Patient-Reported Outcome Measures in Routine Clinical Practice: Practical Guidance for Institutional Review Boards.

The use of patient-reported outcome measures (PROMs) is increasingly common in routine clinical practice. As tools to quantify symptoms and health status, PROMs play an important role in focusing health care on outcomes that matter to patients. The uses of PROM data are myriad, ranging from clinical care to survey-based research and quality improvement. Discerning the boundaries between these use cases can be challenging for institutional review boards (IRBs). In this article, we provide a framework for classifying the three primary PROM use cases (clinical care, human subjects research, and quality improvement) and discuss the level of IRB oversight (if any) necessary for each. One of the most important considerations for IRB staff is whether PROMs are being used primarily for clinical care and thus do not constitute human subjects research. We discuss characteristics of PROMs implemented primarily for clinical care, focusing on: data platform; survey location; questionnaire length; patient interface; and clinician interface. We also discuss IRB oversight of projects involving the secondary use of PROM data that were collected during the course of clinical care, which span human subjects research and quality improvement. This framework provides practical guidance for IRB staff as well as clinicians who use PROMs as communication aids in routine clinical practice.

Surgically-relevant quality of life thresholds for the Short Inflammatory Bowel Disease Questionnaire in Crohn's disease.

BACKGROUND: Despite growing interest in patient-reported outcome measures to track the progression of Crohn's disease, frameworks to apply these questionnaires in the preoperative setting are lacking. Using the Short Inflammatory Bowel Disease Questionnaire (sIBDQ), this study aimed to describe the interpretable quality of life thresholds and examine potential associations with future bowel resection in Crohn's disease. METHODS: Adult patients with Crohn's disease completing an sIBDQ at a clinic visit between 2020 and 2022 were eligible. A stoplight framework was adopted for sIBDQ scores, including a "Resection Red" zone suggesting poor quality of life that may benefit from discussions about surgery as well as a "Nonoperative Green" zone. Thresholds were identified with both anchor- and distribution-based methods using receiver operating characteristic curve analysis and subgroup percentile scores, respectively. To quantify associations between sIBDQ scores and subsequent bowel resection, multivariable logistic regression models were fit with covariates of age, sex assigned at birth, body mass index, medications, disease pattern and location, resection history, and the Harvey Bradshaw Index. The incremental discriminatory value of the sIBDQ beyond clinical factors was assessed through the area under the receiver operating characteristics curve (AUC) with an internal validation through bootstrap resampling. RESULTS: Of the 2003 included patients, 102 underwent Crohn's-related bowel resection. The sIBDQ Nonoperative Green zone threshold ranged from 61 to 64 and the Resection Red zone from 36 to 38. When adjusting for clinical covariates, a worse sIBDQ score was associated with greater odds of subsequent 90-day bowel resection when considered as a 1-point (odds ratio [OR] [95% CI], 1.05 [1.03-1.07]) or 5-point change (OR [95% CI], 1.27 [1.14-1.41]). Inclusion of the sIBDQ modestly improved discriminative performance (AUC [95% CI], 0.85 [0.85-0.86]) relative to models that included only demographics (0.57 [0.57-0.58]) or demographics with clinical covariates (0.83 [0.83-0.84]). CONCLUSION: In the decision-making process for bowel resection, disease-specific patient-reported outcome measures may be useful to identify patients with Crohn's disease with poor quality of life and promote a shared understanding of personalized burden.

Patient-reported predictors of postdischarge mortality after cardiac hospitalization.

