Use of an Automated Bilingual Digital Health Tool to Reduce Unhealthy Alcohol Use Among Latino Emergency Department Patients: A Randomized Clinical Trial.

Importance: Alcohol use disorders have a high disease burden among US Latino groups. In this population, health disparities persist, and high-risk drinking has been increasing. Effective bilingual and culturally adapted brief interventions are needed to identify and reduce disease burden. Objective: To compare the effectiveness of an automated bilingual computerized alcohol screening and intervention (AB-CASI) digital health tool with standard care for the reduction of alcohol consumption among US adult Latino emergency department (ED) patients with unhealthy drinking. Design, Setting, and Participants: This bilingual unblinded parallel-group randomized clinical trial evaluated the effectiveness of AB-CASI vs standard care among 840 self-identified adult Latino ED patients with unhealthy drinking (representing the full spectrum of unhealthy drinking). The study was conducted from October 29, 2014, to May 1, 2020, at the ED of a large urban community tertiary care center in the northeastern US that was verified as a level II trauma center by the American College of Surgeons. Data were analyzed from May 14, 2020, to November 24, 2020. Intervention: Patients randomized to the intervention group received AB-CASI, which included alcohol screening and a structured interactive brief negotiated interview in their preferred language (English or Spanish) while in the ED. Patients randomized to the standard care group received standard emergency medical care, including an informational sheet with recommended primary care follow-up. Main Outcomes and Measures: The primary outcome was the self-reported number of binge drinking episodes within the last 28 days, assessed by the timeline followback method at 12 months after randomization. Results: Among 840 self-identified adult Latino ED patients (mean [SD] age, 36.2 [11.2] years; 433 [51.5%] male; and 697 [83.0%] of Puerto Rican descent), 418 were randomized to the AB-CASI group and 422 to the standard care group. A total of 443 patients (52.7%) chose Spanish as their preferred language at enrollment. At 12 months, the number of binge drinking episodes within the last 28 days was significantly lower in those receiving AB-CASI (3.2; 95% CI, 2.7-3.8) vs standard care (4.0; 95% CI, 3.4-4.7; relative difference [RD], 0.79; 95% CI, 0.64-0.99). Alcohol-related adverse health behaviors and consequences were similar between groups. The effect of AB-CASI was modified by age; at 12 months, the relative reduction in the number of binge drinking episodes within the last 28 days in the AB-CASI vs standard care group was 30% in participants older than 25 years (RD, 0.70; 95% CI, 0.54-0.89) compared with an increase of 40% in participants 25 years or younger (RD, 1.40; 95% CI, 0.85-2.31; P = .01 for interaction). Conclusions and Relevance: In this study, US adult Latino ED patients who received AB-CASI had a significant reduction in the number of binge drinking episodes within the last 28 days at 12 months after randomization. These findings suggest that AB-CASI is a viable brief intervention that overcomes known procedural barriers to ED screening, brief intervention, and referral to treatment and directly addresses alcohol-related health disparities. Trial Registration: ClinicalTrials.gov Identifier: NCT02247388.

Modeling human health behavior with a new index that measures connectivity.

Objective: Health behavior is an important determinant of health. Adherence to medication and abstinence from harmful substances are two critical health behaviors. Although conceptually related, both are assessed using disparate measures. The goal of this study was to develop and test a new index, gamma, which models health behavior by quantifying the connectedness of discrete incidents of health behavior. Study design and setting: We derive gamma from first principles and use it to reanalyze data from a published trial of treatment for alcohol use disorders. We model a primary endpoint, changes in binge drinking, using gamma and a traditional measure: change in number of monthly binges. The original trial was conducted in an urban hospital emergency department in the U.S. Results: Incorporating gamma into the model provided additional insights into the relationship between the intervention and long-term changes in drinking. Conclusion: Gamma provides an additional tool to model the effects of interventions on outcomes in trials of substance use interventions or medication adherence. Gamma measures the pattern of behavior and may increase the explanatory power of models assessing differences between various treatments. The gamma index offers the possibility of novel real-time interventions to promote healthy behaviors.

