Cardiovascular disease risk reduction in rural China: a clustered randomized controlled trial in Zhejiang IMProving Adherence using Combination Therapy (IMPACT): design and protocol of a randomised controlled trial in primary care. Electronic Health Record-Based Patient Identification and Individualized Mailed Outreach for Primary Cardiovascular Disease Prevention: A Cluster Randomized Trial Secondary prevention of cardiovascular disease: a randomised trial of training in information management, evidence-based medicine, both or neither: the PIER trial. Evaluating the impact of population and high-risk strategies for the primary prevention of cardiovascular disease. Motivational interviewing and problem solving treatment to reduce type 2 diabetes and cardiovascular disease risk in real life: a randomized controlled trial An integrated general practice and pharmacy-based intervention to promote the use of appropriate preventive medications among individuals at high cardiovascular disease risk: protocol for a cluster randomized controlled trial A pharmacist-led follow-up program for patients with established coronary heart disease in North Norway – a randomized controlled trial Multifaceted intervention to improve medication adherence and secondary prevention measures after acute coronary syndrome hospital discharge: a randomized clinical trial. Increasing the Detection and Response to Adherence Problems with Cardiovascular Medication in Primary Care through Computerized Drug Management Systems: A Randomized Controlled Trial Multifactorial cardiovascular disease prevention in patients aged 75 years and older: A randomized controlled trial: Drugs and Evidence Based Medicine in the Elderly (DEBATE) Study. Rationale and design of a randomized controlled trial evaluating community health worker-based interventions for the secondary prevention of acute coronary syndromes in India (SPREAD). A multifaceted strategy using mobile technology to assist rural primary healthcare doctors and frontline health workers in cardiovascular disease risk management: protocol for the SMARTHealth India cluster randomised controlled trial Secondary prevention clinics for coronary heart disease: four year follow up of a randomised controlled trial in primary care Improving patient adherence to lifestyle advice (IMPALA): a cluster-randomised controlled trial on the implementation of a nurse-led intervention for cardiovascular risk management in primary care (protocol) Is a targeted and planned GP intervention effective in cardiovascular disease prevention? A randomized controlled trial Improvements in 1-Year Cardiovascular Clinical Outcomes Associated with a Hospital-Based Discharge Medication Program
Background Cardiovascular disease ( CVD ) is a major cause of death in China . Despite government efforts , the majority of hypertensive and diabetic patients in China do not receive proper treatment . Reducing CVD events requires long-term care that is proactive , patient-centred , community-based , and sustainable . We have design ed a package of interventions for patients at high risk of CVD to be implemented by family doctors based in township hospitals ( providers of primary care ) in rural Zhejiang , China . This trial aims to determine whether the systematic CVD risk reduction package results in reduced CVD events among patients at risk of CVD compared with usual care , and whether the package is cost-effective and suitable for routine implementation and scale-up . Methods / Design This is a prospect i ve , open-label , cluster r and omized controlled trial ( RCT ) with blinded data analysis . The trial will r and omize 67 township hospitals with 31,708 participants in three counties in Zhejiang Province . Participants will be identified from existing health records and will comprise adults aged 50 to 74 years , with a calculated 10-year CVD risk of 20 % or higher , or diabetes . In the intervention arm , participants will receive a package of interventions including : 1 ) healthy lifestyle counseling ( smoking cessation , and salt , oil , and alcohol reduction ) ; 2 ) prescription of a combination of drugs ( antihypertensives , aspirin , and statin ) ; and 3 ) adherence support for drug compliance and healthy lifestyle change . In the control arm , participants will receive usual care for hypertension and diabetes management at individual clinicians ’ discretion . The primary outcome is the incidence of severe CVD events over 24 months of follow-up . All CVD events will be defined according to the World Health Organization ( WHO ) monitoring of trends and determinants in cardiovascular disease ( MONICA ) definitions , diagnosed at the county hospital or higher level , and reported by the Zhejiang surveillance system . Secondary outcomes include : mean systolic and diastolic blood pressure , blood glucose , serum total cholesterol ( TC ) , and adherence to appointments , and drugs and lifestyle changes . Discussion This trial focuses on risk reduction of CVD rather than specific diseases . It is not design ed to compare therapeutic and healthy lifestyle interventions , but rather their combined effects in primary care setting s. Through the trial , we intend to underst and the effectiveness of the comprehensive CVD reduction package in routine practice . We also intend to underst and the barriers and facilitators to implementing the package , and thus to advise on policy and practice change . Trial registration Current Controlled Trials : IS RCT BACKGROUND Cardiovascular disease ( CVD ) is the leading cause of death , and principal reason for the large difference in life expectancy between indigenous Māori and the non-indigenous population in New Zeal and . CVD guidelines recommend that people who are at high risk or who have had previous CVD should be offered aspirin , blood pressure lowering and lipid lowering therapies . However , prescribing and adherence rates are low and CVD events remain high . AIM To assess whether a medication strategy using a fixed dose combination pill ( ' polypill ' ) could improve prescribing and adherence to recommended medications , lower blood pressure and improve lipids compared with current care over 12 months . METHODS IMProving Adherence using Combination Therapy ( IMPACT ) is an open-label r and omised controlled trial comparing a once-daily polypill containing four preventive medications with usual care .  