), Canada k Institute for Clinical Evaluative Sciences, Toronto (ON), Canada
Available online 14 February 2008
Abstract Objective. High blood pressure is an important and modifiable cardiovascular disease risk factor that remains under-detected and under-treated. Community-level interventions that address high blood pressure and other modifiable risk factors are a promising strategy to improve cardiovascular health in populations. The present study is a community cluster-randomised trial testing the effectiveness of CHAP (Cardiovascular Health Awareness Program) on the cardiovascular health of older adults. Methods. Thirty-nine mid-sized communities in Ontario, Canada were stratified by geographic location and size of the population aged ≥ 65 years and randomly allocated to receive CHAP or no intervention. In CHAP communities, residents aged ≥65 years were invited to attend cardiovascular risk assessment sessions held in pharmacies over 10 weeks in Fall, 2006. Sessions included blood pressure measurement and feedback to family physicians. Trained volunteers delivered the program with support from pharmacists, community nurses and local organisations. Results. The primary outcome measure is the relative change in the mean annual rate of hospital admission for acute myocardial infarction, congestive heart failure and stroke (composite end-point) among residents aged ≥65 years in intervention and control communities, using routinely collected, population-based administrative health data. Conclusion. This paper highlights considerations in design, implementation and evaluation of a large-scale, community-wide cardiovascular health promotion initiative. © 2008 Elsevier Inc. All rights reserved. Keywords: Aged; Community medicine; Health promotion; Cardiovascular diseases; Hypertension; Randomized controlled trial; Voluntary workers
Introduction ⁎ Corresponding author. UBC Department of Family Practice, 320-5950 University Blvd, Vancouver BC, Canada V6T 1Z3. Fax: +1 604 827 4184. E-mail address: [email protected] (J. Kaczorowski). 1 These authors contributed equally to this work. 0091-7435/$ - see front matter © 2008 Elsevier Inc. All rights reserved. doi:10.1016/j.ypmed.2008.02.005
Cardiovascular diseases (CVD), including ischemic heart disease, heart failure and stroke, are the most common causes of death in Canada (Heart and Stroke Foundation of Canada, 2003). Hypertension (high blood pressure) is one of the most
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readily preventable causes of CVD, and is estimated to be among the top three leading causes of death world-wide (World Health Organization, 2002). In Canada, the overall prevalence of hypertension is estimated to be 27% (Wolf-Maier et al., 2003); however the prevalence increases with age and over 50% of individuals 65 to 74 years of age are estimated to have hypertension (Langille et al., 1999; Vasan et al., 2002). Furthermore, the lifetime residual risk of developing hypertension for middle-aged individuals is estimated to be 90% (Vasan et al., 2002). Treatment of CVD accounts for the largest proportion of health care spending in Canada (Heart and Stroke Foundation of Canada, 2003). At the same time, it is estimated that the vast majority of CVD can be prevented through improved management of modifiable risk factors, and that hypertension is a good starting point for initiating a more comprehensive CVD risk management strategy. Additionally, both lifestyle and pharmacological therapies consistently have been shown to be effective at reducing blood pressure (BP) and associated risk factors, and thus global CVD risk. Hypertension is under-diagnosed and under-treated. A Canada-wide, population-based study found that among hypertensive adults aged 65 to 74 years, 42% were unaware of their condition, 19% were aware but not treated or controlled and 23% were receiving treatment but were not adequately controlled, leaving only 16% who were treated and controlled (Joffres, 1997). The main barriers to optimal diagnosis, treatment and follow-up include over-detection or ‘white coat effect’ (Parati and Mancia, 2003), under-detection or ‘masked hypertension’ (Bobrie et al., 2004), patients presenting with multiple problems (Farquhar et al., 1990; Luepker et al., 1996), reluctance on the part of many family physicians to initiate and maintain aggressive drug therapies (Petrella et al., 2007), and patient nonadherence to both pharmacologic treatments and lifestyle recommendations (Carleton et al., 1995; Düsing 2006; Neuhouser et al., 2002; Salzman 1995; Serour et al., 2007). The cornerstone of appropriate diagnosis, treatment and follow-up of hypertension is accurate BP measurement. Research suggests that strategies that increase the quantity and quality of BP measurements taken in settings other than the doctor's office may help to improve the detection and control of high BP. Community interventions that have included BP monitoring outside of the family physician's office and involved local pharmacies and pharmacists have shown promising results in terms of BP reduction amongst hypertensive patients (Chabot et al., 2003; Zillich et al., 2005). These trials, however, were relatively small, had methodological shortcomings, showed only modest improvements in BP, and were not primarily focused on awareness and prevention. Some of the most notable community-wide interventions for CVD include the North Karelia Project, the Stanford Five City Project, the Minnesota Heart Health Program, the Pawtucket Heart Health Program, and the Franklin Cardiovascular Health Program (Carleton et al., 1995; Farquhar et al., 1990; Luepker et al., 1996; Puska et al., 1983; Record et al., 2000). All have failed to detect changes in CVD risk factors or disease events that could unequivocally be attributed to the interventions. This is in part because none of these studies employed the randomised
controlled trial design which, when properly implemented, offers increased protection against different sources of bias. The weaker designs used, such as quasi-experimental or the beforeand-after approaches, are more susceptible to bias and thus render causal attributions more challenging. The second main reason for the largely null results had to do with the potency, duration and penetration of the interventions themselves, and the outcomes used to assess their effectiveness, including the data sources used. Despite the methodological weaknesses and modest improvements reported by these large community studies, they have underscored the importance of small shifts in the distribution of risk factors on the overall cardiovascular health of the population (Rose, 1992; Thompson et al., 2003). Further, these studies demonstrated that in order to improve CVD status, entire communities need to be engaged in achieving program goals (Mills et al., 2002). Community resources such as volunteers, community health nurses and local organisations are locally available but largely underutilised to support health promotion and primary prevention in Canada. A meta-analysis of 47 peer-based health education programs found a consistent positive health effect of peer programs (Posavac et al., 1999). Community empowerment, including participation, linking with other people and organisations, and resource mobilisation, can lead to improvement in health outcomes of community residents (Laverack, 2006). The Cardiovascular Health Awareness Program (CHAP) is a multi-pronged approach to CVD risk awareness and management. CHAP uses a reliable and accurate method to measure BP in a familiar environment; taps into underutilised local resources such as volunteers and community pharmacies; and ‘closes the loop’ by communicating up-to-date BP and CVD risk information to family physicians, pharmacists and patients via a flexible method of data management. Awareness of the importance of BP monitoring and management, and reducing modifiable risk factors to prevent CVD is increased amongst older adults in the community. CHAP was developed and refined through several pilot studies, scientific trials and community-wide demonstration projects (Chambers et al., 2002; Chambers et al., 2005; CHAP Working Group, 2007; Jones et al., in press; Karwalajtys et al., 2005). The objective of the current trial is to evaluate the impact of CHAP on CVD morbidity and mortality amongst seniors living in medium-sized communities in Ontario, Canada by further developing knowledge in implementing and evaluating community-based cardiovascular health promotion programs. Methods Study design The present study is a cluster-randomised community intervention trial in which eligible mid-sized Ontario communities were stratified and randomly allocated to one of two groups: • an Intervention group in which CHAP sessions were offered to residents 65 years and older for 10 week s in the Fall of 2006 • a Control group, which continued with routine health care and health promotion
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Selection and randomisation of communities We devised a replicable process to determine community eligibility using five explicit criteria: 1) population of 10,000 to 60,000 based on the 1996 and 2001 Canadian Census; 2) ≥5 family physicians; 3) ≥2 pharmacies; 4) Registered Persons Database (RPDB) to Census Population ratio less than 10%; and 5) no recent geopolitical amalgamation into a major centre. The RPDB provides basic demographic information about anyone who has ever received an Ontario health card number and is thus eligible for the universal health insurance. Census data also provides this demographic information but cannot be linked to other databases. Previous studies have identified discrepancies between the RPDB and Census data where the number of persons in the registry has exceeded the number of persons in Census data by 6 to 10%, and up to 30% in some urban areas (Institute for Clinical
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Evaluative Sciences, 2005). Large differences (N10%) reduce our ability to make valid inferences about health system variables in these communities, thus we have elected to use this ratio as an inclusion criterion. We began with all distinct communities with a population of 10,000 to 60,000 (n = 59) based on the 1996 and 2001 Census, and identified a total of 41 communities after excluding townships, first nations reserves, dissolved and amalgamated townships, and counties. We further excluded two communities where CHAP was initially developed and pilot-tested (Grimsby and Brockville, ON) for a final set of 39 communities. The criteria were chosen to ensure adequate capacity to deliver the program on a comparable scale, and a sufficiently large, well-defined population for evaluation purposes. The 39 eligible communities were stratified by size of the population 65 years of age and older (three groups) and geographic location (four groups),
Fig. 1. Legend: Graphical depiction of CHAP trial flow including the main components of the CHAP intervention (Ontario, Canada). January–August, 2006 a.Request for Proposals for funding to deliver CHAP; local lead organisations chosen and local CHAP coordinators hired. b. Mobilisation activities conducted by the local lead organisation including documentation of local capacities (e.g. stakeholders, programs and agencies), review and collection of information and education resources, planning and delivery of stakeholder meetings, identification of a Physician Opinion Leader and Pharmacist Champion, and development of an action plan to implement CHAP. c. Implementation activities led by the local CHAP coordinator with support from the local lead organisations, including hiring a community health nurse, recruiting family physicians and pharmacies, recruiting and training volunteer peer health educators, implementing invitation methods, and developing CHAP session schedules. September–November, 2006 d. Participants assisted by volunteer peer health educators to complete the CVD and stroke risk profile. e. Participants assisted by volunteer peer health educators to measure their BP with BpTRU™ automated device and record result. f. On-call nurse reassessed participants identified as high risk (systolic BP ≥ 180 or diastolic BP ≥ 110 mmHg), and family physician contacted and provided with session results by fax same day. g. Participants provided with targeted educational resources by volunteer peer health educators based on risk profile responses. h. Copy of completed risk profile given to each participant and faxed to a database managed by Clinforma Data Systems. January, 2007 i. Pharmacy session results for the 10-week program sent to participants’ family physicians in the form of reports rank-ordering their patients by systolic BP (from the highest to the lowest) and diagnostic/treatment status. May, 2007 j. Aggregate-level comparative feedback sent to family physicians showing BP control of patients from their practice who participated in CHAP compared to the patients of other family physicians in their own community and across all 20 intervention communities. ⁎CHAP-Cardiovascular Health Awareness Program; CVD – cardiovascular disease; BP – blood pressure.