Comparing a Multimedia Digital Informed Consent Tool With Traditional Paper-Based Methods: Randomized Controlled Trial.

BACKGROUND: The traditional informed consent (IC) process rarely emphasizes research participants' comprehension of medical information, leaving them vulnerable to unknown risks and consequences associated with procedures or studies. OBJECTIVE: This paper explores how we evaluated the feasibility of a digital health tool called Virtual Multimedia Interactive Informed Consent (VIC) for advancing the IC process and compared the results with traditional paper-based methods of IC. METHODS: Using digital health and web-based coaching, we developed the VIC tool that uses multimedia and other digital features to improve the current IC process. The tool was developed on the basis of the user-centered design process and Mayer's cognitive theory of multimedia learning. This study is a randomized controlled trial that compares the feasibility of VIC with standard paper consent to understand the impact of interactive digital consent. Participants were recruited from the Winchester Chest Clinic at Yale New Haven Hospital in New Haven, Connecticut, and healthy individuals were recruited from the community using fliers. In this coordinator-assisted trial, participants were randomized to complete the IC process using VIC on the iPad or with traditional paper consent. The study was conducted at the Winchester Chest Clinic, and the outcomes were self-assessed through coordinator-administered questionnaires. RESULTS: A total of 50 participants were recruited in the study (VIC, n=25; paper, n=25). The participants in both groups had high comprehension. VIC participants reported higher satisfaction, higher perceived ease of use, higher ability to complete the consent independently, and shorter perceived time to complete the consent process. CONCLUSIONS: The use of dynamic, interactive audiovisual elements in VIC may improve participants' satisfaction and facilitate the IC process. We believe that using VIC in an ongoing, real-world study rather than a hypothetical study improved the reliability of our findings, which demonstrates VIC's potential to improve research participants' comprehension and the overall process of IC. TRIAL REGISTRATION: ClinicalTrials.gov NCT02537886; https://clinicaltrials.gov/ct2/show/NCT02537886.

Development and usability evaluation of VOICES: A digital health tool to identify elder mistreatment.

BACKGROUND/OBJECTIVES: A major barrier for society in overcoming elder mistreatment is an inability to accurately identify victims. There are several barriers to self-reporting elder mistreatment, including fear of nursing home placement or losing autonomy or a caregiver. Existing strategies to identify elder mistreatment neglect to empower those who experience it with tools for self-reporting. In this project, we developed and evaluated the usability of VOICES, a self-administrated digital health tool that screens, educates, and motivates older adults to self-report elder mistreatment. DESIGN: Cross-sectional study with User-Centered Design (UCD) approach. SETTING: Yale School of Medicine and the Agency on Aging of South-Central Connecticut. PARTICIPANTS: Thirty eight community-dwelling and cognitively intact older adults aged 60 years and older, caregivers, clinicians, and social workers. INTERVENTION: A tablet-based self-administrated digital health tool that screens, educates, and motivates older adults to self-report elder mistreatment. MEASUREMENTS: Qualitative and quantitative data were obtained from: (1) focus groups participants including: feedback from open-ended discussion, demographics, and a post-session survey; (2) usability evaluation including: demographics, usability measures, comfortability with technology, emotional state, and open-ended feedback. RESULTS: Focus group participants (n = 24) generally favored using a tablet-based tool to screen for elder mistreatment and expressed comfort answering questions on elder mistreatment using tablets. Usability evaluation participants (n = 14) overall scored VOICES a mean System Usability Scale (SUS) score of 86.6 (median = 88.8), higher than the benchmark SUS score of 68, indicating excellent ease of use. In addition, 93% stated that they would recommend the VOICES tool to others and 100% indicated understanding of VOICES' information and content. CONCLUSION: Our findings show that older adults are capable, willing, and comfortable with using the innovative and self-administrated digital tool for elder mistreatment screening. Our future plan is to conduct a feasibility study to evaluate the use of VOICES in identifying suspicion of mistreatment.

Perceptions of older adults and health professionals about digital screening tools for elder mistreatment in the emergency department.