Six hundred participants who have had previous CVD events or are at high risk of CVD will be enrolled , including 300 Māori . Participants are identified , enrolled and prescribed either the polypill or current medications at their usual primary health care practice , with medications ( including the polypill ) dispensed through local community pharmacies . The polypill contains 75 mg aspirin , 40 mg simvastatin , 10 mg lisinopril and either 12.5 mg hydrochlorothiazide or 50 mg atenolol . Primary outcomes are adherence to guidelines -recommended medications and changes in systolic blood pressure and low density lipoprotein at 12 months . Secondary outcomes include other lipids , medication dispensing , barriers to adherence , CVD and other serious adverse events , quality of life and prescriber acceptability . The trial is registered with the Australian New Zeal and Clinical Trial Registry ( ACTRN12606000067572 ) ABSTRACT BACKGROUND Many individuals at higher risk for cardiovascular disease ( CVD ) do not receive recommended treatments . Prior interventions using personalized risk information to promote prevention did not test clinic-wide effectiveness . OBJECTIVE AND DESIGN To perform a 9-month cluster-r and omized trial , comparing a strategy of electronic health record-based identification of patients with increased CVD risk and individualized mailed outreach to usual care . PARTICIPANTS Patients of participating physicians with a Framingham Risk Score of at least 5 % , low-density lipoprotein (LDL)-cholesterol level above guideline threshold for drug treatment , and not prescribed a lipid-lowering medication were included in the intention-to-treat analysis .INTERVENTION Patients of physicians r and omized to the intervention group were mailed individualized CVD risk messages that described benefits of using a statin ( and controlling hypertension or quitting smoking when relevant).MAIN MEASURES The primary outcome was occurrence of a LDL-cholesterol level , repeated in routine practice , that was at least 30 mg/dl lower than prior . A secondary outcome was lipid-lowering drug prescribing . Clinical trials.gov identifier : NCT01286311.KEY RESULTS Fourteen physicians with 218 patients were r and omized to intervention , and 15 physicians with 217 patients to control . The mean patient age was 60.7 years and 77 % were male . There was no difference in the primary outcome ( 11.0 % vs. 11.1 % , OR 0.99 , 95 % CI 0.56–1.74 , P = 0.96 ) , but intervention group patients were twice as likely to receive a prescription for lipid-lowering medication ( 11.9 % , vs. 6.0 % , OR 2.13 , 95 % CI 1.05–4.32 , p = 0.038 ) . In post hoc analysis with extended follow-up to 18 months , the primary outcome occurred more often in the intervention group ( 22.5 % vs. 16.1 % , OR 1.59 , 95 % CI 1.05–2.41 , P = 0.029 ) . CONCLUSIONS In this effectiveness trial , individualized mailed CVD risk messages increased the frequency of new lipid-lowering drug prescriptions , but we observed no difference in proportions lowering LDL-cholesterol after 9 months . With longer follow-up , the intervention ’s effect on LDL-cholesterol levels was apparent BACKGROUND Sub-optimal management of cardiovascular disease ( CVD ) patients is widespread in primary and secondary care , with risk factors frequently unrecorded or untreated . AIM To investigate the effectiveness of educational interventions developed in primary care , on recording , prescribing and control of risk factors among all patients recorded by their general practitioner as having CVD . DESIGN OF STUDY Factorial , duster-r and omised controlled trial . SETTING Primary care teams representing the range of practice development in a geographically defined area in inner London . METHOD Participating practice s were r and omly allocated to one of the four intervention groups : information , evidence , both or neither . Interventions were tailored to suit individual practice needs . At a mean of 19 months after baseline , and three months after the end of intervention , practice s carried out the follow-up assessment of recording , treatment , and control of risk factors in the same CVD patients . RESULTS Adequate recording of all three risk factors , found inapproximately a third of patients at baseline , increased non-significantly by 10.5 % ( 95 % confidence interval [ CI ] = 3.9 to 24.9 ) in the information ( versus not information ) group and by 6.6 % ( 95 % [ CI ] = 8.9 to 22.0 ) in the evidence ( versus not evidence ) group . Factorial improvements in prescribing and control of risk factors tended not to be significant . Adequate recording of an three risk factors showed the greatest improvement in the information plus evidence group ( 19.9 % increase , P for heterogeneity across the four groups < or = 0.001 ) . Mean change from baseline to follow-up within the four intervention groups suggested improvements in the combined information plus evidence group in cholesterol recording ( 22.5 % increase ) , prescribing of lipid lowering drugs ( 4.4 % increase ) and mean cholesterol ( 0.7 mmol/l decrease ) . CONCLUSIONS Adequate risk factor recording did not differ between the information ( versus not information ) or the evidence ( versus not evidence ) intervention groups . Combined training in information systems and evidence -based medicine should be considered in the design of future interventions , to improve secondary prevention of CVD AIMS To estimate the potential effectiveness of different " high-risk " and " population " approaches to the primary prevention of  cardiovascular disease ( CVD ) in middle-aged British men , after correction for regression dilution bias . METHODS AND RESULTS We used a combination of cohort and r and omised controlled trial evidence to estimate the effectiveness of high-risk strategies , based on the identification of high-risk factors or high absolute