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Original Investigation |

An Education Program for Risk Factor Management After an Acute Coronary Syndrome:  A Randomized Clinical Trial FREE

Ariel Cohen, MD, PhD1; Patrick Assyag, MD2; Louise Boyer-Chatenet1; Alain Cohen-Solal, MD, PhD3; Christel Perdrix, MD4; Marie Dalichampt, MSc5; Pierre-Louis Michel, MD6; Gilles Montalescot, MD, PhD6; Philippe Ravaud, MD, PhD5,7,8; P. Gabriel Steg, MD9,10; Isabelle Boutron, MD, PhD5,7,8 ; for the Réseau Insuffisance Cardiaque (RESICARD) PREVENTION Investigators
[+] Author Affiliations
1Service de Cardiologie, Hôpital Saint-Antoine, Assistance Publique des Hôpitaux de Paris, Université Pierre et Marie Curie, Paris, France
2currently in private practice, Paris, France
3Service de Cardiologie, Hôpital Lariboisière, Assistance Publique des Hôpitaux de Paris, Institut National de la Santé et de la Recherche Médicale Unité 738, Paris, France
4Service de Cardiologie, Hôpital La Roseraie, Aubervilliers, France
5Centre d’Epidémiologie Clinique, Hôpital Hôtel Dieu, Assistance Publique des Hôpitaux de Paris, Paris, France
6Institut Cardiologie, Hôpital Pitié-Salpêtrière, Assistance Publique des Hôpitaux de Paris, Université Paris 6 (Université Pierre et Marie Curie), Institut National de la Santé et de la Récherche Médicale Commission Médicale Régionale 937, Paris, France
7Institut National de la Santé et de la Recherche Médicale Unité 738, Paris, France
8Faculté de Médecine, Université Paris Descartes, Sorbonne Paris Cité, Paris, France
9Département Hospitalo-Universitaire Fibrosis-Inflammation-Remodeling (FIRE), Hôpital Bichat, Assistance Publique des Hôpitaux de Paris, Paris, France
10Service de Cardiologie, Institut National de la Santé et de la Recherche Médicale INSERM Unité 698, Université Paris Diderot, Paris, France
JAMA Intern Med. 2014;174(1):40-48. doi:10.1001/jamainternmed.2013.11342.
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Published online

Importance  Lifestyle improvements after an acute coronary syndrome reduce cardiovascular risk but are difficult to achieve.

Objective  To determine whether a nurse-led or dietician-led cardiovascular risk factor education program would improve risk factor reduction over the long term after an acute coronary syndrome.

Design, Setting, and Participants  The Réseau Insuffisance Cardiaque (RESICARD) PREVENTION study was a 2-arm, parallel-group, multicenter, randomized clinical trial at 6 tertiary care hospitals in France. Patients hospitalized in a cardiac intensive care unit for an acute coronary syndrome with at least 1 lifestyle risk factor (current smoking, sedentary lifestyle, or overweight or obesity) were randomized according to a computer-generated list with sequentially numbered, sealed envelopes.

Intervention  Patients underwent an education program in a unique non–hospital setting (a House of Education) or were treated according to physicians’ usual standard of care.

Main Outcomes and Measures  The primary outcome was a composite that included at least 1 of the following: smoking cessation, at least 3 hours per week of physical activity, at least 5% reduction in weight, and at least 4% reduction in waist circumference. Patients were followed up for 1 year. An intent-to-treat analysis was performed.

Results  From June 21, 2006, to July 30, 2008, a total of 251 patients were randomized to the House of Education and 251 to conventional care. The 2 groups did not differ significantly at 12 months in the primary composite outcome (51.8% vs 49.8% success rate; adjusted relative risk [aRR], 1.11; 95% CI, 0.90-1.37) or with correction of all risk factors (aRR, 1.22; 95% CI, 0.89-1.66). Similarly, the 2 groups did not differ by physical activity (aRR, 1.05; 95% CI, 0.92-1.21), smoking cessation (aRR, 0.99; 95% CI, 0.87-1.13), and weight or waist reduction (aRR, 1.07; 95% CI, 0.84-1.36).

Conclusions and Relevance  Compared with conventional care, the House of Education did not result in superior improvement in lifestyle-related cardiovascular risk factors after an acute coronary syndrome.

Trial Registration  clinicaltrials.gov Identifier: NCT00337480

Figures in this Article

Acute coronary syndrome (ACS) has been estimated to affect 1.4 million people each year in Europe.1 Risk factors include poor diet, tobacco smoking, physical inactivity, high body mass index, large waist circumference, and regular alcohol consumption, as well as hypertension, dyslipidemia, diabetes mellitus, and a family history of cardiovascular disease.24 Most of these factors are modifiable, and lifestyle changes such as improved diet, smoking cessation, and increased physical activity can greatly reduce cardiovascular risk.2

Effective management of coronary heart disease is multimodal and includes appropriate drug therapy, revascularization, and cardiac rehabilitation. European5,6 and North American7,8 guidelines recommend pharmacologic treatments and lifestyle interventions to reduce the risk of recurrent events in patients following an ACS. Secondary prevention can be achieved by patient education, exercise programs, and counseling and support.9 However, this approach assumes adequate continuity of patient care, with rapid and accurate communication between the cardiac intensive care unit and primary care physicians, particularly during the patient’s transition from the hospital to community care.10 Indeed, evidence suggests that collaborative models that enhance communication among care providers can improve the quality of care and outcomes for patients with chronic conditions.11

We developed an individualized education program provided in a unique non–hospital setting (a House of Education) to optimize support for patients after an ACS to help them reduce their cardiovascular risk factors. Furthermore, communication between the House of Education providers and the primary and secondary care providers was optimized by a specific Internet system that allowed quick and efficient communication of patient assessment. The primary objective of this randomized study was to determine the effect of the House of Education at 12 months on cardiovascular risk factors in patients discharged from the hospital after an ACS.

