Tobacco Cessation Motivations, Preferences, and Barriers Among Rural Smokers: Implications for Optimizing Referrals in Clinical Practice.

Introduction: Rural‒urban smoking disparities have widened in recent years because smoking prevalence reductions have been experienced disproportionately among urban adults. Tobacco cessation programs that work in urban settings may not be reaching rural smokers or may need tailoring to be effective. Identifying smoking cessation preferences and barriers among rural smokers can facilitate the implementation of acceptable programs to address rural smoking-related disparities. Thus, the aim of this study was to examine tobacco cessation motivations, preferences, and barriers among rural smokers and to assess smokers' likelihood to use various types of tobacco cessation programs. Methods: Using a cross-sectional study design, we distributed a self-administered survey to 100 smokers during regularly scheduled healthcare appointments at 3 rural Michigan practices from June to August 2019. We examined differences in participant characteristics by the readiness to quit using chi-square/Fisher's exact tests and described cessation motivations, preferences, and barriers to tobacco cessation among rural smokers. Results: Participants reporting readiness to quit were less likely to have smoking allowed in their home (31.7% vs. 75.0%; p=0.003) and had a higher prevalence of anxiety (62.1% vs. 6.3%; p=0.0001) and depression (49.2% vs. 18.8%; p=0.04) than those not ready to quit. Preferences were higher for nicotine replacement medications and reward-based approaches, with only 10% of participants being likely to use telephone-based quitlines. Conclusions: These findings suggest that provider referrals to nicotine replacement medications and reward-based approaches can be used to enhance tobacco cessation among rural smokers.

Cascade Genetic Risk Education and Testing in Families With Hereditary Cancer Syndromes: A Pilot Study.

PURPOSE: Cascade genetic risk evaluation in families with hereditary cancer can reduce the burden of disease but the rate of germline genetic testing in relatives of patients at risk is low. METHODS: We identified all 277 women diagnosed with breast cancer in Georgia in 2017 who linked to a clinically actionable germline pathogenic variant through a Surveillance, Epidemiology, and End Results registry-variant linkage initiative. We surveyed them, and then invited eligible respondents to an online platform hosted by a navigator that offered cancer genetic risk education and germline genetic testing to untested relatives. We randomly assigned patient-family clusters at the time of the patient enrollment offer to free versus $50 (USD) test cost. Patients invited relatives to join the study through personalized e-mail. Enrolled relatives received online cancer genetic education and the opportunity to order clinical germline genetic testing through the platform. The primary outcome was the number of relatives who ordered genetic testing. RESULTS: One hundred twenty-five of 277 patients completed surveys (45.2%). Most respondents were eligible for the trial offer (113 of 125; 90.4%). In the free testing arm, 20 of 56 eligible patients participated (35.7% of eligible respondents) and they invited 28 relatives: 12 relatives enrolled and 10 ordered testing. In the $50 (USD) arm, 16 of 57 eligible patients participated (28.1%) and they invited 38 relatives: 18 relatives enrolled and 17 ordered testing. CONCLUSION: Cascade genetic testing in families with hereditary cancer syndromes accrued through a population-based cancer registry can be achieved through an online platform that offers genetic risk education and low-cost testing to relatives. A modest charge did not appear to influence the percentage of participating patients, numbers of participating relatives, and numbers of relatives who received genetic testing.

Smoking Status, Nicotine Medication, Vaccination, and COVID-19 Hospital Outcomes: Findings from the COVID EHR Cohort at the University of Wisconsin (CEC-UW) Study.

INTRODUCTION: Available evidence is mixed concerning associations between smoking status and COVID-19 clinical outcomes. Effects of nicotine replacement therapy (NRT) and vaccination status on COVID-19 outcomes in smokers are unknown. METHODS: Electronic health record data from 104 590 COVID-19 patients hospitalized February 1, 2020 to September 30, 2021 in 21 U.S. health systems were analyzed to assess associations of smoking status, in-hospital NRT prescription, and vaccination status with in-hospital death and ICU admission. RESULTS: Current (n = 7764) and never smokers (n = 57 454) did not differ on outcomes after adjustment for age, sex, race, ethnicity, insurance, body mass index, and comorbidities. Former (vs never) smokers (n = 33 101) had higher adjusted odds of death (aOR, 1.11; 95% CI, 1.06-1.17) and ICU admission (aOR, 1.07; 95% CI, 1.04-1.11). Among current smokers, NRT prescription was associated with reduced mortality (aOR, 0.64; 95% CI, 0.50-0.82). Vaccination effects were significantly moderated by smoking status; vaccination was more strongly associated with reduced mortality among current (aOR, 0.29; 95% CI, 0.16-0.66) and former smokers (aOR, 0.47; 95% CI, 0.39-0.57) than for never smokers (aOR, 0.67; 95% CI, 0.57, 0.79). Vaccination was associated with reduced ICU admission more strongly among former (aOR, 0.74; 95% CI, 0.66-0.83) than never smokers (aOR, 0.87; 95% CI, 0.79-0.97). CONCLUSIONS: Former but not current smokers hospitalized with COVID-19 are at higher risk for severe outcomes. SARS-CoV-2 vaccination is associated with better hospital outcomes in COVID-19 patients, especially current and former smokers. NRT during COVID-19 hospitalization may reduce mortality for current smokers. IMPLICATIONS: Prior findings regarding associations between smoking and severe COVID-19 disease outcomes have been inconsistent. This large cohort study suggests potential beneficial effects of nicotine replacement therapy on COVID-19 outcomes in current smokers and outsized benefits of SARS-CoV-2 vaccination in current and former smokers. Such findings may influence clinical practice and prevention efforts and motivate additional research that explores mechanisms for these effects.