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forming seven sub-strata. Communities within each stratum were randomly allocated to either the intervention (n = 20) or control arm of the study (n = 19) by an independent expert in cluster randomised trials not associated with the study (see Fig. 1). Table 1 provides a comparison of intervention and control communities. Although intervention community members (older adults, family physicians, volunteers, pharmacists) were clearly aware of their group assignment, the names of control communities were not publicized and control community members were not notified that the study was taking place.
CHAP intervention The CHAP intervention was standardised across the 20 communities and consisted of weekday 3-hour morning BP and CVD risk-factor assessment sessions that were held in local pharmacies over 10 weeks in the Fall of 2006. All pharmacies in each intervention community were asked to hold at least one CHAP session each week. At the sessions, volunteer peer health educators, trained by a community health nurse, assisted participants to measure BP using a BpTRU™ automated device (VSM MedTech, 2004) and to record BP and other CVD risk information on a standardised risk profile form adapted from the Heart and Stroke Foundation's online Risk Assessment Tool (see Table 2 for items on the Risk Profile Form). With permission from the participant, summary CVD risk profile forms were sent to the participant's family physician and regular pharmacist. Each participant received a copy of the form, along with risk factorspecific cardiovascular health education materials from the Heart and Stroke Foundation of Canada, Ontario Prevention Clearinghouse, Canadian Hypertension Education Program and Health Canada, and a list of local resources. During the sessions, a community health nurse was on-call to assess participants if their BP was very high, based on a standardised protocol developed with input from the local family physicians. Pharmacists were involved as needed in consulting with participants about their medication (for example, medication adherence, potential drug interactions and side effects) or related concerns. Fax-to-database technology was used to compile all session results and forward information to family physicians at the end of the 10-week program in the form of reports rank-ordering their patients by systolic BP (from the highest to the lowest) and their diagnostic/treatment status (potentially new cases of hypertension and potentially under-treated/non-adherent patients). Family physicians also received aggregate-level comparative feedback six months post, comparing their patients with those of other local family physicians and across all 20 intervention communities in terms of BP control. Results of these assessments and resources were made available to participants and family physicians via a secure website.
Recruitment of participants Local lead organisations A ‘request for proposals’ was publicised in each of the 20 intervention communities (in January 2006) to identify a local organisation to lead CHAP. To be considered, organisations had to have the required capacity to deliver CHAP including: experience working with volunteers; existing relationships in the community, ideally with primary care professionals; and ability to provide inTable 1 Comparison of intervention and control communities (Ontario, 2006)
Number of communities Mean population size (SD) Mean percentage of residents ≥65 y of age (SD) Average median total income ($CAN) of population ≥ 15 y (SD) Mean number of family physicians (SD) Mean number of pharmacies (SD) Mean admission rate for AMI, CHF and stroke per 100 people ≥65 y in 2001 (SD)
CHAP
Control
20 20,337 (10,507) 16.8 (4.1) 22,507 (4,115) 17.1 (8.1) 7.3 (3.3) 7.8 (1.4)
19 27,360 (13,281) 16.5 (3.4) 22,204 (3,419) 19.1 (7.9) 7.8 (3.2) 8.1 (1.2)
CHAP – Cardiovascular Health Awareness Program; SD – standard deviation; AMI –acute myocardial infarction; CHF – congestive heart failure; $ CAN – Canadian dollars.
Table 2 Items on the CVD and stroke risk profile form used in CHAP pharmacy sessions (Ontario, 2006) Question
Response categories
• In general, would you say your health is:
Poor, Fair, Good, Very Good, Excellent
• Have you ever had a TIA or mini-stroke? • Have you ever had a stroke? • Have you ever had a heart attack? • Has your doctor told you that your cholesterol is high? • Has your doctor told you that you have diabetes? • Have you ever been diagnosed with high blood pressure by a doctor? • Are you currently taking prescription pills for high blood pressure?
Yes, No, Not sure
• If you currently use pills for high blood pressure, do you take them each day?
Yes, No, Not applicable
• Do you currently smoke? • Typically, do you drink 2 or more alcoholic drinks a day? • Do you eat 5 servings or more of fruits and vegetables a day? • Are you moderately physically active for 30 – 60 min most days of the week? (e.g. brisk walking, active gardening, swimming, dancing or biking) • Do you live alone?
Yes, No
• How frequently do you add salt to foods during cooking or at the table? • In a typical week, how frequently do you feel overwhelmed or stressed?
Rarely, Sometimes, Often
• In a typical week, how often do you eat high fat or fast foods?
Zero, 1–2, 3 or more
• What is your height and weight?
Continuous
CVD – cardiovascular disease; CHAP – Cardiovascular Health Awareness Program; TIA – transient ischemic attack. kind donations of office space and administrative support for the local coordinator. Twenty-six proposals were submitted and one local organisation in each intervention community was selected by the study investigators using the a priori developed criteria. Table 3 shows the types of agencies that were selected to lead CHAP. Local lead organisations received between $ CAN 20,000 and $ CAN 40,000 to support implementation of the program, and were supported by two Regional Coordinators in the province. Family physician practices All community-based family physicians and general practitioners with an office address (based on postal codes) in intervention communities were eligible to Table 3 Types of CHAP local lead organisations (Ontario, 2006) • Seniors centres • Hospitals • Victorian Order of Nurses • YMCAs • Community Care Access Centres • Not-for-profit Home Care Organizations • Meals on Wheels and Neighbourly Services • District Stroke Centres • Community Centres CHAP – Cardiovascular Health Awareness Program; YMCA – Young Men's Christian Association.
J. Kaczorowski et al. / Preventive Medicine 46 (2008) 537–544 participate. Recruitment strategies for physicians included the use of opinion leaders and peer recruitment (Sellors et al., 2002). Each physician was faxed an introductory letter explaining the program, followed by a visit from the Local CHAP coordinator and/or members of the CHAP Team to provide additional information and seek written agreement to participate. An electronic roster of regular, community-dwelling patients 65 years of age or older was generated, when available, to prepare individualised invitation letters from family physicians. Pharmacies All pharmacies in each intervention community were faxed an introductory letter from the project team pharmacists (LD and BF) explaining the program, followed by a visit or telephone call to seek an agreement to participate. A DVD of a presentation by the project team pharmacists explaining the study with a specific emphasis on the pharmacist role and responsibilities was provided to coordinators to use as a recruitment aid. Volunteers Volunteer peer health educators were recruited by the local lead organisation in each intervention community using a variety of methods. These included using the local lead organisation's existing volunteer base, advertising in the local media, and giving presentations at local seniors' clubs. On average, 28 volunteers were recruited, trained and retained to conduct sessions in each community. Target population: older adults aged 65 years and older Participation in CHAP was open to all residents of the intervention communities; however individuals aged 65 years or older were explicitly targeted. The implementation and evaluation of the CHAP program reflects the orientation toward older adults. For instance, the session location (pharmacies), scheduling of the assessment sessions (weekday mornings), use of age-matched volunteer peer health educators, consideration of the burden of CVD, and availability of prescription data, are all specific to this age group. Individuals who did not meet the inclusion criteria are excluded in the analysis but were permitted to participate in the program. Participants were recruited via a personalised invitation letter from participating family physicians or the local lead organisation. Another strategy consisted of ‘tickets' or referrals to CHAP pharmacy sessions given to eligible patients by their family physician and the office staff. In some communities these tickets were also distributed by pharmacists or the local lead organisation. CHAP sessions were also advertised community-wide using flyers, posters, and advertisements in the local media. Based on previous CHAP studies that have shown attendance rates ranging from 30% to 72% (Chambers et al., 2005; Jones et al., in press; Karwalajtys et al., 2005), it was estimated that at least 30% of the population 65 years of age and older in the participating communities would attend one or more CHAP sessions. This would represent approximately 20,000 older adults residing in CHAP communities out of a possible total of 66,280 (based on Statistics Canada's 2001 Census).
Outcome measures Assessment of CHAP outcomes is based on routinely collected, populationbased administrative health data. With the exception of disease-specific mortality data (obtained from Statistics Canada Vital Statistics), data for outcome assessment are housed at the Institute for Clinical Evaluative Sciences. Data sources include the Canadian Institute for Health Information's Discharge Abstract Database, the Ontario Health Insurance Program's Claims History Database, and the Ontario Drug Benefit Program Database (Ontario Ministry of Health and Long-Term Care, 2006). The primary outcome measure is the relative change in the mean annual rate of hospital admissions for acute myocardial infarction, congestive heart failure and stroke (composite end-point) among the total population of communitydwelling residents aged 65 years and older in intervention and control communities, in the year before compared to the year after the implementation of CHAP (ICD10 codes will be used). Table 4 summarizes the validation studies of the primary outcome measure derived from these databases. Secondary outcome measures include mortality due to CVD and coronary artery disease (CAD), and all-cause mortality; hospitalisations for stroke and CAD; differences in rates of initiation of antihypertensive drug therapy (Tu
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et al., 2002); differences in rates of hypertension drug treatment (one antihypertensive drug versus polytherapy) (Campbell et al., 2007); and health service utilisation and cost-benefit analysis (Drummond et al., 2005).