The study protocol was approved by the ethics committee Comité de Protection des Personnes Île-de-France V, Hôpital Saint-Antoine. All participants gave their written informed consent in accord with the Declaration of Helsinki. The Réseau Insuffisance Cardiaque (RESICARD) PREVENTION study was planned, conducted, and reported following the Consolidated Standards of Reporting Trials guidelines for nonpharmacologic treatments.12 We planned a 2-arm, parallel-group, multicenter, randomized clinical trial performed in cardiac intensive care units of 6 tertiary care hospitals in France.

Setting and Participants

The study was performed in 5 state university hospitals (Hôpital Saint-Antoine, Hôpital Lariboisière, Hôpital Pitié-Salpétrière, Hôpital Bichat, and Hôpital Tenon) and in 1 private hospital (Hôpital La Roseraie). All were located in Paris, France, or its suburbs.

We screened all patients hospitalized in a cardiac intensive care unit for an ACS. Patients were eligible if they were at least 18 years of age, were hospitalized in a cardiac intensive care unit for an ACS (unstable angina, ST-segment elevation myocardial infarction, or non–ST-segment elevation myocardial infarction), and had at least 1 of the following education-modifiable risk factors: current smoking (for ≥12 months), sedentary lifestyle (<3 hours of physical activity per week), or overweight or obesity (body mass index ≥25 for overweight or ≥30 for obesity, calculated as weight in kilograms divided by height in meters squared). Patients also had to be willing and able to attend regular visits at an outpatient program.

Randomization and Interventions

Patients were randomized at a 1:1 ratio during their hospitalization according to a computer-generated list with blocks of varying size stratified on centers. The list was prepared and maintained by an independent statistician (MD) at the clinical trial unit. Allocation was concealed in sequentially numbered, sealed opaque envelopes. After verifying a patient’s eligibility criteria and obtaining informed consent, the investigator included the patient in the trial and informed the clinical trial unit of the inclusion and randomization of the patient.

Baseline characteristics were measured during the hospitalization. Data were sent via the secure Internet system to the House of Education before a patient’s first appointment, which took place within 1 month after discharge.

Blinding was not feasible in this study. However, independent research staff rather than the treating physician performed outcome assessments.

Theoretical Framework

Lifestyle modifications following an ACS are difficult to achieve. Their success depends on the availability of an adequate support system for patients not usually provided by primary and secondary care physicians because of time constraints. They also require effective communication and information sharing between physicians in primary and secondary care settings.

We studied a multidisciplinary individualized education program provided by staff outside of the hospital in a unique House of Education. We hypothesized that such a setting may be beneficial in adequately coordinating the management of cardiovascular risk factors.

House of Education

The House of Education was a non–hospital-based office dedicated to patient education, with no physician involved, and was easily accessible by public transportation. It comprised a nurse who was specialized in smoking cessation counseling, a dietician who had received training in physical activity counseling, and an administrative coordinator who offered individual consultations 5 days per week, with a telephone hotline available from 9 am to 6 pm if patients needed information about cardiovascular risk factors and therapeutic education. A schematic representation of the program is shown in Figure 1.

Place holder to copy figure label and caption
Figure 1.
Description of the Experimental Intervention

Patients attended the House of Education at least 6 times: within the first month after discharge and then at months 2, 3, 6, 9, and 12.

Graphic Jump Location

Patients attended the House of Education at least 6 times: these included a visit within the first month after discharge and then at months 2, 3, 6, 9, and 12. Patients could attend additional consultations at any time up to 12 months after the index event. If a patient could not attend the House of Education, a consultation was provided by telephone.

The content of the consultations at the House of Education was individualized according to a patient’s risk factors. Standardization of the intervention by the nurse and the dietician was achieved with the use of a case report form.

Current smokers attended a consultation with the nurse specialized in the management of smoking cessation. First, the nurse evaluated a patient’s addiction to tobacco using the Fagerström Test for Nicotine Dependence,13 along with previous and current attempts, treatments for stopping smoking, and motivation for and barriers to smoking cessation. Second, the approach to achieve smoking cessation was discussed. Third, a program to avoid or treat smoking relapse was implemented. During these sessions, all the different treatments available (eg, nicotine substitutes and behavioral psychotherapy) were addressed, and patients could be advised to ask their primary care physician or cardiologist to prescribe nicotine substitutes.

The consultation with the dietician comprised an evaluation of the patient’s diet, followed by an explanation of the general principles for an adequately balanced diet. The dietician identified diet errors, provided individualized advice, and determined objectives for each patient according to his or her risk factors (hypertension, dyslipidemia, overweight or obesity, or type 1 or type 2 diabetes mellitus). The dietician provided a list of the patient’s specific objectives, a document for the patient to record his or her diet, and leaflets (if needed) to explain equivalences and the importance of eating adequate quantities. A consultation with the patient’s partner could be organized to improve the patient’s diet. The consultation with the dietician also focused on the importance of regular physical activity (walking or participating in sporting activities) and generated specific objectives for each patient according to his or her general condition and abilities.

Patient information was shared among care providers via a secure Internet system with a digital pen,14 which allowed quick and efficient sharing of data among primary care physicians, primary care cardiologists, physicians in the cardiac intensive care unit, and nurses and dieticians from the House of Education. The patient discharge form and the synthesis of the results are shown in eFigure 1 in the Supplement.