Background: Healthcare settings represent a missed opportunity to systematically identify and address mistreatment. Objective: Our objective was to obtain perspectives of older adults, caregivers, and emergency care providers regarding screening and intervention for elder mistreatment in the emergency department (ED) with a focus on utilizing digital health tools to facilitate the process. These findings will inform the development of a Web-based, digital health tool optimized for a tablet device to educate, screen, and facilitate reporting of elder mistreatment among patients presenting to the ED. Method: We conducted a qualitative study utilizing three in-person focus groups (N=31) with older adults from the community, caregivers for older adults, and clinicians and social workers who worked in the ED. Using a semi-structured interview guide, we identified attitudes about the process of divulging abuse, attitudes towards the ED as the location for screening and information delivery, and perceptions of digital tools for screening and information. Results: Participants identified numerous challenges to the disclosure of mistreatment, including feelings of vulnerability and concerns about losing their homes, social supports, and connection to caregivers. In contrast, they were uncertain about the benefits of disclosure. Digital tools were seen as helpful in terms of overcoming numerous challenges to screening, but participants suggested maintaining a human element to interactions. Conclusion: While challenges to elder mistreatment screening were identified, participants had recommendations for optimizing such efforts and responded positively to digital health tools as a means of screening.

Trial study design to test a bilingual digital health tool for alcohol use disorders among Latino emergency department patients.

We describe an emergency department (ED)-based, Latino patient focused, unblinded, randomized controlled trial to empirically test if automated bilingual computerized alcohol screening and brief intervention (AB-CASI), a digital health tool, is superior to standard care (SC) on measures of alcohol consumption, alcohol-related negative behaviors and consequences, and 30-day treatment engagement. The trial design addresses the full spectrum of unhealthy drinking from high-risk drinking to severe alcohol use disorder (AUD). In an effort to surmount known ED-based alcohol screening, brief intervention, and referral to treatment process barriers, while addressing racial/ethnic alcohol-related health disparities among Latino groups, this trial will purposively use a digital health tool and seek enrollment of English and/or Spanish speaking self-identified adult Latino ED patients. Participants will be randomized (1:1) to AB-CASI or SC, stratified by AUD severity and preferred language (English vs. Spanish). The primary outcome will be the number of binge drinking days assessed using the 28-day timeline followback method at 12 months post-randomization. Secondary outcomes will include mean number of drinks/week and number of episodes of driving impaired, riding with an impaired driver, injuries, arrests, and tardiness and days absent from work/school. A sample size of 820 is necessary to provide 80% power to detect a 1.14 difference between AB-CASI and SC in the primary outcome. Showing efficacy of this promising bilingual ED-based brief intervention tool in Latino patients has the potential to widely and efficiently expand prevention efforts and facilitate meaningful contact with specialized treatment services.

Trial study design to test a bilingual digital health tool for alcohol use disorders among Latino emergency department patients.

We describe an emergency department (ED)-based, Latino patient focused, unblinded, randomized controlled trial to empirically test if automated bilingual computerized alcohol screening and brief intervention (AB-CASI), a digital health tool, is superior to standard care (SC) on measures of alcohol consumption, alcohol-related negative behaviors and consequences, and 30-day treatment engagement. The trial design addresses the full spectrum of unhealthy drinking from high-risk drinking to severe alcohol use disorder (AUD). In an effort to surmount known ED-based alcohol screening, brief intervention, and referral to treatment process barriers, while addressing racial/ethnic alcohol-related health disparities among Latino groups, this trial will purposively use a digital health tool and seek enrollment of English and/or Spanish speaking self-identified adult Latino ED patients. Participants will be randomized (1:1) to AB-CASI or SC, stratified by AUD severity and preferred language (English vs. Spanish). The primary outcome will be the number of binge drinking days assessed using the 28-day timeline followback method at 12 months post-randomization. Secondary outcomes will include mean number of drinks/week and number of episodes of driving impaired, riding with an impaired driver, injuries, arrests, and tardiness and days absent from work/school. A sample size of 820 is necessary to provide 80% power to detect a 1.14 difference between AB-CASI and SC in the primary outcome. Showing efficacy of this promising bilingual ED-based brief intervention tool in Latino patients has the potential to widely and efficiently expand prevention efforts and facilitate meaningful contact with specialized treatment services.

