Disparities in Research Participation by Level of Health Literacy.

OBJECTIVE: To determine at which phase in the recruitment process for participation in clinical research studies do health literacy and other patient characteristics influence recruitment outcomes. PATIENTS AND METHODS: Using a sample of 5872 patients hospitalized with cardiovascular disease approached for participation in the Vanderbilt Inpatient Cohort Study from October 2011 through December 2015, we examined the independent association of patients' health literacy with two steps in their research participation decision-making process: (1) research interest - willingness to hear more about a research study; and (2) research participation - the decision to enroll after an informed consent discussion. Best practices for effective health communication were implemented in recruitment approaches and informed consent processes. Using logistic regression models, we determined patient characteristics independently associated with patients' willingness to hear about and participate in the study. RESULTS: In unadjusted analyses, participants with higher health literacy, and those who were younger, female, or had more education had higher levels of both research interest and research participation. Health literacy remained independently associated with both outcomes in multivariable models, after adjustment for sociodemographic factors. CONCLUSION: Because identical variables predicted both research interest and eventual consent, efforts to recruit broad populations must include acceptable methods of approaching potential participants as well as explaining study materials.

Organizational Readiness for Lung Cancer Screening: A Cross-Sectional Evaluation at a Veterans Affairs Medical Center.

OBJECTIVES: Lung cancer has the highest cancer-related mortality in the United States and among Veterans. Screening of high-risk individuals with low-dose CT (LDCT) can improve survival through detection of early-stage lung cancer. Organizational factors that aid or impede implementation of this evidence-based practice in diverse populations are not well described. We evaluated organizational readiness for change and change valence (belief that change is beneficial and valuable) for implementation of LDCT screening. METHODS: We performed a cross-sectional survey of providers, staff, and administrators in radiology and primary care at a single Veterans Affairs Medical Center. Survey measures included Shea's validated Organizational Readiness for Implementing Change (ORIC) scale and Shea's 10 items to assess change valence. ORIC and change valence were scored on a scale from 1 to 7 (higher scores representing higher readiness for change or valence). Multivariable linear regressions were conducted to determine predictors of ORIC and change valence. RESULTS: Of 523 employees contacted, 282 completed survey items (53.9% overall response rate). Higher ORIC scores were associated with radiology versus primary care (mean 5.48, SD 1.42 versus 5.07, SD 1.22, ß = 0.37, P = .039). Self-identified leaders in lung cancer screening had both higher ORIC (5.56, SD 1.39 versus 5.11, SD 1.26, ß = 0.43, P = .050) and change valence scores (5.89, SD 1.21 versus 5.36, SD 1.19, ß = 0.51, P = .012). DISCUSSION: Radiology health professionals have higher levels of readiness for change for implementation of LDCT screening than those in primary care. Understanding health professionals' behavioral determinants for change can inform future lung cancer screening implementation strategies.

Can Precision Medicine Actually Help People Like Me? African American and Hispanic Perspectives on the Benefits and Barriers of Precision Medicine.

Objective: To better understand African American and Hispanic perspectives on the potential benefits of precision medicine, along with the potential barriers that may prevent precision medicine from being equally beneficial to all. We also sought to identify if there were differences between African American and Hispanic perspectives. Design: Six semi-structured focus groups were conducted between May 2017 and February 2018 to identify benefits and barriers to precision medicine. Three groups occurred in Nashville, TN with African American participants and three groups occurred in Miami, FL with Hispanic participants. Setting: At community-based and university sites convenient to community partners and participants. Participants: A total of 55 individuals participated (27 in Nashville, 28 in Miami). The majority of participants were women (76.5%) and the mean age of participants was 56.2 years old. Results: Both African Americans and Hispanics believed precision medicine has the potential to improve medicine and health outcomes by individualizing care and decreasing medical uncertainty. However, both groups were concerned that inadequacies in health care institutions and socioeconomic barriers would prevent their communities from receiving the full benefits of precision medicine. African Americans were also concerned that the genetic and non-genetic personal information revealed through precision medicine would make African Americans further vulnerable to provider racism and discrimination in and outside of health care. Conclusions: While these groups believed precision medicine might yield benefits for health outcomes, they are also skeptical about whether African Americans and Hispanics would actually benefit from precision medicine given current structural limitations and disparities in health care access and quality.

Current applications of precision medicine: a bibliometric analysis.