BACKGROUND: Adults hospitalized for cardiovascular events are at high risk for postdischarge mortality. Screening of psychosocial risk is prioritized by the Joint Commission. We tested whether key patient-reported psychosocial and behavioral measures could predict posthospitalization mortality in a cohort of adults hospitalized for a cardiovascular event. METHODS: We conducted a prospective cohort study to test the prognostic utility of validated patient-reported measures, including health literacy, social support, health behaviors and disease management, and socioeconomic status. Cox survival analyses of mortality were conducted over a median of 3.5 years. RESULTS: Among 2977 adults hospitalized for either acute coronary syndrome or acute decompensated heart failure, the mean age was 53 years, and 60% were male. After adjusting for demographic, clinical, and other psychosocial factors, mortality risk was greatest among patients who reported being unemployed (hazard ratio [HR]: 1.99, 95% confidence interval [CI]): 1.30-3.06), retired (HR: 2.14, 95% CI: 1.60-2.87), or unable to work due to disability (HR: 2.36, 95% CI: 1.73-3.21), as compared to those who were employed. Patient-reported perceived health competence (PHCS-2) and exercise frequency were also associated with mortality risk after adjusting for all other variables (HR: 0.86, 95% CI: 0.73-1.00 per four-point increase in PHCS-2; HR: 0.86, 95% CI: 0.77-0.96 per 3-day increase in exercise frequency, respectively). CONCLUSIONS: Patient-reported measures of employment status, perceived health competence, and exercise frequency independently predict mortality after a cardiac hospitalization. Incorporating these brief, valid measures into hospital-based screening may help with prognostication and targeting patients for resources during post-discharge transitions of care.

Patient-reported predictors of post-discharge mortality after cardiac hospitalization.

Background: Adults hospitalized for cardiovascular events are at high risk for post-discharge mortality. Hospital-based screening of health-related psychosocial risk factors is now prioritized by the Joint Commission and the National Quality Forum to achieve equitable, high-quality care. We tested our hypothesis that key patient-reported psychosocial and behavioral measures could predict post-hospitalization mortality in a cohort of adults hospitalized for a cardiovascular event. Methods: This was a prospective cohort of adults hospitalized at Vanderbilt University Medical Center. Validated patient-reported measures of health literacy, social support, disease self-management, and socioeconomic status were used as predictors of interest. Cox survival analyses of mortality were conducted over a median 3.5-year follow-up (range: 1.25 - 5.5 years). Results: Among 2,977 adults, 1,874 (63%) were hospitalized for acute coronary syndrome and 1,103 (37%) were hospitalized for acute decompensated heart failure; 60% were male; and the mean age was 53 years. After adjusting for demographic, clinical, and other psychosocial factors, mortality risk was greatest among patients who reported being unable to work due to disability (Hazard Ratio (HR) 2.36, 95% Confidence Interval (CI): 1.73-3.21), who were retired (HR 2.14, 95% CI 1.60-2.87), and who reported unemployment (HR 1.99, 95% CI 1.30-3.06) as compared to those who were employed. Patient-reported measures of disease self-management, perceived health competence and exercise frequency, were also associated with mortality risk after full covariate adjustment (HR 0.86, 95% CI 0.73-1.00 per four-point increase), (HR 0.86, 95% CI 0.77-0.96 per three-day change), respectively. Conclusions: Patient-reported measures of employment status independently predict post-discharge mortality after a cardiac hospitalization. Measure of disease self-management also have prognostic modest utility. Hospital-based screening of psychosocial risk is increasingly prioritized in legislative policy. Incorporating brief, valid measures of employment status and disease self-management factors may help target patients for psychosocial, financial, and rehabilitative resources during post-discharge transitions of care.

Geographic Variation in Access to Cardiac Rehabilitation.

BACKGROUND: There is marked geographic variation in cardiac rehabilitation (CR) initiation, ranging from 10% to 40% of eligible patients at the state level. The potential causes of this variation, such as patient access to CR centers, are not well studied. OBJECTIVES: The authors sought to determine how access to CR centers affects CR initiation in Medicare beneficiaries. METHODS: The authors used Medicare files to identify CR-eligible Medicare beneficiaries and calculate CR initiation rates at the hospital referral region (HRR) level. We used linear regression to evaluate the percent variation in CR initiation accounted for by CR access across HRRs. We then employed geospatial hotspot analysis to identify CR deserts, or counties in which patient load per CR center is disproportionately high. RESULTS: A total of 1,133,657 Medicare beneficiaries were eligible for CR from 2014 to 2017, of whom 263,310 (23%) initiated CR. The West North Central Census Division had the highest adjusted CR initiation rate (35.4%) and the highest density of CR programs (6.58 per 1,000 CR-eligible Medicare beneficiaries). Density of CR programs accounted for 21.2% of geographic variation in CR initiation at the HRR level. A total of 40 largely urban counties comprising 14% of the United States population age ≥65 years had disproportionately low CR access and were identified as CR deserts. CONCLUSIONS: A substantial proportion of geographic variation in CR initiation was related to access to CR programs, with a significant amount of the U.S. population living in CR deserts. These data invite further study on interventions to increase CR access.

