Cardiorespiratory Fitness, Alcohol Intake, and Metabolic Syndrome Incidence in Men

Purpose To prospectively examine the independent and joint effects of alcohol consumption and cardiorespiratory fitness on the incidence of metabolic syndrome in a cohort of men. Methods A prospective examination of 3,411 apparently healthy men at baseline, who came to the Cooper Clinic (Dallas, Texas) for at least 2 preventive visits (1979–2010). Primary exposure variables were cardiorespiratory fitness and alcohol intake; the outcome measure was metabolic syndrome (MetS) and the components thereof. Cox proportional hazard models were computed to assess the relationship between the exposure variables and the incidence of MetS while adjusting for confounders. Results Over a mean follow-up period of 9 years (SD=7.8), 276 men developed MetS. In multivariable analysis, a dose-response relationship was observed between increased levels of fitness and reduced MetS risk (moderate fitness: HR=0.60, 95%CI 0.43–0.82; high fitness: HR=0.49, 95%CI 0.35–0.69). When examining the independent effects of alcohol, light drinking increased the risk for MetS by 66% (HR=1.66, 95%CI 1.11–2.48). No statistically significant interaction effect was observed between alcohol and fitness in relation to MetS (P = 0.32). When assessing the relation between each exposure and the components of MetS, higher fitness consistently reduced the risk of all components; whereas lower alcohol intake reduced the risk of elevated glucose and blood pressure and increased the risk for low HDL-c. Conclusions Among this cohort of men, higher fitness levels reduced the risk for MetS and its components. The relation between alcohol intake levels and metabolic risk was more complex and not reflected when examining MetS as a whole

Factors Related to Implementation and Reach of a Pragmatic Multisite Trial: The My Own Health Report (MOHR) Study

BACKGROUND: Contextual factors relevant to translating healthcare improvement interventions to different settings are rarely collected systematically. This study articulates a prospective method for assessing and describing contextual factors related to implementation and patient reach of a pragmatic trial in primary care. METHODS: In a qualitative case-series, contextual factors were assessed from the My Own Health Report (MOHR) study, focused on systematic health risk assessments and goal setting for unhealthy behaviors and behavioral health in nine primary care practices. Practice staff interviews and observations, guided by a context template were conducted prospectively at three time points. Patient reach was calculated as percentage of patients completing MOHR of those who were offered MOHR and themes describing contextual factors were summarized through an iterative, data immersion process.These included practice members' motivations towards MOHR, practice staff capacity for implementation, practice information system capacity, external resources to support quality improvement, community linkages, and implementation strategy fit with patient populations. CONCLUSIONS: Systematically assessing contextual factors prospectively throughout implementation of quality improvement initiatives helps translation to other health care settings. Knowledge of contextual factors is essential for scaling up of effective interventions

Learning Evaluation: Blending Quality Improvement and Implementation Research Methods to Study Healthcare Innovations

Background: In healthcare change interventions, on-the-ground learning about the implementation process is often lost because of a primary focus on outcome improvements. This paper describes the Learning Evaluation, a methodological approach that blends quality improvement and implementation research methods to study healthcare innovations. Methods: Learning Evaluation is an approach to multi-organization assessment. Qualitative and quantitative data are collected to conduct real-time assessment of implementation processes while also assessing changes in context, facilitating quality improvement using run charts and audit and feedback, and generating transportable lessons. Five principles are the foundation of this approach: (1) gather data to describe changes made by healthcare organizations and how changes are implemented; (2) collect process and outcome data relevant to healthcare organizations and to the research team; (3) assess multi-level contextual factors that affect implementation, process, outcome, and transportability; (4) assist healthcare organizations in using data for continuous quality improvement; and (5) operationalize common measurement strategies to generate transportable results. Results: Learning Evaluation principles are applied across organizations by the following: (1) establishing a detailed understanding of the baseline implementation plan; (2) identifying target populations and tracking relevant process measures; (3) collecting and analyzing real-time quantitative and qualitative data on important contextual factors; (4) synthesizing data and emerging findings and sharing with stakeholders on an ongoing basis; and (5) harmonizing and fostering learning from process and outcome data. Application to a multi-site program focused on primary care and behavioral health integration shows the feasibility and utility of Learning Evaluation for generating real-time insights into evolving implementation processes. Conclusions: Learning Evaluation generates systematic and rigorous cross-organizational findings about implementing healthcare innovations while also enhancing organizational capacity and accelerating translation of findings by facilitating continuous learning within individual sites. Researchers evaluating change initiatives and healthcare organizations implementing improvement initiatives may benefit from a Learning Evaluation approach

