Objective The current Phase 2b study aimed to evaluate the efficacy of mindfulness‐based cognitive therapy for migraine (MBCT‐M) to reduce migraine‐related disability in people with migraine. Background Mindfulness‐based interventions represent a promising avenue to investigate effects in people with migraine. MBCT teaches mindfulness meditation and cognitive‐behavioral skills and directly applies these skills to address disease‐related cognitions. Methods Participants with migraine (6‐30 headache days/month) were recruited from neurology office referrals and local and online advertisements in the broader New York City area. During the 30‐day baseline period, all participants completed a daily headache diary. Participants who met inclusion and exclusion criteria were randomized in a parallel design, stratified by chronic migraine status, to receive either 8 weekly individual MBCT‐M sessions or 8 weeks of waitlist/treatment as usual (WL/TAU). All participants completed surveys including primary outcome evaluations at Months 0, 1, 2, and 4. All participants completed a headache diary during the 30‐day posttreatment evaluation period. Primary outcomes were the change from Month 0 to Month 4 in the headache disability inventory (HDI) and the Migraine Disability Assessment (MIDAS) (total score ≥ 21 indicating severe disability); secondary outcomes (headache days/30 days, average headache attack pain intensity, and attack‐level migraine‐related disability [Migraine Disability Index (MIDI)]) were derived from the daily headache diary. Results Sixty participants were randomized to receive MBCT‐M (n = 31) or WL/TAU (n = 29). Participants (M age = 40.1, SD = 11.7) were predominantly White (n = 49/60; 81.7%) and Non‐Hispanic (N = 50/60; 83.3%) women (n = 55/60; 91.7%) with a graduate degree (n = 35/60; 55.0%) who were working full‐time (n = 38/60; 63.3%). At baseline, the average HDI score (51.4, SD = 19.0) indicated a moderate level of disability and the majority of participants (50/60, 83.3%) fell in the “Severe Disability” range in the MIDAS. Participants recorded an average of 16.0 (SD = 5.9) headache days/30 days, with an average headache attack pain intensity of 1.7 on a 4‐point scale (SD = 0.3), indicating moderate intensity. Average levels of daily disability reported on the MIDI were 3.1/10 (SD = 1.8). For the HDI, mean scores decreased more from Month 0 to Month 4 in the MBCT‐M group (−14.3) than the waitlist/treatment as an usual group (−0.2; P < .001). For the MIDAS, the group*month interaction was not significant when accounting for the divided alpha, P = .027; across all participants in both groups, the estimated proportion of participants falling in the “Severe Disability” category fell significantly from 88.3% at Month 0 to 66.7% at Month 4, P < .001. For diary‐reported headache days/30 days an average headache attack pain intensity, neither the group*month interaction (Ps = .773 and .888, respectively) nor the time effect (Ps = .059 and .428, respectively) was significant. Mean MIDI scores decreased in the ...

Background COVID-19 challenges and needs required health systems to rapidly redesign the delivery of care. Objective To describe our approach in using health information technology to provide a continuum of services during the COVID-19 pandemic. Materials and Methods Our health system deployed four COVID-19 telehealth programs, and four biomedical informatics innovations to screen and care for COVID-19 patients. Using programmatic and electronic health record data we describe the implementation and initial utilization. Results Through collaboration across multi-disciplinary teams and strategic planning, four telehealth program initiatives have been deployed in response to COVID-19: virtual urgent care screening, remote patient monitoring for COVID-19 positive patients, continuous virtual monitoring to reduce workforce risk and utilization of personal protective equipment, and the transition of outpatient care to telehealth. Biomedical Informatics was integral to our institutional response in supporting clinical care through new and reconfigured technologies. Through linking the telehealth systems and the electronic health record, we have the ability to monitor and track patients through a continuum of COVID-19 services. Discussion COVID-19 has facilitated the rapid expansion and utilization of telehealth and health informatics services. We anticipate that patients and providers will view enhanced telehealth services as an essential aspect of the healthcare system. Continuation of telehealth payment models at federal and private levels will be a key factor in whether this new uptake is sustained. Conclusion There are substantial benefits in utilizing telehealth during the COVID-19, including the ability to rapidly scale the number of patients being screened and providing continuity of care.