A bibliometric analysis was conducted to describe trends in the publication of precision medicine literature over time. Searches identified 5552 articles with exponential growth from 2012 to 2018. Most were published in medical specialty journals, particularly oncology. Precision medicine definitions focused on tailored/individualized/personalized treatments and genetics/biology. Little attention was given to social and environmental determinants of health and health disparities. To fulfill the promise of precision medicine to positively impact broad populations, work is needed to develop the science of precision medicine for addressing health disparities and social and environmental determinants of health. While some precision medicine definitions include all factors that contribute to individual differences in health (e.g., genes, environments and lifestyles), future empirical work that includes and integrates all three areas is also required.

Improving Care Transitions for Hospitalized Veterans Discharged to Skilled Nursing Facilities: A Focus on Polypharmacy and Geriatric Syndromes.

Geriatric syndromes and polypharmacy are common in older patients discharged to skilled nursing facilities (SNFs) and increase 30-day readmission risk. In a U.S.A. Department of Veterans Affairs (VA)-funded Quality Improvement study to improve care transitions from the VA hospital to area SNFs, Veterans (N = 134) were assessed for geriatric syndromes using standardized instruments as well as polypharmacy, defined as five or more medications. Warm handoffs were used to facilitate the transfer of this information. This paper describes the prevalence of geriatric syndromes, polypharmacy, and readmission rates. Veterans were prescribed an average of 14.7 medications at hospital discharge. Moreover, 75% of Veterans had more than two geriatric syndromes, some of which began during hospitalization. While this effort did not reduce 30-day readmissions, the high prevalence of geriatric syndromes and polypharmacy suggests that future efforts targeting these issues may be necessary to reduce readmissions among Veterans discharged to SNF.

Association of Health Literacy and Numeracy with Interest in Research Participation.

BACKGROUND: There is much attention to recruitment of diverse populations in research, but little is known about the influence of health literacy and numeracy skills. OBJECTIVE: To determine if health literacy and numeracy affect individuals' interest to participate in research studies. DESIGN: Cross-sectional survey data were pooled from 3 large studies conducted in the Mid-South Clinical Data Research Network. PARTICIPANTS: Adult patients enrolled in 1 of 3 Mid-South Clinical Data Research Network studies. MAIN MEASURES: The survey domains included demographic items, the 3-item Brief Health Literacy Screen (range 3-15), and the 3-item Subjective Numeracy Scale (range 3-18). The outcome was a sum index measure of a 7-item instrument (range 7-21) assessing individuals' interest in participating in different types of research, including research that involves taking surveys, giving a blood sample, participating via phone or internet, taking an investigational medication, meeting at a local community center or school, including family, or staying overnight at a hospital. KEY RESULTS: Respondents (N = 15,973) were predominately women (65.5%), White (81.4%), and middle aged (M = 52.8 years, SD = 16.5); 32.4% previously participated in research. Self-reported health literacy was relatively high (M = 13.5 out of 15, SD = 2.1), and subjective numeracy skills were somewhat lower (M = 14.3 out of 18, SD = 3.6). After adjustment for age, gender, race, income, education, and other characteristics, lower health literacy and numeracy skills were each independently associated with less interest in research participation (p < 0.001 for each). Prior research participation was associated with greater interest in future research participation (p < 0.001). CONCLUSIONS: After adjustment for factors known to be predictive of interest, individuals with lower health literacy or numeracy scores were less interested in participating in research. Additional work is needed to elucidate reasons for this finding and to determine strategies to engage these populations.

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.

Precision Medicine: Familiarity, Perceived Health Drivers, and Genetic Testing Considerations Across Health Literacy Levels in a Diverse Sample.

A clear awareness of a patient's knowledge, values, and perspectives is an important component of effective genetic counseling. Advances in precision medicine, however, have outpaced our understanding of patient perceptions of this new approach. Patient views may differ across the three domains of precision medicine (genetics, behavioral, and environmental determinants of health), ethnic/racial groups, and health literacy levels. This study describes and compares group differences in familiarity, perceptions, and preferences for precision medicine in a diverse sample. Between 2016 and 2017, 252 participants completed a 10-15-min survey in three primary care clinics in Florida and Tennessee. The final sample was 42.5% African American/Black, 25.8% Hispanic/Latino, 25.0% White, and 6.7% other ethnicity/race. Less than a quarter of participants reported being familiar with the term "precision medicine," but were more familiar with basic genetic terms. Participants with higher health literacy reported greater familiarity with terms (p ≤ .003). African Americans/Black participants were more likely to identify ethnicity/race and discrimination as influencing their health (p ≤ .004). When deciding to get a genetic test, individuals across ethnic/racial groups shared similar considerations. Those with higher health literacy, however, gave significantly greater importance to provider trust (p ≤ .008). Given the recent emergence of precision medicine, at present there may be limited differences in patient perceptions across ethnic/racial groups. Culturally sensitive efforts, tailored to health literacy level, may aid equitable precision medicine uptake.

