Faculty Bibliography

BACKGROUND: Same-day discharge after percutaneous coronary intervention (PCI) may be safe for some patients. Few data are available on patient-reported outcomes and preferences for same-day discharge after PCI. METHODS AND RESULTS: Between March 2008 and March 2010, a total of 298 patients undergoing elective PCI via femoral access at 2 medical centers (Mount Sinai Hospital, New York, NY, and Baylor Medical Center, Dallas, TX) were randomized to same-day (n=150) or next-day (n=148) discharge. The primary outcome was high patient coping during the 7 days after discharge defined as scores <20 on the validated postdischarge coping difficulty scale. Safety outcomes, clopidogrel adherence, and patient preferences were secondary outcomes. Before discharge, patients randomized to same-day and next-day discharge were similar with respect to sociodemographic and clinical characteristics. High-coping ability, assessed 7 days after PCI, was present for 79% of patients randomized to same-day discharge and for 77% of patients randomized to next-day discharge. The difference in high coping ability, 2 (95% confidence interval, -7 to 11), did not cross the noninferiority threshold of -12% (P<0.001 that same-day discharge is not noninferior to next-day discharge). At 30 days after PCI, clopidogrel adherence, physician and emergency room visits, and hospitalization were similar in the 2 randomization groups. In addition, 80% and 68% of those randomized to same-day and next-day discharge, respectively, stated they would prefer same-day discharge if they were to have another PCI procedure. CONCLUSIONS: Same-day discharge after PCI was associated with patient-reported and clinical outcomes similar to those of next-day discharge and was preferred by most patients.

It has been hypothesized that high visit-to-visit variability (VVV) of systolic blood pressure (SBP) may be the result of poor antihypertensive medication adherence. The authors studied this association using data from 1391 individuals taking antihypertensive medication selected from a large managed care organization. The 8-item Morisky Medication Adherence Scale, administered during 3 annual surveys, captured self-report adherence, with scores<6, 6 to <8, and 8 representing low, medium. and high adherence, respectively. The mean (standard deviation [SD]) for SD of SBP across study visits was 12.9 (4.4), 13.5 (4.8), and 14.1 (4.5) mm Hg in participants with high, medium, and low self-reported adherence, respectively. After multivariable adjustment and compared with those with high self-report adherence, SD of SBP was 0.60 (95% confidence interval, 0.13-1.07) and 1.08 (95% confidence interval, 0.29-1.87) mm Hg higher among participants with medium and low self-report adherence, respectively. Results were consistent when pharmacy fill was used to define adherence. These data suggest that low antihypertensive medication adherence explains only a small proportion of VVV of SBP.

BACKGROUND: Given the results of the Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) trial, statin initiation may be considered for individuals with elevated high-sensitivity C-reactive protein (hsCRP). However, if followed prospectively, many individuals with elevated CRP may become statin eligible, limiting the impact of elevated CRP as a treatment indication. This analysis estimates the proportion of people with elevated CRP that become statin eligible over time. HYPOTHESIS: Most people with elevated CRP become statin eligible over a short period of time. METHODS: We followed 2153 Multi-Ethnic Study of Atherosclerosis (MESA) participants free of cardiovascular disease and diabetes with low-density lipoprotein cholesterol <130 mg/dL at baseline to determine the proportion who become eligible for statins over 4.5 years. The proportion eligible for statin therapy, defined by the National Cholesterol Education Program (NCEP) 2004 updated guidelines, was calculated at baseline and during follow-up stratified by baseline CRP level (>/=2 mg/L). RESULTS: At baseline, 47% of the 2153 participants had elevated CRP. Among participants with elevated CRP, 29% met NCEP criteria for statins, compared with 28% without elevated CRP at baseline. By 1.5 years later, 26% and 22% (P = 0.09) of those with and without elevated CRP at baseline reached NCEP low-density lipoprotein cholesterol criteria and/or had started statins, respectively. These increased to 42% and 39% (P = 0.24) at 3 years and 59% and 52% (P = 0.01) at 4.5 years following baseline. CONCLUSIONS: A substantial proportion of those with elevated CRP did not achieve NCEP-based statin eligibility over 4.5 years of follow-up. These findings suggest that many patients with elevated CRP may not receive the benefits of statins if CRP is not incorporated into the NCEP screening strategy.

