IMProving Adherence using Combination Therapy (IMPACT): design and protocol of a randomised controlled trial in primary care. Secondary prevention of cardiovascular disease: a randomised trial of training in information management, evidence-based medicine, both or neither: the PIER trial. A Cluster-Randomized Trial of a Centralized Clinical Pharmacy Cardiovascular Risk Service to Improve Guideline Adherence. Preventing Recurrence of Thromboembolic Events through Coordinated Treatment in the District of Columbia Electronic Health Record-Based Patient Identification and Individualized Mailed Outreach for Primary Cardiovascular Disease Prevention: A Cluster Randomized Trial A pharmacist-led follow-up program for patients with established coronary heart disease in North Norway – a randomized controlled trial Increasing the Detection and Response to Adherence Problems with Cardiovascular Medication in Primary Care through Computerized Drug Management Systems: A Randomized Controlled Trial Cardiovascular disease risk reduction in rural China: a clustered randomized controlled trial in Zhejiang Secondary prevention in coronary heart disease: a randomised trial of nurse led clinics in primary care Rationale and Design of the Pharmacist Intervention for Low Literacy in Cardiovascular Disease (PILL-CVD) Study 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 Markov model of the cost-effectiveness of pharmacist care for diabetes in prevention of cardiovascular diseases: evidence from Kaiser Permanente Northern California. Secondary Prevention After Coronary Artery Bypass Graft Surgery: Findings of a National Randomized Controlled Trial and Sustained Society-Led Incorporation Into Practice Mixed methods evaluation of targeted case finding for cardiovascular disease prevention using a stepped wedged cluster RCT [Evaluation of the efficacy of a comprehensive programme of secondary prevention of cardiovascular disease in primary care: the PREseAP Study]. Cost-effectiveness modelling of telehealth for patients with raised cardiovascular disease risk: evidence from a cohort simulation conducted alongside the Healthlines randomised controlled trial Multifaceted intervention to improve medication adherence and secondary prevention measures after acute coronary syndrome hospital discharge: a randomized clinical trial.
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 ) 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 BACKGROUND Numerous studies have demonstrated the value of including pharmacists in team-based care to improve adherence to cardiovascular ( CV ) guidelines , medication adherence , and risk factor control . However , there is limited information on whether these models can be successfully implemented more widely in diverse setting s and population s. The purpose of this study is to evaluate whether a central ized , web-based cardiovascular risk service ( CVRS ) managed by clinical pharmacists will improve guideline adherence in multiple primary care medical offices with diverse geographic and patient characteristics . METHODS This study is a prospect i ve trial in 20 primary care offices stratified by the percent of under-represented minorities and then r and omized to either the CVRS intervention or usual care .  The intervention will last for 12 months and all subjects will have research visits at baseline and 12 months . The primary outcome is the difference in guideline adherence between groups . Data will also be abstract ed from the medical record at 24 months to determine if the intervention effect is sustained after it is discontinued . CONCLUSIONS Patient enrollment will continue through 2016 , with results expected in 2019 . This study will provide information on whether a distant , central ized CVRS can be implemented in large numbers of medical offices , if it is effective in diverse population s , and if there is a long-term sustained effect Rationale PROTECT DC examines whether stroke navigators can improve cardiovascular risk factors in urban underserved individuals newly hospitalized for stroke or ischemic attack . Within one-year of hospital discharge , up to one-third of patients no longer adhere to secondary prevention behaviors . Adherence rates are lower in minority-underserved groups , contributing to health disparities . In-hospital programs increase use of stroke prevention therapies but may not be as successful in underserved individuals . In these groups , low literacy , limited healthcare access , and sparse community re sources may reduce adherence . Lay community health workers ( navigators ) improve adherence in other illnesses through education and assisting in overcoming barriers to achieving desired health behaviors and obtaining needed healthcare services . Aims and design PROTECT DC is a Phase II , single-blind , r and omized , controlled trial comparing in-hospital education plus stroke navigators to usual care .  Atherogenic ischemic stroke and transient ischemic attack survivors are recruited from Washington , DC hospitals .  