Predictors of Early and Late Enrollment in Cardiac Rehabilitation, Among Those Referred, after Acute Myocardial Infarction Running title: Parashar et al.; Cardiac Rehabilitation after Myocardial Infarction

ors, we utilized documentation that patients were educated and given instructions to participate in CR program in addition to the standard referral. Our study shows that despite a fairly high referral rate, participation in CR among those referred remains poor with less than one by gest on A ril 0, 2017 http://ciajournals.org/ D ow nladed from DOI: 10.1161/CIRCULATIONAHA.111.088799 12 in 3 and less than half referred patients actually participating in CR at 1 and 6-months post AMI respectively. Recognition of this remarkably wide gap between referral and participation has prompted the AHA to commission a Presidential Advisory to identify barriers to enrollment in CR. We identified several patient oriented and medical factors that affect early and late CR enrollment even after receiving CR referral, after AMI. Older individuals, non-Caucasians and patients with economic burden and lower education were less likely to participate in CR at 6 months. Although time off from work for attending CR sessions has been suggested as a possible reason for non-participation, in our study, working full time or part-time did not independently predict participation. In addition, contrary to prior studies, Medicaid/Medicare insurance did not predict participation while uninsured patients or those with economic burden were less likely to participate in CR. Although not examined in our study, prior studies have suggested that low participation rates might be explained by a number of health system related variables. These include the high overall cost of services and co-payment for outpatient services, lack of access to CR as well as travel time and patients’ lack of knowledge and motivation for CR. 6, 26 Thus, it seems that system-wide changes are needed to improve both referral to, and enrollment in, CR. 6 While creating a performance measurement for referral is an important first step, creating a second measure to examine actual participation might be a more impactful clinical measure to a successful adjunct to insure participation if proper denominator specifications can be created. In addition, improving incentives, increased reimbursements for CR, effective communication between the referring and CR providers, coordination of the referral as a one-step system, improvement in patient education and development of new models for the delivery of CR including home-based and community based programs could potentially improve CR by gest on A ril 0, 2017 http://ciajournals.org/ D ow nladed from DOI: 10.1161/CIRCULATIONAHA.111.088799 13 participation. 6 Moreover, although it is desirable for pts to be enrolled within one month postAMI, there is no recommendation regarding the median time-to-start or clinical evidence regarding optimal time-to program start post-MI for patient outcomes. Future studies are need to examine the effect of optimal time to program commencement on patient outcomes. We identified important subgroups of patients who are most likely to benefit from CR after AMI, but paradoxically, are less likely to participate. We were further able to identify barriers that may differ at 1 and 6-months after AMI. Women receive equal benefit from CR participation as men after AMI. The Evidence-Based Guidelines for Cardiovascular Disease Prevention in Women specifically recommend CR after a coronary event. However, consistent with prior studies, we found that women are less likely to participate in CR at 1-month, but not 6 months after AMI after adjusting for a comprehensive set of demographic, clinical and treatment factors. 