Relations of Current and Past Cancer with Severe Outcomes among 104,590 Hospitalized COVID-19 Patients: The COVID EHR Cohort at the University of Wisconsin.

BACKGROUND: There is mixed evidence about the relations of current versus past cancer with severe COVID-19 outcomes and how they vary by patient and cancer characteristics. METHODS: Electronic health record data of 104,590 adult hospitalized patients with COVID-19 were obtained from 21 United States health systems from February 2020 through September 2021. In-hospital mortality and ICU admission were predicted from current and past cancer diagnoses. Moderation by patient characteristics, vaccination status, cancer type, and year of the pandemic was examined. RESULTS: 6.8% of the patients had current (n = 7,141) and 6.5% had past (n = 6,749) cancer diagnoses. Current cancer predicted both severe outcomes but past cancer did not; adjusted odds ratios (aOR) for mortality were 1.58 [95% confidence interval (CI), 1.46-1.70] and 1.04 (95% CI, 0.96-1.13), respectively. Mortality rates decreased over the pandemic but the incremental risk of current cancer persisted, with the increment being larger among younger vs. older patients. Prior COVID-19 vaccination reduced mortality generally and among those with current cancer (aOR, 0.69; 95% CI, 0.53-0.90). CONCLUSIONS: Current cancer, especially among younger patients, posed a substantially increased risk for death and ICU admission among patients with COVID-19; prior COVID-19 vaccination mitigated the risk associated with current cancer. Past history of cancer was not associated with higher risks for severe COVID-19 outcomes for most cancer types. IMPACT: This study clarifies the characteristics that modify the risk associated with cancer on severe COVID-19 outcomes across the first 20 months of the COVID-19 pandemic. See related commentary by Egan et al., p. 3.

The first 20 months of the COVID-19 pandemic: Mortality, intubation and ICU rates among 104,590 patients hospitalized at 21 United States health systems.

MAIN OBJECTIVE: There is limited information on how patient outcomes have changed during the COVID-19 pandemic. This study characterizes changes in mortality, intubation, and ICU admission rates during the first 20 months of the pandemic. STUDY DESIGN AND METHODS: University of Wisconsin researchers collected and harmonized electronic health record data from 1.1 million COVID-19 patients across 21 United States health systems from February 2020 through September 2021. The analysis comprised data from 104,590 adult hospitalized COVID-19 patients. Inclusion criteria for the analysis were: (1) age 18 years or older; (2) COVID-19 ICD-10 diagnosis during hospitalization and/or a positive COVID-19 PCR test in a 14-day window (+/- 7 days of hospital admission); and (3) health system contact prior to COVID-19 hospitalization. Outcomes assessed were: (1) mortality (primary), (2) endotracheal intubation, and (3) ICU admission. RESULTS AND SIGNIFICANCE: The 104,590 hospitalized participants had a mean age of 61.7 years and were 50.4% female, 24% Black, and 56.8% White. Overall risk-standardized mortality (adjusted for age, sex, race, ethnicity, body mass index, insurance status and medical comorbidities) declined from 16% of hospitalized COVID-19 patients (95% CI: 16% to 17%) early in the pandemic (February-April 2020) to 9% (CI: 9% to 10%) later (July-September 2021). Among subpopulations, males (vs. females), those on Medicare (vs. those on commercial insurance), the severely obese (vs. normal weight), and those aged 60 and older (vs. younger individuals) had especially high mortality rates both early and late in the pandemic. ICU admission and intubation rates also declined across these 20 months. CONCLUSIONS: Mortality, intubation, and ICU admission rates improved markedly over the first 20 months of the pandemic among adult hospitalized COVID-19 patients although gains varied by subpopulation. These data provide important information on the course of COVID-19 and identify hospitalized patient groups at heightened risk for negative outcomes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04506528 (https://clinicaltrials.gov/ct2/show/NCT04506528).

TrueNTH Sexual Recovery Intervention for couples coping with prostate cancer: Randomized controlled trial results.

