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Objectives Develop and pilot implantable cardioverter-defibrillator (ICD) decision aids (DAs) for patients considering primary prevention ICDs. Background Using DAs for preference-sensitive decisions is an evidence-based way to improve patient-centered decisions. Reimbursement mandates have increased the need for DAs in ICD care, although none have been formally evaluated. Methods Development Phase: An expert panel, including patients and physicians, iteratively developed four DAs: a one-page Option GridTM conversation aid, a four-page in-depth paper tool, a 17-minute video, and an interactive website. Trial phase At three sites, patients with heart failure who were eligible for primary prevention ICDs were randomly assigned 2:1 to intervention (received DAs) or control (usual care). We conducted a mixed-methods evaluation exploring acceptability and feasibility. Results Twenty-one eligible patients enrolled (fifteen intervention). Most intervention participants found the DAs to be unbiased (67%), helpful (89%), and would recommend them to others (100%). The pilot was feasible at all sites; however, using clinic staff to identify eligible patients was more efficient than chart review. Although the main goals were to measure acceptability and feasibility, intervention participants trended towards increased concordance between longevity values and ICD decisions (71% concordant vs. 29%, p = 0.06). Participants preferred the in-depth paper tool and video DAs. Access to a nurse during the decision-making window encouraged questions and improved participant-perceived confidence. Conclusions Participants felt the DAs provided helpful, balanced information that they would recommend to other patients. Further exploration of this larger context of DA use and strategies to promote independent use related to electrophysiology visits are needed. This article is protected by copyright. All rights reserved.

Background Patient-centered care includes matching treatments to patient values and preferences. This assumes clarity and consistency of values and preferences relevant to major medical decisions. We sought to describe stability of patient-reported values regarding aggressiveness of care and preferences for left ventricular assist devices (LVADs) for advanced heart failure. Methods and Results We conducted a secondary analysis of patients undergoing LVAD evaluation at 6 US centers. Surveys at baseline, 1 month, and 6 months included a single 10-point scale on the value of aggressive care (score 1 = “do everything,” 10 = “live with whatever time I have left”) and treatment preference (LVAD, unsure, no LVAD). Data were captured for 232 patients, of whom 196 were ultimately deemed medically eligible for LVAD, and 161 were surgically implanted by 1 month. Values at baseline favored aggressive care (mean [SD], 2.49 [2.63]), trending toward less aggressive over time (1 month, 2.63 [2.05]; 6 months, 3.22 [2.70]). Between baseline and 1 month, values scores changed by ≥2 points in 28% (50/176), as did treatment preferences for 18% (29/161) of patients. Values score changes over time were associated with lower illness acceptance, depression, and eventual LVAD ineligibility. Treatment preference change was associated with values score change. Conclusion Most patients considering LVAD were stable in their values and treatment preferences. This stability, as well as the association between unstable treatment preferences and changes to stated values, highlighted the clinical utility of the values scale of aggressiveness. However, a substantial minority reported significant changes over time that may complicate the process of shared decision making. Improved methods to elicit and clarify values, including support to those with depression and low illness acceptance, is critical for patient-centered care. [Box: see text]

Background CMS reimbursement guidelines for implantable cardioverter-defibrillators (ICDs) include mandated shared decision making, but without any manner of assessing the quality of decisions made. We developed and tested a scale meant to assess patients' knowledge of and preferences specific to ICDs. Such a tool would assess these constructs in the clinical environment, targeting resources and support for patients considering a primary prevention ICD. Methods Development of the ICD decision quality (ICD-DQ) scale included 1) item creation, 2) content validation using surveys of patients (n = 23) and clinicians (n = 31), and 3) examination of validity and reliability using a survey of patients who previously received an ICD (n = 295, response rate = 72%). Results The final scale consists of 12 knowledge and 8 preference items. With respect to content validity, clinician and patient respondents agreed on the importance of 19 of 24 candidate knowledge items (79%), and 9 of 11 treatment preference items (81%). Knowledge items exhibited moderate internal validity (α = 0.62, 1 factor), strong test-retest reliability (mean % correct at first administration = 59%, 62% at follow-up, p>.1) and discriminant validity (59% correct for patients, 93% among cardiologists). Short versions of the ICD-DQ were developed for clinical settings, the scores from both of which correlated with the long version in this cohort (11- item (r = 0.90) and a 5-item (r = 0.75)). Conclusions The ICD-DQ fills a critical gap in measuring the quality of patients' ICD decisions. They may be used to evaluate the effectiveness of patient decision aids or the quality of shared decision making in clinical practice. This article is protected by copyright. All rights reserved.

Background: Major gaps exist in the routine initiation and dose up-titration of guideline-directed medical therapies (GDMT) for patients with heart failure with reduced ejection fraction. Without novel approaches to improve prescribing, the cumulative benefits of heart failure with reduced ejection fraction treatment will be largely unrealized. Direct-to-consumer marketing and shared decision making reflect a culture where patients are increasingly involved in treatment choices, creating opportunities for prescribing interventions that engage patients. Methods: The EPIC-HF (Electronically Delivered, Patient-Activation Tool for Intensification of Medications for Chronic Heart Failure with Reduced Ejection Fraction) trial randomized patients with heart failure with reduced ejection fraction from a diverse health system to usual care versus patient activation tools—a 3-minute video and 1-page checklist—delivered electronically 1 week before, 3 days before, and 24 hours before a cardiology clinic visit. The tools encouraged patients to work collaboratively with their clinicians to “make one positive change” in heart failure with reduced ejection fraction prescribing. The primary endpoint was the percentage of patients with GDMT medication initiations and dose intensifications from immediately preceding the cardiology clinic visit to 30 days after, compared with usual care during the same period. Results: EPIC-HF enrolled 306 patients, 290 of whom attended a clinic visit during the study period: 145 were sent the patient activation tools and 145 were controls. The median age of patients was 65 years; 29% were female, 11% were Black, 7% were Hispanic, and the median ejection fraction was 32%. Preclinic data revealed significant GDMT opportunities, with no patients on target doses of β-blocker, sacubitril/valsartan, and mineralocorticoid receptor antagonists. From immediately preceding the cardiology clinic visit to 30 days after, 49.0% in the intervention and 29.7% in the control experienced an initiation or intensification of their GDMT ( P =0.001). The majority of these changes were made at the clinician encounter itself and involved dose uptitrations. There were no deaths and no significant differences in hospitalization or emergency department visits at 30 days between groups. Conclusions: A patient activation tool delivered electronically before a cardiology clinic visit improved clinician intensification of GDMT. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03334188.

Social workers in healthcare settings often support patient decision-making processes for complex medical decisions. The objective of this study was to examine decision support needs for patients considering aortic valve replacement (AVR) for aortic stenosis. Seventeen qualitative interviews were conducted to explore treatment decision experiences of patients who accepted AVR. Analysis was conducted using a mixed inductive-deductive approach. Fear was a prevalent response for most participants in the face of AVR. Two general paths of decision making emerged: an "active" information seeking approach, or a "passive" simplicity seeking approach. Patients with unique clinical presentations felt alienated by the decision-making process. Acknowledging fear while understanding different decision-making styles provide opportunities for social workers and other members of multidisciplinary teams to support complex patient decisions.

