Equitable Care for Hypertension: Blood Pressure and Patient-Reported Outcomes of the RICH LIFE Cluster Randomized Trial.

BACKGROUND: Disparities in hypertension control are well documented but underaddressed. METHODS: RICH LIFE (Reducing Inequities in Care of Hypertension: Lifestyle Improvement for Everyone) was a 2-arm, cluster randomized trial comparing the effect on blood pressure (BP) control (systolic BP ≤140 mm Hg, diastolic BP ≤90 mm Hg), patient activation, and disparities in BP control of 2 multilevel interventions, standard of care plus (SCP) and collaborative care/stepped care (CC/SC). SCP included BP measurement standardization, audit and feedback, and equity-leadership training. CC/SC added roles to address social or medical needs. Primary outcomes were BP control and patient activation at 12 months. Generalized estimating equations and mixed-effects regression models with fixed effects of time, intervention, and their interaction compared change in outcomes at 12 months from baseline. RESULTS: A total of 1820 adults with uncontrolled BP and ≥1 other risk factors enrolled in the study. Their mean age was 60.3 years, and baseline BP was 152.3/85.5 mm Hg; 59.4% were women; 57.4% were Black, 33.2% were White, and 9.4% were Hispanic; 74% had hyperlipidemia; and 45.1% had type 2 diabetes. CC/SC did not improve BP control rates more than SCP. Both groups achieved statistically and clinically significant BP control rates at 12 months (CC/SC: 57.3% [95% CI, 52.7%-62.0%]; SCP: 56.7% [95% CI, 51.9%-61.5%]). Pairwise comparisons between racial and ethnic groups showed overall no significant differences in BP control at 12 months. Patients with coronary heart disease showed greater achievement of BP control in CC/SC than in SCP (64.0% [95% CI, 54.1%-73.9%] versus 50.8% [95% CI, 42.6%-59.0%]; P=0.04), as did patients in rural areas (67.3% [95% CI, 49.8%-84.8%] versus 47.8% [95% CI, 32.4%-63.2%]; P=0.01). Individuals in both arms experienced statistically and clinically significant reductions in mean systolic BP (CC/SC: -13.8 mm Hg [95% CI, -15.2 to -12.5]; SCP: -14.6 mm Hg [95% CI, -15.9 to -13.2]) and diastolic BP (CC/SC: -6.9 mm Hg [95% CI, -7.8 to -6.1]; SCP: -5.5 mm Hg [95% CI, -6.4 to -4.6]) over time. The difference in diastolic BP reduction between CC/SC and SCP over time was statistically significant (-1.4 mm Hg [95% CI, -2.6 to -0.2). Patient activation did not differ between arms. CC/SC showed greater improvements in patient ratings of chronic illness care (Patient Assessment of Chronic Illness Care score) over 12 months (0.12 [95% CI, 0.02-0.22]). CONCLUSIONS: Adding a collaborative care team to enhanced standard of care did not improve BP control but did improve patient ratings of chronic illness care.

Shared Decision-Making and Cardiovascular Health: A Scientific Statement From the American Heart Association.

Shared decision-making is increasingly embraced in health care and recommended in cardiovascular guidelines. Patient involvement in health care decisions, patient-clinician communication, and models of patient-centered care are critical to improve health outcomes and to promote equity, but formal models and evaluation in cardiovascular care are nascent. Shared decision-making promotes equity by involving clinicians and patients, sharing the best available evidence, and recognizing the needs, values, and experiences of individuals and their families when faced with the task of making decisions. Broad endorsement of shared decision-making as a critical component of high-quality, value-based care has raised our awareness, although uptake in clinical practice remains suboptimal for a range of patient, clinician, and system issues. Strategies effective in promoting shared decision-making include educating clinicians on communication techniques, engaging multidisciplinary medical teams, incorporating trained decision coaches, and using tools (ie, patient decision aids) at appropriate literacy and numeracy levels to support patients in their cardiovascular decisions. This scientific statement shines a light on the limited but growing body of evidence of the impact of shared decision-making on cardiovascular outcomes and the potential of shared decision-making as a driver of health equity so that everyone has just opportunities. Multilevel solutions must align to address challenges in policies and reimbursement, system-level leadership and infrastructure, clinician training, access to decision aids, and patient engagement to fully support patients and clinicians to engage in the shared decision-making process and to drive equity and improvement in cardiovascular outcomes.