BACKGROUND: Despite significant sexual dysfunction and distress after localized prostate cancer treatment, patients typically receive only physiologic erectile dysfunction management. The authors performed a randomized controlled trial of an online intervention supporting couples' posttreatment recovery of sexual intimacy. METHODS: Patients treated with surgery, radiation, or combined radiation and androgen deprivation therapy who had partners were recruited and randomized to an online intervention or a control group. The intervention, tailored to treatment type and sexual orientation, comprised 6 modules addressing expectations for sexual and emotional sequelae of treatment, rehabilitation, and guidance toward sexual intimacy recovery. Couples, recruited from 6 sites nationally, completed validated measures at the baseline and 3 and 6 months after treatment. Primary outcome group differences were assessed with t tests for individual outcomes. RESULTS: Among 142 randomized couples, 105 patients (mostly surgery) and 87 partners completed the 6-month survey; this reflected challenges with recruitment and attrition. There were no differences between the intervention and control arms in Patient-Reported Outcomes Measurement Information System Global Satisfaction With Sex Life scores 6 months after treatment (the primary outcome). Three months after treatment, intervention patients and partners reported more engagement in penetrative and nonpenetrative sexual activities than controls. More than 73% of the intervention participants reported high or moderate satisfaction with module content; more than 85% would recommend the intervention to other couples. CONCLUSIONS: Online psychosexual support for couples can help couples to connect and experience sexual pleasure early after treatment despite patients' sexual dysfunction. Participants' high endorsement of the intervention reflects the importance of sexual health support to couples after prostate cancer treatment. LAY SUMMARY: This study tested a web-based program supporting couples' sexual recovery of sexual intimacy after prostate cancer treatment. One hundred forty-two couples were recruited and randomly assigned to the program (n = 60) or to a control group (n = 82). The program did not result in improvements in participants' satisfaction with their sex life 6 months after treatment, but couples in the intervention group engaged in sexual activity sooner after treatment than couples in the control group. Couples evaluated the program positively and would recommend it to others facing prostate cancer treatment.

Improving the delivery of team-based survivorship care after primary breast cancer treatment through a multi-level intervention: a pilot randomized controlled trial.

PURPOSE: We developed and tested a multi-level intervention, ConnectedCancerCare (CCC), which includes a tailored website and appointment reminder system for women with early-stage breast cancer and a provider summary letter sent to their medical oncologist and primary care provider to improve the delivery of team-based survivorship care. METHODS: We conducted a pilot randomized controlled trial to establish the feasibility and acceptability of CCC. Women diagnosed with stages 0-II breast cancer within one year of completing primary treatment were randomized to CCC (intervention) or a static online survivorship care plan (control). Participants completed baseline and 3-month follow-up surveys online. Post-trial interviews with 5 PCPs, 6 oncology providers, and 8 intervention patients were conducted. RESULTS: Of the 160 eligible women invited to participate, 66 completed the baseline survey and were randomized (41%) and 54 completed a follow-up survey (83%). Participants in the intervention arm found the CCC content to be acceptable, with 82% reporting it was easy to use and 86% reporting they would recommend it to other patients. Women randomized to CCC (vs. control) more often reported scheduling a PCP follow-up visit (64% vs. 42%), communicating with their PCP about provider roles (67% vs. 18%), and higher mean team-based cancer care knowledge scores (3.7 vs. 3.4). CONCLUSION: Deploying CCC in medical oncology practices was feasible, and the intervention content was acceptable. CCC shows promise for improving patient knowledge and patient-provider communication about provider roles in team-based cancer care and encouraging patients to engage with their PCP early in the survivorship period.

Delayed Urological Cancer Care during the COVID-19 Pandemic: Urologists' Experience.

INTRODUCTION: The arrival of coronavirus disrupted health care systems and forced delays in cancer treatment. We explored the experience of urologists who had to delay their patients' cancer care. METHODS: Urologists who treat prostate, bladder, and renal cancers, selected through purposive sampling, responded to a survey about cancer treatment delay. They were asked about their practice setting, decision making and interactions with patients, and they were asked to reflect on their personal experience. A 0 to 10 point scale, modeled on the National Comprehensive Cancer Network' Distress Thermometer (NCCN-DT), validated for cancer patients with cancer, was used to estimate physician distress. We used descriptive statistics to analyze survey results. RESULTS: Of the 64 participating urologists, 98% delayed surgical treatment; fewer delayed cases of advanced cancers (42% for ≥T3/T4 or Gleason ≥8 prostate cancers, 58% for muscle invasive bladder cancer, 61% for ≥T2 renal cancers). They reported feeling anxious (44%) and helpless (29%), and their median distress score was 5 (range 0-10). They relied on their own risk assessments (67%) and consulted colleagues (56%) and national guidelines (53%) when making treatment deferral decisions. They identified a number of concerns as they resumed surgeries. CONCLUSIONS: Based on a comparison to the NCCN-DT clinical cutoff distress level of 4, urologists experienced moderately high levels of distress as they delayed cancer care during the COVID-19 pandemic and expressed concerns going forward. While the focus on patient care is paramount in a pandemic, it is important to recognize physician distress and develop practical and psychological strategies for distress mitigation.