BackgroundFollowing the 2018 mass shooting at Marjory Stoneman Douglas High School in Parkland, Florida, there was a dramatic increase in media coverage of extreme risk protection orders (ERPOs) and in state policy proposals for ERPO laws. This study documents the frequency of news coverage of ERPOs throughout 2018 and examines the narratives used by media outlets to describe this risk-based firearm policy.MethodsUsing a mixed-method descriptive design, we examine the frequency of national news media coverage of ERPO legislation in 2018, before and after the Parkland shooting, and analyze the content of news articles related to a sample of states that considered ERPO legislation after the shooting.ResultsWe find a sharp increase in the frequency of articles related to ERPOs following the Parkland shooting and smaller increases in coverage surrounding ERPO policy proposals and other public mass shootings that year. Nearly three-quarters of articles in our content analysis mentioned the Parkland shooting. The news media often mentioned or quoted politicians compared to other stakeholders, infrequently specified uses for ERPOs (e.g., prevention of mass violence, suicide, or other violence), and rarely included evidence on effectiveness of such policies. More than one-quarter of articles mentioned a mass shooting perpetrator by name, and one-third of articles used the term “gun control.”ConclusionsThis study describes the emerging public discourse, as informed by media messaging and framing, on ERPOs as states continue to debate and implement these risk-based firearm violence prevention policies.

Background Cognitive impairment and behavioral changes associated with Alzheimer's disease and related dementias (ADRDs) can impair safe firearm handling ability, an issue that can be challenging for ADRD caregivers to address. In this qualitative analysis, we sought to explore behavioral disruptions that raise concerns about firearm access in dementia and how caregivers react and respond. Methods Secondary qualitative analysis using data from semi-structured, one-on-one interviews originally conducted as part of a study to develop firearm safety educational materials for ADRD caregivers. Interviewees were English-speaking adults (≥18 years) from three stakeholder groups: ADRD caregivers (professional or informal), medical professionals (geriatricians, neurologists), and firearm professionals (retailers, range employees, instructors). For secondary analysis, transcripts of interviews were recoded and analyzed after an inductive-deductive thematic analysis process. Results Among 24 participants, 17 (70%) were female and 20 (83%) white; 13 (54%) had personal or professional experience with ADRD caregiving; and 5 (21%) had a firearm affiliation. Major themes were: (1) behavioral disturbances that make caregivers concerned about firearm access; (2) caregiver emotional responses to and difficulties associated with these disturbances; and (3) caregiver actions (planned or actual) to limit firearms access. Conclusion Various behavioral disturbances and emotional burdens can trigger ADRD caregiver concern about firearms access, but strategies exist for restricting or safeguarding firearms in the home. Study findings suggest a need for caregiver support on this topic, including counseling by healthcare providers, advance planning for older firearm owners, and development of community resources.

Background: Women who suffer an out-of-hospital cardiac arrest receive bystander cardiopulmonary resuscitation (CPR) less often than men. Understanding public perceptions of why this occurs is a necessary first step toward equitable application of this potentially life-saving intervention. Methods: We conducted a national survey of members of the public using Mechanical Turk, Amazon’s crowdsourcing platform, to determine reasons why women might receive bystander CPR less often than men. Eligible participants were adults (≥18 years) located in the United States. Responses were excluded if the participant was not able to define CPR correctly. Participants were asked to answer the following free-text question: “Do you have any ideas on why women may be less likely to receive CPR than men when they collapse in public?” Descriptive statistics were used to define the cohort. The free-text response was coded using open coding, and major themes were identified via classical content analysis. Results: In total, 548 subjects were surveyed. Mean age was 38.8 years, and 49.8% were female. Participants were geographically distributed as follows: 18.5% West, 9.2% Southwest, 22.0% Midwest, 27.5% Southeast, and 22.9% Northeast. After analysis, 3 major themes were detected for why the public perceives that women receive less bystander CPR. They include the following: (1) sexualization of women’s bodies; (2) women are weak and frail and therefore prone to injury; and (3) misperceptions about women in acute medical distress. Overall, 41.9% (227) were trained in CPR while 4.4% reported having provided CPR in a medical emergency. Conclusions: Members of the general public perceive fears about inappropriate touching, accusations of sexual assault, and fear of causing injury as inhibiting bystander CPR for women. Educational and policy efforts to address these perceptions may reduce the sex differences in the application of bystander CPR.

Background Firearms are common in the households of persons with Alzheimer disease and related dementias (ADRD). Safety in Dementia (SiD) is a free web-based decision aid that was developed to support ADRD caregivers in addressing firearm access. Objective We aimed to evaluate the feasibility and acceptability of SiD among a web-based sample of ADRD caregivers. Methods SiD was tested in 2 phases by using participants who were recruited from a web-based convenience sample (Amazon Mechanical Turk participants). In phase 1, caregivers were randomized to view either the intervention (SiD) or the control (Alzheimer’s Association materials), and the blinding of participants to the study arms was conducted. In phase 2, caregivers of individuals with ADRD and firearm access were recruited; all of these participants viewed the firearm section of SiD. In both phases, participants viewed SiD independently for as long as they wanted. Measures for evaluating decision-making and SiD acceptability were used, and these were assessed via a self-administered web-based questionnaire. Results Participants were recruited for phases 1 (n=203) and 2 (n=54). Although it was feasible to collect the study outcome data in a web-based format, in phase 1, there were no significant differences between SiD and the control in terms of decision-making and self-efficacy. The majority (137/203, 67.5%) of phase 1 participants spent between 5 and 10 minutes reviewing the resources. In phase 2, 61% (33/54) of participants spent 5 to 10 minutes viewing the firearm section, and 31% (17/54) spent 10 to 20 minutes viewing this section. Usability and acceptability were high across the phases. Conclusions SiD represents a new resource for promoting safety among people with dementia, and high acceptability was achieved in a pilot trial. In this sample, SiD performed similarly to Alzheimer’s Association materials in supporting decision-making and self-efficacy.

Background Extreme Risk Protection Orders (ERPOs) are a relatively new type of law that are being considered or implemented in many states in the United States. Colorado’s law went into effect on January 1, 2020, after significant controversy and concern over potential misuse of the law to confiscate weapons; many (n = 37 of 64) counties declared themselves “2nd Amendment (2A) sanctuaries” and said they would not enforce the law. Here, reviewed the patterns of use of the law during its first year. Methods We obtained all court records for ERPO petitions filed between January 1 and December 31, 2020. Data elements were abstracted by trained staff using a standardized guide. We calculated the proportion of petitions that were approved or denied/dismissed, identified cases of obvious misuse, and examined patterns by 2A county status. Finding and results In 2020, 109 ERPO petitions were filed in Colorado; of these, 61 were granted for a temporary ERPO and 49 for a full (year-long) ERPO. Most petitions filed by law enforcement officers were granted (85%), compared to only 15% of petitions filed by family or household members. Of the 37 2A sanctuary counties, 24% had at least one petition filed, versus 48% of non-2A sanctuary counties. Across the 2A counties, there were 1.52 ERPOs filed per 100,000 population, compared to 2.05 ERPOs filed per 100,000 in non-2A counties. There were 4 cases of obvious law misuse; none of those petitions resulted in an ERPO or firearm confiscation. Conclusion State-level studies suggest ERPOs may prevent firearm injuries. Robust implementation, however, is critical for maximal effect. Understanding ERPO experiences and challenges can inform policy creation and enaction in other states, including identifying how best to address concerns and facilitate evaluation.