Use of electronic recruitment methods in a clinical trial of adults with gout.

BACKGROUND/AIMS: Electronic-based recruitment methods are increasingly utilized in clinical trials to recruit and enroll research participants. The cost-effectiveness of electronic-based methods and impact on sample generalizability is unknown. We compared recruitment yields, cost-effectiveness, and demographic characteristics across several electronic and traditional recruitment methods. METHODS: We analyzed data from the diet gout trial recruitment campaign. The diet gout trial was a randomized, controlled, cross-over trial that examined the effects of a dietary approaches to stop hypertension (DASH)-like diet on uric acid levels in adults with gout. We used four electronic medical record and four non-electronic medical record-based recruitment methods to identify and recruit potentially eligible participants. We calculated the response rate, screening visit completion rate, and randomization rate for each method. We also determined cost per response, the screening, and randomization for each method. Finally, we compared the demographic characteristics among individuals who completed the screening visit by recruitment method. RESULTS: Of the 294 adults who responded to the recruitment campaign, 51% were identified from electronic medical record-based methods. Patient portal messaging, an electronic medical record-based method, resulted in the highest response rate (4%), screening visit completion rate (37%), and randomization rate (21%) among these eight methods. Electronic medical record-based methods ($60) were more cost-effective per response than non-electronic medical record-based methods ($107). Electronic-based methods, including patient portal messaging and Facebook, had the highest proportion of White individuals screened (52% and 60%). Direct mail to non-active patient portal increased enrollment of traditionally under-represented groups, including both women and African Americans. CONCLUSION: An electronic medical record-based recruitment strategy that utilized the electronic medical record for participant identification and postal mailing for participant outreach was cost-effective and increased participation of under-represented groups. This hybrid strategy represents a promising approach to improve the timely execution and broad generalizability of future clinical trials.

The RICH LIFE Project: A cluster randomized pragmatic trial comparing the effectiveness of health system only vs. health system Plus a collaborative/stepped care intervention to reduce hypertension disparities.

Disparities in the control of hypertension and other cardiovascular disease risk factors are well-documented in the United States, even among patients seen regularly in the healthcare system. Few existing approaches explicitly address disparities in hypertension care and control. This paper describes the RICH LIFE Project (Reducing Inequities in Care of Hypertension: Lifestyle Improvement for Everyone) design. METHODS: RICH LIFE is a two-arm, cluster-randomized trial, comparing the effectiveness of enhanced standard of care, "Standard of Care Plus" (SCP), to a multi-level intervention, "Collaborative Care/Stepped Care" (CC/SC), for improving blood pressure (BP) control and patient activation and reducing disparities in BP control among 1890 adults with uncontrolled hypertension and at least one other cardiovascular disease risk factor treated at 30 primary care practices in Maryland and Pennsylvania. Fifteen practices randomized to the SCP arm receive standardized BP measurement training; race/ethnicity-specific audit and feedback of BP control rates; and quarterly webinars in management practices, quality improvement and disparities reduction. Fifteen practices in the CC/SC arm receive the SCP interventions plus implementation of the collaborative care model with stepped-care components (community health worker referrals and virtual specialist-panel consults). The primary clinical outcome is BP control (<140/90 mm Hg) at 12 months. The primary patient-reported outcome is change from baseline in self-reported patient activation at 12 months. DISCUSSION: This study will provide knowledge about the feasibility of leveraging existing resources in routine primary care and potential benefits of adding supportive community-facing roles to improve hypertension care and reduce disparities. TRIAL REGISTRATION: Clinicaltrials.govNCT02674464.

The Self-Care of Heart Failure Index: A psychometric study.