At hospital discharge, information related to the hospitalization period, the patient’s risk factors, and objectives for risk factor management was recorded via the Internet system. An e-mail was automatically sent to the staff at the House of Education and to the primary care physicians (general practice and cardiologists). The staff and the primary care physicians could log into the system using a secure access to see all patient information.

After each consultation at the House of Education, the team completed a document indicating the patient’s treatments and risk factors, with the clinical variables (blood pressure, physical activity, tobacco use, and weight and waist circumference) and biological variables (glycated hemoglobin level and low-density lipoprotein cholesterol level). These data were displayed graphically, clearly showing any changes in risk factor level over time, and were accessible to the patient’s care providers at all times via the secure Internet system. Information on levels of physical activity was collected in a self-reported questionnaire (available on request from the author). Adherence to the patient’s diet was evaluated by the dietician in a declarative manner and was recorded in the patient’s file; after the consultation, the dietician provided the patient with a personalized document detailing dietary recommendations.

Comparator Intervention

Patients in the control group attended appointments with their primary care physician and primary care cardiologist within 1 month of discharge. These physicians then followed up with the patients according to their usual practices. The sharing of patient data between physicians in the primary and secondary care settings was not standardized and was done at the physician’s discretion.

Cointerventions

Information was recorded on the prescription of cointerventions (eg, nicotine supplements, hospitalization in a rehabilitation center, and others). The administration was left to the discretion of the care provider.

Outcomes and Follow-up Period

The primary end point was a composite that involved correction of at least 1 of the following 3 cardiovascular risk factors between baseline and month 12: (1) smoking cessation (complete cessation for smokers, with nonsmokers at baseline and month 12 considered successes and nonsmokers at study inclusion who started smoking [or relapsed] during the 12 months considered failures); (2) overweight or obesity (≥4% reduction in waist circumference or ≥5% reduction in weight, with patients having a body mass index of less than 25 at baseline and at 12 months considered successes and patients who became overweight during the study considered failures); and (3) physical activity (≥3 hours per week).

Secondary end points, from baseline to month 12, included the following 6 outcomes: (1) Correction of all 3 cardiovascular risk factors mentioned above. (2) Correction of each individual cardiovascular risk factor mentioned above. (3) Correction of other risk factors, including hypertension (blood pressure to <140/90 mm Hg), diabetes mellitus (glycated hemoglobin level to <6.5%), and dyslipidemia (low-density lipoprotein cholesterol level to <100 mg/dL) (to convert glycated hemoglobin level to proportion of total hemoglobin, multiply by 0.01; to convert cholesterol level to millimoles per liter, multiply by 0.0259). (4) Physical and mental summary scores of the 12-Item Short Form Health Survey for quality of life15 (continuous variables on a scale of 0 to 100, with higher scores indicating higher quality of life). (5) The number of correct answers on a patient knowledge questionnaire comprising 19 questions. (6) Patient satisfaction on a numeric scale rated 0 to 10, with higher scores indicating higher levels of satisfaction.

We had planned to evaluate the levels of satisfaction recorded by the primary care physicians and primary care cardiologists. However, this outcome was not collected for logistic reasons.

Outcome Assessments

Data from all patients were evaluated by an independent data collector at Hôpital Saint-Antoine at 6 and 12 months after enrollment. At these visits, biological variables were recorded, clinical measurements were obtained (blood pressure and weight and waist circumference), and questionnaires were administered (physical activity, 12-Item Short Form Health Survey for quality of life, and patient satisfaction and patient knowledge questionnaire), with treatment modifications and events during the past 6 months documented. All patients had specific case report forms completed at their 6-month and 12-month visits. If a patient could not attend an evaluation visit, an assessment via telephone was performed. Follow-up assessments were obtained at 6 and 12 months after enrollment for all patients.

Statistical Analysis
Sample Size Calculation

Using data from the literature,16,17 we estimated that 45% of patients receiving conventional care and 60% of patients attending the House of Education would have corrected at least 1 cardiovascular risk factor by 12 months. Therefore, 231 participants per group were required for 90% power to demonstrate a clinically relevant difference between the groups. Assuming a dropout rate of 10%, we aimed to recruit 510 patients (255 per group).

Quantitative Data

Quantitative data are expressed as means (SDs); ranges and qualitative data are expressed as counts and percentages. End points were estimated as part of a linear model using generalized estimating equations. A Poisson distribution and log-link function were chosen for the binary criteria to assess relative risks in the context of frequent outcomes, and a normal distribution and identity link function were chosen for continuous criteria. The variance-covariance matrix was postulated by a symmetrical composition so it could consider a constant correlation between 2 patients in the same hospital. For the Poisson distribution, the parameter covariance matrix and the likelihood function were adjusted by the scale parameter (deviance divided by df) to take into account a potential overdispersion. When relevant, an adjustment factor was used to include a prognostic criterion. In addition to generalized estimating equation models, generalized mixed-effects models were performed to assess the robustness of our results. For each of the end points, the significance level was set at 5%.

The primary end point was analyzed according to the intent-to-treat principle. Missing data were imputed by a Markov chain Monte Carlo method of multiple imputations. The primary analysis involved all patients with complete or imputed data. Sensitivity analyses were performed to assess the stability of the results of the primary analysis, one using only patients with complete data and one with replacement of missing data. All statistical analyses were performed using commercially available software (SAS, version 9.2; SAS Institute).

The flow of patients in the trial is shown in Figure 2. From June 21, 2006, to July 30, 2008, a total of 251 patients were randomized to the House of Education and 251 to conventional care; overall, 193 and 207 patients, respectively, attended the 6-month visit, and 203 and 215 patients, respectively, attended the 12-month visit. A total of 21 patients (8 House of Education and 13 conventional care) were assessed during a telephone interview instead of a study visit at 6 months and 63 patients (27 House of Education and 36 conventional care) at 12 months.