Background Nearly half of patients do not take their cardiovascular medications as prescribed, resulting in increased morbidity, mortality, and healthcare costs. Mobile and digital technologies for health promotion and disease self-management offer an opportunity to adapt behavioral “nudges” using ubiquitous mobile phone technology to facilitate medication adherence. The Nudge pragmatic clinical trial uses population-level pharmacy data to deliver nudges via mobile phone text messaging and an artificial intelligent interactive chat bot with the goal of improving medication adherence and patient outcomes in three integrated healthcare delivery systems. Methods The Theory of mHealth, the Expanded RE-AIM/PRISM, and the PRECIS-2 frameworks were used for program planning, implementation and evaluation, along with a focus on dissemination and cost considerations. During the planning phase, the Nudge study team developed and piloted a technology-based nudge message and chat bot of optimized interactive content libraries for a range of diverse patients. Inclusion criteria are very broad and include patients in one of three diverse health systems who take medications to treat hypertension, atrial fibrillation, coronary artery disease, diabetes, or hyperlipidemia. A target of approximately 10,000 participants will be randomized to one of 4 study arms: usual care (no intervention), generic nudge (text reminder), optimized nudge, and optimized nudge plus interactive AI chat bot. The PRECIS-2 tool indicated that the study protocol is very pragmatic, although there is variability across PRECIS-2 dimensions.Discussion The primary effectiveness outcome is medication adherence defined by the proportion of days covered (PDC) using pharmacy refill data. Implementation outcomes are assessed using the RE-AIM framework, with particular focus on reach, consistency of implementation, adaptations, cost, and maintenance/sustainability. The project has limitations including limited power to detect some subgroup effects, medication complications (bleeding) and longer-term outcomes (myocardial infarction). Strengths of the study include the diverse health care systems, a feasible and generalizable intervention, transparent reporting using established pragmatic research and implementation science frameworks, strong stakeholder engagement and planning for dissemination and sustainment.Trial registration The study was funded by the NIH grant number is 4UH3HL144163-02 issued 4/5/19. The Clinicaltrial.gov identifier number is NCT03973931 which was registered on 6/4/2019. URL: https://clinicaltrials.gov/ct2/show/NCT03973931

Objective: Health misinformation on social media threatens public health. One question that could lend insight into how and through whom misinformation spreads is whether certain people are susceptible to many types of health misinformation, regardless of the health topic at hand. This study provided an initial answer to this question and also tested four hypotheses concerning the psychosocial attributes of people who are susceptible to health misinformation: (1) deficits in knowledge or skill, (2) preexisting attitudes, (3) trust in health care and/or science, and (4) cognitive miserliness. Method: Participants in a national U.S. survey (N = 923) rated the perceived accuracy and influence of true and false social media posts about statin medications, cancer treatment, and the Human Papilloma Virus (HPV) vaccine and then responded to individual difference and demographic questions. Results: Perceived accuracy of health misinformation was strongly correlated across statins, cancer, and the HPV vaccine (rs ≥ .70), indicating that individuals who are susceptible to misinformation about one of these topics are very likely to believe misinformation about the other topics as well. Misinformation susceptibility across all three topics was most strongly predicted by lower educational attainment and health literacy, distrust in the health care system, and positive attitudes toward alternative medicine. Conclusions: A person who is susceptible to online misinformation about one health topic may be susceptible to many types of health misinformation. Individuals who were more susceptible to health misinformation had less education and health literacy, less health care trust, and more positive attitudes toward alternative medicine. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Objective Lethal means safety – counseling and guidance about reducing access to home firearms and medications – is recommended for emergency department patients at risk of suicide. Decision aids are tools that can facilitate potentially difficult decisions by incorporating personal preferences and values. The present study evaluates clinician perceptions about the implementation and utility of “Lock to Live,” a lethal means safety decision aid. Method One-on-one qualitative interviews were conducted with clinicians (n = 15) at three large emergency departments. Interviewees were asked to evaluate the “Lock to Live” decision tool and its potential implementation and utilization in the emergency department. Interviews were recorded and transcribed. Data were coded via thematic analysis; two coders developed a shared codebook iteratively with high interrater reliability. Results Perspectives on the tool fell into three domains: (1) patients (use with patients and families), (2) clinicians, and (3) emergency department system. Interviewees noted that the tool had numerous potential benefits but that its uptake and effectiveness would depend on clinicians' perceptions on its utility, time constraints, and integration into workflow. Addressable concerns related to relationship to other resources, fit within emergency department workflow, and clarification about which emergency department clinician types should use the tool. Conclusions “Lock to Live” represents a promising new tool for use in suicide prevention as an aid to lethal means counseling. This qualitative study provides insights into the importance of considering the clinical environment when designing and implementing interventions.

Background Uptake of gun violence restraining orders (GVROs), which temporarily prohibit the possession and purchase of firearms and ammunition from individuals at particularly high risk of harming themselves or others with a firearm, has been slow and heterogenous across California. Insights into the implementation process and perceived effectiveness of the law could guide implementation in California and the many states that have enacted or are considering enacting such a law. Methods We conducted 21 semi-structured interviews with 27 key informants, including judges, law enforcement officers, city and district attorneys, policy experts, and firearm violence researchers. Analysis of transcripts was guided by grounded theory and the Consolidated Framework for Implementation Research (CFIR). Findings The following constructs emerged within 4 CFIR domains as salient features of implementation: 1) implementation characteristics: risk of violence, cost, and adaptability; 2) outer setting: interagency coordination and local firearm ideology; 3) inner setting: readiness for implementation and law enforcement firearm culture; and 4) implementation process: planning and engaging with those involved in implementation. Key informants perceived the law to be effective, particularly for preventing firearm suicide, but agreed that more research was needed. While most indicated that the law resulted in positive outcomes, concerns about the potential for class- and race-based inequities were also raised. Conclusions Implementation of the GVRO law in California was hampered by a lack of funding to support local proactive implementation efforts. This resulted in ad hoc policies and procedures, leading to inconsistent practices and widespread confusion among those responsible for implementation. In states that have not begun implementation, we recommend dedicating funding for implementation and creating local procedures statewide prior to the law’s rollout. In California, recommendations include providing training on the GVRO law—including an explication of agency-specific roles, responsibilities, and procedures—to officers, city attorneys, and civil court judges.