Sample size and power calculations The sample size was fixed, as there were only 39 Ontario communities of 10,000 to 60,000 residents that met our eligibility criteria. Rates of hospital admissions for acute myocardial infarction, congestive heart failure or stroke in the intervention communities and the 2001 census population estimates for persons aged 65 years and older were used for power calculations. In 2001, there were a total of 11,486 hospital admissions for CVD with over 148,589 personyears of observations, giving an overall admission rate for the 39 communities of 7.73 per 100 person-years. The empirical standard deviation of the observed admission rates was 1.79. With the assumption that the mean hospital admission rate in control communities remained constant, 19 communities per arm permit detection of a 21% or greater reduction in the mean annual rate of hospital admission with 80% power (using two-tailed test at alpha = 0.05 level of significance). A more sophisticated sample size calculation that took into account both the cluster size and the coefficient of variation of the true rates between and within clusters called for a sample of comparable size (Hayes and Bennett, 1999).
Statistical analysis The 12 month pre-CHAP period where administrative data will be used to compute baseline values for outcomes ended prior to the beginning of study activity in the intervention and control communities (July 2005 to July 2006). The 12 month follow-up period began from the date the first invitation letters were sent to prospective CHAP participants (August 2006 to August 2007). Fig. 1 provides a more detailed description of the study flow. All analyses will be based on an intention-to-treat approach. Residents of both the intervention and control communities aged 65 years and older who resided in long-term care facilities will be excluded from the analyses, as they had no opportunity to participate in the CHAP sessions. Analysis of the primary outcome will be based on a two-sample t-test carried out on summary change scores for each community cluster and aggregated across the two study arms. Poisson regression will be used to adjust for potential confounders at the community level such as socioeconomic status (median income; unemployment rate; home ownership; ethnic distribution), CVD risk, and the ratio of hospitals, specialists, family physicians and other health care facilities or professionals to residents 65 years or over. Results will be reported as the estimate of the difference, corresponding standard error, 95% confidence interval and associated p-values. P-values will be reported to three decimal places, with p-values less than 0.001 reported as p b 0.001. For all tests, the level of significance will be set at five percent. The data analysts will be blinded to group allocation to minimize the potential for bias. Model assumptions and goodness-offit will be evaluated by examining the residuals (Bennett et al., 2002). All analyses will be conducted using SAS version 9.2 (Cary, North Carolina). Methods to analyse mortality and hospitalisation outcomes will be similar to those used for the primary outcome. Analysis of differences in anti-hypertensive medication initiation will be based on previously developed methods (Tu et al., 2002). Health care costs over the 12 month follow-up period (and 12 month preperiod) will be estimated for patients in both intervention and control communities. Total costs for patients in the intervention communities will be compared to total costs for patients in the control communities to determine whether the higher costs of the intervention are offset by subsequent use of publicly-subsidized health care resources (Drummond et al., 2005). Significance levels of the secondary outcomes will be adjusted for multiple testing using the Bonferroni method, to maintain the overall alpha level at b0.05.
Contamination and co-intervention Local lead organisations were asked not to share CHAP implementation materials or present at events outside the community during the study period. In terms of co-intervention, health departments and the Heart and Stroke Foundation of Ontario branches in each of the intervention and control
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Table 4 The validity of using administrative data to assess AMI, CHF and stroke outcomes in the CHAP trial (Ontario, 2006) References
Positive predictive value (%)
Negative predictive value (%)
Sensitivity (%)
Specificity (%)
Gold standard
AMI (ICD 9: 410) Austin et al., 2002
88.5
NR
92.8
88.8
Lee et al., 2005
81.9
NR
35.7
95.1
Fastrak II Acute Coronary Syndromes Registry Chart review
CHF (ICD 9: 428 x.) Lee et al., 2005
94.3
NR
NR
NR
Austin et al., 2002
65.1
NR
58.5
96.8
Humphries et al., 2000
50.6
97.2
66.1
94.8
Chart review (Framingham criteria) Fastrak II Acute Coronary Syndromes Registry Chart review
Stroke (ICD 9: 430–438) Tirschwell and Longstreth, 2002 (Ischemic stroke) Tirschwell and Longstreth, 2002 (Intracerebral hemorrhage) Tirschwell and Longstreth, 2002 (Subarachnoid hemorrhage) Lee et al., 2005
88 89 94 89.4
NR NR NR NR
74 85 90 24.1
95 96 97 99.2
Chart Chart Chart Chart
review review review review
AMI – acute myocardial infarction; CHF – congestive heart failure; CHAP – Cardiovascular Health Awareness Program; ICD 9 – International Classification of Diseases, 9th Revision; NR – not reported.
communities have been identified and contacted to determine whether any significant cardiovascular health initiatives occurred during the study period. This information will be considered when interpreting the study results and may be integrated into the analysis plan on an ad hoc basis.
collected, population-based health administrative data to assess outcomes. One of the advantages of using the administrative data is that it enables longer follow-up if so desired.
Ethical aspects
Study limitations and strength
The study received approval from the Research Ethics Boards of the SCO Health Service in Ottawa, Sunnybrook Health Sciences Centre in Toronto, and McMaster University in Hamilton. A data monitoring committee was deemed unnecessary as the study is un-blinded and participants were at low risk of harm.
A potential limitation of CHAP is the short duration of the intervention. The 10-week exposure to CHAP may be too short to impact on hospital admission rates. However, previous studies have shown that CHAP consistently reached N30% of older adults. As well, in our Airdrie, Alberta study, CHAP was successful in reducing participants' BP after a six month followup (Jones et al., in press). Another possible limitation is the use of administrative data to assess outcomes. Administrative data lack clinical detail, and concerns have been raised about the validity of diagnosis coding on hospital discharge. We have responded to the latter concern by using codes that have been validated and have high positive predictive value. Because it was infeasible to limit or to accurately track the movement of individuals over time and because our intervention was community-focused, we chose to use ‘community’ as our unit of analysis and compare relative change in community rates of hospitalisation. Though CVD events that do not result in hospitalisation will not be captured, we anticipate this issue to be equally applicable to both the intervention and control communities. In addition, secondary outcomes will include initiation of and changes to antihypertensive drug therapy in both types of communities. As CHAP is multifaceted, it will not be possible to attribute its effects (if demonstrated) to specific components of the intervention. Though unlikely, community members' knowledge of our evaluation could influence outcomes. Along with other secondary outcome measures we will capture pre- and post-intervention rates of all-cause mortality. Thus, in theory, our primary outcome analysis could incorporate adjustments for imbalance in a host of measured baseline covariates.
Discussion We report the protocol of a cluster-randomised controlled trial that seeks to determine the effectiveness of a community cardiovascular health promotion program in improving the cardiovascular health of older adults. We are testing for the effectiveness of CHAP at a multi-community level through the use of hospital admissions for myocardial infarction, congestive heart failure and stroke (composite primary end-point). The evaluation of CHAP represents an important step forward for community-based disease prevention programs which, despite reasonable designs, strong theoretical foundations and best intentions, have produced disappointing population-level effects on health behaviours and clinical outcomes. Issues that have been identified include inadequate statistical power; sampling problems; secular trends; overly optimistic effect size estimates; inadequate intervention intensity, scope, penetration, or duration; and lack of specificity of the interventions' causal mechanisms (Merzel 2003). CHAP is designed to explicitly address the aforementioned limitations and recommendations of large-scale, community-based trials through its rigorous RCT design, use of peer health educators in program delivery, high participation rate of older adults, health professionals and community organisations, and use of routinely
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Hypertension (and other modifiable risk factors for CVD) represents a significant public health problem, and its underdetection and under-treatment leads to an economic burden in terms of health care expenditures and potential years of life lost. CHAP offers a viable, community-based, low-cost and tested means by which to potentially reduce the population risk for CVD. The extent to which the broad application of CHAP might lead to more effective health care in terms of CVD prevention and management will be determined at the end of this trial. Conflict of interest The author(s) declare that they have no competing interests.
Acknowledgments The present study is funded in part by the Canadian Stroke Network and the Ontario Ministry of Health Promotion — Ontario Stroke System. The Canadian Stroke Network is a part of the federal government supported “Networks of Centres of Excellence” whose purpose is to mobilise and support the best stroke research talent in Canada. The Government of Ontario, Ministry of Health Promotion, provided support for the mobilisation and implementation of CHAP including salaries of the local CHAP coordinators in each of the 20 intervention communities. Support for CHAP has also been provided by the Team for Individualising Pharmacotherapy in Primary Care for Seniors, a multidisciplinary research team funded by the Canadian Institutes for Health Research. References Austin, P.C., Daly, P.A., Tu, J.V., 2002. A multicenter study of the coding accuracy of hospital discharge administrative data for patients admitted to cardiac care units in Ontario. Am. Heart J. 144 (2), 290–296. Bennett, S., Parpia, T., Hayes, R.J., Cousens, S., 2002. Methods for the analysis of incidence rates in cluster randomized trials. Int. J. Epidemiol. 31, 839–846. Bobrie, G., Chatellier, G., Genes, N., Clerson, P., Vaur, L., Vaisse, B., Menard, J., Mallion, J.M., 2004. Cardiovascular prognosis of “masked hypertension" detected by blood pressure self-measurement in elderly treated hypertensive patients. JAMA 291 (11), 1342–1349. Campbell, N.R., McAlister, F.A., Duong-Hua, M., Tu, K., 2007. Polytherapy with two or more antihypertensive drugs to lower blood pressure in elderly Ontarians. Room for improvement. Can. J. Cardiol. 23 (10), 783–787. Carleton, R.A., Lasater, T.M., Assaf, A.R., Feldman, H.A., McKinlay, S., 1995. The Pawtucket Heart Health Program: community changes in cardiovascular risk factors and projected disease risk. Am. J. Public Health 85 (6), 777–785. Chabot, I., Moisan, J., Grégoire, J.P., Milot, A., 2003. Pharmacist intervention program for control of hypertension. Ann. Pharmacother. 37, 1186–1193. Chambers, L.W., Kaczorowski, J., Dolovich, L., Karwalajtys, T., Hall, H.L., McDonough, B., Hogg, W., Farrell, B., Hendriks, A., Levitt, C., 2005. A community-based program for cardiovascular health awareness. Can. J. Public Health 96 (4), 294–298. Chambers, L.W., Kaczorowski, J., Levitt, C., Karwalajtys, T., McDonough, B., Lewis, J., 2002. Blood pressure self-monitoring in pharmacies. Building on existing resources. Can. Fam. Physician 48, 1594–1595. CHAP Working Group. CHAP: A community approach to better cardiovascular health! http://www.chapprogram.ca. 2007. Ref Type: Electronic Citation. Drummond, M., Sculpher, M., Torrance, G.W., O'Brien, B.J., Stoddart, G.L., 2005. Methods for the Economic Evaluation of Health Care Programmes, 3rd edn. Oxford University Press, New York, USA.