risk , and strategies based on population -wide reductions in cholesterol and blood pressure . High-risk strategies were potentially effective but would need to be used widely to have a substantial effect on CVD in the population . Aggressive pharmacological treatment ( using statins , beta-blockers , ACE-inhibitors and aspirin ) in individuals with a 10-year Framingham event risk of > or=30 % ( 6 % of population ) would have reduced major CVD by at most 11 % . This figure increased to 34 % at a > or=20 % treatment threshold ( 26 % of population ) . In contrast , modest downwards shifts in the population distributions of serum total cholesterol and systolic blood pressure led to marked expected reductions in major CVD . Taking regression dilution bias into account , 10 % reductions in long-term mean blood cholesterol and blood pressure could have reduced major CVD by 45 % . CONCLUSIONS If high-risk strategies are to have a major impact on CVD in the population , they need to be more widely used than previously envisaged . Population -wide reduction of major risk factors is needed if CVD is to be substantially reduced Background Intensive lifestyle interventions in well-controlled setting s are effective in lowering the risk of chronic diseases such as type 2 diabetes ( T2DM ) and cardiovascular diseases ( CVD ) , but there are still no effective lifestyle interventions for everyday practice . In the Hoorn Prevention Study we aim ed to assess the effectiveness of a primary care based lifestyle intervention to reduce the estimated risk of developing T2DM and for CVD mortality , and to motivate changes in lifestyle behaviors . Methods The Hoorn Prevention Study is a parallel group r and omized controlled trial , implemented in the region of West-Friesl and , the Netherl and s. 622 adults with ≥10 % estimated risk of T2DM and /or CVD mortality were r and omly assigned and monitored over a period of 12 months . The intervention group ( n=314 ) received a theory-based lifestyle intervention based on an innovative combination of motivational interviewing and problem solving treatment , provided by trained practice nurses in 12 general practice s. The control group ( n=308 ) received existing health brochures . Primary outcomes was the estimated diabetes risk according to the formula of the Atherosclerosis Risk In Communities ( ARIC ) Study , and the estimated risk for CVD mortality according to the Systematic COronary Risk Evaluation ( SCORE ) formula . Secondary outcomes included lifestyle behavior ( diet , physical activity and smoking ) . The research assistants , the principal investigator and the general practitioners were blinded to group assignment . Linear and logistic regression analysis was applied to examine the between-group differences in each outcome measure , adjusted for baseline values . Results 536 ( 86.2 % ) of the 622 participants ( age 43.5 years ) completed the 6-month follow-up , and 502 ( 81.2 % ) completed the 12-month follow-up . The mean baseline T2DM risk was 18.9 % ( SD 8.2 ) and the mean CVD mortality risk was 3.8 % ( SD 3.0 ) . The intervention group participated in a median of 2 sessions . Intention-to-treat analyses showed no significant differences in outcomes between the two groups at 6 or 12-months follow-up . Conclusions The lifestyle intervention was not more effective than health brochures in reducing risk scores for T2DM and CVD or improving lifestyle behavior in an at-risk population .Trial registration Current Controlled Trials : IS RCT Background Cardiovascular diseases ( CVD ) are responsible for significant morbidity , premature mortality , and economic burden . Despite established evidence that supports the use of preventive medications among patients at high CVD risk , treatment gaps remain . Building on prior evidence and a theoretical framework , a complex intervention has been design ed to address these gaps among high-risk , under-treated patients in the Australian primary care setting . This intervention comprises a general practice quality improvement tool incorporating clinical decision support and audit/feedback capabilities ; availability of a range of CVD polypills ( fixed-dose combinations of two blood pressure lowering agents , a statin ± aspirin ) for prescription when appropriate ; and access to a pharmacy-based program to support long-term medication adherence and lifestyle modification . Methods Following a systematic development process , the intervention will be evaluated in a pragmatic cluster r and omized controlled trial including 70 general practice s for a median period of 18 months . The 35 general practice s in the intervention group  will work with a nominated partner pharmacy , whereas those in the control group will provide usual care without access to the intervention tools . The primary outcome is the proportion of patients at high CVD risk who were inadequately treated at baseline who achieve target blood pressure ( BP ) and low-density lipoprotein cholesterol ( LDL-C ) levels at the study end . The outcomes will be analyzed using data from electronic medical records , utilizing a vali date d extraction tool . Detailed process and economic evaluations will also be performed . Discussion The study intends to establish evidence about an intervention that combines technological innovation with team collaboration between patients , pharmacists , and general practitioners ( GPs ) for CVD prevention . Trial registration Australian New Zeal and Clinical Trials Registry Objectives : The aim of the study was twofold ; 1 ) to develop a clinical pharmacist-led 12 month lasting follow-up program for patients with established coronary heart disease ( CHD ) discharged from the University Hospital of North Norway , and 2 ) to explore the impact of the program with regards to adherence to a medication assessment tool for secondary prevention of CHD and change in biomedical risk factors . Methods : A total of 102 patients aged 18 - 82 years were enrolled in a non-blinded r and omized controlled trial with an intervention group and a control group . The intervention comprised medication reconciliation , medication review and patient education during three meetings ; at discharge , after three months and after twelve months . The control group received st and ard care from their general practitioner . Primary outcomes were adherence to clinical guideline recommendations concerning prescription , therapy goal achievement and lifestyle education  defined in the medication assessment tool for secondary prevention of CHD ( MAT-CHDSP ) . Secondary outcomes included changes in the biomedical risk factors cholesterol , blood pressure and blood glucose . Results : Ninety-four patients completed the trial , 48 intervention group patients and 46 controls . Appropriate prescribing was high , but therapy goal achievement was low in both groups . Overall adherence to MAT-CHDSP criteria increased in both groups and was significantly higher in the intervention group at study end , 78.4 % vs. 62.0 % , p<0.001 . The difference was statistically significant for the documented lifestyle advices in intervention group patients . No significant improvements in biomedical risk factors were observed in favor of the intervention group . Conclusions : The study showed an increased guideline adherence in both study groups . This indicates that attention to clinical practice guideline recommendations in itself increases adherence – which may be a clinical pharmacist task . A larger adequately powered study is needed to show a significant difference in biomedical risk factor improvements in favor of the intervention . Amendments to the follow-up program are suggested before implementation in st and ard patient care can be recommended IMPORTANCE Adherence to cardioprotective medication regimens in the year after hospitalization for acute coronary syndrome ( ACS ) is poor . OBJECTIVE To test a multifaceted intervention to improve adherence to cardiac medications . DESIGN , SETTING , AND PARTICIPANTS In this r and omized clinical trial , 253 patients from 4 Department of Veterans Affairs medical centers located in Denver ( Colorado ) , Seattle ( Washington ) ; Durham ( North Carolina ) , and Little Rock ( Arkansas ) admitted with ACS were r and omized to the multifaceted intervention ( INT ) or usual care ( UC ) prior to discharge . INTERVENTIONS The INT lasted for 1 year following discharge and comprised ( 1 ) pharmacist-led medication reconciliation and tailoring ; ( 2 ) patient education ; ( 3 ) collaborative care between pharmacist and a patient 's primary care clinician and /or cardiologist ; and ( 4 ) 2 types of voice messaging ( educational and medication refill reminder calls ) . MAIN OUTCOMES AND MEASURES The primary outcome of interest was proportion of patients adherent to medication regimens based on a mean proportion of days covered ( PDC ) greater than 0.80 in the year after hospital discharge using pharmacy refill data for 4 cardioprotective medications ( clopidogrel , β-blockers , 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors [ statins ] , and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers [ ACEI/ARB ] ) . Secondary outcomes included achievement of blood pressure ( BP ) and low-density lipoprotein cholesterol ( LDL-C ) level targets . RESULTS Of 253 patients , 241 ( 95.3 % ) completed the study ( 122 in INT and 119 in UC ) . In the INT group , 89.3 % of patients were adherent compared with 73.9 % in the UC group ( P = .003 ) . Mean PDC was higher in the INT group ( 0.94 vs 0.87 ; P < .001 ) . A greater proportion of intervention patients were adherent to clopidogrel ( 86.8 % vs 70.7 % ; P = .03 ) , statins ( 93.2 % vs 71.3 % ; P < .001 ) , and ACEI/ARB ( 93.1 % vs 81.7 % ; P = .03 ) but not β-blockers ( 88.1 % vs 84.8 % ; P = .59 ) . There were no statistically significant differences in the proportion of patients who achieved BP and LDL-C level goals . CONCLUSIONS AND RELEVANCE A multifaceted intervention comprising pharmacist-led medication reconciliation and tailoring , patient education , collaborative care between pharmacist and patients ' primary care clinician and /or cardiologist , and voice messaging increased adherence to medication regimens in the year after ACS hospital discharge without improving BP and LDL-C levels . Underst and ing the impact of such improvement in adherence on clinical outcomes is needed prior to broader dissemination of the program . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00903032 Background . Adherence with antihypertensive and lipid-lowering therapy is poor , result ing in an almost 2-fold increase in hospitalization . Treatment side effects , cost , and complexity are common reasons for nonadherence , and physicians are often unaware of these potentially modifiable problems . Objective . To determine if a cardiovascular medication tracking and nonadherence alert system , incorporated into a computerized health record system , would increase drug profile review by primary care physicians , increase the likelihood of therapy change , and improve adherence with antihypertensive and lipid-lowering drugs . Methods . There were 2293 primary care patients prescribed lipid-lowering or antihypertensive drugs who were r and omized to the adherence tracking and alert system or active medication list alone  to determine if the intervention increased drug profile review , changes in cardiovascular drug treatment , and refill adherence in the first 6 months . An intention to treat analysis was conducted using generalized estimating equations to account for clustering within physician . Results . Overall , medication adherence was below 80 % for 36.3 % of patients using lipid-lowering drugs and 40.8 % of patients using antihypertensives at the start of the trial . There was a significant increase in drug profile review in the intervention compared to the control group ( 44.5 % v. 35.5 % ; P < 0.001 ) , a nonsignificant increase in drug discontinuations due to side effects ( 2.3 % v. 2.0 % ; P = 0.61 ) , and a reduction in therapy increases ( 28.5 % v. 29.1 % ; P = 0.86 ) . There was no significant change in refill adherence after 6 months of follow-up . Conclusion . An adherence tracking and alert system increases drug review