Background Decision-making about when to stop driving for older adults involves assessment of driving risk, availability of support or resources, and strong emotions about loss of independence. Although the risk of being involved in a fatal crash increases with age, driving cessation can negatively impact an older adult’s health and well-being. Decision aids can enhance the decision-making process by increasing knowledge of the risks and benefits of driving cessation and improve decision quality. The impact of decision aids regarding driving cessation for older adults is unknown. Methods The Advancing Understanding of Transportation Options (AUTO) study is a multi-site, two-armed randomized controlled trial that will test the impact of a decision aid on older adults’ decisions about changes in driving behaviors and cessation. AUTO will enroll 300 drivers age ≥ 70 years with a study partner (identified by each driver); the dyads will be randomized into two groups (n = 150/group). The decision aid group will view the web-based decision aid created by Healthwise at baseline and the control group will review information about driving that does not include evidence-based elements on risks and benefits and values clarification about driving decisions. The AUTO trial will compare the effect of the decision aid, versus control, on a) immediate decision quality (measured by the Decisional Conflict Scale; primary outcome); b) longitudinal psychosocial outcomes at 12 and 24 months (secondary outcomes); and c) longitudinal driving behaviors (including reduction or cessation) at 12 and 24 months (secondary outcomes). Planned stratified analyses will examine the effects in subgroups defined by cognitive function, decisional capacity, and readiness to stop driving. Discussion The AUTO study is the first large-scale randomized trial of a driving decision aid for older adults. Results from this study will directly inform clinical practice about how best to support older adults in decision-making about driving. Trial registration ClinicalTrials.gov: NCT04141891. Registered on October 28, 2019. Located at https://clinicaltrials.gov/ct2/show/NCT04141891

Background: Little is known about practices used to disseminate findings to non-research, practitioner audiences. This study describes the perspectives, experience and activities of dissemination & implementation (D&I) scientists around disseminating their research findings. Methods: The study explored D&I scientists’ experiences and recommendations for assessment of dissemination activities to non-research audiences. Existing list serves were used to recruit scientists. Respondents were asked three open-ended questions on an Internet survey about dissemination activities, recommendations for changing evaluation systems and suggestions to improve their own dissemination of their work. Results: Surveys were completed by 159 scientists reporting some training, funding and/or publication history in D&I. Three themes emerged across each of the three open-ended questions. Question 1 on evaluation generated the themes of: 1a) promotional review; 1b) funding requirements and 1c) lack of acknowledgement of dissemination activities. Question 2 on recommended changes generated the themes of: 2a) dissemination as a requirement of the academic promotion process; 2b) requirement of dissemination plan and 2c) dissemination metrics. Question 3 on personal changes to improve dissemination generated the themes of: 3a) allocation of resources for dissemination activities; 3b) emerging dissemination channels and 3c) identify and address issues of priority for stakeholders. Conclusions: Our findings revealed different types of issues D&I scientists encounter when disseminating findings to clinical, public health or policy audiences and their suggestions to improve the process. Future research should consider key requirements which determine academic promotion and grant funding as an opportunity to expand dissemination efforts.

BackgroundNearly half of patients do not take their cardiovascular medications as prescribed, resulting in increased morbidity, mortality, and healthcare costs. Mobile and digital technologies for health promotion and disease self-management offer an opportunity to adapt behavioral “nudges” using ubiquitous mobile phone technology to facilitate medication adherence. The Nudge pragmatic clinical trial uses population-level pharmacy data to deliver nudges via mobile phone text messaging and an artificial intelligent interactive chat bot with the goal of improving medication adherence and patient outcomes in three integrated healthcare delivery systems.MethodsThe Theory of mHealth, the Expanded RE-AIM/PRISM, and the PRECIS-2 frameworks were used for program planning, implementation, and evaluation, along with a focus on dissemination and cost considerations. During the planning phase, the Nudge study team developed and piloted a technology-based nudge message and chat bot of optimized interactive content libraries for a range of diverse patients. Inclusion criteria are very broad and include patients in one of three diverse health systems who take medications to treat hypertension, atrial fibrillation, coronary artery disease, diabetes, or hyperlipidemia. A target of approximately 10,000 participants will be randomized to one of 4 study arms: usual care (no intervention), generic nudge (text reminder), optimized nudge, and optimized nudge plus interactive AI chat bot. The PRECIS-2 tool indicated that the study protocol is very pragmatic, although there is variability across PRECIS-2 dimensions.DiscussionThe primary effectiveness outcome is medication adherence defined by the proportion of days covered (PDC) using pharmacy refill data. Implementation outcomes are assessed using the RE-AIM framework, with a particular focus on reach, consistency of implementation, adaptations, cost, and maintenance/sustainability. The project has limitations including limited power to detect some subgroup effects, medication complications (bleeding), and longer-term outcomes (myocardial infarction). Strengths of the study include the diverse healthcare systems, a feasible and generalizable intervention, transparent reporting using established pragmatic research and implementation science frameworks, strong stakeholder engagement, and planning for dissemination and sustainment.Trial registrationClinicalTrials.govNCT03973931. Registered on 4 June 2019. The study was funded by the NIH; grant number is 4UH3HL144163-02 issued 4/5/19.

Introduction: Women who suffer an out of hospital cardiac arrest receive bystander cardiopulmonary resuscitation (bCPR) less often than men. We sought to determine if there were differences in potential deterrents to providing CPR if the rescuer was a man or a woman. Methods: We surveyed participants via Amazon’s Mechanical Turk, a national crowdsourcing platform, to query why women receive less bCPR than men based on the sex of the rescuer. We asked participants to rank five themes previously identified. Eligible participants were ≥18 years, US residents, and correctly defined CPR. Participants were asked to rank the 5 following themes if the sex of the rescuer was unidentified sex, male, and female: 1) Rescuers are afraid to injure or hurt women; 2) Rescuers might have a misconception that women don’t suffer cardiac arrest; 3) Rescuers are afraid to be accused of sexual assault or sexual harassment; 4) Rescuers have a fear of touching women or that the touch might be inappropriate; 5) Rescuers think that women are “faking it” or being “overdramatic.” Results: In total, 576 participants were surveyed, and 520 responses were formally analyzed. The respondents were 42.3% female, 74.2% Caucasian, 10.4% African American, and 6.7% Hispanic. To determine a “consensus” ranking, a statistical model that finds the mode of the rankings was used, generating separate results for each of the categories of rescuer. This method determined that the modal ranking for respondents asked about a female rescuer was Hurt/Injure, Touch, Overdramatic, Misconception, Sexual Assault/Harassment. By contrast, when respondents were asked about a male rescuer, the modal ranking was found to be Touch, Sexual Assault/Harassment, Hurt/Injure, Misconception, Overdramatic. When the sex of the rescuer was not identified, the modal ranking was identical to that for the male rescuer question. Conclusion: When querying the public as to why women receive less-bystander CPR than men, there were differences in response based on the sex of the rescuer. Participants reported that a male rescuer would potentially be hindered by fears of accusation of sexual assault/harassment or inappropriate touch, while female rescuers would be more deterred due to fears of causing physical injury or harm.

Background Many mobile health (mHealth) technologies exist for patients with heart failure (HF). However, HF mhealth lacks evidence of efficacy, caregiver involvement, and clinically useful real-time data. Objective We aim to capture health care providers’ perceived value of HF mHealth, particularly for pairing patient–caregiver-generated data with clinical intervention to inform the design of future HF mHealth. Methods This study is a subanalysis of a larger qualitative study based on interviewing patients with HF, their caregivers, and health care providers. This analysis included interviews with health care providers (N=20), focusing on their perceived usefulness of HF mHealth tools and interventions. Results A total of 5 themes emerged: (1) bio-psychosocial-spiritual monitoring, (2) use of sensors, (3) interoperability, (4) data sharing, and (5) usefulness of patient-reported outcomes in practice. Providers remain interested in mHealth technologies for HF patients and their caregivers. However, providers report being unconvinced of the clinical usefulness of robust real-time patient-reported outcomes. Conclusions The use of assessments, sensors, and real-time data collection could provide value in patient care. Future research must continually explore how to maximize the utility of mHealth for HF patients, their caregivers, and health care providers.