Place holder to copy figure label and caption
Figure 2.
Flow of Patients in the Study

From June 21, 2006, to July 30, 2008, a total of 251 patients were randomized to the House of Education and 251 to conventional care.

Graphic Jump Location

Baseline characteristics for patients in the 2 treatment groups were well balanced (Table 1). Overall, 84.3% of patients were male, and the mean (SD) age was 56.9 (10.9) years. The most common types of ACS were ST-elevation myocardial infarction (47.9%) and non–ST-elevation myocardial infarction (34.1%). Regarding cardiovascular risk factors, 54.5% of patients were current smokers, 27.5% had a sedentary lifestyle, 51.8% were overweight, and 26.0% were obese. Each hospital recruited 7.4% to 23.1% of the total number of patients (Figure 2). At discharge from the hospital, 96.6% of patients were taking aspirin, 94.6% took statins, 89.6% took β-blockers, 86.7% took clopidogrel bisulfate, 65.5% took angiotensin-converting enzyme inhibitors, and 38.3% took nitrate derivatives (Table 1).

Table Graphic Jump LocationTable 1.  Patient Baseline Characteristics
Attendance at the House of Education and Content of the Intervention

Overall, attendance at the House of Education decreased with time. At 1 month, 80.5% to 81.2% of the patients attended; at 12 months, 37.3% of patients had a nurse consultation, and 56.9% had a dietician consultation (Figure 3). The median numbers of visits during the 12 months were 2 (range, 1-5) with the nurse and 5 (range, 1-6) with the dietician. The number of consultations provided by telephone increased with time and mainly involved the nurse.

Place holder to copy figure label and caption
Figure 3.
Adherence to Individual Consultations With the Nurse (A) and the Dietician (B)

The percentages are based on the number of patients who were expected to have a consultation with the nurse (n = 126) and with the dietician (n = 207).

Graphic Jump Location
Primary and Secondary Outcomes

The 2 treatment groups did not differ in the primary composite end point (correction of at least smoking, physical inactivity, overweight, or obesity), with an adjusted relative risk of 1.11 (95% CI, 0.90-1.37) (Table 2). Similarly, the 2 treatment groups did not differ in any of the secondary end points (Table 2 and Table 3).

Table Graphic Jump LocationTable 2.  Results of the Primary and Secondary End Points for the House of Education vs Conventional Care (Primary Analyses and Adjusted Models)a
Table Graphic Jump LocationTable 3.  Results of the 12-Item Short Form Health Survey for Quality of Life and Patient Knowledge Questionnaire Secondary End Points for the House of Education vs Conventional Care (Primary Analyses and Adjusted Models)a

The mixed-effects approach produced similar estimated relative risks (95% CIs). These results are summarized in eTable 1 and eTable 2 in the Supplement.

Medical Changes

At 12 months, the following proportions of patients had maintained and decreased their drug dosages, respectively: 84.6% and 0.2% for aspirin, 82.6% and 1.8% for β-blockers, 83.6% and 2.1% for clopidogrel, 80.0%, and 3.1% for angiotensin-converting enzyme inhibitors, and 72.6% and 13.7% for nitrate derivatives. No major differences were observed among the groups. These results are summarized in eTable 3 in the Supplement.

Adverse Events

The most common serious adverse events during the study in the House of Education and conventional care groups, respectively, were the following: death (2.9% and 2.8%); arrhythmia (1.6% and 2.8%); coronary angiography (7.3% and 8.9%); scheduled angioplasty (4.9% and 3.2%); ACS, stent thrombosis, or chest pain (13.5% and 12.6%); and dyspnea, lung edema, or congestive heart failure (3.7% and 2.4%). Seven deaths occurred in each group: 3 in the House of Education and 5 in the conventional care group were cardiovascular, 1 in the House of Education and 1 in the conventional care group were noncardiovascular, and 3 in the House of Education and 1 in the conventional care group were from an unknown cause.

This multicenter randomized trial evaluated the effect of a specific individualized education program on lifestyle risk factors to optimize support for patients after an ACS and to improve control of their cardiovascular risk factors. This novel approach used a secure Internet system with a digital pen and was provided in a House of Education, a unique setting outside of the hospital and without direct physician involvement. We had speculated that a nonmedical approach (with no direct prescription of medication) at a House of Education involving a dietician, a nurse trained in smoking cessation, and efficient communication with primary care physicians via the Internet would facilitate patient adherence to our program of risk factor reduction; however, we found no additional benefit with this method over usual care in achieving target cardiovascular risk levels.

Various patient education programs to improve cardiovascular risk factors have been assessed. The Coaching Patients on Achieving Cardiovascular Health (COACH) trial18 used an approach that was somewhat similar to ours. It compared the addition of regular personal coaching (The COACH Program) via telephone and mailings to achieve target levels for specific risk factors vs usual care alone. After 6 months, patients who received coaching had achieved greater reductions in their mean total cholesterol and low-density lipoprotein cholesterol levels and in their weight, dietary improvements, and regular walking regimens compared with control subjects, but coaching had no effect on triglycerides or high-density lipoprotein cholesterol levels or on smoking cessation.

In a recently published study of 703 patients with symptomatic ischemic heart disease, Fihn et al11 showed that a collaborative care intervention had no effect on symptoms of angina or self-perceived health. However, collaborative care increased physician adherence to practice guidelines by 4.5% but largely with respect to the use of diagnostic testing and not greater use of evidence-based treatments.