Association of Perceived Health Competence With Cardiac Rehabilitation Initiation.

PURPOSE: Cardiac rehabilitation (CR), a program of supervised exercise and cardiovascular risk management, is widely underutilized. Psychological factors such as perceived health competence, or belief in one's ability to achieve health-related goals, may play a role in CR initiation. The aim of this study was to evaluate the association of perceived health competence with CR initiation among patients hospitalized for acute coronary syndrome (ACS) after adjusting for demographic, clinical, and psychosocial characteristics. METHODS: The Vanderbilt Inpatient Cohort Study (VICS) characterized the effect of psychosocial characteristics on post-discharge outcomes in ACS inpatients hospitalized from 2011 to 2015. The primary outcome for this analysis was participation in an outpatient CR program. The primary predictor was the two-item Perceived Health Competence Scale (PHCS-2), which yields a score from 2 to 10 (higher scores indicate greater perceived health competence). Multiple logistic regression was used to evaluate the relationship between the PHCS-2 and CR initiation. RESULTS: A total of 1809 VICS participants (median age: 61 yr, 39% female) with ACS were studied, of whom 294 (16%) initiated CR. The PHCS-2 was associated with a higher odds of CR initiation (OR = 1.15/point increase: 95% CI, 1.06-1.26, P = .001) after adjusting for covariates. Participants with comorbid heart failure had a lower odds of CR initiation (OR = 0.31: 95% CI, 0.16-0.60, P < .001) as did current smokers (OR = 0.64: 95% CI, 0.43-0.96, P = .030). CONCLUSION: Perceived health competence is associated with outpatient CR initiation in patients hospitalized with ACS. Interventions designed to support perceived health competence may be useful for improving CR participation.

Collection and Utilization of Patient-Reported Outcome Measures in a Colorectal Surgery Clinic.

INTRODUCTION: The routine collection of patient-reported outcome measures (PROMs) promises to improve patient care. However, in colorectal surgery, PROMs are uncommonly collected outside of clinical research studies and rarely used in clinical care. We designed and implemented a quality improvement project with the goals of routinely collecting PROMs and increasing the frequency that PROMs are utilized by colorectal surgeons in clinical practice. METHODS: This mixed-methods, quality improvement project was conducted in the colorectal surgery clinic of a tertiary academic medical center. Patients were administered up to five PROMs before each appointment. PROM completion rates were measured. Additionally, we performed two educational interventions to increase utilization of our electronic health record's PROM dashboard by colorectal surgeons. Utilization rates and attitudes toward the PROM dashboard were measured. RESULTS: Overall, patients completed 3600 of 3977 (90.9%) administered PROMs during the study period. At baseline, colorectal surgeons reviewed 6.7% of completed PROMs. After two educational interventions, this increased to 39.3% (P = 0.004). Colorectal surgeons also felt that the PROM dashboard was easier to use. Barriers to greater PROM dashboard utilization included poor user interface/user experience and a perceived lack of knowledge, time, and relevance. CONCLUSIONS: The collection of PROMs in colorectal surgery clinics is feasible and can result in high PROM completion rates. Educational interventions can improve the utilization of PROMs by colorectal surgeons in clinical practice. Our experience collecting PROMs through this quality improvement initiative can serve as a template for other colorectal surgery clinics interested in collecting and utilizing data from PROMs.

Developing an Implementation Strategy for Systematic Measurement of Patient-Reported Outcomes at an Academic Health Center.