Navigators meet with participants during the index hospitalization , perform home visits , and meet by phone . They focus on stroke education , medication compliance , and overcoming practical barriers to adherence . The interventions are driven by the theories of reasoned action and planned behavior . Study outcomes The primary dependent measure is a summary score of four objective measures of stroke risk factor control : systolic blood pressure , low-density lipoprotein , hemoglobin Hb A1C , and antiplatelet agent pill counts . Secondary outcomes include stroke knowledge , exercise , dietary modification , and smoking cessation . Conclusion PROTECT DC will determine whether a Phase III trial of stroke navigation for urban underserved individuals to improve adherence to secondary stroke prevention behaviors is warranted 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 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 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 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 Objective To evaluate whether  nurse run clinics in general practice improve secondary prevention in patients with coronary heart disease . Design R and omised controlled trial . Setting A r and om sample of 19 general practice s in northeast Scotl and . Patients 1173 patients ( 685 men and 488 women ) under 80 years with working diagnoses of coronary heart disease , but without terminal illness or dementia and not housebound .  Intervention Nurse run clinics promoted medical and lifestyle aspects of secondary prevention and offered regular follow up . Main outcome measures Components of secondary prevention assessed at baseline and one year were : aspirin use ; blood pressure management ; lipid management ; physical activity ; dietary fat ; and smoking status . A cumulative score was generated by counting the number of appropriate components of secondary prevention for each patient . Results There were significant improvements in aspirin management ( odds ratio 3.22 , 95 % confidence interval 2.15 to 4.80 ) , blood pressure management ( 5.32 , 3.01 to 9.41 ) , lipid management ( 3.19 , 2.39 to 4.26 ) , physical activity ( 1.67 , 1.23 to 2.26 ) and diet ( 1.47 , 1.10 to 1.96 ) . There was no effect on smoking cessation ( 0.78 , 0.47 to 1.28 ) . Of six possible components of secondary prevention , the baseline mean was 3.27 . The adjusted mean improvement attributable to intervention was 0.55 of a component ( 0.44 to 0.67 ) . Improvement was found regardless of practice baseline performance . Conclusions  Nurse run clinics proved practical to implement in general practice and effectively increased secondary prevention in coronary heart disease . Most patients gained at least one effective component of secondary prevention and , for them , future cardiovascular events and mortality could be reduced by up to a third Background —Medication errors and adverse drug events are common after hospital discharge due to changes in medication regimens , suboptimal discharge instructions , and prolonged time to follow-up . Pharmacist-based interventions may be effective in promoting the safe and effective use of medications , especially among high-risk patients such as those with low health literacy . Methods and Results —The Pharmacist Intervention for Low Literacy in Cardiovascular Disease ( PILL-CVD ) study is a r and omized controlled trial conducted at 2 academic centers — V and erbilt University Hospital and Brigham and Women 's Hospital . Patients admitted with acute coronary syndrome or acute decompensated heart failure were r and omly assigned to usual care or intervention . The intervention consisted of pharmacist-assisted medication reconciliation , inpatient pharmacist counseling , low-literacy adherence aids , and tailored telephone follow-up after discharge . The primary outcome is the occurrence of serious medication errors in the first 30 days after hospital discharge . Secondary outcomes are health care utilization , disease-specific quality of life , and cost-effectiveness .  Enrollment was completed September 2009 . A total of 862 patients were enrolled , and 430 patients were r and omly assigned to receive the intervention . Analyses will determine whether the intervention was effective in reducing serious medication errors , particularly in patients with low health literacy . Conclusions —The PILL-CVD study was design ed to reduce serious medication errors after hospitalization through a pharmacist-based intervention . The intervention , if effective , will inform health care facilities on the use of pharmacist-assisted medication reconciliation , inpatient counseling , low-literacy adherence aids , and patient follow-up after discharge . Clinical Trial Registration — clinical trials.gov . Identifier : NCT00632021 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 BACKGROUND It has been demonstrated in previous studies that pharmacist management of patients with type 2 diabetes mellitus ( T2DM ) in the outpatient setting not only improves diabetes-related clinical outcomes such as hemoglobin A1c but also blood pressure ( BP ) , total cholesterol ( TC ) , and quality of life . Improved control of BP and TC has been shown to reduce the risks of cardiovascular disease ( CVD ) , which has placed a heavy economic burden on the health care system . However , no study has evaluated the cost-effectiveness of pharmacist intervention programs with respect to the long-term preventive effects on CVD outcomes among T2DM patients . OBJECTIVES To ( a ) quantify the long-term preventive effects of pharmacist intervention on CVD outcomes among T2DM patients using evidence from a matched cohort study in the outpatient primary care setting and ( b ) assess the relative cost-effectiveness of adding a clinical pharmacist to the primary care team for the management of patients with T2DM based on improvement in CVD risks with the aid of an economic model . METHODS Clinical data between the periods of June 2007 to February 2010 