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Düsing, R., 2006. Overcoming barriers to effective blood pressure control in patients with hypertension. Curr. Med. Res. Opin. 22 (8), 1545–1553. Farquhar, J.W., Fortmann, S.P., Flora, J.A., Taylor, C.B., Haskell, W.L., Williams, P.T., Maccoby, N., Wood, P.D., 1990. Effects of communitywide education on cardiovascular disease risk factors. The Stanford Five-City Project. JAMA 264 (3), 359–365. Hayes, R.J., Bennett, S., 1999. Simple sample size calculations for cluster randomized trials. Int. J. Epidemiol. 28, 319–326. Heart and Stroke Foundation of Canada. The Growing Burden of Heart Disease and Stroke in Canada. http://www.cvdinfobase.ca/cvdbook/CVD_En03. pdf2003. Ref Type: Electronic Citation. Humphries, K.H., Rankin, J.M., Carere, R.G., Buller, C.E., Kiely, F.M., Spinelli, J.J., 2000. Co-morbidity data in outcomes research: are clinical data derived from administrative databases a reliable alternative to chart review? J. Clin. Epidemiol. 53 (4), 343–349. Institute for Clinical Evaluative Sciences. Improving health care data in Ontario. ICES investigative report. http://www.ices.on.ca/file/HealthData.pdf. 2005. Toronto, ON. Ref Type: Electronic Citation. Joffres, M., 1997. Awareness, Treatment, and Control of Hypertension in Canada. Am. J. Hypertens. 10 (10), 1097–1102. Jones, C., Simpson, S.H., Mitchell, D., Haggarty, S., Campbell, N., Then, K., Lewanczuk, R.Z., Sebaldt, R.J., Farrell, B., Dolovich, L., Kaczorowski, J., Chambers, L.W., in press Enhancing Hypertension Awareness and Management in the Elderly:Lessons Learned from the Airdrie-Community Hypertension Awareness and Management Program (A-CHAMP), Can. J. Cardiol. Karwalajtys, T., Kaczorowski, J., Chambers, L.W., Levitt, C., Dolovich, L., McDonough, B., Patterson, C., Williams, J.E., 2005. A randomized trial of mail vs. telephone invitation to a community-based cardiovascular health awareness program for older family practice patients [ISRCTN61739603]. BMC Fam. Pract. 19, 35. Langille, D.B., Joffres, M., MacPherson, K.M., Andreou, P., Kirkland, S.A., MacLean, D.R., 1999. Prevalence of risk factors for cardiovascular disease in Canadians 55 to 74 years of age: results from the Canadian Heart Health Surveys, 1986–1992. CMAJ 161 (8), S3–S9. Laverack, G., 2006. Improving health outcomes through community empowerment: a review of the literature. J. Health Popul. Nutr. 24 (1), 113–120. Lee, D.S., Donovan, L., Austin, P.C., Gong, Y., Liu, P.P., Rouleau, J.L., Tu, J.V., 2005. Comparison of coding of heart failure and comorbidities in administrative and clinical data for use in outcomes research. Med. Care 43 (2), 182–188. Luepker, R.V., Rastam, L., Hannan, P.J., Murray, D.M., Gray, C., Baker, W.L., Crow, R., Jacobs Jr., D.R., Pirie, P.L., Mascioli, S.R., Mittelmark, M.B., Blackburn, H., 1996. Community education for cardiovascular disease prevention. Morbidity and mortality results from the Minnesota Heart Health Program. Am. J. Epidemiol. 144 (4), 351–362. Merzel, C.D.J., 2003. Reconsidering community-based health promotion: promise, performance, and potential. Am. J. Public Health 93, 557–574. Mills, C., Manske, S., Dobbins, M., Cameron, R., 2002. From stroke prevention to health gain. Final Report, CCS/NCIC Centre for Behavioural Research and Program Evaluation. University of Waterloo, Ontario, Canada. Neuhouser, M.L., Miller, D.L., Kristal, A.R., Barnett, M.J., Cheskin, L.J., 2002. Diet and exercise habits of patients with diabetes, dyslipidemia, cardiovascular disease or hypertension. J. Am. Coll. Nutr. 21 (5), 394–401. Ontario Ministry of Health and Long-Term Care. Ontario Health Planning Data Guide. http://www.health.gov.on.ca/transformation/providers/information/ resources/healthplan_guide.pdf [3.0]. 2006. Ref Type: Electronic Citation. Parati, G., Mancia, G., 2003. White coat effect: semantics, assessment and pathophysiological implications. J. Hypertens. 21 (3), 481–486. Petrella, R.J., Merikle, E.P., Jones, J., 2007. Prevalence, treatment, and control of hypertension in primary care: gaps, trends, and opportunities. J. Clin. Hypertens. 9 (1), 28–35. Posavac, E.J., Kattapong, K.R., Dew Jr., D.E., 1999. Peer-based interventions to influence health-related behaviours and attitudes: a meta-analysis. Psychol. Rep. 85, 1179–1194. Puska, P., Salonen, J.T., Nissinen, A., Tuomilehto, J., Vartiainen, E., Korhonen, H., Tanskanen, A., Ronnqvist, P., Koskela, K., Huttunen, J., 1983. Change in
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risk factors for coronary heart disease during 10 years of a community intervention programme (North Karelia project). Br. Med. J. (Clin.Res.Ed). 287 (6408), 1840–1844. Record, N.B., Harris, D.E., Record, S.S., Gilbert-Arcari, J., DeSisto, M., Bunnell, S., 2000. Mortality impact of an integrated community cardiovascular health program. Am. J. Prev. Med. 19 (1), 30–38. Rose, G., 1992. The Strategy of Preventive Medicine. Oxford University Press Inc., Oxford. Salzman, C., 1995. Medication compliance in the elderly. J. Clin. Psychiatry 56 (Suppl 1), 18–22. Sellors, J., et al., Seniors Medication Assessment Research Trial (SMART Group), 2002. Recruiting family physicians and patients for a clinical trial: lessons learned. Fam. Pract. 19, 99–104. Serour, M., Alqhenaei, H., Al-Saqabi, S., Mustafa, A.R., Ben-Nakhi, A., 2007. Cultural factors and patients' adherence to lifestyle measures. Br. J. Gen. Pract. 57 (537), 291–295. Thompson, B.T., Coronado, G., Snipes, S.A., Puschel, K., 2003. Methodological advances and ongoing challenges in designing communitybased health promotion programs. Annu. Rev. Public Health 24, 315–340.
Tirschwell, D.L., Longstreth Jr., W.T., 2002. Validating administrative data in stroke research. Stroke 33 (10), 2465–2470. Tu, K., Mamdani, M.M., Tu, J.V., 2002. Hypertension guidelines in elderly patients: is anybody listening? Am. J. Med. 113, 52–58. Vasan, R.S., Beiser, A., Seshadri, S., Larson, M.G., Kannel, W.B., D'Agostino, R.B., Levy, D., 2002. Residual lifetime risk for developing hypertension in middle-aged women and men: The Framingham Heart Study. JAMA 287 (8), 1003–1010. VSM MedTech. BpTRU: Medical Advances Through Technology. http://www. bptru.com/. 2004. Ref Type: Electronic Citation. Wolf-Maier, K., Cooper, R.S., Banegas, J.R., Giampaoli, S., Hense, H.W., Joffres, M., Kastarinen, M., Poulter, N., Primatesta, P., Rodriguez-Artalejo, F., Stegmayr, B., Thamm, M., Tuomilehto, J., Vanuzzo, D., Vescio, F., 2003. Hypertension prevalence and blood pressure levels in 6 European countries, Canada and the United States. JAMA 289, 2363–2369. World Health Organization, 2002. The World Health Report 2002 Geneva, Switzerland. Zillich, A.J., Sutherland, J.M., Kumbera, P.A., Carter, B.L., 2005. Hypertension outcomes through blood pressure monitoring and evaluation by pharmacists (HOME Study). J. Gen. Intern. Med. 20, 1091–1096.