Background: Nearly half of patients do not take their cardiovascular medications as prescribed, resulting in increased morbidity, mortality, and healthcare costs. Mobile and digital technologies for health promotion and disease self-management offer an opportunity to adapt behavioral “nudges” using ubiquitous mobile phone technology to facilitate medication adherence. The Nudge pragmatic clinical trial uses population-level pharmacy data to deliver nudges via mobile phone text messaging and an artificial intelligent interactive chat bot with the goal of improving medication adherence and patient outcomes in three integrated healthcare delivery systems. Methods: The Theory of mHealth, the Expanded RE-AIM/PRISM, and the PRECIS-2 frameworks were used for program planning, implementation and evaluation, along with a focus on dissemination and cost considerations. During the planning phase, the Nudge study team developed and piloted a technology-based nudge message and chat bot of optimized interactive content libraries for a range of diverse patients. Inclusion criteria are very broad and include patients in one of three diverse health systems who take medications to treat hypertension, atrial fibrillation, coronary artery disease, diabetes, or hyperlipidemia. A target of approximately 10,000 participants will be randomized to one of 4 study arms: usual care (no intervention), generic nudge (text reminder), optimized nudge, and optimized nudge plus interactive AI chat bot. The PRECIS-2 tool indicated that the study protocol is very pragmatic, although there is variability across PRECIS-2 dimensions. Discussion: The primary effectiveness outcome is medication adherence defined by the proportion of days covered (PDC) using pharmacy refill data. Implementation outcomes are assessed using the RE-AIM framework, with particular focus on reach, consistency of implementation, adaptations, cost, and maintenance/sustainability. The project has limitations including limited power to detect some subgroup effects, medication complications (bleeding) and longer-term outcomes (myocardial infarction). Strengths of the study include the diverse health care systems, a feasible and generalizable intervention, transparent reporting using established pragmatic research and implementation science frameworks, strong stakeholder engagement and planning for dissemination and sustainment. Trial registration: The study was funded by the NIH grant number is 4UH3HL144163-02 issued 4/5/19. The Clinicaltrial.gov identifier number is NCT03973931 which was registered on 6/4/2019. URL: https://clinicaltrials.gov/ct2/show/NCT03973931

This survey study of caregivers of people with Alzheimer disease and related dementias assesses caregiver views on firearm safety risks, experiences with health care professional–delivered counseling, and preferred sources of information about firearm safety., Key Points Question What proportion of adults living in homes with firearms are caregivers for people with Alzheimer disease and related dementias, and what are their characteristics, experiences, and preferences related to firearms? Findings In this survey study of US adults (aged ≥35 years) living in homes with firearms, 2.6% reported being caregivers of a person with Alzheimer disease and related dementias, and 41% of these caregivers lived with that person. Although most caregivers were open to health care professional counseling about firearm safety for persons with Alzheimer disease and related dementias, few caregivers had ever received any such counseling. Meaning The findings suggest that many community-dwelling adults with dementia have firearm access and that there may be a need for enhanced education and resources for their caregivers., Importance The population of adults with Alzheimer disease and related dementias (ADRD) is increasing, and many people with ADRD have access to firearms. Little is known, however, about how caregivers of people with ADRD think about or address firearm safety. Objective To assess views on firearm safety risks among caregivers of persons with ADRD, experiences of caregivers with health care professional–delivered counseling, and their preferred sources of information about firearm safety. Design, Setting, and Participants This survey study used a probability-based online survey (National Firearms Survey, July 30 to August 11, 2019) with weights used to generate nationally representative estimates of adults living in households with firearms to assess firearm safety views of English-speaking adults 35 years or older. Respondents for the National Firearm Survery were drawn from I KnowledgePanel, a frame with approximately 55 000 US adults selected on an ongoing basis using address-based sampling methods. Main Outcomes and Measures Caregivers were asked whether the person with ADRD owned or had access to firearms. Additional ADRD-related measures assessed perceptions about the likelihood of types of firearm injuries involving people with ADRD, support for firearm safety counseling by health care professionals with regard to dementia, and history of ever having received such counseling. Results Of 6712 invited panel members, 4030 completed the survey (completion rate, 65%). For this analysis, we excluded the youngest participants (aged 18-34 years; n = 498); among the remaining 3532 participants, 124 reported being caregivers for persons with ADRD. Of the 124 caregivers, 51% were female and the mean (SD) age was 60 (12.5) years. Most participants (71%; 95% CI, 69%-72%) thought that a person with ADRD was more likely to hurt someone else unintentionally than intentionally hurt themselves or someone else. Many participants thought health care professionals should always (45%; 95% CI, 43%-47%) or sometimes (34%; 95% CI, 32%-37%) talk about firearm safety with caregivers or patients with dementia, but only 5% of caregivers (95% CI, 2%-12%) reported that a health care professional had ever spoken to them about firearm safety. Among the 41% (95% CI, 31%-51%) of caregivers who lived with a person with dementia, 31% (95% CI, 18%-49%) said the person with dementia could access firearms in the home. Conclusions and Relevance In this study, few caregivers of adults with ADRD reported having received health care professional counseling about firearm safety, although most thought health care professionals should provide such counseling. These findings raise concerns about home firearm access among adults with ADRD and indicate potential opportunities for enhanced education by health care professionals and community organizations.

Background Heart failure with reduced ejection fraction (HFrEF) benefits from initiation and intensification of multiple pharmacotherapies. Unfortunately, there are major gaps in the routine use of these drugs. Without novel approaches to improve prescribing, the cumulative benefits of HFrEF treatment will be largely unrealized. Direct-to-consumer marketing and shared decision making reflect a culture where patients are increasingly involved in treatment choices, creating opportunities for prescribing interventions that engage patients. Hypothesis Encouraging patients to engage providers in HFrEF prescribing decisions will improve the use of guideline-directed medical therapies. Design The Electronically delivered, Patient-activation tool for Intensification of Chronic medications for Heart Failure with reduced ejection fraction (EPIC-HF) trial randomizes patients with HFrEF to usual care versus patient-activation tools—a 3-minute video and 1-page checklist—delivered prior to cardiology clinic visits that encourage patients to work collaboratively with their clinicians to intensify HFrEF prescribing. The study assesses the effectiveness of the EPIC-HF intervention to improve guideline-directed medical therapy in the month after its delivery while using an implementation design to also understand the reach, adoption, implementation, and maintenance of this approach within the context of real-world care delivery. Study enrollment was completed in January 2020, with a total 305 patients. Baseline data revealed significant opportunities, with Summary The EPIC-HF trial assesses the implementation, effectiveness, and safety of patient engagement in HFrEF prescribing decisions. If successful, the tool can be easily disseminated and may inform similar interventions for other chronic conditions.