A recent Cochrane systematic review19 showed that an intervention using counseling and education aimed at behavioral changes did not reduce total or coronary heart disease mortality or clinical events in the general population but demonstrated that it may be effective in reducing mortality among high-risk populations. This systematic review and other studies2025 in the field have also highlighted the high heterogeneity of the educational programs proposed to patients (eg, direct counseling, telephone monitoring, or schemes that included patient-level, provider-level, or system-level interventions). These programs are usually complex interventions involving several components and are difficult to describe, standardize, and administer consistently to patients or to evaluate.26 Complex interventions also tend to work in a complicated manner, and any effect may vary by patient characteristics, skills of care providers, and the setting and circumstances of their delivery.27

In this study, we aimed to perform a pragmatic trial. Consequently, we used broad eligibility criteria, which included patients with at least 1 cardiovascular risk factor who were selected just after an ACS in the cardiac intensive care unit. We cannot exclude that the intervention might be useful in a more selected population, such as patients with more cardiovascular risk factors or a population that would be formally selected according to their motivation for the program.

Furthermore, we did not implement any intervention to improve patient adherence to the program that would not subsequently be used in clinical practice. Our results highlight that attendance at the House of Education greatly decreased over time, and many patients failed to receive the care available. To overcome this issue, the consultation could be provided by telephone. Nevertheless, treatment adherence was low, especially for smoking cessation support.

The American College of Cardiology and the American Heart Association7,8 recommend pharmacologic treatments and lifestyle interventions to reduce the risk of recurrent events in patients following an ACS. Our results demonstrated that most patients receive pharmacologic therapies. At hospital discharge, more than 80% of the patients in our study received pharmacologic therapies (aspirin, statins, β-blockers, or clopidogrel), and most patients maintained or increased their treatment dosage during 1 year. In contrast, our findings showed that modification of patient behavior is difficult and that, despite a specific education program, only about one-quarter of patients could correct all their cardiovascular risk factors.

Our study has some limitations. First, patients, care providers, and data collectors were not blinded to the intervention, which may have influenced the care and behavior of patients in the control group. Second, 11.9% of patients were unable to be reached for follow-up analysis or refused a follow-up visit at 12 months. To assess potential bias, we performed a sensitivity analysis that excluded these patients, and the results were consistent with the main intent-to-treat analysis (data not shown). Third, at the 12-month assessment, follow-up data could be collected by telephone instead of during a visit, and levels of physical activity were self-reported for 10.7% and 14.3% of the experimental and control patients, respectively. However, an ancillary study that evaluated the reproducibility of an assessment by telephone or during a follow-up visit indicated that the risk of bias was negligible (eTable 4 and eFigure 2 in the Supplement). Fourth, the results achieved herein may differ from those that might be achieved in other health care systems, where routine clinical care may not yield similar outcomes.

In conclusion, treatment following an ACS was assessed by a health care network that included management in a House of Education. The program resulted in no additional reductions in cardiovascular risk factors compared with conventional care.

Accepted for Publication: August 14, 2013.

Corresponding Author: Ariel Cohen, MD, PhD, Service de Cardiologie, Hôpital Saint-Antoine, Assistance Publique des Hôpitaux de Paris, Université Pierre et Marie Curie, 184 Rue du Faubourg Saint-Antoine, 75571 Paris CEDEX 12, France (ariel.cohen@sat.aphp.fr).

Published Online: October 14, 2013. doi:10.1001/jamainternmed.2013.11342.

Author Contributions: Dr Cohen had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Study concept and design: Cohen, Assyag, Ravaud, Boutron.

Acquisition of data: Cohen, Boyer-Chatenet, Cohen-Solal, Perdrix, Michel, Montalescot, Steg, Boutron.

Analysis and interpretation of data: Cohen, Cohen-Solal, Dalichampt, Montalescot, Ravaud, Boutron.

Drafting of the manuscript: Cohen, Assyag, Boyer-Chatenet, Perdrix, Dalichampt, Ravaud, Boutron.

Critical revision of the manuscript for important intellectual content: Cohen, Cohen-Solal, Michel, Montalescot, Ravaud, Steg, Boutron.

Statistical analysis: Dalichampt, Ravaud, Boutron.

Obtained funding: Cohen, Ravaud.

Administrative, technical, and material support: Cohen, Assyag, Boyer-Chatenet, Ravaud.

Study supervision: Cohen, Michel, Montalescot, Ravaud, Boutron.

Conflict of Interest Disclosures: Dr Cohen has received a research grant for research nurses (RESICARD) and consultant and lecture fees from AstraZeneca, Bayer Pharma, Bohringer-Ingelheim, Daiichi Sankyo, GlaxoSmithKline, and sanofi-aventis. Dr Solol has received grants and honorarium from Servier, Roche, Pfizer, Bayer Pharma, Novartis, Alere, Thermofischer, sanofi-aventis, Ipsen, and Vifor. Dr Montalescot has received research grants to the institution or consultant and lecture fees from Bayer Pharma, Bristol-Myers Squibb, Boehriinger-Ingelheim, Duke Institute, Europa, GlaxoSmithKline, Iroko, Lead-Up, Novartis, Springer, TIMI group, WebMD, Wolters, AstraZeneca, Biotronik, Eli Lilly, The Medicines Company, Medtronic, Menarini, Roche, sanofi-aventis, Pfizer, Accumetrics, Abbott Vascular, Daiichi Sankyo, Fédération Française de Cardiologie, Fondation de France, INSERM, Institut de France, Nanosphere, Stentys, and Société Française de Cardiologie. Dr Steg has received research grants from New York University School of Medicine, Servier, and sanofi-aventis. He has served as a speaker or consultant to Ablynx, Amarin, Amgen, Astellas, AstraZeneca, Bayer Pharma, Boehringer-Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Eisai, GlaxoSmithKline, Eli Lilly, Medtronic, Merck-Sharpe Dohme, Novartis, Otsuka, Pfizer, Roche, sanofi-aventis, Servier, The Medicines Company, and Vivus. He has equity ownership in Aterovax. No other disclosures were reported.