EXECUTIVE SUMMARY: Patient-reported outcome measures (PROMs) are used in research and have the potential to improve clinical care. We sought to develop a strategy for integrating PROMs into routine clinical care at an academic health center. The implementation strategy consisted of three phases. The first, exploratory phase, focused on engaging leadership and conducting an inventory of current efforts to collect PROMs. The inventory revealed 87 patient-reported outcome efforts, 47 of which used validated PROMs (62% for research, 21% for clinical care, 17% for quality). In the second, preparatory phase, we identified three pilot implementation sites chosen with facilitators determined in the exploratory phase. Using data from local needs assessments at the pilot sites, we constructed a timeline for inclusion of PROM efforts across the clinical enterprise. In the third phase, we adapted a technology platform for capturing PROMs using the electronic health record and began implementing this platform at the pilot sites. We found that integrating PROMs into routine clinical practice is highly complex. This complexity necessitates change management at the enterprise level.

Association of Cardiac Rehabilitation With Decreased Hospitalization and Mortality Risk After Cardiac Valve Surgery.

Importance: National guidelines recommend cardiac rehabilitation (CR) after cardiac valve surgery, and CR is covered by Medicare for this indication. However, few data exist regarding current CR enrollment after valve surgery. Objective: To characterize CR enrollment after cardiac valve surgery and its association with outcomes, including hospitalizations and mortality. Design, Setting, and Participants: This cohort study of patients undergoing valve surgery was conducted in calendar year 2014, with follow-up through 2015. The study included all fee-for-service Medicare beneficiaries undergoing open cardiac valve surgery in 2014. Patients identified by inpatient diagnosis codes for open aortic, mitral, tricuspid, and pulmonary valve surgery were included. Data analysis occurred from January 2018 to March 2019. Exposures: Logistic regression was used to evaluate sociodemographic and clinical factors associated with CR enrollment. Main Outcomes and Measures: We used Andersen-Gill models to evaluate the association of CR enrollment with 1-year hospitalization risk and Cox regression models to evaluate the association of CR enrollment with 1-year mortality risk. Results: A total of 41 369 Medicare beneficiaries (median [interquartile range] age, 73 [68-79] years; 16 935 [40.9%] female) underwent open valve surgery in the United States in 2014. Fewer than half of patients (17 855 [43.2%]) who had valve surgery enrolled in CR programs. Several racial/ethnic groups had lower odds of enrolling in CR programs after valve surgery compared with white patients, including Asian patients (odds ratio [OR], 0.36 [95% CI, 0.28-0.47]), black patients (OR, 0.60 [95% CI, 0.54-0.67]), and Hispanic patients (OR, 0.36 [95% CI, 0.28-0.46]). Patients undergoing concomitant coronary artery bypass grafting had higher odds of CR enrollment (OR, 1.26 [95% CI, 1.20-1.31]) than those without the concomitant coronary artery bypass graft procedure, as did patients in the Midwest census region (OR, 2.40 [95% CI, 2.28-2.54]) compared with those in the South (reference). Cardiac rehabilitation enrollment was associated with fewer hospitalizations within 1 year of discharge (hazard ratio, 0.66 [95% CI, 0.63-0.69] after multivariable adjustment). Enrollment was also associated with a 4.2% absolute decrease in 1-year mortality risk (hazard ratio, 0.39 [95% CI, 0.35-0.44] after multivariable adjustment). Conclusions and Relevance: Fewer than half of Medicare beneficiaries undergoing cardiac valve surgery enroll in CR programs, and there are marked racial/ethnic disparities among those that do. Cardiac rehabilitation is associated with decreased 1-year cumulative hospitalization and mortality risk after valve surgery. These results invite further study on barriers to CR enrollment in this population.

Depressed Mood, Perceived Health Competence and Health Behaviors: aCross-Sectional Mediation Study in Outpatients with Coronary Heart Disease.