Purpose: To describe potential gender differences in the psychosocial evaluation for left ventricular assist devices (VADs) using retrospective data from the DECIDE-LVAD trial. Method: Psychosocial evaluations performed as part of pre-VAD evaluations, including all female participants as well as men matched by site and age. 55 notes from 5 institutions were analyzed using a mixed method approach. Analytic codes were developed a priori, using domains assessed in the Stanford Integrated Psychosocial Assessment for Transplant (SIPAT) and others addressing caregiver attributes. Overall risk was calculated using a composite percent-of-perfect formula based on various adaptations of the SIPAT used in some evaluations. After notes were coded across each domain, a content analysis was performed. Results: Records from 28 male and 27 female patients were analyzed. Lack of standardized assessment limited our ability to draw comparisons. However, men were more likely to be clinically depressed (55.9% vs 44.1%), have substance use problems (53.4% vs. 46.6%), understand their HF (57.7% vs. 42.3%), and to have a caregiver (54.5% vs. 45.6%). While the number of assessments including quantitative assessment was low, men scored better than women (53.1% men [n=11] vs. 46.9% women [n=12]).The way in which caregivers were identified was different for men and women. Qualitatively, female caregivers seemed to be preferred, implicitly favoring male patients in many circumstances. This was apparent in how caregiving plans were described and in a seeming desire to supplement male caregivers' effort with support from women ( Table 1). Conclusion: Across our sample, men trended toward being rated as better VAD candidates than women, despite higher rates of depression and substance use. Caregiver identification was different in ways which may be due to differences in how male vs. female caregivers are perceived. Differences in caregiver identification need to be explored further, but could stem from women being unable to find a caregiver for themselves, serving as caregivers for others, or from men not being viewed as able caregivers. Standardized evaluation, including quantification of risk and caregiver appropriateness, would enhance efforts to reduce implicit bias in evaluation.

Background: Home-based cardiac rehabilitation (CR) has similar efficacy as center-based CR, but the choice of which meets the needs of individual patients is preference-sensitive. Our objective was to develop a knowledge measure to be used to evaluate a shared decision-making tool for patients choosing between home and center-based CR. Methods: We generated 11 true/false questions about home and hospital-based CR. The statements were reviewed for accuracy by 8 exercise physiologists. Cognitive testing was performed with 10 patients using the “think-aloud” method to understand their interpretation of what each item was asking. The statements were then revised to improve acceptability and clarity. We tested the knowledge statements in a sample of 124 participates from the lay public recruited via mTurk. Psychometric properties of item difficulty, item uncertainty, and index of discrimination were evaluated. Differences between groups based on education level, age, sex, and race/ethnicity were also evaluated. Results: Of 124 respondents 66% were female, 69% were white, 69% were between 18-44 years of age, and 89% had at least some college education. On average respondents answered 70% of questions correctly. Item difficulty ranged from 51% to 98% correct. Item uncertainty ranged from 9% to 36%. Index of discrimination was highest for questions 2 (75%), 7 (74%) and 9 (68%). (see Table) Within each subgroup, the following groups had the highest average score: African Americans, (77%), females (74%), advanced degree (80%) and ages 55-64 (78%). Conclusion: The knowledge measure developed in this study can be used to assesses knowledge about key concepts central to making an informed decision about home vs. hospital-based CR. This knowledge measure will be further validated and used to evaluate a decision aid for patients in our safety net hospital system choosing between home and hospital-based CR.

Shared decision making (SDM) facilitates delivery of medical therapies that are in alignment with patients' goals and values. Medicare national coverage decision for several interventions now includes SDM mandates, but few have been evaluated in nationwide studies. Based upon a detailed needs assessment with diverse stakeholders, we developed pamphlet and video patient decision aids (PtDAs) for implantable cardioverter/defibrillator (ICD) implantation, ICD replacement, and cardiac resynchronization therapy with defibrillation to help patients contemplate, forecast, and deliberate their options. These PtDAs are the foundation of the Multicenter Trial of a Shared Decision Support Intervention for Patients Offered Implantable Cardioverter-Defibrillators (DECIDE-ICD), a multicenter, randomized trial sponsored by the National Heart, Lung, and Blood Institute aimed at understanding the effectiveness and implementation of an SDM support intervention for patients considering ICDs. Finalization of a Medicare coverage decision mandating the inclusion of SDM for new ICD implantation occurred shortly after trial initiation, raising novel practical and statistical considerations for evaluating study end points. METHODS/DESIGN: A stepped-wedge randomized controlled trial was designed, guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) planning and evaluation framework using an effectiveness-implementation hybrid type II design. Six electrophysiology programs from across the United States will participate. The primary effectiveness outcome is decision quality (defined by knowledge and values-treatment concordance). Patients with heart failure who are clinically eligible for an ICD are eligible for the study. Target enrollment is 900 participants. DISCUSSION: Study findings will provide a foundation for implementing decision support interventions, including PtDAs, with patients who have chronic progressive illness and are facing decisions involving invasive, preference-sensitive therapy options.

ObjectivesWe sought to (1) clarify decision needs among suicidal adults with home firearm access; (2) identify accurate, unbiased and acceptable approaches for content and messaging; and (3) develop a tablet-delivered decision aid for firearm storage options.MethodsFollowing international standards, we used stakeholder interviews to develop a decision aid for the decision, ‘what option(s) to choose to reduce home access to firearms for an adult at risk of suicide’. Participants were adults with personal or family history of suicidal ideation or behaviours, firearm ownership or employment in a firearm range or store, involvement in suicide prevention field, or work as emergency department or other healthcare provider.ResultsThrough 64 interviews, we created the ‘Lock to Live’ decision aid, which includes (1) introduction specifying the decision, (2) clarification of preferences and logistics, (3) table of storage options and (4) summary with specific next steps. The final tool had high user acceptability.ConclusionsShould the ‘Lock to Live’ decision aid prove useful in a pilot feasibility trial and subsequent testing, it could enhance lethal means counselling and help prevent firearm suicide.

Social work interventions in health care, particularly those that involve working with people being treated for chronic and life-threatening conditions, frequently involve efforts to educate patients about their disease, treatment options, safety planning, medical adherence, and other associated issues. Despite an intuitive notion that patients access information about all of these issues through a variety of media—both inside and outside the clinical encounter, created by professionals and by others—there currently exists no validated means of assessing patients’ use of these forms of information. To address this gap, authors first created candidate item measures with input from both physicians and a small group of diverse patients who currently have an implantable cardioverter defibrillator (ICD), a sophisticated cardiac device for which a trajectory model of social work intervention was recently outlined. Authors then surveyed a group of 205 individuals who have these devices, assessing their use of various media to learn about ICDs. They then conducted factor and item analysis to refine and remove poorly performing items while delineating forms of media use by type. The resultant preliminary measure of informational media use can be further refined and adapted for use with any clinical population.

Over the past two decades, state and local governments across the U.S. have been increasingly reforming marijuana laws. Despite growing support for marijuana as a medical treatment, little is known about medical students' perceptions of marijuana use.To assess Colorado medical students' personal and professional opinions on current and future marijuana use in a healthcare setting.A voluntary, anonymous, online cross-sectional survey.Medical students (n = 624) at the University of Colorado School of Medicine between January and February 2014 were invited to participate.Numerical responses were quantified using counts and percentages, and Likert scale responses were collapsed for bivariate analysis. Items were gathered thematically and additively scored for each subscale. Internal consistency reliability statistics were calculated for each subscale to ensure that items were assessing similar constructs. Unadjusted t tests and one-way analysis of variance (ANOVA) were used to calculate mean differences in subscale scores between subgroups.We received 236 responses (37%). Students indicated support for marijuana legalization (64%), and few believed that physicians should be penalized for recommending marijuana to patients (6%). Nearly all (97%) believed that further marijuana research should be conducted, and believed marijuana could play a role in the treatment of various medical conditions. Seventy-seven percent reported that they believed marijuana use had the potential for psychological harm, and 68% indicated concern for potential physical harm. Only a minority of students would recommend marijuana to a patient under current law (29%), or if it were legally available (45%). Acceptability of marijuana for treatment of approved conditions was not correlated with age or gender, but was positively correlated with living in Colorado prior to medical school (p 0.001) and with prior marijuana use (p 0.001).Medical students support marijuana legal reform, medicinal uses of marijuana, and increased research, but have concerns regarding risks of marijuana use, and appear hesitant to recommend marijuana to patients.