Funding/Support: The study was funded by grant 960 110 211 from the Unions Régionales des Caisses d’Assurance Maladie.

Role of the Sponsor: Unions Régionales des Caisses d’Assurance Maladie had no role in the design or conduct of the study; in the collection, analysis, or interpretation of the data; or in the preparation, review, or approval of the manuscript.

Group Information: The Réseau Insuffisance Cardiaque (RESICARD) PREVENTION Investigators comprise all authors of this study.

Additional Contributions: Jenny Lloyd, PhD, and Sophie Rushton-Smith, PhD, provided editorial assistance, including editing, checking content and language, and formatting and referencing and received payment by the authors for this service.

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Van de Werf  F, Ardissino  D, Betriu  A,  et al; Task Force on the Management of Acute Myocardial Infarction of the European Society of Cardiology.  Management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J. 2003;24(1):28-66.
PubMed   |  Link to Article
Anderson  JL, Adams  CD, Antman  EM,  et al; American College of Cardiology; American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non ST-Elevation Myocardial Infarction); American College of Emergency Physicians; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons; American Association of Cardiovascular and Pulmonary Rehabilitation; Society for Academic Emergency Medicine.  ACC/AHA 2007 guidelines for the management of patients with unstable angina/non–ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non ST-Elevation Myocardial Infarction): developed in collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons: endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine. Circulation. 2007;116(7):e148-e304. http://circ.ahajournals.org/content/116/7/e148.long. Accessed September 8, 2013.
PubMed   |  Link to Article
Antman  EM, Anbe  DT, Armstrong  PW,  et al; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; Canadian Cardiovascular Society.  ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1999 Guidelines for the Management of Patients with Acute Myocardial Infarction) [published corrections appear in Circulation. 2005;111(15):2013-2014; 2007;115(15):e411; and 2010;121(23):e441]. Circulation. 2004;110(9):e82-e292. http://circ.ahajournals.org/content/110/9/e82.long. Accessed September 8, 2013.
PubMed
Taylor  RS, Dalal  H, Jolly  K, Moxham  T, Zawada  A.  Home-based versus centre-based cardiac rehabilitation. Cochrane Database Syst Rev. 2010;(1):CD007130. http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD007130.pub2/abstract;jsessionid=8D18E9EDB503C94656F47F340F5461C0.d03t04. Accessed September 8, 2013.
PubMed
Yee  J, Unsworth  K, Suskin  N, Reid  RD, Jamnik  V, Grace  SL.  Primary care provider perceptions of intake transition records and shared care with outpatient cardiac rehabilitation programs. BMC Health Serv Res. 2011;11:231. http://ncbi.nlm.nih.gov/pmc/articles/PMC3189395/. Accessed September 8, 2013.
PubMed   |  Link to Article
Fihn  SD, Bucher  JB, McDonell  M,  et al.  Collaborative care intervention for stable ischemic heart disease. Arch Intern Med. 2011;171(16):1471-1479.
PubMed   |  Link to Article
Boutron  I, Moher  D, Altman  DG, Schulz  KF, Ravaud  P; CONSORT Group.  Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008;148(4):295-309.
PubMed   |  Link to Article
Heatherton  TF, Kozlowski  LT, Frecker  RC, Fagerström  KO.  The Fagerström Test for Nicotine Dependence: a revision of the Fagerström Tolerance Questionnaire. Br J Addict. 1991;86(9):1119-1127.
PubMed   |  Link to Article
Estellat  C, Tubach  F, Costa  Y, Hoffmann  I, Mantz  J, Ravaud  P.  Data capture by digital pen in clinical trials: a qualitative and quantitative study. Contemp Clin Trials. 2008;29(3):314-323.
PubMed   |  Link to Article
Ware  J  Jr, Kosinski  M, Keller  SD.  A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996;34(3):220-233.
PubMed   |  Link to Article
Mullen  PD, Mains  DA, Velez  R.  A meta-analysis of controlled trials of cardiac patient education. Patient Educ Couns. 1992;19(2):143-162.
Link to Article
Dusseldorp  E, van Elderen  T, Maes  S, Meulman  J, Kraaij  V.  A meta-analysis of psychoeducational programs for coronary heart disease patients. Health Psychol. 1999;18(5):506-519.
Link to Article
Vale  MJ, Jelinek  MV, Best  JD,  et al; COACH Study Group.  Coaching Patients on Achieving Cardiovascular Health (COACH): a multicenter randomized trial in patients with coronary heart disease. Arch Intern Med. 2003;163(22):2775-2783.
PubMed   |  Link to Article
Brown  JP, Clark  AM, Dalal  H, Welch  K, Taylor  RS.  Patient education in the management of coronary heart disease. Cochrane Database Syst Rev. 2011;(12):CD008895. http://ncbi.nlm.nih.gov/pubmed/22161440?dopt=Abstract. Accessed September 8, 2013.
PubMed
Müller-Riemenschneider  F, Meinhard  C, Damm  K,  et al.  Effectiveness of nonpharmacological secondary prevention of coronary heart disease. Eur J Cardiovasc Prev Rehabil. 2010;17(6):688-700.
PubMed   |  Link to Article
Dalal  HM, Zawada  A, Jolly  K, Moxham  T, Taylor  RS.  Home based versus centre based cardiac rehabilitation: Cochrane systematic review and meta-analysis [published correction appears in BMJ. 2010;340:c1133]. BMJ. 2010;340:b5631. http://ncbi.nlm.nih.gov/pmc/articles/PMC2808470/. Accessed September 8, 2013.
PubMed   |  Link to Article
Auer  R, Gaume  J, Rodondi  N, Cornuz  J, Ghali  WA.  Efficacy of in-hospital multidimensional interventions of secondary prevention after acute coronary syndrome: a systematic review and meta-analysis. Circulation. 2008;117(24):3109-3117.
PubMed   |  Link to Article
Mullen  PD, Mains  DA, Velez  R.  A meta-analysis of controlled trials of cardiac patient education. Patient Educ Couns. 1992;19(2):143-162.
PubMed   |  Link to Article
Dusseldorp  E, van Elderen  T, Maes  S, Meulman  J, Kraaij  V.  A meta-analysis of psychoeducational programs for coronary heart disease patients. Health Psychol. 1999;18(5):506-519.
PubMed   |  Link to Article
Ebrahim  S, Taylor  F, Ward  K, Beswick  A, Burke  M, Davey Smith  G.  Multiple risk factor interventions for primary prevention of coronary heart disease. Cochrane Database Syst Rev. 2011;(1):CD001561. http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD001561.pub3/abstract. Accessed September 11, 2013.
PubMed
Medical Research Council. Developing and evaluating complex interventions: new guidance. www.sphsu.mrc.ac.uk/Complex_interventions_guidance.pdf. Accessed December 3, 2012.
Yudkin  P, Perera  R, Glasziou  P. Complexity of the intervention. In: Boutron  I, Ravaud  P, Moher  D, eds. Randomized Clinical Trials of Nonpharmacological Treatments. Boca Raton, FL: Chapman & Hall/CRC; 2011.