25, 28, 29 Although barriers to CR participation in women are not clear, others have suggested that women were more likely to have barriers related to transportation, family responsibilities, comorbidities and perceived exercise as tiring compared with men. 29 It is possible that women are able to overcome some of these barrier within 6-months after AMI leading to equal participation in CR compared with men. Similarly, patients with PAD, prior PCI and those with lower physical function are less likely to participate at 1-month despite a demonstrated benefit from CR. Further studies are needed to identify barriers to participation unique to these patients. Although we included a comprehensive set of demographic, clinical and treatment factors in our prospective multicenter study, our findings should be interpreted in the context of the following potential limitations. PREMIER did not audit whether referral forms were generated or if CR programs received them. In addition, we did not capture information on the types of CR by gest on A ril 0, 2017 http://ciajournals.org/ D ow nladed from DOI: 10.1161/CIRCULATIONAHA.111.088799 14 programs available. Nevertheless, we used a very inclusive definition of participation, capturing any participation in any CR program after AMI. In addition, we did not collect data on the specific CR referral steps used at each site. It seems that the combined approach of systematic (i.e., use of discharge order sets), plus liaison (personal bedside provision of information and invitation to enroll) appears to offer promise. Although a recent comprehensive review demonstrates that the evidence for any specific referral strategy is lacking. Future studies are needed to assess the effect of comprehensive strategies on CR enrollment. Participation in CR was self-reported using interviewer-administered questionnaires and we did not validate patients’ reported participation in CR. Since our objective was to examine the patient related predictors of CR enrollment, we did not evaluate health care system factors such as delay in test results for risk stratification, limited program capacity, access and cost of services that may affect CR enrollment. Future studies should evaluate healthcare system factors as potential predictors of CR enrollment. Additionally, in our study, 21% of patients were missing at least one covariate. However, missing covariate data were imputed using multiple imputation, including all potential covariates. Although we examined predictors of CR participation in multivariable analysis after controlling for multiple patient and clinical characteristics, unmeasured confounding is always a potential limitation in an observational study. Our study was not undertaken to develop a prediction model, but provides the foundation for developing one in the future. Finally, although our study was conducted between January, 2003 and June, 2004, we believe that our results are still valid. Our study data are consistent and more recent than the studies that were used for commissioning of the AHA Presidential Advisory 6 to make recommendations about CR delivery including the largest and most comprehensive evaluation to date regarding use of CR by Suaya et al (2007). This study assessed Medicare beneficiaries who had index hospitalization in 1997. by gest on A ril 0, 2017 http://ciajournals.org/ D ow nladed from DOI: 10.1161/CIRCULATIONAHA.111.088799 15 Our data are also consistent and more recent than the study by Mazzini et al (2008) that evaluated AHA Get With the Guidelines based clinical pathway on referral and enrollment into CR after AMI. Thus, there does not seem to be any narrowing of the gap between referral and CR enrollment. Conclusions CR is a key component of the comprehensive care of AMI patients and is a Class I recommendation after AMI. While improving the use of CR has been a longstanding goal for quality improvement, there remains a gap between referral to CR and subsequent participation. In our study, only 29% referred patients participated in CR at 1-month and 48% participated at 6months after AMI. Women, uninsured and patients with hypertension, PAD, lower physical function and prior PCI were less likely to participate at 1-month while non-Caucasians, older individuals, smokers and individuals with economic burden were less likely to participate at 6months after AMI. Since CR is associated with beneficial changes in CV risk factors and better outcomes, more aggressive efforts to increase CR participation after AMI are needed. Funding Sources: Cardiovascular Therapeutics