but not therapy changes or adherence in prevalent users of cardiovascular drug treatment . Targeting incident users where adverse treatment effects are more common and combining adherence tracking and alert tools with motivational interventions provided by multidisciplinary primary care teams may improve the effectiveness of the intervention BACKGROUND The number of patients aged 75 + years with cardiovascular diseases ( CVD ) is increasing , but few studies of secondary prevention in this age group exist . The aim of the Drug and Evidence Based Medicine in the Elderly ( DEBATE ) study is to test the applicability and effectiveness of established CVD treatments in elderly patients . METHODS From 1998 to 2000 , population -based postal surveys were performed in Helsinki , Finl and , including the age groups 75 , 80 , 85 , 90 , and 95 years ( n = 4821 ) . Of the 812 individuals reporting any atherosclerotic disease , 400 patients ( 66 % of those eligible ) were included in a r and omized trial . In the intervention group , CVD treatments will be individualized according to current guidelines . A control group will receive the usual care . The trial period will last 2 years with a 3-year extension . The primary end point will be a composite of major CVD . In addition , a number of secondary end points will be recorded , including permanent institutionalization , decline in cognitive and physical function , and quality of life . RESULTS During 2000 , 400 home-dwelling patients were r and omized to the intervention ( n = 199 ) and control ( n = 201 ) groups . The mean age is 80.2 years and 65.3 % are women . Of the participants , 82 % have coronary heart disease ( 41 % with history of myocardial infa rct ion ) , 37 % history of stroke , 19 % non-insulin-dependent diabetes mellitus , and 45 % hypertension , and 6 % are current smokers . Before r and omization , 67 % used aspirin , 40 % b-blockers , 14 % angiotensin-converting enzyme inhibitors , 36 % nitrates , and 20 % lipid-lowering drugs . The groups were well balanced at baseline . CONCLUSION We have successfully r and omized elderly patients with a high degree of comorbidity into a multifactorial CVD prevention trial BACKGROUND There is a need to evaluate and implement cost-effective strategies to improve adherence to treatments in coronary heart disease . There are no studies from low- to middle income countries ( LMICs ) evaluating trained community health worker (CHW)-based interventions for the secondary prevention of coronary heart disease . METHODS We design ed a hospital-based , open r and omized trial of CHW-based interventions versus st and ard care .  Patients after an acute coronary syndrome ( ACS ) were r and omized to an intervention group ( a CHW-based intervention package , comprising education tools to enhance self-care and adherence , and regular follow-up by the CHW ) or to st and ard care for 12 months during which study outcomes were recorded . The CHWs were trained over a period of 6 months . The primary outcome measure was medication adherence . The secondary outcomes were differences in adherence to lifestyle modification , physiological parameters ( blood pressure [ BP ] , body weight , body mass index [ BMI ] , heart rate , lipids ) , and major adverse cardiovascular events . RESULTS We recruited 806 patients stabilized after an ACS from 14 hospitals in 13 Indian cities . The mean age was 56.4 ( ± 11.32 ) years , and 17.2 % were females . A high prevalence of risk factors such as hypertension ( 43.4 % ) , diabetes ( 31.9 % ) , tobacco consumption ( 35.4 % ) , and inadequate physical activity ( 70.5 % ) was documented . A little over half had ST-elevation myocardial infa rct ion ( 53.7 % ) , and 46.3 % had non-ST-elevation myocardial infa rct ion or unstable angina . CONCLUSION The CHW interventions and training for SPREAD have been developed and adapted for local use . The results and experience of this study will be important to counter the burden of cardiovascular diseases in low- to middle income countries Background Blood Pressure related disease affected 118 million people in India in the year 2000 ; this figure will double by 2025 . Around one in four adults in rural India have hypertension , and of those , only a minority are accessing appropriate care . Health systems in India face substantial challenges to meet these gaps in care , and innovative solutions are needed . Methods We hypothesise that a multifaceted intervention involving capacity strengthening of primary healthcare doctors and non-physician healthcare workers through use of a mobile device-based clinical decision support system will result in improved blood pressure control for individuals at high risk of a cardiovascular disease event when compared with usual healthcare . This intervention will be implemented as a stepped wedge , cluster r and omised controlled trial in 18 primary health centres and 54 villages in rural And hra Pradesh involving adults aged ≥40 years at high cardiovascular disease event risk ( approximately 15,000 people ) . Cardiovascular disease event risk will be calculated based on World Health Organisation/International Society of Hypertension ’s region-specific risk charts . Cluster r and omisation will occur at the level of the primary health centres . Outcome analyses will be conducted blinded to intervention allocation . Expected outcomes The primary study outcome is the difference in the proportion of people meeting guideline -recommended blood pressure targets in the intervention period vs. the control period . Secondary outcomes include mean reduction in blood pressure levels ; change in other cardiovascular disease risk factors , including body mass index , current smoking , reported healthy eating habits , and reported physical activity levels ; self-reported use of blood pressure and other cardiovascular medicines ; quality of life ( using the EQ-5D ) ; and cardiovascular disease events ( using hospitalisation data ) . Trial outcomes will be accompanied by detailed process and economic evaluations . Significance The findings are likely to inform policy on a scalable strategy to overcome