BACKGROUND: Identifying potential mechanisms that link depressed mood with worse health behaviors is important given the prevalence of depressed mood in patients with coronary heart disease (CHD) and its relationship with subsequent mortality. Perceived health competence is an individual's confidence in his/her ability to successfully engineer solutions to achieve health goals and may explain how depressed mood affects multiple health behaviors. OBJECTIVE: Examine whether or not perceived health competence mediates the relationship between depressed mood and worse health behaviors. DESIGN: A cross-sectional study conducted by the Patient-Centered Outcomes Research Institute-funded Mid-South Clinical Data Research Network between August 2014 and September 2015. Bootstrapped mediation was used. PARTICIPANTS: Patients with coronary heart disease (n = 2334). MAIN MEASURES: Two items assessing perceived health competence, a single item assessing depressed mood, and a Health Behaviors Index including: the International Physical Activity Questionnaire (IPAQ); select items from the National Adult Tobacco Survey and the Alcohol Use Disorder Inventory Test; and single items assessing diet and medication adherence. KEY RESULTS: Depressed mood was associated with lower perceived health competence (a = - 0.21, p < .001) and lower perceived health competence was associated with worse performance on a Health Behaviors Index(b = 0.18, p < .001). Perceived health competence mediated the influence of depressed mood on health behaviors (ab = - 0.04, 95% CI = - 0.05 to - 0.03). The ratio of the indirect effect to the total effect was used as a measure of effect size (PM = 0.26, 95% CI: 0.18 to 0.39). CONCLUSIONS: Depressed mood is associated with worse health behaviors directly and indirectly via lower perceived health competence. Interventions to increase perceived health competence may lessen the deleterious impact of depressed mood on health behaviors and cardiovascular outcomes.

Design and outcomes of the Patient Centered Outcomes Research Institute coronary heart disease cohort study.

BACKGROUND: The Patient Centered Outcomes Research Institute (PCORI) established Clinical Data Research Networks (CDRNs) to support pragmatic research. The objective was to electronically identify, recruit, and survey coronary heart disease (CHD) patients and describe their characteristics, health status, and willingness to participate in future research. METHODS: We developed a computable phenotype and assembled CHD patients 30 years or older and had visits or hospitalizations between 2009 and 2015. A sample of patients was surveyed between August 2014 and September 2015. Survey administration included the following methods: face-to-face, telephone, paper or web portal. Survey items covered broad domains including: health literacy and numeracy, and socio-demographics, physical and mental health, health behaviors, access to medical care, and willingness to participate in future research. RESULTS: Of 5517 approached patients, 2605 completed the survey. Participants were mostly white (∼88%), male (68%) and had a median age of 69 years (interquartile range [IQR] 61-76 years). Most respondents' health literacy and numeracy were adequate (83.2% and 84.3%, respectively). Only 4% of respondents reported that their overall health or physical health was excellent. The majority (∼58%) reported that their health was good or very good, while 40% reported that their general and physical health were fair or poor. The majority reported that their quality of life was good to excellent (81%). Limitations in physical health and function were common, including often/always having fatigue (25%), pain (38.7%), or sleep difficulty (19.7%). A patient sample (n = 1936) was provided with a trial summary which would randomize their aspirin dose; and 63% reported that they would consider participating. CONCLUSION: Many patients with CHD had limitations in physical health. However, the majority reported a good or excellent quality of life.

Relation of Perceived Health Competence to Physical Activity in Patients With Coronary Heart Disease.

Physical inactivity is highly associated with mortality, especially in patients with coronary heart disease. We evaluated the effect of perceived health competence, a patient's belief in his or her ability to achieve health-related goals, on cumulative physical activity levels in the Mid-South Coronary Heart Disease Cohort Study. The Mid-South Coronary Heart Disease Cohort Study consists of 2,587 outpatients (32% were female) with coronary heart disease at an academic medical center network in the United States. Cumulative physical activity was quantified in metabolic equivalent (MET)-minutes per week with the International Physical Activity Questionnaire. We investigated associations between the 2-item Perceived Health Competence Scale (PHCS-2) and MET-minutes/week after adjusting for co-morbidities and psychosocial factors with linear regression. Nearly half of participants (47%) exhibited low physical activity levels (<600 MET-minutes/week). Perceived health competence was highly associated with physical activity after multivariable adjustment. A nonlinear relation was observed, with the strongest effect on physical activity occurring at lower levels of perceived health competence. There was effect modification by gender (p = 0.03 for interaction). The relation between perceived health competence and physical activity was stronger in women compared with men; an increase in the PHCS-2 from 3 to 4 was associated with a 73% increase in MET-minutes/week in women (95% confidence interval 43% to 109%, p <0.0001) compared with a 53% increase in men (95% confidence interval 27% to 84%, p <0.0001). In conclusion, low perceived health competence was strongly associated with less physical activity in patients with coronary heart disease and may represent a potential target for behavioral interventions.