and Cardiovascular Outcomes funded the PREMIER data collection and analysis. This study was also supported by the Emory University General Clinical Research Center (NIH MO1-RR00039) and NIH grant K12RR17643 (Dr Parashar and Mentored Clinical Scientist Development Award 1K23RR023171 (Dr Parashar). Dr. Vaccarino is supported by grant K24HL077506. Dr Spertus and Fengming Tang had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Role of the Sponsor: The grants and sponsors had no role in the design and conduct of the study; in the collection, analysis, and interpretation of the data; in the preparation of the data; or in the preparation, review or approval of the manuscript. Conflict of Interest Disclosures: None by gest on A ril 0, 2017 http://ciajournals.org/ D ow nladed from DOI: 10.1161/CIRCULATIONAHA.111.088799 16 References: 1. Leon AS, Franklin BA, Costa F, Balady GJ, Berra KA, Stewart KJ, Thompson PD, Williams MA, Lauer MS. Cardiac rehabilitation and secondary prevention of coronary heart disease An American Heart Association Scientific Statement from the Council on Clinical Cardiology (Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention) and the Council on Nutrition, Physical Activity, and Metabolism (Subcommittee on Physical Activity), in collaboration with the American Association of Cardiovascular and Pulmonary Rehabilitation. Circulation. 2005;111:369-376. 2. 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Characteristics of the study population according to participation in cardiac rehabilitation at 1-month after myocardial infarction Participated n = 419 Not Participated n = 1031 P-Value Sociodemographic Factors Age, years, mean (±SD) 60.2 ± 11.9 60.6 ± 12.1 0.561 Male 313 (74.7%) 702 (68.1%) 0.013 Caucasian 386 (92.1%) 830 (81.0%) < 0.001 Married 314 (75.8%) 668 (65.9%) 0.008 Greater than high school education 246 (59.1%) 506 (50.0%) 0.002 Current cigarette smoking 130 (31.2%) 353 (34.6%) 0.028 Avoided getting health care due to cost 63 (15.3%) 159 (15.8%) 0.820 Working full or part time at baseline 249 (60.0%) 506 (49.8%) < 0.001 ENRICHD Social Support Score 30.0 ± 5.0 29.9 ± 5.3 0.733 Health Care Insurance Uninsured/Self-Pay 23 (5.6%) 115 (11.6%) < 0.001 Medicare 134 (32.3%) 382 (38.5%) 0.028 Medicaid 8 (1.9%) 65 (6.5%) < 0.001 Medical History Hypercholesterolemia 219 (52.3%) 517 (50.1%) 0.464 Hypertension 201 (48.0%) 642 (62.3%) < 0.001 Diabetes 79 (18.9%) 267 (25.9%) 0.004 Peripheral arterial disease 15 (3.6%) 80 (7.8%) 0.004 Prior AMI 52 (12.4%) 200 (19.4%) 0.001 Prior CABG 30 (7.2%) 120 (11.6%) 0.011 Prior PCI 46 (11.0%) 197 (19.1%) < 0.001 Prior MI/CABG/PCI 79 (18.9%) 309 (30.0%) < 0.001 Chronic lung disease 28 (6.7%) 122 (11.8%) 0.004 Chronic renal failure 11 (2.6%) 50 (4.8%) 0.056 Family history of CHD 160 (38.2%) 363 (35.2%) 0.284 Prior angina 53 (12.6%) 180 (17.5%) 0.024 Congestive heart failure 16 (3.8%) 67 (6.5%) 0.046 Prior cerebrovascular accident 12 (2.9%) 53 (5.1%) 0.058 Body mass index 29.9 ± 5.7 29.3 ± 6.4 0.113 PHQ depression score 5.1 ± 5.3 5.1 ± 5.1 0.990 Baseline Health Status SF-36 Physical Component Scale, mean (±SD) 48± 10.7 43.9± 11.9 <0.001 Clinical characteristics at admission Other acute non-cardiac condition 3 (0.7%) 21 (2.0%) 0.074 Presenting systolic blood pressure 139.5 ± 29.2 137.7 ± 30.6 0.305 Presenting heart rate 78.0 ± 17.7 79.5 ± 19.9 0.190 STEMI 242 (57.8%) 538 (52.2%) 0.054 Left ventricular ejection fraction <40% 90 (21.5%) 256 (24.9%) 0.169 Diseased coronary vessels 0 1 2 3 25 (6.2%) 231 (56.9%) 85 (20.9%) 65 (16.0%) 67 (6.8%) 511 (52.0%) 227 (23.1%) 177 (18.0%) 0.434 Quality of Care ASA at Arrival 394 (97.5%) 991 (98.1%) 0.476 ASA at Discharge 391 (96.8%) 961 (95.1%) 0.175 by gest on A ril 0, 2017 http://ciajournals.org/ D ow nladed from DOI: 10.1161/CIRCULATIONAHA.111.088799 20 Participated n = 419 Not Participated n = 1031 P-Value ACE Inhibitor for LVSD at Discharge 70 (86.4%) 185 (84.1%) 0.618 Smoking Cessation Instructions 116 (87.2%) 297 (76.2%) 0.007 Beta Blocker at Discharge 383 (95.0%) 925 (94.5%) 0.678 Beta Blocker at Arrival 364 (93.3%) 888 (93.4%) 0.978 Reperfusion for STEMI/LBBB 202 (82.8%) 439 (76.9%) 0.060 Timely Reperfusion