entrenched inequities in access to effective healthcare for under-served population s in low and middle income country setting s . Trial registration Clinical Trial Registry India CTRI/2013/06/003753 Abstract Objectives : To evaluate the effects of nurse led clinics in primary care on secondary prevention , total mortality , and coronary event rates after four years . Design : Follow up of a r and omised controlled trial by postal question naires and review of case notes and national data sets . Setting : Stratified , r and om sample of 19 general practice s in north east Scotl and . Participants : 1343 patients ( 673 intervention and 670 control ) under 80 years with a working diagnosis of coronary heart disease but without terminal illness or dementia and not housebound . Intervention : Nurse led secondary prevention clinics promoted medical and lifestyle components of secondary prevention and offered regular follow up for one year . Main outcome measures : Components of secondary prevention ( aspirin , blood pressure management , lipid management , healthy diet , exercise , non-smoking ) , total mortality , and coronary events ( non-fatal myocardial infa rct ions and coronary deaths ) . Results : Mean follow up was at 4.7 years . Significant improvements were shown in the intervention group in all components of secondary prevention except smoking at one year , and these were sustained after four years except for exercise . The control group , most of whom attended clinics after the initial year , caught up before final follow up , and differences between groups were no longer significant . At 4.7 years , 100 patients in the intervention group and 128 in the control group had died : cumulative death rates were 14.5 % and 18.9 % , respectively ( P=0.038 ) . 100 coronary events occurred in the intervention group and 125 in the control group : cumulative event rates were 14.2 % and 18.2 % , respectively ( P=0.052 ) . Adjusting for age , sex , general practice , and baseline secondary prevention , proportional hazard ratios were 0.75 for all deaths ( 95 % confidence intervals 0.58 to 0.98 ; P=0.036 ) and 0.76 for coronary events ( 0.58 to 1.00 ; P=0.049 ) Conclusions : Nurse led secondary prevention improved medical and lifestyle components of secondary prevention and this seemed to lead to significantly fewer total deaths and probably fewer coronary events .  Secondary prevention clinics should be started sooner rather than later . What is already known on this topic Several effective interventions exist for the secondary prevention of coronary heart disease , but implementing them in practice has proved difficult Secondary prevention programmes for coronary heart disease have improved short term outcomes such as processes of care and quality of life What this study adds Short term improvements in uptake of secondary prevention produced by nurse led clinics are maintained in the longer term Improved medical and lifestyle components of secondary prevention produced by nurse led clinics seem to lead to fewer total deaths and coronary Background Many patients at high risk of cardiovascular diseases are managed and monitored in general practice . Recommendations for cardiovascular risk management , including lifestyle change , are clearly described in the Dutch national guideline . Although lifestyle interventions , such as advice on diet , physical exercise , smoking and alcohol , have moderate , but potentially relevant effects in these patients , adherence to lifestyle advice in general practice is not optimal . The IMPALA study intends to improve adherence to lifestyle advice by involving patients in decision making on cardiovascular prevention by nurse-led clinics . The aim of this paper is to describe the design and methods of a study to evaluate an intervention aim ed at involving patients in cardiovascular risk management . Methods A cluster-r and omised controlled trial in 20 general practice s , 10 practice s in the intervention arm and 10 in the control arm , starting on October 2005 . A total of 720 patients without existing cardiovascular diseases but eligible for cardiovascular risk assessment will be recruited . In both arms , the general practitioners and nurses will be trained to apply the national guideline for cardiovascular risk management . Nurses in the intervention arm will receive an extended training in risk assessment , risk communication , the use of a decision aid and adapted motivational interviewing . This communication technique will be used to support the shared decision-making process about risk reduction . The intervention comprises 2 consultations and 1 follow-up telephone call . The nurses in the control arm will give usual care after the risk estimation , according to the national guideline . Primary outcome measures are self-reported adherence to lifestyle advice and drug treatment . Secondary outcome measures are the patients ' perception of risk and their motivation to change their behaviour . The measurements will take place at baseline and after 12 and 52 weeks . Clinical endpoints will not be measured , but the absolute 10-year risk of cardiovascular events will be estimated for each patient from medical records at baseline and after 1 year . Discussion The combined use of risk communication , a decision aid and motivational interviewing to enhance patient involvement in decision making is an innovative aspect of the intervention . Trial registration Current Controlled Trials IS RCT Background The optimal intensity and duration of the intervention to achieve sustained risk reduction in patients at high and very high cardiovascular ( CV ) risk still need to be established . The aim of this study was to evaluate the impact of general practitioner ’s ( GP ’s ) systematic and planned intervention on total CV risk reduction and a change in individual CV risk factors . Material / Methods This was a cluster-r and omized trial ( IS RCT N31857696 ) including 64 practice s and 3245 patients aged ≥40 . The participating GPs and their examinees were r and omized into an intervention or to a control group ( st and ard care ) . Intervention