BACKGROUND: The Self-Care of Heart Failure Index is an empirically tested instrument to measure self-care of heart failure patients across different populations and cultures. AIMS: To develop and evaluate the psychometric properties of the Nepali Self-Care of Heart Failure Index. DESIGN: This psychometric study used a cross-sectional, observational, study design to collect data. The study was guided and reported following the Strengthening the Reporting of Observational Studies in Epidemiology guideline. METHODS: To develop and culturally validate Nepali Self-Care of Heart Failure Index, a combination of the recommended methods for cross-cultural validation studies were applied such as translation, back translation, expert committee review of the translated version and validity/reliability testing. Face and content validity were ensured using expert review. Construct validity was examined using exploratory factor analysis and confirmatory factor analysis. Composite reliability scores were calculated for each sub-scale of the Nepali Self-Care of Heart Failure Index. RESULTS: A total of 221 heart failure patients in Nepal were enrolled in the study. Adequate face and content validity were ensured through expert review. Exploratory factor analysis and confirmatory factor analysis supported the original three-factor model. Although the three factors explained only 41% of the variance, confirmatory factor analysis fit indexes and error measures were found reasonable. The composite reliability coefficients for self-care maintenance, management and confidence scale were 0.6, 0.7 and 0.8, respectively. CONCLUSIONS: The Nepali Self-Care of Heart Failure Index is a theoretically based, culturally acceptable and appropriate instrument for use among Nepali heart failure patients. However, further studies are needed to refine its psychometric properties. RELEVANCE TO CLINICAL PRACTICE: Access to reliable, valid and culturally appropriate instruments is crucial in describing the state of the problem as well as for developing and evaluating tailored and targeted self-care practice interventions for Nepali patients living with heart failure.

Association of sex, age and education level with patient reported outcomes in atrial fibrillation.

BACKGROUND: In atrial fibrillation (AF), there are known sex and sociodemographic disparities in clinical outcomes such as stroke. We investigate whether disparities also exist with respect to patient-reported outcomes. We explored the association of sex, age, and education level with patient-reported outcomes (AF-related quality of life, symptom severity, and emotional and functional status). METHODS: The PaTH AF cohort study recruited participants (N = 953) with an AF diagnosis and age ≥ 18 years across 4 academic medical centers. We performed longitudinal multiple regression with random effects to determine if individual characteristics were associated with patient-reported outcomes. RESULTS: Women reported poorer functional status (ß - 2.23, 95% CI: -3.52, - 0.94) and AF-related quality of life (ß - 4.12, 95% CI: -8.10, - 0.14), and higher symptoms of anxiety (ß 2.08, 95% CI: 0.76, 3.40), depression (ß 1.44, 95% CI: 0.25, 2.63), and AF (ß 0.29, 95% CI: 0.08, 0.50). Individuals < 60 years were significantly (p < 0.05) more likely to report higher symptoms of depression, anxiety, and AF, and poorer AF-related quality of life. Lack of college education was associated with reporting higher symptoms of AF (ß 0.42, 95% CI: 0.17, 0.68), anxiety (ß 1.86, 95% CI: 0.26, 3.45), and depression (ß 1.11, 95% CI: 0.15, 2.38), and lower AF-related quality of life (ß - 4.41, 95% CI: -8.25, - 0.57) and functional status. CONCLUSION: Women, younger adults, and individuals with lower levels of education reported comparatively poor patient-reported outcomes. These findings highlight the importance of understanding why individuals experience AF differently based on certain characteristics.

The impact of an innovative curriculum to introduce patient safety and quality improvement content.