for STEMI/LBBB 121 (68.4%) 287 (69.5%) 0.785 Number of Eligible Indicators 5.3 ± 1.3 5.4 ± 1.3 0.581 Percent of Eligible Indicators Received 91.3 ± 13.5 89.8 ± 14.5 0.067 Revascularization: PCI (primary or other) or CABG 364 (86.9%) 869 (84.3%) 0.211 Abbreviations SD: Standard deviation LBBB: Left bundle branch block ACEI: Angiotensin converting enzyme inhibitor LVSD: Left ventricular systolic dysfunction ASA: Acetyl salicylic acid NSTEMI: Non-ST elevation myocardial infarction AMI: Acute myocardial infarction PCI: Percutaneous coronary intervention CHD: Coronary heart disease PHD: Patient Health Questionnaire CABG: Coronary artery bypass grafting STEMI: ST elevation myocardial infarction Table 2. Characteristics of the study population according to participation in cardiac rehabilitation at 6-months after myocardial infarction 6 month Participated Not Participated n = 650 n = 697 P-value Sociodemographic Factors Age, years, mean (±SD) 60.5 ± 11.5 61.0 ± 12.3 0.388 Male 465 (71.5%) 471 (67.6%) 0.114 Caucasian 597 (92.1%) 547 (78.8%) < 0.001 Married 475 (74.2%) 447 (65.1%) < 0.001 Greater than high school education 406 (62.9%) 307 (44.8%) < 0.001 Current cigarette smoking 178 (27.6%) 258 (37.3%) < 0.001 Avoided getting health care due to cost 67 (10.5%) 132 (19.4%) < 0.001 Working full or part time at baseline 366 (56.9%) 336 (48.8%) 0.003 ENRICHD social support score 30.2 ± 4.7 29.9 ± 5.5 0.22 Health Care Insurance Uninsured/Self-Pay 41 (6.5%) 83 (12.3%) < 0.001 Medicare 218 (34.3%) 272 (40.1%) 0.029 Medicaid 16 (2.5%) 45 (6.6%) < 0.001 Medical History Hypercholesterolemia 346 (53.2%) 343 (49.2%) 0.14 Hypertension 371 (57.1%) 419 (60.1%) 0.258 Diabetes 138 (21.2%) 179 (25.7%) 0.054 Peripheral arterial disease 32 (4.9%) 48 (6.9%) 0.128 Prior AMI 81 (12.5%) 145 (20.8%) < 0.001 by gest on A ril 0, 2017 http://ciajournals.org/ D ow nladed from DOI: 10.1161/CIRCULATIONAHA.111.088799 21 Abbreviations: SD: Standard deviation LBBB: Left bundle branch block ACEI: Angiotensin converting enzyme inhibitor LVSD: Left ventricular systolic dysfunction ASA: Acetyl salicylic acid NSTEMI: Non-ST elevation myocardial infarction AMI: Acute myocardial infarction PCI: Percutaneous coronary intervention CHD: Coronary heart disease PHD: Patient Health Questionnaire CABG: Coronary artery bypass grafting STEMI: ST elevation myocardial infarction Prior CABG 50 (7.7%) 91 (13.1%) 0.001 Prior PCI 81 (12.5%) 138 (19.8%) < 0.001 Prior MI/CABG/PCI 134 (20.6%) 219 (31.4%) < 0.001 Chronic lung disease 54 (8.3%) 75 (10.8%) 0.126 Chronic renal failure 16 (2.5%) 39 (5.6%) 0.004 Family history of CHD 243 (37.4%) 245 (35.2%) 0.394 Prior angina 91 (14.0%) 123 (17.6%) 0.067 Congestive heart failure 21 (3.2%) 52 (7.5%) < 0.001 Prior CVA 17 (2.6%) 39 (5.6%) 0.006 Body mass index 29.6 ± 5.9 29.3 ± 6.3 0.352 PHQ depression score 4.9 ± 5.1 5.1 ± 5.1 0.424 Baseline Health Status SF-36 Physical Component Scale, mean (±SD) 46.7 ± 11.2 44.0 ± 12.0 < 0.001 Clinical characteristics at admission Other acute non-cardiac condition 6 (0.9%) 15 (2.2%) 0.069 Presenting systolic blood pressure 138.6 ± 30.1 138.1 ± 29.7 0.777 Presenting heart rate 77.0 ± 17.4 79.9 ± 20.4 0.005 STEMI 376 (57.8%) 346 (49.6%) 0.003 Left ventricular ejection fraction <40% 152 (23.4%) 160 (23.0%) 0.875 Diseased coronary vessels 0.593 0 37 (5.9%) 47 (7.1%) 1 348 (55.1%) 350 (53.0%) 2 145 (22.9%) 144 (21.8%) 3 102 (16.1%) 119 (18.0%) Quality of Care ASA at arrival 617 (97.9%) 670 (98.1%) 0.835 ASA at discharge 611 (96.7%) 649 (95.2%) 0.167 ACE Inhibitor for LVSD at discharge 115 (86.5%) 118 (84.3%) 0.611 Smoking Cessation Instructions 154 (79.8%) 219 (79.1%) 0.847 Beta Blocker at arrival 562 (93.5%) 606 (93.5%) 0.996 Beta Blocker at discharge 597 (96.3%) 619 (93.1%) 0.011 Reperfusion for STEMI/LBBB 308 (82.1%) 290 (75.7%) 0.03 Timely reperfusion for STEMI/LBBB 201 (71.8%) 182 (66.7%) 0.192 Number of eligible Indicators 5.3 ± 1.3 5.4 ± 1.3 0.451 Percent of eligible Indicators received 91.5 ± 12.9 89.4 ± 14.9 0.007 Revascularization: PCI or CABG (primary or other) 574 (88.3%) 577 (82.8%) 0.004 by gest on A ril 0, 2017 http://ciajournals.org/ D ow nladed from DOI: 10.1161/CIRCULATIONAHA.111.088799