Momentary assessment of impulsive choice and impulsive action: Reliability, stability, and correlates.

Impulsivity is associated with substance use, including tobacco use. The degree to which impulsivity fluctuates over time within persons, and the degree to which such intra-individual changes can be measured reliably and validly in ambulatory assessments is not known, however. The current study evaluated two novel ambulatory measures of impulsive choice and impulsive action. Impulsive choice was measured with an eight-item delay discounting task designed to estimate the subjective value of delayed monetary rewards. Impulsive action was measured with a two-minute performance test to assess behavioral disinhibition (the inability to inhibit a motor response when signaled that such a response will not be rewarded). Valid data on impulsive choice were collected at 70% of scheduled reports and valid data on impulsive action were collected on 55% of scheduled reports, on average. Impulsive choice and action data were not normally distributed, but models of relations of these measures with within- and between-person covariates were robust across distributional assumptions. Intra-class correlations were substantial for both impulsive choice and action measures. Between persons, random intercepts in impulsive choice and action were significantly related to laboratory levels of their respective facets of impulsivity, but not self-reported or other facets of impulsivity. Validity of the ambulatory measures is supported by associations between abstinence from smoking and increased impulsivity, but challenged by an association between strong temptations to smoke and reduced impulsive choice. Results suggest that meaningful variance in impulsive choice and action can be captured using ambulatory methods, but that additional measure refinement is needed.

A randomized clinical trial of a tailored behavioral smoking cessation preparation program.

Despite considerable progress in reducing cigarette smoking prevalence and enhancing smoking cessation treatments, most smokers who attempt to quit relapse. The current randomized clinical trial evaluated the efficacy of an adjunctive behavioral smoking cessation treatment based on learning theory. Adult daily smokers were randomly assigned to standard treatment (N = 47) with nicotine patch and individual counseling or to standard treatment plus a "practice quitting" program involving seven sessions of escalating prescribed abstinence periods (N = 46) prior to a target stop smoking date. Practice quitting was designed to extinguish smoking in response to withdrawal symptoms. Retention in treatment was excellent and the treatment manipulation increased the interval between cigarettes across practice quitting sessions on average by 400%. The primary endpoint, seven-day point-prevalence abstinence four weeks post-quit, was not significantly affected by practice quitting (31.9% in the standard treatment condition, 37.0% in the practice quitting condition). Practice quitting increased latency to a first lapse among those who quit smoking for at least one day and prevented progression from a first lapse to relapse (smoking daily for a week) relative to standard treatment, however. Practice quitting is a promising adjunctive treatment in need of refinement to enhance adherence and efficacy.

Reliability and validity of measures of impulsive choice and impulsive action in smokers trying to quit.

Cross-sectional research suggests that smokers are more impulsive than are nonsmokers, but few studies have examined relations between impulsiveness and later success in quitting smoking. The purpose of this study was to investigate the reliability and predictive validity of facets of impulsiveness in adult smokers trying to quit. Baseline behavioral measures of impulsive choice (assessed with a delay discounting task) and impulsive action (assessed with a measure of behavioral disinhibition) were used as predictors of smoking cessation success over 12 weeks. The sample included 116 adult (18 years old or older) daily smokers from central New Jersey. Impulsive choice, impulsive action, and self-reported impulsiveness were not significantly related to one another at baseline. Impulsive choice had high test-retest reliability from pre- to postquit, whereas impulsive action was less stable. Test-retest reliability from prequit to 3 weeks' postquit was moderated by achievement of 7-day abstinence. Baseline impulsive action was significantly negatively related to quitting for at least 1 day in the first 2 weeks of a quit attempt and of prolonged abstinence (no relapse over the next 10 weeks). Baseline impulsive choice was robustly associated with biochemically verified 7-day point-prevalence abstinence 12 weeks' postquit, such that those with lower delay discounting were more likely to achieve abstinence. Facets of impulsiveness appear to function largely independently in adult smokers, as indicated by their lack of intercorrelation, differential stability, and differential relations with abstinence. Impulsive action may impede initial quitting, whereas impulsive choice may be an obstacle to maintaining lasting abstinence.