Association of Cardiac Rehabilitation With Decreased Hospitalizations and Mortality After Ventricular Assist Device Implantation.

OBJECTIVES: This study characterized cardiac rehabilitation (CR) use in ventricular assist device (VAD) recipients in the United States and the association of CR with 1-year hospitalization and mortality by using the 2013 to 2015 Medicare files. BACKGROUND: Exercise-based CR is indicated in patients with heart failure with reduced ejection fraction, but no data exist regarding CR participation after VAD implantation. METHODS: The study included Medicare beneficiaries enrolled for disability or age >65 years. The investigators identified VAD recipients by diagnosis codes and cumulated CR sessions occurring within 1 year after VAD implantation. Multivariable-adjusted Andersen-Gill models were used to evaluate the association of CR with 1-year hospitalization risk, and Cox regression was used to evaluate the association of CR with 1-year mortality. RESULTS: There were 1,164 VADs implanted in Medicare beneficiaries in the United States in 2014. CR use was low, with 348 patients (30%) participating in CR programs. The Midwest had the highest proportion of VAD recipients who began CR (38%), whereas the Northeast had the lowest proportion of CR participants (25%). Each 5-year increase in age was associated with attending an additional 1.6 CR sessions (95% confidence interval [CI]: 0.7 to 2.5; p < 0.001). CR participation was associated with a 23% lower 1-year hospitalization risk (95% CI: 11% to 33%; p < 0.001) and a 47% lower 1-year mortality risk (95% CI: 18% to 66%; p < 0.01) after multivariable adjustment. CONCLUSIONS: Approximately one-third of VAD recipients attend CR. Although it is not possible to account fully for unmeasured confounding, VAD recipients who participate in CR appear to have lower risks for hospitalization and mortality.

Neighborhood Deprivation Predicts Heart Failure Risk in a Low-Income Population of Blacks and Whites in the Southeastern United States.

BACKGROUND: Recent data suggest that neighborhood socioeconomic environment predicts heart failure (HF) hospital readmissions. We investigated whether neighborhood deprivation predicts risk of incident HF beyond individual socioeconomic status in a low-income population. METHODS AND RESULTS: Participants were 27 078 whites and blacks recruited during 2002 to 2009 in the SCCS (Southern Community Cohort Study), who had no history of HF and were using Centers for Medicare or Medicaid Services. Incident HF diagnoses through December 31, 2010, were ascertained using International Classification of Diseases, Ninth Revision, codes 428.x via linkage with Centers for Medicare or Medicaid Services research files. Participant residential information was geocoded and census tract determined by a spatial join to the US Census Bureau TIGER/Line Shapefiles. The neighborhood deprivation index was constructed using principal components analysis based on census tract-level socioeconomic variables. Cox models with Huber-White cluster sandwich estimator of variance were used to investigate the association between neighborhood deprivation index and HF risk. The study sample was predominantly middle aged (mean, 55.5 years), black (69%), female (63%), low income (70% earned <$15 000/y), and >50% of participants lived in the most deprived neighborhoods (third neighborhood deprivation index tertile). Over median follow-up of 5.2 years, 4300 participants were diagnosed with HF. After adjustment for demographic, lifestyle, and clinical factors, a 1 interquartile increase in neighborhood deprivation index was associated with a 12% increase in risk of HF (hazard ratio, 1.12; 95% confidence interval, 1.07-1.18), and 4.8% of the variance in HF risk (intraclass correlation coefficient, 4.8; 95% confidence interval, 3.6-6.4) was explained by neighborhood deprivation. CONCLUSIONS: In this low-income population, scant neighborhood resources compound the risk of HF above and beyond individual socioeconomic status and traditional cardiovascular risk factors. Improvements in community resources may be a significant axis for curbing the burden of HF.