Figures

Place holder to copy figure label and caption
Figure 1.
Description of the Experimental Intervention

Patients attended the House of Education at least 6 times: within the first month after discharge and then at months 2, 3, 6, 9, and 12.

Graphic Jump Location
Place holder to copy figure label and caption
Figure 2.
Flow of Patients in the Study

From June 21, 2006, to July 30, 2008, a total of 251 patients were randomized to the House of Education and 251 to conventional care.

Graphic Jump Location
Place holder to copy figure label and caption
Figure 3.
Adherence to Individual Consultations With the Nurse (A) and the Dietician (B)

The percentages are based on the number of patients who were expected to have a consultation with the nurse (n = 126) and with the dietician (n = 207).

Graphic Jump Location

Tables

Table Graphic Jump LocationTable 1.  Patient Baseline Characteristics
Table Graphic Jump LocationTable 2.  Results of the Primary and Secondary End Points for the House of Education vs Conventional Care (Primary Analyses and Adjusted Models)a
Table Graphic Jump LocationTable 3.  Results of the 12-Item Short Form Health Survey for Quality of Life and Patient Knowledge Questionnaire Secondary End Points for the House of Education vs Conventional Care (Primary Analyses and Adjusted Models)a

References

National Institutes of Health. Heart disease: symptoms, diagnosis, treatment. www.nlm.nih.gov/medlineplus/magazine/issues/winter09/articles/winter09pg25-27.html. Accessed February 14, 2011.
Mozaffarian  D, Furberg  CD, Psaty  BM, Siscovick  D.  Physical activity and incidence of atrial fibrillation in older adults: the Cardiovascular Health Study. Circulation. 2008;118(8):800-807.
PubMed   |  Link to Article
Lafitte  M, Pradeau  V, Leroux  L,  et al.  Efficacy over time of a short overall atherosclerosis management programme on the reduction of cardiovascular risk in patients after an acute coronary syndrome. Arch Cardiovasc Dis. 2009;102(1):51-58.
PubMed   |  Link to Article
Yusuf  S, Hawken  S, Ounpuu  S,  et al; INTERHEART Study Investigators.  Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet. 2004;364(9438):937-952.
PubMed   |  Link to Article
Bassand  JP, Hamm  CW, Ardissino  D,  et al; Task Force for Diagnosis and Treatment of Non–ST-Segment Elevation Acute Coronary Syndromes of European Society of Cardiology.  Guidelines for the diagnosis and treatment of non–ST-segment elevation acute coronary syndromes. Eur Heart J. 2007;28(13):1598-1660.
PubMed   |  Link to Article
Van de Werf  F, Ardissino  D, Betriu  A,  et al; Task Force on the Management of Acute Myocardial Infarction of the European Society of Cardiology.  Management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J. 2003;24(1):28-66.
PubMed   |  Link to Article
Anderson  JL, Adams  CD, Antman  EM,  et al; American College of Cardiology; American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non ST-Elevation Myocardial Infarction); American College of Emergency Physicians; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons; American Association of Cardiovascular and Pulmonary Rehabilitation; Society for Academic Emergency Medicine.  ACC/AHA 2007 guidelines for the management of patients with unstable angina/non–ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non ST-Elevation Myocardial Infarction): developed in collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons: endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine. Circulation. 2007;116(7):e148-e304. http://circ.ahajournals.org/content/116/7/e148.long. Accessed September 8, 2013.
PubMed   |  Link to Article
Antman  EM, Anbe  DT, Armstrong  PW,  et al; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; Canadian Cardiovascular Society.  ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1999 Guidelines for the Management of Patients with Acute Myocardial Infarction) [published corrections appear in Circulation. 2005;111(15):2013-2014; 2007;115(15):e411; and 2010;121(23):e441]. Circulation. 2004;110(9):e82-e292. http://circ.ahajournals.org/content/110/9/e82.long. Accessed September 8, 2013.
PubMed
Taylor  RS, Dalal  H, Jolly  K, Moxham  T, Zawada  A.  Home-based versus centre-based cardiac rehabilitation. Cochrane Database Syst Rev. 2010;(1):CD007130. http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD007130.pub2/abstract;jsessionid=8D18E9EDB503C94656F47F340F5461C0.d03t04. Accessed September 8, 2013.
PubMed
Yee  J, Unsworth  K, Suskin  N, Reid  RD, Jamnik  V, Grace  SL.  Primary care provider perceptions of intake transition records and shared care with outpatient cardiac rehabilitation programs. BMC Health Serv Res. 2011;11:231. http://ncbi.nlm.nih.gov/pmc/articles/PMC3189395/. Accessed September 8, 2013.