An experimental investigation of reactivity to ecological momentary assessment frequency among adults trying to quit smoking.

AIMS: Ecological Momentary Assessment (EMA) captures real-time reports in subjects' natural environments. This experiment manipulated EMA frequency to estimate effects on abstinence and peri-cessation subjective experiences. DESIGN: In this randomized trial, subjects had an equal chance of being assigned to low-frequency (once) or high-frequency (six times) daily EMA for 4 weeks (1 week pre- and 3 weeks post-cessation). Participants completed six office visits over 5 weeks and 6- and 12-week follow-up telephone interviews. SETTING: Community participants were recruited from central New Jersey, USA. PARTICIPANTS: One hundred and ten adult daily smokers seeking to quit smoking were included in intent-to-treat analyses of tobacco abstinence; 94 were available for secondary analyses of peri-cessation subjective ratings. MEASUREMENTS: Primary outcomes were cessation (abstaining at least 24 hours within 2 weeks of attempting to quit) and prolonged abstinence (no relapse between weeks 2 and 12 post-quit). Secondary outcomes were mean levels and growth in ratings of cigarette craving, affect and quitting motivation and self-efficacy. FINDINGS: EMA frequency was unrelated to cessation (odds ratio = 1.367, 95% confidence interval = 0.603-3.098) or prolonged abstinence (odds ratio = 1.040, 95% confidence interval = 0.453-2.388) in intent-to-treat analyses. High-frequency EMA was associated with lower craving (B = -0.544, standard error (SE) = 0.183, P = 0.004, anxiety (B = -0.424, SE = 0.170, P = 0.015), anger (B = -0.474, SE = 0.139, P = 0.001), hunger (B = -0.388, SE = 0.170, P = 0.025) and positive affect (B = -0.430, SE = 0.196, P = 0.03). CONCLUSIONS: In smokers trying to quit, more frequent ecological momentary assessment self-monitoring results in lower craving, anxiety, anger, hunger and positive affect. It is not clear whether this translates into higher rates of smoking abstinence.

Dense breast tissue notification: impact on women's perceived risk, anxiety, and intentions for future breast cancer screening.

PURPOSE: The aim of this study was to explore how women respond to the wording of dense breast tissue notifications, which are increasingly required by state law after mammography. The specific aims were to (1) determine whether perceived lifetime risk for breast cancer and intentions to undergo mammography increase after reviewing a sample notification, (2) explore individual difference variables (eg, minority status, insurance coverage) that may influence intentions for additional ultrasound screening, and (3) assess whether anxiety mediates the relationship between perceived risk and screening intentions. METHODS: A total of 184 women aged >40 years in the United States were recruited from Amazon Mechanical Turk to respond to a dense breast tissue notification as if they had personally received it. RESULTS: After reviewing a notification, women reported greater perceived risk (d = 0.67) and intentions to undergo mammography (d = 0.25) than before. Most women intended to undergo additional ultrasound screening, although to a lesser extent when ultrasound was covered by insurance than when it was not (d = 1.03). All screening intentions were lower in women with ambiguity aversion, a tendency to avoid tests without medical consensus, and those who preferred an active decision-making role. Anxiety mediated the relationship between perceived breast cancer risk and all screening intentions. CONCLUSIONS: Women who receive dense breast tissue notifications may generally increase their breast cancer screening intentions; however, intention strength varies depending on internal (eg, ambiguity aversion) and external (eg, insurance for ultrasound) factors. Although perceived risk increases after notification, it is anxiety that drives women's intentions for future screening.

Disseminating hypnosis to health care settings: Applying the RE-AIM framework.