Preventive Medicine 46 (2008) 537 – 544 www.elsevier.com/locate/ypmed
Cardiovascular Health Awareness Program (CHAP): A community cluster-randomised trial among elderly Canadians Janusz Kaczorowski a,b,g,i,⁎,1 , Larry W. Chambers c,d,e,f,1 , Tina Karwalajtys g , Lisa Dolovich g,h,i , Barbara Farrell c , Beatrice McDonough j , Rolf Sebaldt h,i , Cheryl Levitt g , William Hogg c,e , Lehana Thabane h,i , Karen Tu k , Ron Goeree h , J. Michael Paterson g,i,k , Mamdouh Shubair h,j , Tracy Gierman c , Shannon Sullivan c , Megan Carter c b
a Department of Family Practice, University of British Columbia, Canada Primary Care and Community Research, Child and Family Research Institute (CFRI), Vancouver (BC), Canada c Élisabeth Bruyère Research Institute, Ottawa (ON), Canada d Department of Epidemiology and Community Medicine, University of Ottawa, Canada e Department of Family Medicine, University of Ottawa, Canada f School of Nursing, University of Ottawa, Canada g Department of Family Medicine, McMaster University, Canada h Department of Clinical Epidemiology and Biostatistics, McMaster University, Canada i Centre for Evaluation of Medicines, St. Joseph's Healthcare, Hamilton (ON), Canada j City of Hamilton Public Health Services, Hamilton (ON), Canada k Institute for Clinical Evaluative Sciences, Toronto (ON), Canada
Available online 14 February 2008
Abstract Objective. High blood pressure is an important and modifiable cardiovascular disease risk factor that remains under-detected and under-treated. Community-level interventions that address high blood pressure and other modifiable risk factors are a promising strategy to improve cardiovascular health in populations. The present study is a community cluster-randomised trial testing the effectiveness of CHAP (Cardiovascular Health Awareness Program) on the cardiovascular health of older adults. Methods. Thirty-nine mid-sized communities in Ontario, Canada were stratified by geographic location and size of the population aged ≥ 65 years and randomly allocated to receive CHAP or no intervention. In CHAP communities, residents aged ≥65 years were invited to attend cardiovascular risk assessment sessions held in pharmacies over 10 weeks in Fall, 2006. Sessions included blood pressure measurement and feedback to family physicians. Trained volunteers delivered the program with support from pharmacists, community nurses and local organisations. Results. The primary outcome measure is the relative change in the mean annual rate of hospital admission for acute myocardial infarction, congestive heart failure and stroke (composite end-point) among residents aged ≥65 years in intervention and control communities, using routinely collected, population-based administrative health data. Conclusion. This paper highlights considerations in design, implementation and evaluation of a large-scale, community-wide cardiovascular health promotion initiative. © 2008 Elsevier Inc. All rights reserved. Keywords: Aged; Community medicine; Health promotion; Cardiovascular diseases; Hypertension; Randomized controlled trial; Voluntary workers
Introduction ⁎ Corresponding author. UBC Department of Family Practice, 320-5950 University Blvd, Vancouver BC, Canada V6T 1Z3. Fax: +1 604 827 4184. E-mail address: [email protected] (J. Kaczorowski). 1 These authors contributed equally to this work. 0091-7435/$ - see front matter © 2008 Elsevier Inc. All rights reserved. doi:10.1016/j.ypmed.2008.02.005
Cardiovascular diseases (CVD), including ischemic heart disease, heart failure and stroke, are the most common causes of death in Canada (Heart and Stroke Foundation of Canada, 2003). Hypertension (high blood pressure) is one of the most
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readily preventable causes of CVD, and is estimated to be among the top three leading causes of death world-wide (World Health Organization, 2002). In Canada, the overall prevalence of hypertension is estimated to be 27% (Wolf-Maier et al., 2003); however the prevalence increases with age and over 50% of individuals 65 to 74 years of age are estimated to have hypertension (Langille et al., 1999; Vasan et al., 2002). Furthermore, the lifetime residual risk of developing hypertension for middle-aged individuals is estimated to be 90% (Vasan et al., 2002). Treatment of CVD accounts for the largest proportion of health care spending in Canada (Heart and Stroke Foundation of Canada, 2003). At the same time, it is estimated that the vast majority of CVD can be prevented through improved management of modifiable risk factors, and that hypertension is a good starting point for initiating a more comprehensive CVD risk management strategy. Additionally, both lifestyle and pharmacological therapies consistently have been shown to be effective at reducing blood pressure (BP) and associated risk factors, and thus global CVD risk. Hypertension is under-diagnosed and under-treated. A Canada-wide, population-based study found that among hypertensive adults aged 65 to 74 years, 42% were unaware of their condition, 19% were aware but not treated or controlled and 23% were receiving treatment but were not adequately controlled, leaving only 16% who were treated and controlled (Joffres, 1997). The main barriers to optimal diagnosis, treatment and follow-up include over-detection or ‘white coat effect’ (Parati and Mancia, 2003), under-detection or ‘masked hypertension’ (Bobrie et al., 2004), patients presenting with multiple problems (Farquhar et al., 1990; Luepker et al., 1996), reluctance on the part of many family physicians to initiate and maintain aggressive drug therapies (Petrella et al., 2007), and patient nonadherence to both pharmacologic treatments and lifestyle recommendations (Carleton et al., 1995; Düsing 2006; Neuhouser et al., 2002; Salzman 1995; Serour et al., 2007). The cornerstone of appropriate diagnosis, treatment and follow-up of hypertension is accurate BP measurement. Research suggests that strategies that increase the quantity and quality of BP measurements taken in settings other than the doctor's office may help to improve the detection and control of high BP. Community interventions that have included BP monitoring outside of the family physician's office and involved local pharmacies and pharmacists have shown promising results in terms of BP reduction amongst hypertensive patients (Chabot et al., 2003; Zillich et al., 2005). These trials, however, were relatively small, had methodological shortcomings, showed only modest improvements in BP, and were not primarily focused on awareness and prevention. Some of the most notable community-wide interventions for CVD include the North Karelia Project, the Stanford Five City Project, the Minnesota Heart Health Program, the Pawtucket Heart Health Program, and the Franklin Cardiovascular Health Program (Carleton et al., 1995; Farquhar et al., 1990; Luepker et al., 1996; Puska et al., 1983; Record et al., 2000). All have failed to detect changes in CVD risk factors or disease events that could unequivocally be attributed to the interventions. This is in part because none of these studies employed the randomised
controlled trial design which, when properly implemented, offers increased protection against different sources of bias. The weaker designs used, such as quasi-experimental or the beforeand-after approaches, are more susceptible to bias and thus render causal attributions more challenging. The second main reason for the largely null results had to do with the potency, duration and penetration of the interventions themselves, and the outcomes used to assess their effectiveness, including the data sources used. Despite the methodological weaknesses and modest improvements reported by these large community studies, they have underscored the importance of small shifts in the distribution of risk factors on the overall cardiovascular health of the population (Rose, 1992; Thompson et al., 2003). Further, these studies demonstrated that in order to improve CVD status, entire communities need to be engaged in achieving program goals (Mills et al., 2002). Community resources such as volunteers, community health nurses and local organisations are locally available but largely underutilised to support health promotion and primary prevention in Canada. A meta-analysis of 47 peer-based health education programs found a consistent positive health effect of peer programs (Posavac et al., 1999). Community empowerment, including participation, linking with other people and organisations, and resource mobilisation, can lead to improvement in health outcomes of community residents (Laverack, 2006). The Cardiovascular Health Awareness Program (CHAP) is a multi-pronged approach to CVD risk awareness and management. CHAP uses a reliable and accurate method to measure BP in a familiar environment; taps into underutilised local resources such as volunteers and community pharmacies; and ‘closes the loop’ by communicating up-to-date BP and CVD risk information to family physicians, pharmacists and patients via a flexible method of data management. Awareness of the importance of BP monitoring and management, and reducing modifiable risk factors to prevent CVD is increased amongst older adults in the community. CHAP was developed and refined through several pilot studies, scientific trials and community-wide demonstration projects (Chambers et al., 2002; Chambers et al., 2005; CHAP Working Group, 2007; Jones et al., in press; Karwalajtys et al., 2005). The objective of the current trial is to evaluate the impact of CHAP on CVD morbidity and mortality amongst seniors living in medium-sized communities in Ontario, Canada by further developing knowledge in implementing and evaluating community-based cardiovascular health promotion programs. Methods Study design The present study is a cluster-randomised community intervention trial in which eligible mid-sized Ontario communities were stratified and randomly allocated to one of two groups: • an Intervention group in which CHAP sessions were offered to residents 65 years and older for 10 week s in the Fall of 2006 • a Control group, which continued with routine health care and health promotion
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Selection and randomisation of communities We devised a replicable process to determine community eligibility using five explicit criteria: 1) population of 10,000 to 60,000 based on the 1996 and 2001 Canadian Census; 2) ≥5 family physicians; 3) ≥2 pharmacies; 4) Registered Persons Database (RPDB) to Census Population ratio less than 10%; and 5) no recent geopolitical amalgamation into a major centre. The RPDB provides basic demographic information about anyone who has ever received an Ontario health card number and is thus eligible for the universal health insurance. Census data also provides this demographic information but cannot be linked to other databases. Previous studies have identified discrepancies between the RPDB and Census data where the number of persons in the registry has exceeded the number of persons in Census data by 6 to 10%, and up to 30% in some urban areas (Institute for Clinical
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Evaluative Sciences, 2005). Large differences (N10%) reduce our ability to make valid inferences about health system variables in these communities, thus we have elected to use this ratio as an inclusion criterion. We began with all distinct communities with a population of 10,000 to 60,000 (n = 59) based on the 1996 and 2001 Census, and identified a total of 41 communities after excluding townships, first nations reserves, dissolved and amalgamated townships, and counties. We further excluded two communities where CHAP was initially developed and pilot-tested (Grimsby and Brockville, ON) for a final set of 39 communities. The criteria were chosen to ensure adequate capacity to deliver the program on a comparable scale, and a sufficiently large, well-defined population for evaluation purposes. The 39 eligible communities were stratified by size of the population 65 years of age and older (three groups) and geographic location (four groups),
Fig. 1. Legend: Graphical depiction of CHAP trial flow including the main components of the CHAP intervention (Ontario, Canada). January–August, 2006 a.Request for Proposals for funding to deliver CHAP; local lead organisations chosen and local CHAP coordinators hired. b. Mobilisation activities conducted by the local lead organisation including documentation of local capacities (e.g. stakeholders, programs and agencies), review and collection of information and education resources, planning and delivery of stakeholder meetings, identification of a Physician Opinion Leader and Pharmacist Champion, and development of an action plan to implement CHAP. c. Implementation activities led by the local CHAP coordinator with support from the local lead organisations, including hiring a community health nurse, recruiting family physicians and pharmacies, recruiting and training volunteer peer health educators, implementing invitation methods, and developing CHAP session schedules. September–November, 2006 d. Participants assisted by volunteer peer health educators to complete the CVD and stroke risk profile. e. Participants assisted by volunteer peer health educators to measure their BP with BpTRU™ automated device and record result. f. On-call nurse reassessed participants identified as high risk (systolic BP ≥ 180 or diastolic BP ≥ 110 mmHg), and family physician contacted and provided with session results by fax same day. g. Participants provided with targeted educational resources by volunteer peer health educators based on risk profile responses. h. Copy of completed risk profile given to each participant and faxed to a database managed by Clinforma Data Systems. January, 2007 i. Pharmacy session results for the 10-week program sent to participants’ family physicians in the form of reports rank-ordering their patients by systolic BP (from the highest to the lowest) and diagnostic/treatment status. May, 2007 j. Aggregate-level comparative feedback sent to family physicians showing BP control of patients from their practice who participated in CHAP compared to the patients of other family physicians in their own community and across all 20 intervention communities. ⁎CHAP-Cardiovascular Health Awareness Program; CVD – cardiovascular disease; BP – blood pressure.