"Radiotherapy for older women (ROW)": A risk calculator for women with early-stage breast cancer.

OBJECTIVE: Among older adult women with early-stage breast cancer who undergo lumpectomy, the benefits of radiotherapy vary according to tumor characteristics and life expectancy. We aimed to develop a risk calculator to predict individualized probability of long-term survival and local recurrence, accounting for these factors. METHODS: We developed a simulation model to estimate an individual patient's risk of local recurrence and all-cause mortality according to age, comorbidities, functional status, tumor characteristics, and radiotherapy status. We integrated two existing prediction models, the Early Breast Cancer Trialist's Collaborative Group prediction model for breast cancer specific outcomes and ePrognosis for life expectancy. An online risk calculator "Radiotherapy for Older Women (ROW)" was developed through an iterative multi-stage process, that included individual consultation and group meetings with an advisory committee (AC) comprised of patients, advocates, clinicians, and researchers. RESULTS: We developed the tool over 40 months and had 15 group meetings. The risk calculator developed as a simulation model with 16 factors (5 tumor-related, 3 demographic, 4 comorbidities, and 4 functional statuses). Across 56,700 simulated scenarios, the benefit of RT in terms of absolute 10-year local recurrence reduction, ranged from 0% to 34%, depending on individual characteristics. Based on feedback from the AC, overall survival and local recurrence were chosen as the output for ROW, with these outcomes displayed numerically (percentages and natural frequencies) and graphically (pictographs). CONCLUSIONS: This tool "ROW" could facilitate shared decision making regarding receipt of radiotherapy for older women with early breast cancer. Additional studies to examine usability testing are underway.

Fingerprint-based background checks for personal care workers: Stakeholder views of policy criteria.

Decision makers face difficult choices when tasked with identifying and implementing appropriate mechanisms for protecting the elderly and other vulnerable adults from abuse. A pilot project involving fingerprint-based criminal history background checks for personal care workers in Michigan has supplied an opportunity to examine one such mechanism. In conjunction with the pilot project, we have conducted a stakeholder analysis with the aim of informing decision makers about stakeholder perceptions of standard policy criteria like effectiveness, efficiency, and equity. We employed focus groups and a Web-based survey to collect data from stakeholders. While stakeholders generally see fingerprint-based background checks for personal care workers as potentially effective and as a net benefit, they also point to a variety of contingencies. They also recognize difficulties and constraints for government involvement. This preliminary analysis provides solid foundational information for decision makers and for more extensive benefit-cost analysis.

Patient-Centered Decision Support: Formative Usability Evaluation of Integrated Clinical Decision Support With a Patient Decision Aid for Minor Head Injury in the Emergency Department.

BACKGROUND: The Canadian Computed Tomography (CT) Head Rule, a clinical decision rule designed to safely reduce imaging in minor head injury, has been rigorously validated and implemented, and yet expected decreases in CT were unsuccessful. Recent work has identified empathic care as a key component in decreasing CT overuse. Health information technology can hinder the clinician-patient relationship. Patient-centered decision tools to support the clinician-patient relationship are needed to promote evidence-based decisions. OBJECTIVE: Our objective is to formatively evaluate an electronic tool that not only helps clinicians at the bedside to determine the need for CT use based on the Canadian CT Head Rule but also promotes evidence-based conversations between patients and clinicians regarding patient-specific risk and patients' specific concerns. METHODS: User-centered design with practice-based and participatory decision aid development was used to design, develop, and evaluate patient-centered decision support regarding CT use in minor head injury in the emergency department. User experience and user interface (UX/UI) development involved successive iterations with incremental refinement in 4 phases: (1) initial prototype development, (2) usability assessment, (3) field testing, and (4) beta testing. This qualitative approach involved input from patients, emergency care clinicians, health services researchers, designers, and clinical informaticists at every stage. RESULTS: The Concussion or Brain Bleed app is the product of 16 successive iterative revisions in accordance with UX/UI industry design standards. This useful and usable final product integrates clinical decision support with a patient decision aid. It promotes shared use by emergency clinicians and patients at the point of care within the emergency department context. This tablet computer app facilitates evidence-based conversations regarding CT in minor head injury. It is adaptable to individual clinician practice styles. The resultant tool includes a patient injury evaluator based on the Canadian CT Head Rule and provides patient specific risks using pictographs with natural frequencies and cues for discussion about patient concerns. CONCLUSIONS: This tool was designed to align evidence-based practices about CT in minor head injury patients. It establishes trust, empowers active participation, and addresses patient concerns and uncertainty about their condition. We hypothesize that, when implemented, the Concussion or Brain Bleed app will support-not hinder-the clinician-patient relationship, safely reduce CT use, and improve the patient experience of care.