The impact of behavioral and mental health risk assessments on goal setting in primary care

Patient-centered health risk assessments (HRAs) that screen for unhealthy behaviors, prioritize concerns, and provide feedback may improve counseling, goal setting, and health. To evaluate the effectiveness of routinely administering a patient-centered HRA, My Own Health Report, for diet, exercise, smoking, alcohol, drug use, stress, depression, anxiety, and sleep, 18 primary care practices were randomized to ask patients to complete My Own Health Report (MOHR) before an office visit (intervention) or continue usual care (control). Intervention practice patients were more likely than control practice patients to be asked about each of eight risks (range of differences 5.3-15.8 %, p < 0.001), set goals for six risks (range of differences 3.8-16.6 %, p < 0.01), and improve five risks (range of differences 5.4-13.6 %, p < 0.01). Compared to controls, intervention patients felt clinicians cared more for them and showed more interest in their concerns. Patient-centered health risk assessments improve screening and goal setting.Trial RegistrationClinicaltrials.gov identifier: NCT01825746

Designing a valid randomized pragmatic primary care implementation trial: the my own health report (MOHR) project

BACKGROUND: There is a pressing need for greater attention to patient-centered health behavior and psychosocial issues in primary care, and for practical tools, study designs and results of clinical and policy relevance. Our goal is to design a scientifically rigorous and valid pragmatic trial to test whether primary care practices can systematically implement the collection of patient-reported information and provide patients needed advice, goal setting, and counseling in response. METHODS: This manuscript reports on the iterative design of the My Own Health Report (MOHR) study, a cluster randomized delayed intervention trial. Nine pairs of diverse primary care practices will be randomized to early or delayed intervention four months later. The intervention consists of fielding the MOHR assessment – addresses 10 domains of health behaviors and psychosocial issues – and subsequent provision of needed counseling and support for patients presenting for wellness or chronic care. As a pragmatic participatory trial, stakeholder groups including practice partners and patients have been engaged throughout the study design to account for local resources and characteristics. Participatory tasks include identifying MOHR assessment content, refining the study design, providing input on outcomes measures, and designing the implementation workflow. Study outcomes include the intervention reach (percent of patients offered and completing the MOHR assessment), effectiveness (patients reporting being asked about topics, setting change goals, and receiving assistance in early versus delayed intervention practices), contextual factors influencing outcomes, and intervention costs. DISCUSSION: The MOHR study shows how a participatory design can be used to promote the consistent collection and use of patient-reported health behavior and psychosocial assessments in a broad range of primary care settings. While pragmatic in nature, the study design will allow valid comparisons to answer the posed research question, and findings will be broadly generalizable to a range of primary care settings. Per the pragmatic explanatory continuum indicator summary (PRECIS) framework, the study design is substantially more pragmatic than other published trials. The methods and findings should be of interest to researchers, practitioners, and policy makers attempting to make healthcare more patient-centered and relevant. TRIAL REGISTRATION: Clinicaltrials.gov: NCT0182574

Use of Quality Improvement Strategies Among Small to Medium-Size US Primary Care Practices

PURPOSE Improving primary care quality is a national priority, but little is known about the extent to which small to medium-size practices use quality improvement (QI) strategies to improve care. We examined variations in use of QI strategies among 1,181 small to medium-size primary care practices engaged in a national initiative spanning 12 US states to improve quality of care for heart health and assessed factors associated with those variations. METHODS In this cross-sectional study, practice characteristics were assessed by surveying practice leaders. Practice use of QI strategies was measured by the validated Change Process Capability Questionnaire (CPCQ) Strategies Scale (scores range from −28 to 28, with higher scores indicating more use of QI strategies). Multivariable linear regression was used to examine the association between practice characteristics and the CPCQ strategies score. RESULTS The mean CPCQ strategies score was 9.1 (SD = 12.2). Practices that participated in accountable care organizations and those that had someone in the practice to configure clinical quality reports from electronic health records (EHRs), had produced quality reports, or had discussed clinical quality data during meetings had higher CPCQ strategies scores. Health system–owned practices and those experiencing major disruptive changes, such as implementing a new EHR system or clinician turnover, had lower CPCQ strategies scores. CONCLUSION There is substantial variation in the use of QI strategies among small to medium-size primary care practices across 12 US states. Findings suggest that practices may need external support to strengthen their ability to do QI and to be prepared for new payment and delivery models