Several landmark studies based on the DASH diet have established the effectiveness of a lifestyle approach to blood pressure control that emphasizes a diet rich in fruits and vegetables with moderate portions of low-fat dairy and lean protein along with increased physical activity and reduced sodium intake. However, this evidence base remains underused due feasibility limitations of implementing these intense in-person interventions and poor engagement with desktop computer based versions. Mobile technologies such as smartphones and wireless sensors have the ability to deliver behavioral interventions in-the-moment and with reduced user burden. DASH Mobile is a new mHealth system being developed to deliver this evidence-based lifestyle intervention to hypertensive patients. The system consists of an Android based "app" that facilitates easy tracking of DASH food portions, integrated Bluetooth blood pressure, weight and pedometer monitoring, goal setting, simple data visualizations and multimedia video clips to train patients in the basic concepts of the lifestyle change plan. At present, the system is undergoing usability testing with a pilot clinical trial planned for Spring 2013.

PURPOSE: Usability evaluations can improve the usability and workflow integration of clinical decision support (CDS). Traditional usability testing using scripted scenarios with think-aloud protocol analysis provide a useful but incomplete assessment of how new CDS tools interact with users and clinical workflow. "Near-live" clinical simulations are a newer usability evaluation tool that more closely mimics clinical workflow and that allows for a complementary evaluation of CDS usability as well as impact on workflow. METHODS: This study employed two phases of testing a new CDS tool that embedded clinical prediction rules (an evidence-based medicine tool) into primary care workflow within a commercial electronic health record. Phase I applied usability testing involving "think-aloud" protocol analysis of 8 primary care providers encountering several scripted clinical scenarios. Phase II used "near-live" clinical simulations of 8 providers interacting with video clips of standardized trained patient actors enacting the clinical scenario. In both phases, all sessions were audiotaped and had screen-capture software activated for onscreen recordings. Transcripts were coded using qualitative analysis methods. RESULTS: In Phase I, the impact of the CDS on navigation and workflow were associated with the largest volume of negative comments (accounting for over 90% of user raised issues) while the overall usability and the content of the CDS were associated with the most positive comments. However, usability had a positive-to-negative comment ratio of only 0.93 reflecting mixed perceptions about the usability of the CDS. In Phase II, the duration of encounters with simulated patients was approximately 12 min with 71% of the clinical prediction rules being activated after half of the visit had already elapsed. Upon activation, providers accepted the CDS tool pathway 82% of times offered and completed all of its elements in 53% of all simulation cases. Only 12.2% of encounter time was spent using the CDS tool. Two predominant clinical workflows, accounting for 75% of all cases simulations, were identified that characterized the sequence of provider interactions with the CDS. These workflows demonstrated a significant variation in temporal sequence of potential activation of the CDS. CONCLUSIONS: This study successfully combined "think-aloud" protocol analysis with "near-live" clinical simulations in a usability evaluation of a new primary care CDS tool. Each phase of the study provided complementary observations on problems with the new onscreen tool and was used to refine both its usability and workflow integration. Synergistic use of "think-aloud" protocol analysis and "near-live" clinical simulations provide a robust assessment of how CDS tools would interact in live clinical environments and allows for enhanced early redesign to augment clinician utilization. The findings suggest the importance of using complementary testing methods before releasing CDS for live use.

Low medication adherence may explain part of the high prevalence of apparent treatment-resistant hypertension (aTRH). The authors assessed medication adherence and aTRH among 4026 participants taking >/= 3 classes of antihypertensive medication in the population-based Reasons for Geographic and Racial Differences in Stroke (REGARDS) trial using the 4-item Morisky Medication Adherence Scale (MMAS). Low adherence was defined as an MMAS score >/= 2. Overall, 66% of participants taking >/= 3 classes of antihypertensive medication had aTRH. Perfect adherence on the MMAS was reported by 67.8% and 70.9% of participants with and without aTRH, respectively. Low adherence was present among 8.1% of participants with aTRH and 5.0% of those without aTRH (P<.001). Among those with aTRH, female sex, residence outside the US stroke belt or stroke buckle, physical inactivity, elevated depressive symptoms, and a history of coronary heart disease were associated with low adherence. In the current study, a small percentage of participants with aTRH had low adherence.