Hypnosis is a brief intervention ready for wider dissemination in medical contexts. Overall, hypnosis remains underused despite evidence supporting its beneficial clinical impact. This review will evaluate the evidence supporting hypnosis for dissemination using guidelines formulated by Glasgow and colleagues (1999). Five dissemination dimensions will be considered: Reach, Efficacy, Adoption, Implementation, and Maintenance (RE-AIM). REACH: In medical settings, hypnosis is capable of helping a diverse range of individuals with a wide variety of problems. EFFICACY: There is evidence supporting the use of hypnosis for chronic pain, acute pain and emotional distress arising from medical procedures and conditions, cancer treatment-related side-effects and irritable bowel syndrome. ADOPTION: Although hypnosis is currently not a part of mainstream clinical practices, evidence suggests that patients and healthcare providers are open to trying hypnosis, and may become more so when educated about what hypnosis can do. IMPLEMENTATION: Hypnosis is a brief intervention capable of being administered effectively by healthcare providers. MAINTENANCE: Given the low resource needs of hypnosis, opportunities for reimbursement, and the ability of the intervention to potentially help medical settings reduce costs, the intervention has the qualities necessary to be integrated into routine care in a self-sustaining way in medical settings. In sum, hypnosis is a promising candidate for further dissemination.

Relations among affect, abstinence motivation and confidence, and daily smoking lapse risk.

This study tested the hypothesis that changes in momentary affect, abstinence motivation, and confidence would predict lapse risk over the next 12-24 hr using Ecological Momentary Assessment (EMA) data from smokers attempting to quit smoking. One hundred and three adult, daily, treatment-seeking smokers recorded their momentary affect, motivation to quit, abstinence confidence, and smoking behaviors in near real time with multiple EMA reports per day using electronic diaries postquit. Multilevel models indicated that initial levels of negative affect were associated with smoking, even after controlling for earlier smoking status, and that short-term increases in negative affect predicted lapses up to 12, but not 24, hr later. Positive affect had significant effects on subsequent abstinence confidence, but not motivation to quit. High levels of motivation appeared to reduce increases in lapse risk that occur over hours although momentary changes in confidence did not predict lapse risk over 12 hr. Negative affect had short-lived effects on lapse risk, whereas higher levels of motivation protected against the risk of lapsing that accumulates over hours. An increase in positive affect was associated with greater confidence to quit, but such changes in confidence did not reduce short-term lapse risk, contrary to expectations. Relations observed among affect, cognitions, and lapse seem to depend critically on the timing of assessments.

Adherence to evidence-based guidelines among diabetes self-management apps.

Smartphone apps can provide real-time, interactive self-management aid to individuals with diabetes. It is currently unclear whether existing diabetes self-management apps follow evidence-based guidelines. The purpose of this study was to evaluate the extent to which existing diabetes self-management apps address the seven self-management behaviors recommended by the American Association of Diabetes Educators (the AADE7™). The term "diabetes" identified relevant self-management apps via the Apple App Store search engine in March 2012. Ratings were based on app descriptions and downloads. Chi-square analyses assessed differences in apps based on developer type. Apps promoted a median of two AADE7™ skills. Overall reliability between description and download ratings was good (kappa = .66). Reliability of individual skills was variable (kappa = .25 to .91). Most diabetes apps do not conform to evidence-based recommendations, and future app reviews would benefit from testing app performance. Future apps may also benefit from theory-based designs.

An ecological momentary assessment analysis of prequit markers for smoking-cessation failure.

This study aimed to identify correlates of smoking-cessation failure, a failure to establish abstinence during a quit-smoking attempt. Identifying risk factors for early failure could facilitate the development of tailored interventions to promote cessation. The current study used existing ecological momentary assessment (EMA) data to investigate the extent to which prequit craving, negative affect, and recent smoking were associated with cessation failure in 374 smokers (189, 50.5% female). Subjects were prompted to complete 4-7 real-time reports of craving, negative affect, and recent smoking daily in the four days prior to quitting. Multilevel models of craving and negative affect (mean level, growth, volatility, and association with smoking) were estimated. Results indicated that recent smoking was associated with significantly lower craving among smokers who failed to quit than those who achieved a full day of cessation, but this held only among smokers who reduced smoking by at least 10% in the days preceding the quit attempt. Smokers who failed to quit on the quit day also experienced slower increases in negative affect in the days preceding the quit attempt than did initial abstainers, but delayed quitters and delayed cessation failures did not differ in negative-affect trajectories. These results suggest that successful abstainers and cessation failures can be differentiated by specific dimensions of prequit craving and negative-affect experiences, but the effects hold only in certain circumstances.