BACKGROUND: The Fuld Fellows Program provides selected pre-licensure nursing students with a foundation in the science of patient safety, quality improvement and leadership through coursework and a mentored experience working on a quality improvement project. We evaluated this program's impact on Fellows' patient safety competence and systems thinking. METHODS: Cohorts I-VI (n = 116) completed pre-post program evaluation that included measurement of patient safety competence through the Health Professional Education in Patient Safety Survey (H-PEPSS) and systems thinking using the Systems Thinking Scale. Pre- and post-program H-PEPSS and Systems Thinking Scale scores were compared using the Wilcoxon Signed-Rank Test. The Fellows were compared to non-Fellows on patient safety competence and systems thinking using t-tests. RESULTS: Patient safety competence on all H-PEPSS scales improved from baseline to end of program: teamwork (2.6 to 3.1), communication (2.1 to 3.2), managing risk (2.2 to 3.3), human environment (2.8 to 3.7), recognize and respond to risk (2.7 to 3.6), and culture (2.9 to 3.8) (p < 0.05). The Fellows, in comparison to the non-Fellows, reported a significantly higher (p < 0.05) mean change score in five of the six H-PEPSS subscales. Fellows' mean systems thinking score increased from 66 ± 7 at baseline to 70 ± 6 at program completion (p < 0.05), this mean post completion score was significantly higher than the non-Fellows reported mean STS score of 62 ± 7. CONCLUSION: The Fuld Fellows Program effectively facilitated patient safety and quality improvement and systems thinking learning among pre-licensure nursing students. This program can serve as a model for integrating quality and safety concepts into health professionals' curricula.

Atrial Fibrillation Symptoms and Sex, Race, and Psychological Distress: A Literature Review.

BACKGROUND: Atrial fibrillation (AF) symptoms are a major component of treatment decisions for patients with AF and impact quality of life and functional ability yet are poorly understood. OBJECTIVE: This review aimed to determine what is known about the prevalence of symptoms and the association of symptoms to AF characteristics, psychological distress, sex, and race. METHODS: We performed a structured review of AF symptoms as of March 2016 using PubMed, EMBASE, and CINAHL and reference searches of retrieved articles. Full-text, published, peer-reviewed, English-language articles were examined. Articles were included if they reported original research data on symptom prevalence and type among patients with AF. RESULTS: The 3 most common symptoms were dyspnea, palpitations, and fatigue. The results suggested that, although AF characteristics are not a significant predictor of symptoms, tachycardia, female sex, race, and psychological distress have a positive association to symptoms. CONCLUSIONS: There is a scarcity of research examining symptoms in AF. Furthermore, the inconsistency in measurement methods and the failure to include diverse populations in AF research make it difficult to draw definitive conclusions from the current literature. Given the prevalence of AF in the United States and the impact of symptoms on quality of life and healthcare use, further research examining predictors of symptoms and interventions to alleviate symptoms is crucial.

Cooccurrence of and remission from general anxiety, depression, and posttraumatic stress disorder symptoms after acute lung injury: a 2-year longitudinal study.

OBJECTIVE: To evaluate the cooccurrence, and predictors of remission, of general anxiety, depression, and posttraumatic stress disorder symptoms during 2-year follow-up in survivors of acute lung injury treated in an ICU. DESIGN: Prospective cohort study, with follow-up at 3, 6, 12, and 24 months post-acute lung injury. SETTING: Thirteen medical and surgical ICUs in four hospitals. PATIENTS: Survivors among 520 patients with acute lung injury. MEASUREMENTS AND MAIN RESULTS: The outcomes of interest were measured using the Hospital Anxiety and Depression Scale anxiety and depression subscales (scores ≥ 8 indicating substantial symptoms) and the Impact of Event Scale-Revised (scores ≥ 1.6 indicating substantial posttraumatic stress disorder symptoms). Of the 520 enrolled patients, 274 died before 3-month follow-up; 186 of 196 consenting survivors (95%) completed at least one Hospital Anxiety and Depression Scale and Impact of Event Scale-Revised assessment during 2-year follow-up, and most completed multiple assessments. Across follow-up time points, the prevalence of suprathreshold general anxiety, depression, and posttraumatic stress disorder symptoms ranged from 38% to 44%, 26% to 33%, and 22% to 24%, respectively; more than half of the patients had suprathreshold symptoms in at least one domain during 2-year follow-up. The majority of survivors (59%) with any suprathreshold symptoms were above threshold for two or more types of symptoms (i.e., general anxiety, depression, and/or posttraumatic stress disorder). In fact, the most common pattern involved simultaneous general anxiety, depression, and posttraumatic stress disorder symptoms. Most patients with general anxiety, depression, or posttraumatic stress disorder symptoms during 2-year follow-up had suprathreshold symptoms at 24-month (last) follow-up. Higher Short-Form-36 physical functioning domain scores at the prior visit were associated with a greater likelihood of remission from general anxiety and posttraumatic stress disorder symptoms during follow-up. CONCLUSIONS: The majority of acute lung injury survivors had clinically significant general anxiety, depression, or posttraumatic stress disorder symptoms, and these symptoms tended to co-occur across domains. Better physical functioning during recovery predicted subsequent remission of general anxiety and posttraumatic stress disorder symptoms.