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forming seven sub-strata. Communities within each stratum were randomly allocated to either the intervention (n = 20) or control arm of the study (n = 19) by an independent expert in cluster randomised trials not associated with the study (see Fig. 1). Table 1 provides a comparison of intervention and control communities. Although intervention community members (older adults, family physicians, volunteers, pharmacists) were clearly aware of their group assignment, the names of control communities were not publicized and control community members were not notified that the study was taking place.
CHAP intervention The CHAP intervention was standardised across the 20 communities and consisted of weekday 3-hour morning BP and CVD risk-factor assessment sessions that were held in local pharmacies over 10 weeks in the Fall of 2006. All pharmacies in each intervention community were asked to hold at least one CHAP session each week. At the sessions, volunteer peer health educators, trained by a community health nurse, assisted participants to measure BP using a BpTRU™ automated device (VSM MedTech, 2004) and to record BP and other CVD risk information on a standardised risk profile form adapted from the Heart and Stroke Foundation's online Risk Assessment Tool (see Table 2 for items on the Risk Profile Form). With permission from the participant, summary CVD risk profile forms were sent to the participant's family physician and regular pharmacist. Each participant received a copy of the form, along with risk factorspecific cardiovascular health education materials from the Heart and Stroke Foundation of Canada, Ontario Prevention Clearinghouse, Canadian Hypertension Education Program and Health Canada, and a list of local resources. During the sessions, a community health nurse was on-call to assess participants if their BP was very high, based on a standardised protocol developed with input from the local family physicians. Pharmacists were involved as needed in consulting with participants about their medication (for example, medication adherence, potential drug interactions and side effects) or related concerns. Fax-to-database technology was used to compile all session results and forward information to family physicians at the end of the 10-week program in the form of reports rank-ordering their patients by systolic BP (from the highest to the lowest) and their diagnostic/treatment status (potentially new cases of hypertension and potentially under-treated/non-adherent patients). Family physicians also received aggregate-level comparative feedback six months post, comparing their patients with those of other local family physicians and across all 20 intervention communities in terms of BP control. Results of these assessments and resources were made available to participants and family physicians via a secure website.
Recruitment of participants Local lead organisations A ‘request for proposals’ was publicised in each of the 20 intervention communities (in January 2006) to identify a local organisation to lead CHAP. To be considered, organisations had to have the required capacity to deliver CHAP including: experience working with volunteers; existing relationships in the community, ideally with primary care professionals; and ability to provide inTable 1 Comparison of intervention and control communities (Ontario, 2006)
Number of communities Mean population size (SD) Mean percentage of residents ≥65 y of age (SD) Average median total income ($CAN) of population ≥ 15 y (SD) Mean number of family physicians (SD) Mean number of pharmacies (SD) Mean admission rate for AMI, CHF and stroke per 100 people ≥65 y in 2001 (SD)
CHAP
Control
20 20,337 (10,507) 16.8 (4.1) 22,507 (4,115) 17.1 (8.1) 7.3 (3.3) 7.8 (1.4)
19 27,360 (13,281) 16.5 (3.4) 22,204 (3,419) 19.1 (7.9) 7.8 (3.2) 8.1 (1.2)
CHAP – Cardiovascular Health Awareness Program; SD – standard deviation; AMI –acute myocardial infarction; CHF – congestive heart failure; $ CAN – Canadian dollars.
Table 2 Items on the CVD and stroke risk profile form used in CHAP pharmacy sessions (Ontario, 2006) Question
Response categories
• In general, would you say your health is:
Poor, Fair, Good, Very Good, Excellent
• Have you ever had a TIA or mini-stroke? • Have you ever had a stroke? • Have you ever had a heart attack? • Has your doctor told you that your cholesterol is high? • Has your doctor told you that you have diabetes? • Have you ever been diagnosed with high blood pressure by a doctor? • Are you currently taking prescription pills for high blood pressure?
Yes, No, Not sure
• If you currently use pills for high blood pressure, do you take them each day?
Yes, No, Not applicable
• Do you currently smoke? • Typically, do you drink 2 or more alcoholic drinks a day? • Do you eat 5 servings or more of fruits and vegetables a day? • Are you moderately physically active for 30 – 60 min most days of the week? (e.g. brisk walking, active gardening, swimming, dancing or biking) • Do you live alone?
Yes, No
• How frequently do you add salt to foods during cooking or at the table? • In a typical week, how frequently do you feel overwhelmed or stressed?
Rarely, Sometimes, Often
• In a typical week, how often do you eat high fat or fast foods?
Zero, 1–2, 3 or more
• What is your height and weight?
Continuous
CVD – cardiovascular disease; CHAP – Cardiovascular Health Awareness Program; TIA – transient ischemic attack. kind donations of office space and administrative support for the local coordinator. Twenty-six proposals were submitted and one local organisation in each intervention community was selected by the study investigators using the a priori developed criteria. Table 3 shows the types of agencies that were selected to lead CHAP. Local lead organisations received between $ CAN 20,000 and $ CAN 40,000 to support implementation of the program, and were supported by two Regional Coordinators in the province. Family physician practices All community-based family physicians and general practitioners with an office address (based on postal codes) in intervention communities were eligible to Table 3 Types of CHAP local lead organisations (Ontario, 2006) • Seniors centres • Hospitals • Victorian Order of Nurses • YMCAs • Community Care Access Centres • Not-for-profit Home Care Organizations • Meals on Wheels and Neighbourly Services • District Stroke Centres • Community Centres CHAP – Cardiovascular Health Awareness Program; YMCA – Young Men's Christian Association.
J. Kaczorowski et al. / Preventive Medicine 46 (2008) 537–544 participate. Recruitment strategies for physicians included the use of opinion leaders and peer recruitment (Sellors et al., 2002). Each physician was faxed an introductory letter explaining the program, followed by a visit from the Local CHAP coordinator and/or members of the CHAP Team to provide additional information and seek written agreement to participate. An electronic roster of regular, community-dwelling patients 65 years of age or older was generated, when available, to prepare individualised invitation letters from family physicians. Pharmacies All pharmacies in each intervention community were faxed an introductory letter from the project team pharmacists (LD and BF) explaining the program, followed by a visit or telephone call to seek an agreement to participate. A DVD of a presentation by the project team pharmacists explaining the study with a specific emphasis on the pharmacist role and responsibilities was provided to coordinators to use as a recruitment aid. Volunteers Volunteer peer health educators were recruited by the local lead organisation in each intervention community using a variety of methods. These included using the local lead organisation's existing volunteer base, advertising in the local media, and giving presentations at local seniors' clubs. On average, 28 volunteers were recruited, trained and retained to conduct sessions in each community. Target population: older adults aged 65 years and older Participation in CHAP was open to all residents of the intervention communities; however individuals aged 65 years or older were explicitly targeted. The implementation and evaluation of the CHAP program reflects the orientation toward older adults. For instance, the session location (pharmacies), scheduling of the assessment sessions (weekday mornings), use of age-matched volunteer peer health educators, consideration of the burden of CVD, and availability of prescription data, are all specific to this age group. Individuals who did not meet the inclusion criteria are excluded in the analysis but were permitted to participate in the program. Participants were recruited via a personalised invitation letter from participating family physicians or the local lead organisation. Another strategy consisted of ‘tickets' or referrals to CHAP pharmacy sessions given to eligible patients by their family physician and the office staff. In some communities these tickets were also distributed by pharmacists or the local lead organisation. CHAP sessions were also advertised community-wide using flyers, posters, and advertisements in the local media. Based on previous CHAP studies that have shown attendance rates ranging from 30% to 72% (Chambers et al., 2005; Jones et al., in press; Karwalajtys et al., 2005), it was estimated that at least 30% of the population 65 years of age and older in the participating communities would attend one or more CHAP sessions. This would represent approximately 20,000 older adults residing in CHAP communities out of a possible total of 66,280 (based on Statistics Canada's 2001 Census).