OBJECTIVE: Diabetes incidence is increasing worldwide and providers often do not feel they can effectively counsel about preventive lifestyle changes. The goal of this paper is to describe the development and initial feasibility testing of the Avoiding Diabetes Thru Action Plan Targeting (ADAPT) program to enhance counseling about behavior change for patients with pre-diabetes. METHODS: Primary care providers and patients were interviewed about their perspectives on lifestyle changes to prevent diabetes. A multidisciplinary design team incorporated this data to translate elements from behavior change theories to create the ADAPT program. The ADAPT program was pilot tested to evaluate feasibility. RESULTS: Leveraging elements from health behavior theories and persuasion literature, the ADAPT program comprises a shared goal-setting module, implementation intentions exercise, and tailored reminders to encourage behavior change. Feasibility data demonstrate that patients were able to use the program to achieve their behavior change goals. CONCLUSION: Initial findings show that the ADAPT program is feasible for helping improve primary care providers' counseling for behavior change in patients with pre-diabetes. PRACTICE IMPLICATIONS: If successful, the ADAPT program may represent an adaptable and scalable behavior change tool for providers to encourage lifestyle changes to prevent diabetes.

Major depressive disorder (MDD) is prevalent in clinical weight-loss settings and predicts poor weight-loss outcomes. It is unknown whether the severity of depressive symptoms among those with MDD is associated with diet quality or physical activity levels. This knowledge is important for improving weight-loss treatment for these patients. It was hypothesized that more severe depression is associated with poorer diet quality and lower physical activity levels among individuals with obesity and MDD. Participants were 161 women with current MDD and obesity enrolled in the baseline phase of a weight-loss trial between 2007 and 2010. Depression severity was measured with the Beck Depression Inventory II. The Alternate Healthy Eating Index was applied to data from three 24-hour diet recalls to capture overall diet quality. Daily metabolic equivalents expended per day were calculated from three 24-hour physical activity recalls. Greater depression severity was associated with poorer overall diet quality (estimate=-0.26, standard error 0.11; P=0.02), but not with physical activity (estimate=0.07, standard error 0.05; P=0.18), in linear regression models controlling for income, education, depression-related appetite change, binge eating disorder, and other potential confounds. Associations with diet quality were primarily driven by greater intake of sugar (r=0.20; P<0.01), saturated fat (r=0.21; P<0.01), and sodium (r=0.22; P<0.01). More severe depression was associated with poorer overall diet quality, but not physical activity, among treatment-seeking women with MDD and obesity. Future studies should identify mechanisms linking depression to diet quality and determine whether diet quality improves with depression treatment.

The association between within-visit variability of systolic blood pressure (SBP) and diastolic blood pressure (DBP) and all-cause and cardiovascular (CVD) mortality was examined using the Third National Health and Nutrition Survey (n=15,317). Three SBP and DBP readings were taken by physicians during a single medical evaluation. Within-visit variability for each participant was defined using the standard deviation of SBP and DBP across these measurements. Mortality was assessed over 14 years (n=3848 and n=1684 deaths from all causes and CVD, respectively). After age, sex, and race-ethnicity adjustment, the hazard ratios (95% confidence intervals) for all-cause mortality associated with the 4 highest quintiles of within-visit standard deviation of SBP (2.00-2.99 mm Hg, 3.00-3.99 mm Hg, 4.00-5.29 mm Hg, and >/=5.30 mm Hg) compared with participants in the lowest quintile of within-visit standard deviation of SBP (<2.0 mm Hg) were 1.04 (0.87-1.26), 1.09 (0.92-1.29), 1.06 (0.88-1.28), and 1.13 (0.95-1.33), respectively (P=.136). The analogous hazard ratios for CVD mortality were 0.95 (0.69-1.32), 0.96 (0.67-1.36), 0.95 (0.74-1.23), and 1.04 (0.80-1.35), respectively (P=.566). No association with mortality was present after further adjustment and when modeling within-visit standard deviation of SBP as a continuous variable. Standard deviation of DBP was not associated with mortality.