PubMed   |  Link to Article
Fihn  SD, Bucher  JB, McDonell  M,  et al.  Collaborative care intervention for stable ischemic heart disease. Arch Intern Med. 2011;171(16):1471-1479.
PubMed   |  Link to Article
Boutron  I, Moher  D, Altman  DG, Schulz  KF, Ravaud  P; CONSORT Group.  Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008;148(4):295-309.
PubMed   |  Link to Article
Heatherton  TF, Kozlowski  LT, Frecker  RC, Fagerström  KO.  The Fagerström Test for Nicotine Dependence: a revision of the Fagerström Tolerance Questionnaire. Br J Addict. 1991;86(9):1119-1127.
PubMed   |  Link to Article
Estellat  C, Tubach  F, Costa  Y, Hoffmann  I, Mantz  J, Ravaud  P.  Data capture by digital pen in clinical trials: a qualitative and quantitative study. Contemp Clin Trials. 2008;29(3):314-323.
PubMed   |  Link to Article
Ware  J  Jr, Kosinski  M, Keller  SD.  A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996;34(3):220-233.
PubMed   |  Link to Article
Mullen  PD, Mains  DA, Velez  R.  A meta-analysis of controlled trials of cardiac patient education. Patient Educ Couns. 1992;19(2):143-162.
Link to Article
Dusseldorp  E, van Elderen  T, Maes  S, Meulman  J, Kraaij  V.  A meta-analysis of psychoeducational programs for coronary heart disease patients. Health Psychol. 1999;18(5):506-519.
Link to Article
Vale  MJ, Jelinek  MV, Best  JD,  et al; COACH Study Group.  Coaching Patients on Achieving Cardiovascular Health (COACH): a multicenter randomized trial in patients with coronary heart disease. Arch Intern Med. 2003;163(22):2775-2783.
PubMed   |  Link to Article
Brown  JP, Clark  AM, Dalal  H, Welch  K, Taylor  RS.  Patient education in the management of coronary heart disease. Cochrane Database Syst Rev. 2011;(12):CD008895. http://ncbi.nlm.nih.gov/pubmed/22161440?dopt=Abstract. Accessed September 8, 2013.
PubMed
Müller-Riemenschneider  F, Meinhard  C, Damm  K,  et al.  Effectiveness of nonpharmacological secondary prevention of coronary heart disease. Eur J Cardiovasc Prev Rehabil. 2010;17(6):688-700.
PubMed   |  Link to Article
Dalal  HM, Zawada  A, Jolly  K, Moxham  T, Taylor  RS.  Home based versus centre based cardiac rehabilitation: Cochrane systematic review and meta-analysis [published correction appears in BMJ. 2010;340:c1133]. BMJ. 2010;340:b5631. http://ncbi.nlm.nih.gov/pmc/articles/PMC2808470/. Accessed September 8, 2013.
PubMed   |  Link to Article
Auer  R, Gaume  J, Rodondi  N, Cornuz  J, Ghali  WA.  Efficacy of in-hospital multidimensional interventions of secondary prevention after acute coronary syndrome: a systematic review and meta-analysis. Circulation. 2008;117(24):3109-3117.
PubMed   |  Link to Article
Mullen  PD, Mains  DA, Velez  R.  A meta-analysis of controlled trials of cardiac patient education. Patient Educ Couns. 1992;19(2):143-162.
PubMed   |  Link to Article
Dusseldorp  E, van Elderen  T, Maes  S, Meulman  J, Kraaij  V.  A meta-analysis of psychoeducational programs for coronary heart disease patients. Health Psychol. 1999;18(5):506-519.
PubMed   |  Link to Article
Ebrahim  S, Taylor  F, Ward  K, Beswick  A, Burke  M, Davey Smith  G.  Multiple risk factor interventions for primary prevention of coronary heart disease. Cochrane Database Syst Rev. 2011;(1):CD001561. http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD001561.pub3/abstract. Accessed September 11, 2013.
PubMed
Medical Research Council. Developing and evaluating complex interventions: new guidance. www.sphsu.mrc.ac.uk/Complex_interventions_guidance.pdf. Accessed December 3, 2012.
Yudkin  P, Perera  R, Glasziou  P. Complexity of the intervention. In: Boutron  I, Ravaud  P, Moher  D, eds. Randomized Clinical Trials of Nonpharmacological Treatments. Boca Raton, FL: Chapman & Hall/CRC; 2011.

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Multimedia

Supplement.

eTable 1. Results of the Primary and Secondary End Points for the House of Education vs Conventional Care (Primary Analyses, Adjusted Models) by Generalized Estimating Equation Model and by Linear Mixed-effects Model

eTable 2. Results of the Quality-of-Life and Patient Knowledge Secondary End Points for the House of Education vs Conventional Care (Primary Analyses, Adjusted Models)

eTable 3. Medication Changes at 12 Months

eTable 4. Ancillary Studies on the Agreement Between Measured and Reported Weight, Height, Waist Circumference, SBP, and DBP*

eFigure 1. Form for Communication Between Health Care Providers Using a Secure Internet System With a Digital Pen

eFigure 2. Plots of Identity and Bland-Altman Plots

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