Geographic Variation in Cardiac Rehabilitation Participation in Medicare and Veterans Affairs Populations: Opportunity for Improvement.

BACKGROUND: Cardiac rehabilitation is strongly recommended after myocardial infarction, percutaneous coronary intervention, or coronary artery bypass surgery, but it is historically underused. We sought to evaluate variation in cardiac rehabilitation participation across the United States. METHODS: From administrative data from the Veterans Affairs (VA) healthcare system and a 5% Medicare sample, we used International Classification of Diseases, 9th Revision codes to identify patients hospitalized for myocardial infarction, percutaneous coronary intervention, or coronary artery bypass surgery from 2007 to 2011. After excluding patients who died in ≤30 days of hospitalization, we calculated the percentage of patients who participated in ≥1 outpatient visits for cardiac rehabilitation during the 12 months after hospitalization. We estimated adjusted and standardized rates of participation in cardiac rehabilitation by state using hierarchical logistic regression models. RESULTS: Overall, participation in cardiac rehabilitation was 16.3% (23 403/143 756) in Medicare and 10.3% (9123/88 826) in VA. However, participation rates varied widely across states, ranging from 3.2% to 41.8% in Medicare and 1.2% to 47.6% in VA. Similar regional variation was observed in both populations. Patients in the West North Central region (Iowa, Kansas, Minnesota, Missouri, Nebraska, North Dakota, and South Dakota) had the highest participation, whereas those in the Pacific region (Alaska, California, Hawaii, Oregon, and Washington) had the lowest participation in both Medicare (33.7% versus 10.6%) and VA (16.6% versus 5.1%) populations. Significant hospital-level variation was also present, with participation ranging from 3% to 75% in Medicare and 1% to 43% in VA. CONCLUSIONS: Cardiac rehabilitation participation remains low overall in both Medicare and VA populations. However, remarkably similar regional variation exists, with some regions and hospitals achieving high rates of participation in both populations. This provides an opportunity to identify best practices from higher performing hospitals and regions that could be used to improve cardiac rehabilitation participation in lower performing hospitals and regions.

Cardiac rehabilitation and readmissions after heart transplantation.

BACKGROUND: Exercise-based cardiac rehabilitation (CR) is under-utilized. CR is indicated after heart transplantation, but there are no data regarding CR participation in transplant recipients. We characterized current CR utilization among heart transplant recipients in the United States and the association of CR with 1-year readmissions using the 2013-2014 Medicare files. METHODS: The study population included Medicare beneficiaries enrolled due to disability (patients on the transplant list are eligible for disability benefits under Medicare regulations) or age ≥65 years. We identified heart transplant patients by diagnosis codes and cumulative CR sessions occurring within 1 year after the transplant hospitalization. RESULTS: There were 2,531 heart transplant patients in the USA in 2013, of whom 595 (24%) received Medicare coverage and were included in the study. CR utilization was low, with 326 patients (55%) participating in CR programs. The Midwest had the highest proportion of transplant recipients initiating CR (68%, p = 0.001). Patients initiating CR attended a mean of 26.7 (standard deviation 13.3) sessions, less than the generally prescribed program of 36 sessions. Transplant recipients age 35 to 49 years were less likely to initiate CR (odds ratio [OR] 0.39, 95% confidence interval [CI] 0.23 to 0.66, p < 0.001) and attended 8.2 fewer sessions (95% CI 3.5 to 12.9, p < 0.001) than patients age ≥65 years. CR participation was associated with a 29% lower 1-year readmission risk (95% CI 13% to 42%, p = 0.001). CONCLUSIONS: Only half of cardiac transplant recipients participate in CR, and those who do have a lower 1-year readmission risk. These data invite further study on barriers to CR in this population.

Association of Neighborhood Socioeconomic Context With Participation in Cardiac Rehabilitation.