Perspectives on Oncology-Specific Language During the Coronavirus Disease 2019 Pandemic: A Qualitative Study.

IMPORTANCE: The novel coronavirus disease 2019 (COVID-19) pandemic has dramatically changed the US health care system, causing an influx of patients who require resources. Many oncologists are having challenging conversations with their patients about how the COVID-19 pandemic is affecting cancer care and may desire evidence-based communication guidance. OBJECTIVES: To identify the clinical scenarios that pose communication challenges, understand patient reactions to these scenarios, and develop a communication guide with sample responses. DESIGN, SETTING, AND PARTICIPANTS: This qualitative study that was conducted at a single Midwestern academic medical center invited physicians to respond to a brief semistructured interview by email or telephone and then disseminated an anonymous online survey among patients with cancer. Oncology-specific, COVID-19-related clinical scenarios were identified by the physicians, and potential reactions to these scenarios were gleaned from the patient responses to the survey. Health communication experts were invited to participate in the iterative development of a communication guide, comprising 3 essential communication principles and strategies and informed by insights from physicians and patients. This study was conducted from March 25, 2020, to April 2, 2020. INTERVENTIONS: Expert review, interviews, and surveys assessing challenging situations specific to cancer management during the COVID-19 pandemic. MAIN OUTCOMES AND MEASURES: Oncology-specific, COVID-19-related clinical scenarios from physician interviews; responses to each scenario from patient surveys; and applicable communication principles from health communication expert literature review. RESULTS: Of the 8 physicians who participated in interviews, 4 were men (50%) and 4 were women (50%). These physicians represented the following disciplines: internal medicine (n = 1), hematology/oncology (n = 2), radiation oncology (n = 3), and surgical oncology (n = 2). Their disease site specialization included cancers of the breast, head and neck, melanoma, and gastrointestinal and genitourinary tracts. A total of 48 patients with cancer completed the online survey; no demographic information was collected from the patients. The physicians identified 8 oncology-specific, COVID-19-related scenarios in which communication might be challenging: (1) worse outcomes from COVID-19, (2) delay in cancer screening, (3) delay in diagnostic workup, (4) delay in initiation of treatment, (5) offer of nonstandard treatment, (6) treatment breaks, (7) delay in follow-up imaging or care, and (8) inability to be admitted into the hospital for management. Potential patient reactions to each of these scenarios were compiled from survey responses. For most scenarios, patient reactions involved anger, fear, and anxiety (eg, "I'm scared"; "This isn't fair. I am upset."). These emotional patient responses informed the selection of the 3 general communication principles, which suggested language and strategies that physicians can use to respond to patients. CONCLUSIONS AND RELEVANCE: In this qualitative study, physicians and patients identified communication needs used by health communication experts to inform the development of a practical, evidence-based communication guide for oncology care during the COVID-19 pandemic.

Effects of a Novel Contextual Just-In-Time Mobile App Intervention (LowSalt4Life) on Sodium Intake in Adults With Hypertension: Pilot Randomized Controlled Trial.

BACKGROUND: High dietary sodium intake is a significant public health problem in the United States. High sodium consumption is associated with high blood pressure and high risk of cardiovascular disease. OBJECTIVE: The aim of this study was to evaluate the effect of a just-in-time adaptive mobile app intervention, namely, LowSalt4Life, on reducing sodium intake in adults with hypertension. METHODS: In this study, 50 participants aged ≥18 years who were under treatment for hypertension were randomized (1:1, stratified by gender) into 2 groups, namely, the App group (LowSalt4Life intervention) and the No App group (usual dietary advice) in a single-center, prospective, open-label randomized controlled trial for 8 weeks. The primary endpoint was the change in the 24-hour urinary sodium excretion estimated from spot urine by using the Kawasaki equation, which was analyzed using unpaired two-sided t tests. Secondary outcomes included the change in the sodium intake measured by the food frequency questionnaire (FFQ), the 24-hour urinary sodium excretion, blood pressure levels, and the self-reported confidence in following a low-sodium diet. RESULTS: From baseline to week 8, there was a significant reduction in the Kawasaki-estimated 24-hour urinary sodium excretion calculated from spot urine in the App group compared to that in the No App group (-462 [SD 1220] mg vs 381 [SD 1460] mg, respectively; P=.03). The change in the 24-hour urinary sodium excretion was -637 (SD 1524) mg in the App group and -322 (SD 1485) mg in the No App group (P=.47). The changes in the estimated sodium intake as measured by 24-hour dietary recall and by FFQ in the App group were -1537 (SD 2693) mg and -1553 (SD 1764) mg while those in the No App group were -233 (SD 2150) mg and -515 (SD 1081) mg, respectively (P=.07 and P=.01, respectively). The systolic blood pressure change from baseline to week 8 in the App group was -7.5 mmHg while that in the No App group was -0.7 mmHg (P=.12), but the self-confidence in following a low-sodium diet was not significantly different between the 2 groups. CONCLUSIONS: This study shows that a contextual just-in-time mobile app intervention resulted in a greater reduction in the dietary sodium intake in adults with hypertension than that in the control group over a 8-week period, as measured by the estimated 24-hour urinary sodium excretion from spot urine and FFQ. The intervention group did not show a significant difference from the control group in the self-confidence in following a low sodium diet and in the 24-hour urinary sodium excretion or dietary intake of sodium as measured by the 24-hour dietary recall. A larger clinical trial is warranted to further elucidate the effects of the LowSalt4Life intervention on sodium intake and blood pressure levels in adults with hypertension. TRIAL REGISTRATION: ClinicalTrials.gov NCT03099343; https://clinicaltrials.gov/ct2/show/NCT03099343. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/11282.