Disparities in the treatment of early breast cancer

Context: Breast cancer is the most common cancer and the second leading cause of cancer death among US women. Compounding the impact of breast cancer are significant age and race differences that have been noted in the incidence and mortality of breast cancer. The elderly suffer disproportionately from the burden of breast cancer because they are a rapidly growing population in the US and they also have relatively higher mortality and morbidity from this disease. There is conclusive evidence of the efficacy of adjuvant systemic treatment in prolonging survival. However, very little is known about the frequency of use of this treatment in the elderly. On the other hand, racial differences in breast cancer reveal that although black women have lower incidence of breast cancer than whites, they sustain higher mortality rates. There is evidence that the reduced survival among blacks may be attributable more to differences in socioeconomic status and access to appropriate care, rather than to biological differences between the races. Therefore, it is apparent that the elderly and ethnic minority groups, especially black women, experience poorer outcomes from their breast cancers than their counterparts. Age and race disparities in treatment of early breast cancer may be one mechanism by which these women suffer poorer outcomes. Therefore, the overall goal of this dissertation was to examine age and race disparities in the treatment of early breast cancer as articulated in the three specific aims described below. Specific Aims: The aims of this dissertation were to: (1) determine the frequency of use of adjuvant systemic treatment for early breast cancer among women 65 years of age and older, (2) examine whether differences exist in receipt of standard treatment for early breast cancer between black and white women, and (3) examine whether differences exist in delays in initiation of treatment for early breast cancer between black and white women. Design, Setting, and Patients: Aim 1 utilized data from the population-based New Jersey Cancer Registry (NJSCR) to ascertain the frequency of use of adjuvant systemic treatment among 200 women (100 fatal cases and 100 non-fatal cases) who were ≥ 65 years of age and diagnosed with early stage breast cancer during 1987-1998. Study subjects were stratified based on their estrogen receptor (ER) status into ER positive and ER negative cases. NJSCR data provided information on patient and tumor characteristics as well as information on treatment received and their providers. Cancer registry data are usually obtained from hospital tumor registrars, while adjuvant systemic treatment is frequently administered on an outpatient basis. Therefore, cancer registry data was supplemented with data obtained from patients' primary care physicians and oncologists. For Aims 2 and 3 of this dissertation, a retrospective cohort study was designed using a linked NJSCR and New Jersey Medicaid dataset for the years 1997 through 2001. Participants in these studies were women 20-64 years of age who were diagnosed with early-stage breast cancer (SEER Summary Stage 'localized' and 'regional spread to lymph nodes') between January 1997 and December 2001. Women who were neither white nor black, who were diagnosed with other cancers, and whose breast cancer was not the primary cancer were excluded. The linked database was used to obtain diagnostic, prognostic, and treatment information on 237 black and 485 white women. Descriptive analyses were done to characterize the study populations for all three aims. For Aim 1, the frequency of use of surgical therapy, hormonal therapy alone, chemotherapy alone, and hormonal therapy in combination with chemotherapy was calculated separately for subjects with ER positive and ER negative tumors. Multivariate logistic regression models were constructed to examine the predictors of adjuvant hormonal and chemotherapy use. For Aim 2, logistic regression models were constructed to compare receipt of standard treatment between blacks and whites. Racial differences in breast cancer specific and overall survival were evaluated using Cox proportional hazard models. For Aim 3, we compared blacks and whites with respect to delays in initiation of surgical treatment after confirmed diagnosis, of adjuvant radiation therapy after breast conserving surgery, and of adjuvant hormonal and chemotherapy after definitive surgery. Logistic regression models were constructed to examine the association between delays in initiation of surgical treatment (≥1 month vs. &lt;1 month), radiation treatment after breast conserving surgery (≥2 months vs. &lt; 2 months), adjuvant hormonal therapy and chemotherapy (≥1 month vs. &lt;1 month, ≥2 months vs. &lt;2 months, and ≥3 months vs. &lt;3 months) and race. Results: Aim 1 of this dissertation showed that 28% of elderly New Jersey women with early breast cancer received chemotherapy alone or in combination with hormonal therapy whereas 42% received hormonal therapy alone. Only 40% of the women with ER negative tumors received chemotherapy alone or in combination with hormonal treatment and 30% of patients did not receive any adjuvant therapy. Examination of racial differences in receipt of standard treatment (Aim 2) revealed no differences in receipt of surgical, radiation, or adjuvant systemic treatment. Breast cancer specific mortality (Hazard ratio=1.37; 95% confidence interval = 0.94 -- 1.98) and all-cause mortality (Hazard Ratio=1.43; 95% confidence interval=1.08-1.89) were higher among blacks than whites. Although no racial differences were noted in receipt of standard treatment, Aim 3 showed that blacks as compared to whites more often experienced delays of 2 or more months and 3 or more months in initiation of adjuvant chemotherapy after definitive surgery. Also, delays of 2 or more months in adjuvant radiation therapy after breast conserving surgery were observed more frequently among blacks (76.7%) as compared to whites (63.0%). After controlling for other predictors, compared with white women, black women had 1.49-fold odds (95% confidence interval, 0.89, 2.50) of delay of 2 or more months and 1.90-fold odds (95% confidence interval, 0.92, 3.93) of delay of 3 or more months in adjuvant chemotherapy. Delays in adjuvant radiation and chemotherapy were also associated with poorer survival as compared to those who did not experience such delays. No racial differences were observed in delays in initiation of surgical treatment and adjuvant hormonal therapy. Conclusion: The research in this dissertation confirmed that significant age and race disparities exist in the treatment of early breast cancer and factors underlying these disparities need to be studied further. Among elderly New Jersey women, almost 40% of women with ER positive tumors did not receive adjuvant hormonal therapy, while 60% of women with ER negative tumors did not receive adjuvant chemotherapy. The frequency of use of adjuvant systemic therapy in the elderly New Jersey population is significantly lower than that reported among middle aged women from other reports. Efforts in increasing the use of hormonal and adjuvant chemotherapy may help to reduce the excess mortality burden among elderly women with early breast cancer. The results from Aims 2 and 3 show that although receipt of standard treatment for early breast cancer was similar between black and white New Jersey Medicaid beneficiaries with early breast cancer, blacks experienced delays in initiation of adjuvant radiation and chemotherapy more often than their white counterparts. This implies that when socioeconomic status and access to care are similar between blacks and whites, receipt of standard treatment is also similar. In spite of this, blacks experience longer delays in treatment initiation suggesting that other factors may also play a role. Identifying the reasons for this difference requires a more in-depth look at the role of several patient, physician, and care-process level factors involved in the complex management of patients with breast cancer.Ph.D.Includes bibliographical references