Outcome measures Assessment of CHAP outcomes is based on routinely collected, populationbased administrative health data. With the exception of disease-specific mortality data (obtained from Statistics Canada Vital Statistics), data for outcome assessment are housed at the Institute for Clinical Evaluative Sciences. Data sources include the Canadian Institute for Health Information's Discharge Abstract Database, the Ontario Health Insurance Program's Claims History Database, and the Ontario Drug Benefit Program Database (Ontario Ministry of Health and Long-Term Care, 2006). The primary outcome measure is the relative change in the mean annual rate of hospital admissions for acute myocardial infarction, congestive heart failure and stroke (composite end-point) among the total population of communitydwelling residents aged 65 years and older in intervention and control communities, in the year before compared to the year after the implementation of CHAP (ICD10 codes will be used). Table 4 summarizes the validation studies of the primary outcome measure derived from these databases. Secondary outcome measures include mortality due to CVD and coronary artery disease (CAD), and all-cause mortality; hospitalisations for stroke and CAD; differences in rates of initiation of antihypertensive drug therapy (Tu
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et al., 2002); differences in rates of hypertension drug treatment (one antihypertensive drug versus polytherapy) (Campbell et al., 2007); and health service utilisation and cost-benefit analysis (Drummond et al., 2005).
Sample size and power calculations The sample size was fixed, as there were only 39 Ontario communities of 10,000 to 60,000 residents that met our eligibility criteria. Rates of hospital admissions for acute myocardial infarction, congestive heart failure or stroke in the intervention communities and the 2001 census population estimates for persons aged 65 years and older were used for power calculations. In 2001, there were a total of 11,486 hospital admissions for CVD with over 148,589 personyears of observations, giving an overall admission rate for the 39 communities of 7.73 per 100 person-years. The empirical standard deviation of the observed admission rates was 1.79. With the assumption that the mean hospital admission rate in control communities remained constant, 19 communities per arm permit detection of a 21% or greater reduction in the mean annual rate of hospital admission with 80% power (using two-tailed test at alpha = 0.05 level of significance). A more sophisticated sample size calculation that took into account both the cluster size and the coefficient of variation of the true rates between and within clusters called for a sample of comparable size (Hayes and Bennett, 1999).
Statistical analysis The 12 month pre-CHAP period where administrative data will be used to compute baseline values for outcomes ended prior to the beginning of study activity in the intervention and control communities (July 2005 to July 2006). The 12 month follow-up period began from the date the first invitation letters were sent to prospective CHAP participants (August 2006 to August 2007). Fig. 1 provides a more detailed description of the study flow. All analyses will be based on an intention-to-treat approach. Residents of both the intervention and control communities aged 65 years and older who resided in long-term care facilities will be excluded from the analyses, as they had no opportunity to participate in the CHAP sessions. Analysis of the primary outcome will be based on a two-sample t-test carried out on summary change scores for each community cluster and aggregated across the two study arms. Poisson regression will be used to adjust for potential confounders at the community level such as socioeconomic status (median income; unemployment rate; home ownership; ethnic distribution), CVD risk, and the ratio of hospitals, specialists, family physicians and other health care facilities or professionals to residents 65 years or over. Results will be reported as the estimate of the difference, corresponding standard error, 95% confidence interval and associated p-values. P-values will be reported to three decimal places, with p-values less than 0.001 reported as p b 0.001. For all tests, the level of significance will be set at five percent. The data analysts will be blinded to group allocation to minimize the potential for bias. Model assumptions and goodness-offit will be evaluated by examining the residuals (Bennett et al., 2002). All analyses will be conducted using SAS version 9.2 (Cary, North Carolina). Methods to analyse mortality and hospitalisation outcomes will be similar to those used for the primary outcome. Analysis of differences in anti-hypertensive medication initiation will be based on previously developed methods (Tu et al., 2002). Health care costs over the 12 month follow-up period (and 12 month preperiod) will be estimated for patients in both intervention and control communities. Total costs for patients in the intervention communities will be compared to total costs for patients in the control communities to determine whether the higher costs of the intervention are offset by subsequent use of publicly-subsidized health care resources (Drummond et al., 2005). Significance levels of the secondary outcomes will be adjusted for multiple testing using the Bonferroni method, to maintain the overall alpha level at b0.05.
Contamination and co-intervention Local lead organisations were asked not to share CHAP implementation materials or present at events outside the community during the study period. In terms of co-intervention, health departments and the Heart and Stroke Foundation of Ontario branches in each of the intervention and control
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Table 4 The validity of using administrative data to assess AMI, CHF and stroke outcomes in the CHAP trial (Ontario, 2006) References
Positive predictive value (%)
Negative predictive value (%)
Sensitivity (%)
Specificity (%)
Gold standard
AMI (ICD 9: 410) Austin et al., 2002
88.5
NR
92.8
88.8
Lee et al., 2005
81.9
NR
35.7
95.1
Fastrak II Acute Coronary Syndromes Registry Chart review
CHF (ICD 9: 428 x.) Lee et al., 2005
94.3
NR
NR
NR
Austin et al., 2002
65.1
NR
58.5
96.8
Humphries et al., 2000
50.6
97.2
66.1
94.8
Chart review (Framingham criteria) Fastrak II Acute Coronary Syndromes Registry Chart review
Stroke (ICD 9: 430–438) Tirschwell and Longstreth, 2002 (Ischemic stroke) Tirschwell and Longstreth, 2002 (Intracerebral hemorrhage) Tirschwell and Longstreth, 2002 (Subarachnoid hemorrhage) Lee et al., 2005
88 89 94 89.4
NR NR NR NR
74 85 90 24.1
95 96 97 99.2
Chart Chart Chart Chart
review review review review
AMI – acute myocardial infarction; CHF – congestive heart failure; CHAP – Cardiovascular Health Awareness Program; ICD 9 – International Classification of Diseases, 9th Revision; NR – not reported.
communities have been identified and contacted to determine whether any significant cardiovascular health initiatives occurred during the study period. This information will be considered when interpreting the study results and may be integrated into the analysis plan on an ad hoc basis.
collected, population-based health administrative data to assess outcomes. One of the advantages of using the administrative data is that it enables longer follow-up if so desired.
Ethical aspects
Study limitations and strength
The study received approval from the Research Ethics Boards of the SCO Health Service in Ottawa, Sunnybrook Health Sciences Centre in Toronto, and McMaster University in Hamilton. A data monitoring committee was deemed unnecessary as the study is un-blinded and participants were at low risk of harm.
A potential limitation of CHAP is the short duration of the intervention. The 10-week exposure to CHAP may be too short to impact on hospital admission rates. However, previous studies have shown that CHAP consistently reached N30% of older adults. As well, in our Airdrie, Alberta study, CHAP was successful in reducing participants' BP after a six month followup (Jones et al., in press). Another possible limitation is the use of administrative data to assess outcomes. Administrative data lack clinical detail, and concerns have been raised about the validity of diagnosis coding on hospital discharge. We have responded to the latter concern by using codes that have been validated and have high positive predictive value. Because it was infeasible to limit or to accurately track the movement of individuals over time and because our intervention was community-focused, we chose to use ‘community’ as our unit of analysis and compare relative change in community rates of hospitalisation. Though CVD events that do not result in hospitalisation will not be captured, we anticipate this issue to be equally applicable to both the intervention and control communities. In addition, secondary outcomes will include initiation of and changes to antihypertensive drug therapy in both types of communities. As CHAP is multifaceted, it will not be possible to attribute its effects (if demonstrated) to specific components of the intervention. Though unlikely, community members' knowledge of our evaluation could influence outcomes. Along with other secondary outcome measures we will capture pre- and post-intervention rates of all-cause mortality. Thus, in theory, our primary outcome analysis could incorporate adjustments for imbalance in a host of measured baseline covariates.
Discussion We report the protocol of a cluster-randomised controlled trial that seeks to determine the effectiveness of a community cardiovascular health promotion program in improving the cardiovascular health of older adults. We are testing for the effectiveness of CHAP at a multi-community level through the use of hospital admissions for myocardial infarction, congestive heart failure and stroke (composite primary end-point). The evaluation of CHAP represents an important step forward for community-based disease prevention programs which, despite reasonable designs, strong theoretical foundations and best intentions, have produced disappointing population-level effects on health behaviours and clinical outcomes. Issues that have been identified include inadequate statistical power; sampling problems; secular trends; overly optimistic effect size estimates; inadequate intervention intensity, scope, penetration, or duration; and lack of specificity of the interventions' causal mechanisms (Merzel 2003). CHAP is designed to explicitly address the aforementioned limitations and recommendations of large-scale, community-based trials through its rigorous RCT design, use of peer health educators in program delivery, high participation rate of older adults, health professionals and community organisations, and use of routinely
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Hypertension (and other modifiable risk factors for CVD) represents a significant public health problem, and its underdetection and under-treatment leads to an economic burden in terms of health care expenditures and potential years of life lost. CHAP offers a viable, community-based, low-cost and tested means by which to potentially reduce the population risk for CVD. The extent to which the broad application of CHAP might lead to more effective health care in terms of CVD prevention and management will be determined at the end of this trial. Conflict of interest The author(s) declare that they have no competing interests.