group practitioners followed up their examinees during 1 , 3 , 6 , 12 , and 18 months . The main outcome measures were change in proportion of patients with low , moderate , high , and very high CV risk , and change in individual CV risk factors from the first to the second registration . Results The proportion of patients with very high CV risk was lower in the intervention group , the same as of patients with high blood pressure , total and LDL cholesterol , and increased intake of alcohol . The mean systolic ( −1.49 mmHg ) and diastolic ( −1.57 mmHg ) blood pressure , triglycerides ( −0.18 mmol/L ) , body mass index ( −0.22 ) , and waist ( −0.4 cm ) and hip circumference ( −1.08 cm ) was reduced significantly in the intervention group . There was no additional impact in the intervention group of other tested CV risk factors . Conclusions Systematic and planned GP ’s intervention in CVD prevention reduces the number of patients with very high total CV risk and influences a change in lifestyle habits Context Despite evidence to support the effectiveness of a variety of interventions for the secondary prevention of cardiovascular disease , many eligible patients do not receive these interventions . Contribution Compared with a baseline period , patients hospitalized with cardiovascular disease who received an  intervention that focused on discharge medications had higher rates of prescription of aspirin , -blockers , statins , angiotensin-converting enzyme inhibitors , and warfarin at hospital discharge . The risk for death and readmission was lower in the intervention period than in the baseline period . Caution s The prepost design of this study does not permit conclusions about a causal relationship between the intervention and the observed improvements . The Editors Cardiovascular disease remains the most common source of morbidity and mortality in western countries ( 1 ) . During the past 2 decades , a variety of significant medical advances have been made in the treatment and prevention of complications associated with major cardiovascular disorders , including coronary artery disease , congestive heart failure ( CHF ) , and atrial fibrillation . Many of these advances in secondary prevention relate simply to the appropriate use of certain medications , for example , aspirin and statins for coronary artery disease , -blockers and angiotensin-converting enzyme inhibitors for CHF , and warfarin for prevention of stroke and other embolic events in patients with atrial fibrillation . Each of these medical therapies has been proven in large , multicenter , r and omized , double-blind , placebo-controlled trials to save lives under appropriate circumstances ( 2 - 7 ) . However , despite the overwhelming evidence supporting the benefit of these medications , many studies have documented a significant treatment gap . Often , far fewer than 50 % of potential beneficiaries actually receive treatment ( 8 - 13 ) , and studies from our institution and others have shown that many patients do not receive indicated medications at hospital discharge ( 14 , 15 ) . On the other h and , the chances of long-term adherence are significantly higher when medications are provided at hospital discharge , and this difference is associated with decreased mortality rates ( 13 , 16 ) . Hospital discharge is a critical juncture in the process of care . Patients are available for consultation and are often more disposed to adopt health care recommendations . A hospital dischargebased intervention could be more easily implemented , more effectively managed and measured , and more cost-effective than other potential outpatient intervention strategies . Consequently , there is substantial justification for focusing on hospital discharge as the ideal time to improve prescription of medications for secondary prevention of cardiovascular disease . In the current study , our objectives were to 1 ) determine the feasibility of implementing a comprehensive quality improvement initiative in a large multihospital network to significantly increase rates of prescription at discharge of evidence -based , secondary prevention medications for life-threatening cardiovascular diseases ; 2 ) ascertain the effect of such a program on long-term clinical outcomes ; and 3 ) determine whether good adherence to such an initiative is sustainable . Methods Intermountain Health Care ( IHC ) is a nonprofit , integrated health care system including 20 hospitals , a system of health plans , and both employed and affiliated physicians . The approximately 400 employed physicians mainly practice primary care , and the approximately 2500 affiliated physicians are mostly specialists . Intermountain Health Care serves approximately 60 % of the population of Utah and southern Idaho . The system 's 10 largest hospitals were included in the quality improvement initiative , accounting for more than 90 % of the total population of cardiovascular patients . The major intent of this initiative was to ensure that appropriate secondary prevention medications were prescribed at discharge to all patients ( excluding those with documented contraindications ) who were hospitalized with a principal cardiovascular diagnosis of acute myocardial infa rct ion ( MI ) , coronary heart disease ( CHD ) , CHF , or atrial fibrillation . Table 1 shows the guidelines that were developed for each of the diagnostic categories , and Appendix Figure 1 shows the reference card that was developed to aid physicians and clinical staff . All of the guidelines were based on the current class IA American Heart Association/American College of Cardiology recommendations , except for the recommendation of a statin in all patients with CHD , including those with a low-density lipoprotein cholesterol level less than 2.59 mmol/L ( < 100 mg/dL ) . Our research ( 17 ) showed that a statin provided significant benefit in this population , a notion that has since been supported by a large clinical trial ( 18 ) . -Blocker therapy for patients with CHF was deferred until after discharge . Table 1 . Discharge Medication Guidelines for the Secondary Prevention of