Attitudes of south asian women to breast health and breast cancer screening: Findings from a community based sample in the United States

Background: Breast cancer incidence is increasing among South Asian migrants to the United States (US). However, their utilization of cancer screening services is poor. This study characterizes attitudes of South Asians towards breast health and screening in a community sample. Materials and Methods: A cross-sectional survey based on the Health Belief Model (HBM) was conducted among South Asians (n=124) in New Jersey and Chicago. The following beliefs and attitudes towards breast cancer screening were assessed-health motivation, breast self-examination confidence, breast cancer susceptibility and fear, and mammogram benefits and barriers. Descriptive statistics and Spearman rank correlation coefficients were computed for HBM subscales. Findings: Mean age of participants was 36 years with an average 10 years stay in the US. Most women strived to care for their health (3.82±1.18) and perceived high benefits of screening mammography (3.94±0.95). However, they perceived lower susceptibility to breast cancer in the future (2.30±0.94). Conclusions: Increasing awareness of breast cancer risk for South Asian women may have a beneficial effect on cancer incidence because of their positive attitudes towards health and breast cancer screening. This is especially relevant because South Asians now constitute one of the largest minority populations in the US and their incidence of breast cancer is steadily increasing

Principles of the Patient-Centered Medical Home and Preventive Services Delivery

PURPOSE Limited research exists examining the principles of the patient-centered medical home (PCMH) and improved outcomes. We examined whether PCMH principles (personal physician, physician-directed team, whole-person orientation, coordination of care, quality and safety, and enhanced access) are associated with receipt of preventive services