Building an Informed Consent Tool Starting with the Patient: The Patient-Centered Virtual Multimedia Interactive Informed Consent (VIC).

Patient safety and quality of care are at risk if the informed consent process does not emphasize patient comprehension. In this paper, we describe how we designed, developed, and evaluated an mHealth tool for advancing the informed consent process. Our tool enables the informed consent process to be performed on tablets (e.g., iPads) utilizing virtual coaching with text-to-speech automated translation as well as an interactive multimedia elements (e.g., graphics, video clips, animations, presentations, etc.). We designed our tool to enhance patient comprehension and quality of care, while improving the efficiency of obtaining patient consent. We present the Used-Centered Design approach we adopted to develop the tool and the results of the different methods we used during the development of the tool. Also, we describe the results of the usability study which we conducted to evaluate the effectiveness, efficiency, and user satisfaction with our mHealth App to enhance the informed consent process. Using the UCD approach we were able to design, develop, and evaluate a highly interactive mHealth App to deliver the informed consent process.

Back to the Bedside: Developing a Bedside Aid for Concussion and Brain Injury Decisions in the Emergency Department.

CONTEXT: Current information-rich electronic health record (EHR) interfaces require large, high-resolution screens running on desktop computers. This interface compromises the provider's already limited time at the bedside by physically separating the patient from the doctor. The case study presented here describes a patient-centered clinical decision support (CDS) design process that aims to bring the physician back to the bedside by integrating a patient decision aid with CDS for shared use by the patient and provider on a touchscreen tablet computer for deciding whether or not to obtain a CT scan for minor head injury in the emergency department, a clinical scenario that could benefit from CDS but has failed previous implementation attempts. CASE DESCRIPTION: This case study follows the user-centered design (UCD) approach to build a bedside aid that is useful and usable, and that promotes shared decision-making between patients and their providers using a tablet computer at the bedside. The patient-centered decision support design process focuses on the prototype build using agile software development, but also describes the following: (1) the requirement gathering phase including triangulated qualitative research (focus groups and cognitive task analysis) to understand current challenges, (2) features for patient education, the physician, and shared decision-making, (3) system architecture and technical requirements, and (4) future plans for formative usability testing and field testing. LESSONS LEARNED: We share specific lessons learned and general recommendations from critical insights gained in the patient-centered decision support design process about early stakeholder engagement, EHR integration, external expert feedback, challenges to two users on a single device, project management, and accessibility. CONCLUSIONS: Successful implementation of this tool will require seamless integration into the provider's workflow. This protocol can create an effective interface for shared decision-making and safe resource reduction at the bedside in the austere and dynamic clinical environment of the ED and is generalizable for these purposes in other clinical environments as well.

mHealth Tool for Alcohol Use Disorders Among Latinos in Emergency Department.

Latino drinkers experience a disparate number of negative health and social consequences. Emergency Department Alcohol Screening Brief Intervention and Referral to Treatment (ED-SBIRT) is viable and effective at reducing harmful and hazardous drinking. However, barriers (e.g. readily available language translators, provider time burden, resources) to broad implementation remain and account for a major lag in adherence to national guidelines. We describe our approach to the design of a patient-centered bilingual Web-based mobile health ED-SBIRT App that could be integrated into a clinically complex ED environment and used regularly to provide ED-SBIRT for Spanish speaking patients.