Feasibility of a Smartphone-Based Tobacco Treatment for HIV-Infected Smokers.

BACKGROUND: Cigarette smoking is common among persons living with HIV (PLWH) in the United States. It is the leading cause of mortality in this group, and efforts to promote cessation have been largely unsuccessful. METHODS: From 2015 to 2017, we performed a randomized controlled trial of Positively Smoke Free-Mobile (PSF-M) versus standard care. PSF-M is a mobile Web site that offers a 42-day text message-based quit-smoking program with smartphone features including quit-day selection/calendar, educational/motivational videos, and HELP button for cravings. RESULTS: One hundred individuals enrolled, 48 were randomized to PSF-M (mean age = 45 years, 54% male, 81% black, 31% Latino) and 52 to the standard care condition. All participants were offered a 3-month supply of nicotine patches. Participants randomized to the mobile intervention visited the PSF-M home page a mean of 83 times, viewed 5.6/8 videos, logged in on 13 of 42 possible days, and received 131 texts. Among them, 77% tapped HELP for cravings, and craving response options were used by the following proportions: phone-a-friend, 58%; play-a-game, 29%; play-a-song, 4%. Older age and nonblack race were both associated with higher levels of engagement with the site. Of participants, 61% rated PSF-M very or extremely helpful, and 98% would recommend PSF-M to PLWH family or friends. Abstinence at 3 months, quit attempts, and daily cigarette intake all favored PSF-M over standard care but did not achieve statistical significance in our pilot sample. CONCLUSIONS: Smartphone-based tobacco treatment for PLWH was feasible and achieved moderate-high rates of engagement and satisfaction in a middle-aged, ethnic or racial minority group in the poorest urban community in the United States. IMPLICATIONS: Cigarette smoking has emerged as the leading killer of PLWH. Behavioral interventions have achieved only limited success in promoting cessation in this population. In this study, we explore the feasibility and preliminary efficacy of a multimodal, Web-based, quit-smoking intervention delivered to PLWH smokers via their smartphones.

Implementation of Evidence-Based Practice for Benign Paroxysmal Positional Vertigo in the Emergency Department: A Stepped-Wedge Randomized Trial.

STUDY OBJECTIVE: We evaluated a strategy to increase use of the test (Dix-Hallpike's test [DHT]) and treatment (canalith repositioning maneuver [CRM]) for benign paroxysmal positional vertigo in emergency department (ED) dizziness visits. METHODS: We conducted a stepped-wedge randomized trial in 6 EDs. The population was visits with dizziness as a principal reason for the visit. The intervention included educational sessions and decision aid materials. Outcomes were DHT or CRM documentation (primary), head computed tomography (CT) use, length of stay, admission, and 90-day stroke events. The analysis was multilevel logistic regression with intervention, month, and hospital as fixed effects and provider as a random effect. We assessed fidelity with monitoring intervention use and semistructured interviews. RESULTS: We identified 7,635 dizziness visits during 18 months. The DHT or CRM was documented in 1.5% of control visits (45/3,077; 95% confidence interval 1% to 1.9%) and 3.5% of intervention visits (159/4,558; 95% confidence interval 3% to 4%; difference 2%, 95% confidence interval 1.3% to 2.7%). Head CT use was lower in intervention visits compared with control visits (44.0% [1,352/3,077] versus 36.9% [1,682/4,558]). No differences were observed in admission or 90-day subsequent stroke risk. In fidelity evaluations, providers who used the materials typically reported positive clinical experiences but provider engagement was low at facilities without an emergency medicine residency program. CONCLUSION: These findings provide evidence that an implementation strategy of a benign paroxysmal positional vertigo-focused approach to ED dizziness visits can be successful and safe in promoting evidence-based care. Absolute rates of DHT and CRM use, however, were still low, which relates in part to our broad inclusion criteria for dizziness visits.