ObjectiveIn seriously ill cardiac patients, several psychotherapy efficacy studies demonstrate little to no reduction in depression or improvement in quality of life, and little is known about how to improve psychotherapies to best address the range of patient needs. An interpersonal and behavioral activation psychotherapy was a key component of the Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) multisite randomized clinical trial. Although depressive symptoms did improve in the CASA trial, questions remain about how best to tailor psychotherapies to the needs of seriously ill patient populations. The study objective was to describe psychosocial needs emerging during a clinical trial of a palliative care and interpersonal and behavioral activation psychotherapy intervention that were not specifically addressed by the psychotherapy.MethodDuring the CASA trial, patient needs were prospectively tracked by the psychotherapist in each visit note using an a priori code list. Preplanned analysis of study data using directed content analysis was conducted analyzing the a priori code list, which were collapsed by team consensus into larger themes. The frequency of each code and theme were calculated into a percentage of visits.ResultA total of 150 patients received one or more visits from the therapist and were included in the analysis. Participants screened positive for depressive disorder (47%), had poor heart failure-specific health status (mean Kansas City Cardiomyopathy Questionnaire score = 48.6; SD = 17.4), and multiple comorbidities (median 4.3). Common needs that emerged during the therapy included difficulty coping with fatigue (48%), pain (28%), and satisfaction issues with medical care (43%). The following broader themes emerged: social support (77% of sessions), unmet symptom needs (67%), healthcare navigation (48%), housing, legal, safety, and transportation (32%), and end of life (12%).Significance of resultsCoping with chronic symptoms and case management needs commonly emerged during psychotherapy visits. Future psychotherapy interventions in seriously ill populations should consider the importance of coping with chronic symptoms and case management.

IntroductionThere has been an increasing focus on disseminating research findings, but less about practices specific to disseminating and engaging non-researchers. The present project sought to describe dissemination practices and engagement of stakeholders among dissemination & implementation (D&I) scientists.MethodsMethods to disseminate to and engage non-research stakeholders were assessed using an online survey sent to a broad, diverse sample of D&I scientists.ResultsSurveys were received from 210 participants. The majority of respondents were from university or research settings in the U.S. (69%) or Canada (13%), representing a mix of clinical (28%) and community settings (34%). 26% had received formal training in D&I. Respondents indicated routinely engaging in a variety of dissemination-related activities, with academic journal publications (88%), conference presentations (86%), and reports to funders (74%) being the most frequent. Journal publication was identified as the most impactful on respondents’ careers (94%), but face-to-face meetings with stakeholders were rated as most impactful on practice or policy (40%). Stakeholder involvement in research was common, with clinical and community-based researchers engaging stakeholder groups in broadly similar ways, but with critical differences noted between researchers with greater seniority, those with more D&I training, those based in the US, and those in community vs, clinical research settings.ConclusionsThere have been increases in stakeholder engagement, but few other practices since the 2012 survey, and some differences across subgroups. Methods to engage different stakeholders deserve more in-depth investigation. D&I researchers report substantial misalignment of incentives and behaviors related to dissemination to non-research audiences.

Introduction Guideline Directed Medical Therapy (GDMT) recommends a combined regimen of beta blockers, ACE-I/ARB/ARNI, and mineralocorticoid receptor agents for optimal treatment of patients with Heart Failure with Reduced Ejection Fraction (HFrEF). Unfortunately, data from numerous heart failure registries show that HFrEF patients by-and-large continue to remain on suboptimal therapy. Interventions to improve medication plans often target either patient adherence or provider prescribing methods, with mixed results. This suggests that a more novel approach—in which provider and patient are equally involved—may be necessary to incite change. Hypothesis Aspects of Direct-to-Consumer (DTC) methods and Shared Decision Making models can be harnessed to encourage patients to engage providers in HFrEF prescribing decisions. This in turn may improve use of guideline-directed medical therapies. Methods Using DTC and Shared Decision Making models as our framework (Figure 1), we developed a user-friendly patient activation intervention—a 3-minute video and a HFrEF medication checklist—to encourage patients to discuss with their provider “one thing” that can be done to improve their medication plan. Patients were enrolled across three medical centers within the UCHealth medical system, and randomized to either intervention or control arms. Data on HFrEF medication prescribing and dosing was collected at enrollment, at time of intervention, and at 1-and-6 months from intervention. Results 305 patients were enrolled in total. At time of enrollment, 8.5% were on GDMT at suboptimal doses; only one patient (.3%) was on GDMT at target doses. Conclusions Our baseline results highlight the clear need for effective interventions to improve HFrEF prescribing. If successful, our intervention is simple enough to be adapted and implemented across a multitude of settings.

Background Counseling to reduce access to lethal means such as firearms and medications is recommended for suicidal adults but does not routinely occur. We developed the Web-based Lock to Live (L2L) decision aid to help suicidal adults and their families choose options for safer home storage. Objective This study aimed to test the feasibility and acceptability of L2L among suicidal adults in emergency departments (EDs). Methods At 4 EDs, we enrolled participants (English-speaking, community-dwelling, suicidal adults) in a pilot randomized controlled trial. Participants were randomized in a 13:7 ratio to L2L or control (website with general suicide prevention information) groups and received a 1-week follow-up telephone call. Results Baseline characteristics were similar between the intervention (n=33) and control (n=16) groups. At baseline, many participants reported having access to firearms (33/49, 67%), medications (46/49, 94%), or both (29/49, 59%). Participants viewed L2L for a median of 6 min (IQR 4-10 min). L2L also had very high acceptability; almost all participants reported that they would recommend it to someone in the same situation, that the options felt realistic, and that L2L was respectful of values about firearms. In an exploratory analysis of this pilot trial, more participants in the L2L group reported reduced firearm access at follow-up, although the differences were not statistically significant. Conclusions The L2L decision aid appears feasible and acceptable for use among adults with suicide risk and may be a useful adjunct to lethal means counseling and other suicide prevention interventions. Future large-scale studies are needed to determine the effect on home access to lethal means. Trial Registration ClinicalTrials.gov NCT03478501; https://clinicaltrials.gov/ct2/show/NCT03478501

Commercial sexual exploitation of children (CSEC) is a pervasive public health crisis that affects children across the United States. After receiving public attention in recent years, several approaches have been developed to aid in identifying and intervening with trafficked youth to prevent further exploitation. Despite these developments, intervention efforts are plagued by client dropout, treatment nonadherence, and failures in placement, partially due to the failure of service systems to recognize the child's voice and preferences in decision-making conversations. We propose a new approach to addressing CSEC by applying shared decision making, a model developed in other areas of medicine, to working with high-risk and trafficked juveniles to increase youth voice and participation in care and to prevent revictimization.