Social engagement and chronic disease risk behaviors: the Multi-Ethnic Study of Atherosclerosis.

OBJECTIVE: Although engagement in social networks is important to health, multiple different dimensions exist. This study identifies which dimensions are associated with chronic disease risk behaviors. METHODS: Cross-sectional data on social support, loneliness, and neighborhood social cohesion from 5381 participants, aged 45-84 from the Multi-Ethnic Study of Atherosclerosis was used. RESULTS: After adjusting for individual characteristics and all social engagement variables, social support was associated with lower smoking prevalence (PR=0.88, 95% CI: 0.82, 0.94), higher probability of having quit (PR=1.03, 95% CI: 1.01, 1.06) and a slightly higher probability of achieving physical activity recommendations (PR=1.03, 95% CI: 1.01, 1.06). Neighborhood social cohesion was associated with very slightly higher probability of achieving recommended (PR=1.03, 95% CI: 1.01, 1.05) or any regular (PR=1.0, 95% CI: 1.01, 1.04) physical activity, and a higher probability of consuming at least five daily fruit and vegetable servings (PR=1.05, 95% CI: 1.01, 1.09). CONCLUSIONS: Both social support and neighborhood social cohesion, a less commonly considered aspect of social engagement, appear to be important for chronic disease prevention interventions and likely act via separate pathways.

Construct validity of the Chinese version of the Self-care of Heart Failure Index determined using structural equation modeling.

BACKGROUND: The Self-care of Heart Failure Index (SCHFI) is an empirically tested instrument for measuring the self-care of patients with heart failure. OBJECTIVE: The aim of this study was to develop a simplified Chinese version of the SCHFI and provide evidence for its construct validity. METHODS: A total of 182 Chinese with heart failure were surveyed. A 2-step structural equation modeling procedure was applied to test construct validity. RESULTS: Factor analysis showed 3 factors explaining 43% of the variance. Structural equation model confirmed that self-care maintenance, self-care management, and self-care confidence are indeed indicators of self-care, and self-care confidence was a positive and equally strong predictor of self-care maintenance and self-care management. Moreover, self-care scores were correlated with the Partners in Health Scale, indicating satisfactory concurrent validity. CONCLUSION: The Chinese version of the SCHFI is a theory-based instrument for assessing self-care of Chinese patients with heart failure.

Functional status in left ventricular assist device-supported patients: a literature review.

The prevalence of advanced heart failure (HF) is increasing because of the aging population and improvements in HF management strategies. Left ventricular assist device (LVAD) technology and management continue to advance rapidly, and it is anticipated that the number of LVAD implants will increase. LVADs have been demonstrated to extend life and improve outcomes in patients with advanced HF. The purpose of this article is to review and synthesize the evidence on impact of LVAD therapy on functional status. Significant functional gains were demonstrated in patients supported by LVAD throughout the 1st year, with most improvement in distance walked and peak oxygen consumption demonstrated in the 1st 6 months. Interventions to enhance exercise performance have had inconsistent effects on functional status. Poor exercise performance was associated with increased risk of adverse events. Functional status improved with LVAD therapy, although performance remained substantially reduced compared with age-adjusted norms. There is tremendous need to enhance our understanding of factors influencing functional outcomes in this high-risk population.