An Educational Intervention for Acute Dizziness Care: A Randomized, Vignette-based Study.

IMPORTANCE: Benign paroxysmal positional vertigo (BPPV) is a common cause of acute dizziness. Strong evidence exists for diagnosing BPPV using the Dix-Hallpike Test (DHT) and treating it with the canalith repositioning maneuver (CRM). Despite this, both are infrequently used in the emergency department (ED). OBJECTIVE: As an early method to evaluate a BPPV-focused educational intervention, we evaluated whether an educational intervention improved ED provider performance on hypothetical stroke and BPPV cases delivered by vignette. DESIGN: A randomized, controlled, educational intervention study in ED physicians. The intervention aimed to promote the appropriate use of the DHT and CRM. A BPPV vignette, a stroke-dizziness (safety) vignette, and vignette scoring schemes (higher scores indicating more optimal care) used previously established vignette methodology. SETTING: We recruited participants at the exhibitor hall of an emergency medicine annual meeting. PARTICIPANTS: We recruited 48 emergency physicians. All were board certified or residency trained and board eligible. All were engaged in the active practice of emergency medicine. None were trainees. INTERVENTIONS: Intervention group: a narrated, educational presentation by computer followed by the clinical vignettes. CONTROL GROUP: Received no educational intervention and completed the clinical vignettes-intended to mirror current clinician practice. MAIN OUTCOME MEASURE: Primary endpoint: total score (out of 200 points) on a vignette-based scoring instrument assessing the performance of history, physical, and diagnostic testing on hypothetical stroke and BPPV cases. RESULTS: The efficacy threshold was crossed at the interim analysis. The intervention group had higher performance scores compared with controls (113.2 versus 68.6, p < 0.00001). BPPV and safety subscores were both significantly higher in the intervention group. Sixty-two percent of the intervention group planned to use the DHT versus 29% of controls. After the vignette described characteristic BPPV nystagmus, 100% of the intervention group planned to use the CRM versus 17% of controls. CONCLUSIONS AND RELEVANCE: The educational intervention increased provider performance in dizziness vignettes, including more frequent appropriate use of the DHT/CRM. These findings indicate the intervention positively influenced planned behavior. Future work is needed to implement and evaluate this intervention in clinical practice.

Neural Mechanisms of Emotion Regulation Moderate the Predictive Value of Affective and Value-Related Brain Responses to Persuasive Messages.

Emotionally evocative messages can be an effective way to change behavior, but the neural pathways that translate messages into effects on individuals and populations are not fully understood. We used a human functional neuroimaging approach to ask how affect-, value-, and regulation-related brain systems interact to predict effects of graphic anti-smoking messages for individual smokers (both males and females) and within a population-level messaging campaign. Results indicated that increased activity in the amygdala, a region involved in affective reactivity, predicted both personal quit intentions and population-level information-seeking and this was mediated by activity in ventromedial prefrontal cortex (vmPFC), a region involved in computing an integrative value signal. Further, the predictive value of these regions was moderated by expression of a meta-analytically defined brain pattern indexing emotion regulation. That is, amygdala and vmPFC activity strongly tracked with population behavior only when participants showed low recruitment of this brain pattern, which consists of regions involved in goal-driven regulation of affective responses. Overall, these findings suggest that affective and value-related brain responses can predict the success of persuasive messages and that neural mechanisms of emotion regulation can shape these responses, moderating the extent to which they track with population-level message impact.SIGNIFICANCE STATEMENT People and organizations often appeal to our emotions to persuade us, but how these appeals engage the brain to drive behavior is not fully understood. We present an fMRI-based model that integrates affect-, control-, and value-related brain responses to predict the impact of graphic anti-smoking stimuli within a small group of smokers and a larger-scale public messaging campaign. This model indicated that amygdala activity predicted the impact of the anti-smoking messages, but that this relationship was mediated by ventromedial prefrontal cortex and moderated by expression of a distributed brain pattern associated with regulating emotion. These results suggest that neural mechanisms of emotion regulation can shape the extent to which affect and value-related brain responses track with population behavioral effects.

Implementation of evidence-based practice for benign paroxysmal positional vertigo: DIZZTINCT- A study protocol for an exploratory stepped-wedge randomized trial.