BACKGROUND: Cardiac rehabilitation (CR) is underutilized in the United States, with fewer than 20% of eligible patients participating in CR programs. Individual socioeconomic status is associated with CR utilization, but data regarding neighborhood characteristics and CR are sparse. We investigated the association of neighborhood socioeconomic context with CR participation in the SCCS (Southern Community Cohort Study). METHODS AND RESULTS: The SCCS is a prospective cohort study of 84 569 adults in the southeastern United States from 2002 to 2009, 52 117 of whom have Medicare or Medicaid claims. Using these data, we identified participants with hospitalizations for myocardial infarction, percutaneous coronary intervention, or coronary artery bypass surgery and ascertained their CR utilization. Neighborhood socioeconomic context was assessed using a neighborhood deprivation index derived from 11 census-tract level variables. We analyzed the association of CR utilization with neighborhood deprivation after adjusting for individual socioeconomic status. A total of 4096 SCCS participants (55% female, 57% black) with claims data were eligible for CR. CR utilization was low, with 340 subjects (8%) participating in CR programs. Study participants residing in the most deprived communities (highest quintile of neighborhood deprivation) were less than half as likely to initiate CR (odds ratio 0.42, 95% confidence interval, 0.27-0.66, P<0.001) as those in the lowest quintile. CR participation was inversely associated with all-cause mortality (hazard ratio 0.77, 95% confidence interval, 0.60-0.996, P<0.05). CONCLUSIONS: Lower neighborhood socioeconomic context was associated with decreased CR participation independent of individual socioeconomic status. These data invite research on interventions to increase CR access in deprived communities.

Group Enrollment and Open Gym Format Decreases Cardiac Rehabilitation Wait Times.

PURPOSE: Wait times for the first cardiac rehabilitation (CR) session are inversely related to CR participation rates. We hypothesized that changing from individually scheduled appointments to a group enrollment and open gym format, in which patients were enrolled during group intake sessions and could arrive for subsequent CR sessions any time during open gym periods, would decrease wait times. METHODS: A total of 603 patients enrolled in CR at Vanderbilt University Medical Center from July 2012 to December 2014 were included in the study. We evaluated the effect of changing to a group enrollment and open gym format after adjusting for referral diagnosis, insurance status, seasonality, and other factors. We compared outcomes, including exercise capacity and quality of life, between the 2 groups. RESULTS: Patients in the group enrollment and open gym format had significantly lower average wait times than those receiving individual appointments (14.9 vs 19.5 days, P < .001). After multivariable adjustment, the new CR delivery model was associated with a 22% (3.7 days) decrease in average wait times (95% CI, 1.9-5.6, P < .001). Patients completing CR had equally beneficial changes in 6-minute walk distance and Patient Health Questionnaire scores between the 2 groups, although there was no significant difference in participation rates or the number of sessions attended. CONCLUSIONS: Implementation of a group enrollment and open gym format was associated with a significant decrease in wait times for first CR sessions. This CR delivery model may be an option for programs seeking to decrease wait times.

Recruitment methods for survey research: Findings from the Mid-South Clinical Data Research Network.

PURPOSE: The objective of this study was to report survey response rates and demographic characteristics of eight recruitment approaches to determine acceptability and effectiveness of large-scale patient recruitment among various populations. METHODS: We conducted a cross sectional analysis of survey data from two large cohorts. Patients were recruited from the Mid-South Clinical Data Research Network using clinic-based recruitment, research registries, and mail, phone, and email approaches. Response rates are reported as patients who consented for the survey divided by the number of eligible patients approached. RESULTS: We contacted more than 90,000 patients and 13,197 patients completed surveys. Median age was 56.3years (IQR 40.9, 67.4). Racial/ethnic distribution was 84.1% White, non-Hispanic; 9.9% Black, non-Hispanic; 1.8% Hispanic; and 4.0% other, non-Hispanic. Face-to-face recruitment had the highest response rate of 94.3%, followed by participants who "opted-in" to a registry (76%). The lowest response rate was for unsolicited emails from the clinic (6.1%). Face-to-face recruitment enrolled a higher percentage of participants who self-identified as Black, non-Hispanic compared to other approaches (18.6% face-to-face vs. 8.4% for email). CONCLUSIONS: Technology-enabled recruitment approaches such as registries and emails are effective for recruiting but may yield less racial/ethnic diversity compared to traditional, more time-intensive approaches.