Cardiovascular Disorders Design and Implementation of the Quality Improvement Program In 1998 , before the new discharge medication program ( DMP ) was initiated , a new institution-wide data base was developed to assist in its implementation and long-term management . Simultaneously , all participating institutions began prospect ively tracking prescription of applicable discharge medications for all cardiac patients discharged from their respective cardiovascular departments ( Appendix Figure 2 ) . The DMP was implemented on 1 January 1999 , and tracking of discharge prescriptions continued . Maintenance of the discharge medication data base is ongoing , and information through February 2002 was included in this study . Appendix Figure 2 . Data collection form for the discharge medication program . Implementation of the DMP required support and commitment from every level of the health care system , including administration , physicians , nurses , and other staff . To gain this support , the IHC Cardiovascular Clinical Program leadership conducted an extensive education campaign in all participating hospitals . Before the actual initiation of the DMP , this group conducted an extensive tour to engage physicians , residents , and nurses with the program , its goals , and its rationale . The actual DMP implementation and documentation process varied from hospital to hospital but always included the essential core elements . The appropriate indication for each medication was printed directly on the patient discharge form , so physicians needed only to check the correct box or record the specific contraindication ( Appendix Figure 3 ) . This form served as a project management and data collection tool . When an appropriate medication was not prescribed , the discharge-planning nurse contacted the attending physician or resident directly , after which the missing medication could be added to the discharge prescriptions or an appropriate contraindication for its use could be documented . All information was entered into a computerized data base for tracking . Other than the additional re sources for data management , the DMP used existing hospital personnel . No organized effort was made to guarantee long-term adherence to prescribed medications after discharge . Appendix Figure 2 . Discharge orders form .. Documentation of Short-Term Success of the Program To measure and manage the short-term success of the program , monthly reports were generated showing the proportion of cardiovascular patients discharged with prescriptions for the indicated secondary prevention medications at each of the 10 hospitals . These reports were shared extensively with all participating health care providers from each contributing institution in an effort to further increase adherence . Long-Term Follow-up To monitor the effect of DMP implementation on long-term clinical outcomes , the baseline characteristics ( age , sex , and discharge diagnosis ) of each cardiovascular patient discharged from the 10 participating facilities were compiled from the central ized IHC informatics data base . Each patient was followed prospect ively for up to 1 year for hospital readmission due to a cardiovascular indication or for death . If no evidence of hospital readmission or death could be found for a patient , we assumed that the patient had not experienced either event . Information was included from 1996 , 3 years before DMP  initiation , to February 2002 , more than 3 years afterward . Rehospitalizations ( cardiovascular only ) were determined through the IHC informatics system 's electronic data warehouse , and death was ascertained by using the IHC system and the Social Security Administration 's death records . Such electronic follow-up , in our experience ( 16 ) , has proven more thorough and accurate than telephone surveys . Although a limited proportion of patients may have been readmitted to other hospitals for subsequent care , they were probably r and omly distributed between the pre-DMP and DMP sample s. Characteristics of patients admitted before ( 1996 to 1998 ) and after ( 1999 to 2002 ) DMP implementation were evaluated separately and compared . Statistical Analysis The chi-square test was used to evaluate differences in the proportions of patients receiving appropriate discharge prescriptions  in the  pre-DMP and DMP groups . To evaluate the effect of the DMP , we formed 4 mutually exclusive diagnostic or procedural categories for patients with the following index admissions : CHD without CHF , MI , or coronary artery bypass grafting ( CABG ) ; CHF without MI or CABG ; MI without CABG ; and CABG . The category of atrial fibrillation was not mutually exclusive of the other 4 categories . These categories reflected different patient sample s and were not design ed to evaluate groups on the basis of indications for each separate medication , since more than 1 medication could have been indicated in any given patient . Differences between baseline characteristics of the pre-DMP and DMP groups were
While the results of this systematic review are promising , there is insufficient evidence to draw conclusions on the effectiveness of text message-based interventions for adherence to medications for secondary prevention of CVD .
BACKGROUND Worldwide at least 100 million people are thought to have prevalent cardiovascular disease ( CVD ) .
This population has a five times greater chance of suffering a recurrent cardiovascular event than people without known CVD .
Secondary CVD prevention is defined as action aim ed to reduce the probability of recurrence of such events .
Drug interventions have been shown to be cost-effective in reducing this risk and are recommended in international guidelines .
However , adherence to recommended treatments remains sub-optimal .
In order to influence non-adherence , there is a need to develop scalable and cost-effective behaviour-change interventions .
OBJECTIVES To assess the effects of mobile phone text messaging in patients with established arterial occlusive events on adherence to treatment , fatal and non-fatal cardiovascular events , and adverse effects .