BACKGROUND: Benign paroxysmal positional vertigo (BPPV) is the most common peripheral vestibular disorder, and accounts for 8% of individuals with moderate or severe dizziness. BPPV patients experience substantial inconveniences and disabilities during symptomatic periods. BPPV therapeutic processes - the Dix-Hallpike Test (DHT) and the Canalith Repositioning Maneuver (CRM) - have an evidence base that is at the clinical practice guideline level. The most commonly used CRM is the modified Epley maneuver. The DHT is the gold standard test for BPPV and the CRM is supported by numerous randomized controlled trials and systematic reviews. Despite this, BPPV care processes are underutilized. METHODS/DESIGN: This is a stepped-wedge, randomized clinical trial of a multi-faceted educational and care-process-based intervention designed to improve the guideline-concordant care of patients with BPPV presenting to the emergency department (ED) with dizziness. The unit of randomization and target of intervention is the hospital. After an initial observation period, the six hospitals will undergo the intervention in five waves (two closely integrated hospitals will be paired). The order will be randomized. The primary endpoint is measured at the individual patient level, and is the presence of documentation of either the Dix-Hallpike Test or CRM. The secondary endpoints are referral to a health care provider qualified to treat dizziness for CRM and 90-day stroke rates following an ED dizziness visit. Formative evaluations are also performed to monitor and identify potential and actual influences on the progress and effectiveness of the implementation efforts. DISCUSSION: If this study safely increases documentation of the DHT/CRM, this will be an important step in implementing the use of these evidenced-based processes of care. Positive results will support conducting larger-scale follow-up studies that assess patient outcomes. The data collection also enables evaluation of potential and actual influences on the progress and effectiveness of the implementation efforts. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02809599 . The record was first available to the public on 22 June 2016 prior to the enrollment of the first patients in October 2016.

A Novel Just-in-Time Contextual Mobile App Intervention to Reduce Sodium Intake in Hypertension: Protocol and Rationale for a Randomized Controlled Trial (LowSalt4Life Trial).

BACKGROUND: High sodium intake is a significant public health problem in the United States. Interventions that lower sodium intake can decrease blood pressure and improve cardiovascular outcomes. Restaurants and grocery stores are prime targets for intervention with about 77% of all sodium intake in the average US diet coming from processed and restaurant foods. OBJECTIVE: This study proposes that a mobile app intervention that promotes low-sodium alternatives at grocery stores and restaurants will reduce dietary intake of sodium and improve confidence following a low-sodium diet in hypertension. METHODS: In this single-center, prospective, open-label study, patients will be randomized to a mobile app or usual care for 8 weeks. We will randomize 50 patients (age>18 years) diagnosed with hypertension and on antihypertensive therapy for at least 3 months in a 1:1 manner stratified by gender. Study subjects will receive the mobile app, LowSalt4Life, or usual dietary advice for 8 weeks. LowSalt4Life provides a multifaceted intervention based on just-in-time contextual tailored messages at grocery stores and restaurants. The primary endpoint is the change in the estimated 24-hour urinary excretion of sodium from spot urine. Secondary outcomes include change in the sodium content of the food frequency questionnaire, confidence in following a low-sodium diet, urine chloride and creatinine dipsticks, and blood pressure. RESULTS: The project was funded in May 2016 until April 2018. This trial is currently enrolling patients. To date, 26 of the 50 patients needed have been enrolled. Results will be available in the Spring of 2019. CONCLUSIONS: This randomized controlled trial will test the efficacy of just-in-time contextual tailored messages through a novel mobile app 8-week intervention on urinary sodium excretion in patients with hypertension. We will address a critical evidence gap in the care of patients with hypertension. If effective, this intervention could be scaled to assess effects on blood pressure and cardiovascular events in hypertension. TRIAL REGISTRATION: ClinicalTrials.gov NCT03099343; https://clinicaltrials.gov/ct2/show/NCT03099343 (Archived by WebCite at http://www.webcitation.org/735HNzKlQ). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/11282.

Knowledge regarding and patterns of genetic testing in patients newly diagnosed with breast cancer participating in the iCanDecide trial.

BACKGROUND: The current study reports rates of knowledge regarding the probability of a BRCA1 and/or S pathogenic variant and genetic testing in patients with breast cancer, collected as part of a randomized controlled trial of a tailored, comprehensive, and interactive decision tool (iCanDecide). METHODS: A total of 537 patients newly diagnosed with early-stage breast cancer were enrolled at the time of their first visit in 22 surgical practices, and were surveyed 5 weeks (496 patients; Response Rate [RR], 92%) after enrollment after treatment decision making. Primary outcomes included knowledge regarding the probability of carrying a BRCA1 and/or BRCA2 pathogenic variant and genetic testing after diagnosis. RESULTS: Overall knowledge regarding the probability of having a BRCA1 and/or BRCA2 pathogenic variant was low (29.8%). Significantly more patients in the intervention group compared with the control group had knowledge regarding the probability of a BRCA1 and/or BRCA2 pathogenic variant (35.8% vs 24.4%; P <.006). In multivariable logistic regression, the intervention arm remained significantly associated with knowledge regarding the probability of having a BRCA1 and/or BRCA2 pathogenic variant (odds ratio, 1.79; 95% confidence interval, 1.18-2.70). CONCLUSIONS: The results of the current study suggest that although knowledge concerning the probability of having a BRCA1 and/or BRCA2 pathogenic variant remains low in this patient population, the interactive decision tool improved rates compared with a static Web site. As interest in genetic testing continues to rise, so will the need to integrate tools into the treatment decision process to improve informed decision making.