Acknowledgments The present study is funded in part by the Canadian Stroke Network and the Ontario Ministry of Health Promotion — Ontario Stroke System. The Canadian Stroke Network is a part of the federal government supported “Networks of Centres of Excellence” whose purpose is to mobilise and support the best stroke research talent in Canada. The Government of Ontario, Ministry of Health Promotion, provided support for the mobilisation and implementation of CHAP including salaries of the local CHAP coordinators in each of the 20 intervention communities. Support for CHAP has also been provided by the Team for Individualising Pharmacotherapy in Primary Care for Seniors, a multidisciplinary research team funded by the Canadian Institutes for Health Research. References Austin, P.C., Daly, P.A., Tu, J.V., 2002. A multicenter study of the coding accuracy of hospital discharge administrative data for patients admitted to cardiac care units in Ontario. Am. Heart J. 144 (2), 290–296. Bennett, S., Parpia, T., Hayes, R.J., Cousens, S., 2002. Methods for the analysis of incidence rates in cluster randomized trials. Int. J. Epidemiol. 31, 839–846. Bobrie, G., Chatellier, G., Genes, N., Clerson, P., Vaur, L., Vaisse, B., Menard, J., Mallion, J.M., 2004. Cardiovascular prognosis of “masked hypertension" detected by blood pressure self-measurement in elderly treated hypertensive patients. JAMA 291 (11), 1342–1349. Campbell, N.R., McAlister, F.A., Duong-Hua, M., Tu, K., 2007. Polytherapy with two or more antihypertensive drugs to lower blood pressure in elderly Ontarians. Room for improvement. Can. J. Cardiol. 23 (10), 783–787. Carleton, R.A., Lasater, T.M., Assaf, A.R., Feldman, H.A., McKinlay, S., 1995. The Pawtucket Heart Health Program: community changes in cardiovascular risk factors and projected disease risk. Am. J. Public Health 85 (6), 777–785. Chabot, I., Moisan, J., Grégoire, J.P., Milot, A., 2003. Pharmacist intervention program for control of hypertension. Ann. Pharmacother. 37, 1186–1193. Chambers, L.W., Kaczorowski, J., Dolovich, L., Karwalajtys, T., Hall, H.L., McDonough, B., Hogg, W., Farrell, B., Hendriks, A., Levitt, C., 2005. A community-based program for cardiovascular health awareness. Can. J. Public Health 96 (4), 294–298. Chambers, L.W., Kaczorowski, J., Levitt, C., Karwalajtys, T., McDonough, B., Lewis, J., 2002. Blood pressure self-monitoring in pharmacies. Building on existing resources. Can. Fam. Physician 48, 1594–1595. CHAP Working Group. CHAP: A community approach to better cardiovascular health! http://www.chapprogram.ca. 2007. Ref Type: Electronic Citation. Drummond, M., Sculpher, M., Torrance, G.W., O'Brien, B.J., Stoddart, G.L., 2005. Methods for the Economic Evaluation of Health Care Programmes, 3rd edn. Oxford University Press, New York, USA.
543
Düsing, R., 2006. Overcoming barriers to effective blood pressure control in patients with hypertension. Curr. Med. Res. Opin. 22 (8), 1545–1553. Farquhar, J.W., Fortmann, S.P., Flora, J.A., Taylor, C.B., Haskell, W.L., Williams, P.T., Maccoby, N., Wood, P.D., 1990. Effects of communitywide education on cardiovascular disease risk factors. The Stanford Five-City Project. JAMA 264 (3), 359–365. Hayes, R.J., Bennett, S., 1999. Simple sample size calculations for cluster randomized trials. Int. J. Epidemiol. 28, 319–326. Heart and Stroke Foundation of Canada. The Growing Burden of Heart Disease and Stroke in Canada. http://www.cvdinfobase.ca/cvdbook/CVD_En03. pdf2003. Ref Type: Electronic Citation. Humphries, K.H., Rankin, J.M., Carere, R.G., Buller, C.E., Kiely, F.M., Spinelli, J.J., 2000. Co-morbidity data in outcomes research: are clinical data derived from administrative databases a reliable alternative to chart review? J. Clin. Epidemiol. 53 (4), 343–349. Institute for Clinical Evaluative Sciences. Improving health care data in Ontario. ICES investigative report. http://www.ices.on.ca/file/HealthData.pdf. 2005. Toronto, ON. Ref Type: Electronic Citation. Joffres, M., 1997. Awareness, Treatment, and Control of Hypertension in Canada. Am. J. Hypertens. 10 (10), 1097–1102. Jones, C., Simpson, S.H., Mitchell, D., Haggarty, S., Campbell, N., Then, K., Lewanczuk, R.Z., Sebaldt, R.J., Farrell, B., Dolovich, L., Kaczorowski, J., Chambers, L.W., in press Enhancing Hypertension Awareness and Management in the Elderly:Lessons Learned from the Airdrie-Community Hypertension Awareness and Management Program (A-CHAMP), Can. J. Cardiol. Karwalajtys, T., Kaczorowski, J., Chambers, L.W., Levitt, C., Dolovich, L., McDonough, B., Patterson, C., Williams, J.E., 2005. A randomized trial of mail vs. telephone invitation to a community-based cardiovascular health awareness program for older family practice patients [ISRCTN61739603]. BMC Fam. Pract. 19, 35. Langille, D.B., Joffres, M., MacPherson, K.M., Andreou, P., Kirkland, S.A., MacLean, D.R., 1999. Prevalence of risk factors for cardiovascular disease in Canadians 55 to 74 years of age: results from the Canadian Heart Health Surveys, 1986–1992. CMAJ 161 (8), S3–S9. Laverack, G., 2006. Improving health outcomes through community empowerment: a review of the literature. J. Health Popul. Nutr. 24 (1), 113–120. Lee, D.S., Donovan, L., Austin, P.C., Gong, Y., Liu, P.P., Rouleau, J.L., Tu, J.V., 2005. Comparison of coding of heart failure and comorbidities in administrative and clinical data for use in outcomes research. Med. Care 43 (2), 182–188. Luepker, R.V., Rastam, L., Hannan, P.J., Murray, D.M., Gray, C., Baker, W.L., Crow, R., Jacobs Jr., D.R., Pirie, P.L., Mascioli, S.R., Mittelmark, M.B., Blackburn, H., 1996. Community education for cardiovascular disease prevention. Morbidity and mortality results from the Minnesota Heart Health Program. Am. J. Epidemiol. 144 (4), 351–362. Merzel, C.D.J., 2003. Reconsidering community-based health promotion: promise, performance, and potential. Am. J. Public Health 93, 557–574. Mills, C., Manske, S., Dobbins, M., Cameron, R., 2002. From stroke prevention to health gain. Final Report, CCS/NCIC Centre for Behavioural Research and Program Evaluation. University of Waterloo, Ontario, Canada. Neuhouser, M.L., Miller, D.L., Kristal, A.R., Barnett, M.J., Cheskin, L.J., 2002. Diet and exercise habits of patients with diabetes, dyslipidemia, cardiovascular disease or hypertension. J. Am. Coll. Nutr. 21 (5), 394–401. Ontario Ministry of Health and Long-Term Care. Ontario Health Planning Data Guide. http://www.health.gov.on.ca/transformation/providers/information/ resources/healthplan_guide.pdf [3.0]. 2006. Ref Type: Electronic Citation. Parati, G., Mancia, G., 2003. White coat effect: semantics, assessment and pathophysiological implications. J. Hypertens. 21 (3), 481–486. Petrella, R.J., Merikle, E.P., Jones, J., 2007. Prevalence, treatment, and control of hypertension in primary care: gaps, trends, and opportunities. J. Clin. Hypertens. 9 (1), 28–35. Posavac, E.J., Kattapong, K.R., Dew Jr., D.E., 1999. Peer-based interventions to influence health-related behaviours and attitudes: a meta-analysis. Psychol. Rep. 85, 1179–1194. Puska, P., Salonen, J.T., Nissinen, A., Tuomilehto, J., Vartiainen, E., Korhonen, H., Tanskanen, A., Ronnqvist, P., Koskela, K., Huttunen, J., 1983. Change in
544
J. Kaczorowski et al. / Preventive Medicine 46 (2008) 537–544
risk factors for coronary heart disease during 10 years of a community intervention programme (North Karelia project). Br. Med. J. (Clin.Res.Ed). 287 (6408), 1840–1844. Record, N.B., Harris, D.E., Record, S.S., Gilbert-Arcari, J., DeSisto, M., Bunnell, S., 2000. Mortality impact of an integrated community cardiovascular health program. Am. J. Prev. Med. 19 (1), 30–38. Rose, G., 1992. The Strategy of Preventive Medicine. Oxford University Press Inc., Oxford. Salzman, C., 1995. Medication compliance in the elderly. J. Clin. Psychiatry 56 (Suppl 1), 18–22. Sellors, J., et al., Seniors Medication Assessment Research Trial (SMART Group), 2002. Recruiting family physicians and patients for a clinical trial: lessons learned. Fam. Pract. 19, 99–104. Serour, M., Alqhenaei, H., Al-Saqabi, S., Mustafa, A.R., Ben-Nakhi, A., 2007. Cultural factors and patients' adherence to lifestyle measures. Br. J. Gen. Pract. 57 (537), 291–295. Thompson, B.T., Coronado, G., Snipes, S.A., Puschel, K., 2003. Methodological advances and ongoing challenges in designing communitybased health promotion programs. Annu. Rev. Public Health 24, 315–340.
Tirschwell, D.L., Longstreth Jr., W.T., 2002. Validating administrative data in stroke research. Stroke 33 (10), 2465–2470. Tu, K., Mamdani, M.M., Tu, J.V., 2002. Hypertension guidelines in elderly patients: is anybody listening? Am. J. Med. 113, 52–58. Vasan, R.S., Beiser, A., Seshadri, S., Larson, M.G., Kannel, W.B., D'Agostino, R.B., Levy, D., 2002. Residual lifetime risk for developing hypertension in middle-aged women and men: The Framingham Heart Study. JAMA 287 (8), 1003–1010. VSM MedTech. BpTRU: Medical Advances Through Technology. http://www. bptru.com/. 2004. Ref Type: Electronic Citation. Wolf-Maier, K., Cooper, R.S., Banegas, J.R., Giampaoli, S., Hense, H.W., Joffres, M., Kastarinen, M., Poulter, N., Primatesta, P., Rodriguez-Artalejo, F., Stegmayr, B., Thamm, M., Tuomilehto, J., Vanuzzo, D., Vescio, F., 2003. Hypertension prevalence and blood pressure levels in 6 European countries, Canada and the United States. JAMA 289, 2363–2369. World Health Organization, 2002. The World Health Report 2002 Geneva, Switzerland. Zillich, A.J., Sutherland, J.M., Kumbera, P.A., Carter, B.L., 2005. Hypertension outcomes through blood pressure monitoring and evaluation by pharmacists (HOME Study). J. Gen. Intern. Med. 20, 1091–1096.