were collected from electronic medical records at 2 separate clinics at Kaiser Permanente ( KP ) Northern California , 1 with primary care physicians only ( control group ) and the other with the addition of a pharmacist ( enhanced care group ) . Patients in the enhanced care group were matched 1:1 with patients in the control group according to baseline characteristics that included age , gender , A1c , and Charlson comorbidity score . The estimated 10-year CVD risk for both groups was calculated by the United Kingdom Prospect i ve Diabetes Study ( UKPDS ) Risk Engine ( version 2 ) based on age , sex , race , smoking status , atrial fibrillation , duration of diabetes , levels of A1c , systolic BP ( SBP ) and TC , and high-density lipoprotein cholesterol ( HDL-C ) observed at 12 months . There was no statistical difference in the baseline clinical inputs to the Risk Engine ( A1c [ P=0.115 ] , SBP [ P=0.184 ] , TC [ P=0.055 ] , and HDL-C [ P=0.475 ] ) between the 2 groups . A Markov model was developed to simulate the estimated CVD outcomes over 10 years and to estimate cost-effectiveness . The final outcomes examined included incremental cost and effectiveness measured by life years and per quality -adjusted life year gained . Both deterministic sensitivity analysis ( SA ) and probabilistic SA were conducted to examine the robustness of the results . RESULTS The estimated risks for coronary heart disease ( CHD ) and stroke ( both nonfatal and fatal ) at the end of the follow-up were consistently lower in the enhanced care group compared with the control group , even though baseline risks in both groups were similar . The absolute risk reduction ( ARR ) between the enhanced care and control groups increased over time . For example , the ARR for nonfatal CHD risk in year 1 was 0.5 % ( 1.2 % vs. 0.7 % ) , whereas the ARR increased to 5.5 % in year 10 ( 14.8 % vs. 9.3 % ) . Similarly , the ARR between the enhanced care and the control groups was calculated as 0.3 % for fatal CHD in year 1 and increased to 4.6 % in year 10 . Results from the Markov model suggest that the enhanced care group was shown to be a dominant strategy ( less expensive and more effective ) compared with the control group in the 10-year evaluation period in the base-case ( average or mean results ) scenario . Sensitivity analysis that took into account the uncertainty in all important variables , such as wage of pharmacists , utility weight ( the degree of preference individuals have for a particular health state or condition ) , response rate to pharmacists ' care , and uncertainty associated with the estimated 10 years of CVD risk , revealed that the relative value of enhanced care was robust to most of the variations in these parameters . Notably , the level of cost-effectiveness measured by net monetary value depends on the time horizon adopted by the payers and the magnitude of CVD risk reduction . The enhanced care group has a higher chance of being considered as a cost-effective strategy when a longer time horizon such as a minimum of 4 to 5 years is adopted . CONCLUSIONS Adding pharmacists to the health care management team for diabetic patients improves the long-term CVD risks . The longer-term CVD risk reductions were shown to be more dramatic than the short-term reduction . A longer time horizon adopted by health plans in managing T2DM patients has a higher probability of making the intervention cost-effective Background — Despite evidence supporting the use of aspirin , & bgr;-blockers , angiotensin-converting enzyme inhibitors , and lipid-lowering therapies in eligible patients , adoption of these secondary prevention measures after coronary artery bypass grafting has been inconsistent . We sought to rigorously test on a national scale whether low-intensity continuous quality improvement interventions can be used to speed secondary prevention adherence after coronary artery bypass grafting . Methods and Results — A total of 458 hospitals participating in the Society of Thoracic Surgeons National Cardiac Data base and treating 361 328 patients undergoing isolated coronary artery bypass grafting were r and omized to either a control or an intervention group . The intervention group received continuous quality improvement material s design ed to influence the prescription of the secondary prevention medications at discharge . The primary outcome measure was discharge prescription rates of the targeted secondary prevention medications at intervention versus control sites , assessed by measuring preintervention and postintervention site differences . Prer and omization treatment patterns and baseline data were similar in the control ( n=234 ) and treatment ( n=224 ) groups . Individual medication use and composite adherence increased over 24 months in both groups , with a markedly more rapid rate of adherence uptake among the intervention hospitals and a statistically significant therapy hazard ratio in the intervention versus control group for all 4 secondary prevention medications . Conclusions — Provider-led , low-intensity continuous quality improvement efforts can improve the adoption of care processes into national practice within the context of a medical specialty society infrastructure . The findings of the present trial have led to the incorporation of study outcome metrics into a medical society rating system for ongoing quality improvement Background A pilot project cardiovascular prevention was implemented in S and well ( West Midl and s , UK ) . This used electronic