Background: Therapy for aortic stenosis (AS) is quickly evolving, with treatment options expanded by transcatheter aortic valve replacement (TAVR). The complexity of information patients need to make value-concordant decisions highlights the need for accessible, acceptable, and unbiased decision aids (DAs) for patients considering AS treatment. Methods: Using a rapid-development process adapted from our team’s earlier work creating DAs for ICD and LVAD candidates, and guided by International Patient Decision Aid Standards (IPDAS), we created decision support materials for AS patients. This process included simultaneous 1) qualitative assessments of decision support needs & experience among TAVR recipients, 2) alpha testing iterative versions of paper DAs with patients to assess for accessibility & bias, and 3) assessment of clinical accuracy and usability of DAs with clinicians through individual feedback and expert panel consensus (Figure 1). Results: Over a 14 month period, we created two paper and two video DAs (corresponding to high or non-operative surgical risk), including input from interviews with 17 patients and 3 caregivers, 6 clinician reviews, and 4 expert panel assessments. Patient/caregiver feedback included DA usability and when it should be introduced into the clinical process. Clinician feedback focused on expected valve durability, procedural risks, and clinical accuracy. While most patients and clinicians expressed enthusiasm about TAVR, they described subpopulations of AS patients for whom the decision of whether to accept TAVR should be weighed within the context of clinical uncertainty about expected benefits (i.e. patients with prohibitive surgical risk and multi-comorbid conditions) or valve durability (i.e. surgery candidates). The DAs are currently available on the American College of Cardiology’s patient-facing CardioSmart website. Conclusion: AS treatment options are technically complex and have patient-centered trade-offs. Developing and adapting patient decision aids for AS can improve the decision making process. This development process offers lessons for improving shared decision making for evolving therapies for other life-threatening disease.

Since their initial clinical demonstration in 1980, implantable cardioverter–defibrillators (ICDs) have prolonged countless lives with successful treatment of sudden cardiac arrest.1 No other therapy has proved as effective in preventing death from ventricular arrhythmias, and important advances in ICD technology continue to improve outcomes for well-selected patients.2 Although indicated for a wide range of inherited and acquired conditions,3 ICDs are predominantly placed in older patients with left ventricular systolic dysfunction and either previous myocardial infarction or congestive heart failure.4 In the United States alone, >50 000 ICDs are placed annually in patients aged > 65 years, and nearly 500 000 more may meet current guidelines for device implantation.5 However, decision making for older patients considering ICD implantation is particularly challenging. Subjects in the landmark trials had average ages in the 60s, and thus the survival benefits of ICDs in older age groups is less well-established.6 In addition, compared with the younger participants in most clinical trials, older adults have a lower ratio of arrhythmic death to nonarrhythmic death because of competing risks for mortality, resulting in a potentially lower absolute risk reduction. At the same time, living and eventually dying with an ICD introduces potential risks, including a lower quality of life (QoL), hospitalizations, and potential suffering at the end of life.7 A rigorous consideration of the benefits, risks, and ongoing care surrounding ICD use in older patients is long overdue. On April 22, 2014, we convened a conference of multidisciplinary experts in cardiac electrophysiology, heart failure, geriatrics, ethics, and palliative care in Boston, supported by the Hartford Change AGEnts and Paul B. Beeson Career Development Award programs, and the Hebrew SeniorLife Institute for Aging Research. The objectives of the conference were (1) to review what is currently known about ICD use in …

Introduction: Medical and public health societies advocate that healthcare providers (HCPs) counselat-risk patients to reduce firearm injury risk. Anonymous online media comments often contain extremeviewpoints and may therefore help in understanding challenges of firearm safety counseling. To helpinform injury prevention efforts, we sought to examine commenters’ stated opinions regarding firearmsafety counseling HCPs. Methods: Qualitative descriptive analysis of online comments posted following news items (in May-June, 2016) about a peer-reviewed publication addressing when and how HCPs should counsel patientsregarding firearms. Results: Among 871 comments posted by 522 individuals, most (57%) were generally negative towardfirearm discussions, 17% were positive, and 26% were neutral/unclear. Two major categories andmultiple themes emerged. “Areas of agreement” included that discussions may be valuable (1) whenaddressing risk of harm to self or others, (2) in pediatric injury prevention, and (3) as general safetyeducation (without direct questioning), and that (4) HCPs lack gun safety and cultural knowledge. “Areasof tension” included whether (1) firearms are a public health issue, (2) counseling is effective preventionpractice, (3) suicide could/should be prevented, and (4) firearm safety counseling is within HCPs’ purview. Conclusion: Among this set of commenters with likely extreme viewpoints, opinions were generallynegative toward firearm safety conversations, but with some support in specific situations. Providingeducation, counseling, or materials without asking about firearm ownership was encouraged. Engagingfirearm advocates when developing materials may enhance the acceptability of prevention activities.[West J Emerg Med. 2017;18(5)903-912.]

Background: Shared decision making (SDM) is a mainstream component of cardiovascular disease care in the US. This is particularly true in light of support for SDM from the IOM, the ACA, the FDA 1-3, several professional societies, and Cochrane Review findings of improved patient-centered outcomes4. Given the complex nature of advanced CV therapies - characterized by the IOM as having “more to do, more to manage, and more people involved than ever before”5 - SDM programs are critical to patient-centered assessment of quality of care in CV. Human rights-based approaches (HRBAs)6-7 are common in evaluations of programs targeting communicable disease in developing countries, but are underutilized in CVD care in the US. HRBAs ground assessment in international human rights law, and provide a normative framework for the design, implementation, monitoring and evaluation of interventions, policy, and programs. An HRBA to health aims to realize the right to the “highest attainable standard of health”—including the availability, accessibility, acceptability, and quality of health facilities, information, goods, and services—and other health-related human rights (including autonomy and full and informed decisionmaking, the right to participation, and accountability).8-12 Approach: Using decision support regarding ICDs as a model, we created a conceptual framework highlighting synergies between HRBAs and SDM. This model of HRBA assessment of SDM programs covers four stages of design/deployment of decision aids (design of tools; implementation; use of PtDAs with patients; monitoring, evaluation and accountability), with accompanying rights-based considerations for each. The model is replicable across decision support related to other complex therapies with preference-sensitive trade-offs. Results & Implications: There is considerable synergy between HRBAs and SDM. Both empower patients, emphasize autonomy, and have potential to improve processes and outcomes. This model offers legal grounding and a normative framework through which one can evaluate SDM programming, improving decisionmaking processes and better aligning outcomes with patients’ values and goals. Research into the use of HRBA assessment of SDM is warranted; the goal being to respect, protect, and fulfill human rights obligations.

Background: Patients use Web-based medical information to understand medical conditions and treatments. A number of efforts have been made to understand the quality of professionally created content; however, none have described the quality of advice being provided between anonymous members of Web-based message boards. Objective: The objective of this study was to characterize the quality of medical information provided between members of an anonymous internet message board addressing treatment with an implantable cardioverter-defibrillator (ICD). Methods: We quantitatively analyzed 2 years of discussions using a mixed inductive-deductive framework, first, for instances in which members provided medical advice and, then, for the quality of the advice. Results: We identified 82 instances of medical advice within 127 discussions. Advice covered 6 topical areas: (1) Device information, (2) Programming, (3) Cardiovascular disease, (4) Lead management, (5) Activity restriction, and (6) Management of other conditions. Across all advice, 50% (41/82) was deemed generally appropriate, 24% (20/82) inappropriate for most patients, 6% (5/82) controversial, and 20% (16/82) without sufficient context. Proportions of quality categories varied between topical areas. We have included representative examples. Conclusions: The quality of advice shared between anonymous members of a message board regarding ICDs varied considerably according to topical area and the specificity of advice. This report provides a model to describe the quality of the available Web-based patient-generated material.