Improving Breast Cancer Surgical Treatment Decision Making: The iCanDecide Randomized Clinical Trial.

Purpose This study was conducted to determine the effect of iCanDecide, an interactive and tailored breast cancer treatment decision tool, on the rate of high-quality patient decisions-both informed and values concordant-regarding locoregional breast cancer treatment and on patient appraisal of decision making. Methods We conducted a randomized clinical trial of newly diagnosed patients with early-stage breast cancer making locoregional treatment decisions. From 22 surgical practices, 537 patients were recruited and randomly assigned online to the iCanDecide interactive and tailored Web site (intervention) or the iCanDecide static Web site (control). Participants completed a baseline survey and were mailed a follow-up survey 4 to 5 weeks after enrollment to assess the primary outcome of a high-quality decision, which consisted of two components, high knowledge and values-concordant treatment, and secondary outcomes (decision preparation, deliberation, and subjective decision quality). Results Patients in the intervention arm had higher odds of making a high-quality decision than did those in the control arm (odds ratio, 2.00; 95% CI, 1.37 to 2.92; P = .0004), which was driven primarily by differences in the rates of high knowledge between groups. The majority of patients in both arms made values-concordant treatment decisions (78.6% in the intervention arm and 81.4% in the control arm). More patients in the intervention arm had high decision preparation (estimate, 0.18; 95% CI, 0.02 to 0.34; P = .027), but there were no significant differences in the other decision appraisal outcomes. The effect of the intervention was similar for women who were leaning strongly toward a treatment option at enrollment compared with those who were not. Conclusion The tailored and interactive iCanDecide Web site, which focused on knowledge building and values clarification, positively affected high-quality decisions largely by improving knowledge compared with static online information. To be effective, future patient-facing decision tools should be integrated into the clinical workflow to improve decision making.

Barriers and facilitators to ED physician use of the test and treatment for BPPV.

BACKGROUND: The test and treatment for benign paroxysmal positional vertigo (BPPV) are evidence-based practices supported by clinical guideline statements. Yet these practices are underutilized in the emergency department (ED) and interventions to promote their use are needed. To inform the development of an intervention, we interviewed ED physicians to explore barriers and facilitators to the current use of the Dix-Hallpike test (DHT) and the canalith repositioning maneuver (CRM). METHODS: We conducted semi-structured in-person interviews with ED physicians who were recruited at annual ED society meetings in the United States. We analyzed data thematically using qualitative content analysis methods. RESULTS: Based on 50 interviews with ED physicians, barriers that contributed to infrequent use of DHT/CRM that emerged were (1) prior negative experiences or forgetting how to perform them and (2) reliance on the history of present illness to identify BPPV, or using the DHT but misattributing patterns of nystagmus. Based on participants' responses, the principal facilitator of DHT/CRM use was prior positive experiences using these, even if infrequent. When asked which clinical supports would facilitate more frequent use of DHT/CRM, participants agreed supports needed to be brief, readily accessible, and easy to use, and to include well-annotated video examples. CONCLUSIONS: Interventions to promote the use of the DHT/CRM in the ED need to overcome prior negative experiences with the DHT/CRM, overreliance on the history of present illness, and the underuse and misattribution of patterns of nystagmus. Future resources need to be sensitive to provider preferences for succinct information and video examples.

Decision-support networks of women newly diagnosed with breast cancer.

BACKGROUND: Little is known about the size and characteristics of the decision-support networks of women newly diagnosed with breast cancer and whether their involvement improves breast cancer treatment decisions. METHODS: A population-based sample of patients newly diagnosed with breast cancer in 2014 and 2015, as reported to the Georgia and Los Angeles Surveillance, Epidemiology, and End Results registries, were surveyed approximately 7 months after diagnosis (N = 2502; response rate, 68%). Network size was estimated by asking women to list up to 3 of the most important decision-support persons (DSPs) who helped them with locoregional therapy decisions. Decision deliberation was measured using 4 items assessing the degree to which patients thought through the decision, with higher scores reflecting more deliberative breast cancer treatment decisions. The size of the network (range, 0-3 or more) was compared across patient-level characteristics, and adjusted mean deliberation scores were estimated across levels of network size using multivariable linear regression. RESULTS: Of the 2502 women included in this analysis, 51% reported having 3 or more DSPs, 20% reported 2, 18% reported 1, and 11% reported not having any DSPs. Married/partnered women, those younger than 45 years, and black women all were more likely to report larger network sizes (all P < .001). Larger support networks were associated with more deliberative surgical treatment decisions (P < .001). CONCLUSIONS: Most women engaged multiple DSPs in their treatment decision making, and involving more DSPs was associated with more deliberative treatment decisions. Future initiatives to improve treatment decision making among women with breast cancer should acknowledge and engage informal DSPs. Cancer 2017;123:3895-903. © 2017 American Cancer Society.