primary care records to identify untreated patients at high risk of cardiovascular disease then invited these high risk patients for assessment by a nurse in their own general practice . Those found to be eligible for treatment were offered treatment . During the pilot a higher proportion of high risk patients were started on treatment in the intervention practice s than in control practice s. Following the apparent success of the prevention project , it was intended to extend the service to all practice s across the S and well area . However the pilot project was not a robust evaluation . There was a need for an efficient evaluation that would not disrupt the planned rollout of the project . Methods / design Project nurses will sequentially implement targeted cardiovascular case finding in a phased way across all general practice s , with the sequence of general practice s determined r and omly . This is a stepped wedge r and omised controlled trial design . The target population is patients aged 35 to 74 , without diabetes or cardiovascular disease whose ten-year cardiovascular risk , ( determined from data in their electronic records ) is ≥20 % . The primary outcome is the number of high risk patients started on treatment , because these data could be efficiently obtained from electronic primary care records . From this we can determine the effects of the case finding programme on the proportion of high risk patients started on treatment in practice s before and after implementation of targeted case finding . Cost-effectiveness will be modelled from the predicted effects of treatments on cardiovascular events and associated health service costs . Alongside the implementation it is intended to interview clinical staff and patients who participated in the programme in order to determine acceptability to patients and clinicians . Practical considerations meant that 26 practice s in S and well could be r and omised , including about 6,250 patients at high risk of cardiovascular disease . This gives sufficient power for evaluation . Discussion It is possible to design a stepped wedge r and omised controlled trial using routine data to determine the primary outcome to evaluate implementation of a cardiovascular prevention programme OBJECTIVES To assess the efficacy of a comprehensive secondary prevention programme to reduce morbidity and mortality in patients who have suffered a cardiovascular ( CV ) event ; to control CV risk factors and prophylactic treatment in order to prevent recurrence ; and to improve the quality of life of patients with cardiovascular disease . DESIGN R and omised , pragmatic , open clinical trial in primary care . SETTING A total of 42 primary care centres of 8 different areas in Spain . PARTICIPANTS Men and women below 86 years old , diagnosed with coronary disease and /or stroke and /or peripheral vascular disease in the preceding year , and who have no serious or terminal disease . INTERVENTION Primary care centres will be r and omised to following usual care ( control group ) , or to following a comprehensive programme of secondary prevention ( intervention group ) . MAIN MEASUREMENTS Cardiovascular fatal events , cardiovascular non-fatal events , total mortality and health-related quality of life ( SF-36 ) Objectives To investigate the long-term cost-effectiveness ( measured as the ratio of incremental NHS cost to incremental quality -adjusted life years ) of a telehealth intervention for patients with raised cardiovascular disease ( CVD ) risk . Design A cohort simulation model developed as part of the economic evaluation conducted alongside the Healthlines r and omised controlled trial . Setting Patients recruited through primary care , and intervention delivered via telehealth service .  Participants Participants with a 10-year CVD risk ≥20 % , as measured by the QRISK2 algorithm , and with at least 1 modifiable risk factor , individually r and omised from 42 general practice s in Engl and . Intervention A telehealth service delivered over a 12-month period . The intervention involved a series of responsive , theory-led encounters between patients and trained health information advisors who provided access to information re sources and supported medication adherence and coordination of care . Primary and secondary outcome measures Cost-effectiveness measured by net monetary benefit over the simulated lifetime of trial participants from a UK National Health Service perspective . Results The probability that the intervention was cost-effective depended on the duration of the effect of the intervention . The intervention was cost-effective with high probability if effects persisted over the lifetime of intervention recipients . The probability of cost-effectiveness was lower for shorter duration s of effect . Conclusions The intervention was likely to be cost-effective under a lifetime perspective . Trial registration number IS RCT N27508731 ; Results 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
Full prescription coverage , reduced copayments , FDC and counselling were facilitators associated with higher adherence .
BACKGROUND Secondary prevention is cost-effective for cardiovascular disease ( CVD ) , but uptake is suboptimal .
Underst and ing barriers and facilitators to adherence to secondary prevention for CVD at multiple health system levels may inform policy .
OBJECTIVES To conduct a systematic review of barriers and facilitators to adherence/persistence to secondary CVD prevention medications at health system level .