Objective Audio-enhanced computer-assisted self-interviews (ACASIs) are useful adjuncts for clinical care but are rarely integrated into the electronic health record (EHR). We created a flexible framework for integrating an ACASIs with clinical decision support (CDS) into the EHR. We used this program to identify adolescents at risk for sexually transmitted infections (STIs) in the emergency department (ED). We provide an overview of the software platform and qualitative user acceptance. Materials and Methods We created an ACASI with a CDS algorithm to identify adolescents in need of STI testing. We offered it to 15- to 21-year-old patients in our ED, regardless of ED complaint. We collected user feedback via the ACASI. These were programmed into REDCap (Research Electronic Data Capture), and an iOS application utilizing Apple ResearchKit generated a tablet compatible representation of the ACASI for patients. A custom software program created an HL7 (Health Level Seven) message containing a summary of responses, CDS recommendations, and STI test orders, which were transmitted to the EHR. Results In the first year, 1788 of 6227 (28.7%) eligible adolescents completed the survey. Technical issues led to decreased use for several months. Patients rated the system favorably, with 1583 of 1787 (88.9%) indicating that they were “somewhat” or “very comfortable” answering questions electronically and 1291 of 1787 (72.2%) preferring this format over face-to-face interviews or paper questionnaires. Conclusions We present a novel use for REDCap to combine patient-answered questionnaires and CDS to improve care for adolescents at risk for STIs. Our program was well received and the platform can be used across disparate patients, topics, and information technology infrastructures.

Introduction Some evidence suggests that female smokers may show more context-dependent smoking and that males may show more stereotyped smoking (regardless of stress or cue exposure). The goal of this study was to characterize sex differences in response to stressful and smoking cues ecologically presented in daily life and variability in day-to-day smoking behavior. Methods Adult smokers (N = 177) provided ratings of mood and cigarette craving before and after stress and smoking cues were presented four times daily for 14 days via a mobile device. Linear mixed models tested whether (1) female smokers exhibited greater reactivity to stressful cues than male smokers; (2) pre-cue negative affect increased reactivity to smoking cues more in female smokers than male smokers; (3) across both sexes, greater reactivity to stressful and smoking cues correlated with greater quantity of smoking within a day; and (4) female smokers exhibited greater variability in cigarettes per day (CPD) relative to males. Results Relative to male smokers, female smokers reported greater negative affect, stress, and craving in response to stressful cues, but not smoking cues, after accounting for time since last cigarette and pre-cue responding. No sex differences in CPD or variability in CPD were detected. Days with higher subjective reactivity to cues were not associated with increased smoking, in either males or females. Conclusions Sex differences were observed in response to stress but not smoking cues in the natural environment of regular cigarette smokers. Further research is necessary to evaluate whether stress reactivity in female smokers is associated with reduced latency to smoke following stress exposure in daily life. Implications This study provides naturalistic evidence that female smokers may not be more reactive to smoking cues than males, but experience heightened stress and craving following stress exposure. There was no evidence to support the hypothesis that amount smoked per day varied more for females, relative to males, as a result of more context-driven smoking for females.

Background Falls are a common problem among older adults that lead to injury, emergency department (ED) visits, and institutionalization. The Apple Watch can detect falls and alert caregivers and clinicians that help is needed; the device could also be used to objectively collect data on gait, fitness, and falls as part of clinical trials. However, little is known about the ease of use of this technology among older adult ED patients, a population at high risk of recurrent falls. Objective The goal of this study—the Geriatric Acute and Post-Acute Fall Prevention Intervention (GAPcare) II—is to examine the feasibility, acceptability, and usability of the Apple Watch Series 4 paired with the iPhone and our research app Rhode Island FitTest (RIFitTest) among older adult ED patients seeking care for falls. Methods We will conduct field-testing with older adult ED patients (n=25) who sustained a fall and their caregivers (n=5) to determine whether they can use the Apple Watch, iPhone, and app either (1) continuously or (2) periodically, with or without telephone assistance from the research staff, to assess gait, fitness, and/or falls over time. During the initial encounter, participants will receive training in the Apple Watch, iPhone, and our research app. They will receive an illustrated training manual and a number to call if they have questions about the research protocol or device usage. Participants will complete surveys and cognitive and motor assessments on the app during the study period. At the conclusion of the study, we will solicit participant feedback through semistructured interviews. Qualitative data will be summarized using framework matrix analyses. Sensor and survey response data will be analyzed using descriptive statistics. Results Recruitment began in December 2019 and was on pause from April 2020 until September 2020 due to the COVID-19 pandemic. Study recruitment will continue until 30 participants are enrolled. This study has been approved by the Rhode Island Hospital Institutional Review Board (approval 1400781-16). Conclusions GAPcare II will provide insights into the feasibility, acceptability, and usability of the Apple Watch, iPhone, and the RIFitTest app in the population most likely to benefit from the technology: older adults at high risk of recurrent falls. In the future, wearables could be used as part of fall prevention interventions to prevent injury before it occurs. Trial Registration ClinicalTrials.gov NCT04304495; https://clinicaltrials.gov/ct2/show/NCT04304495 International Registered Report Identifier (IRRID) DERR1-10.2196/24455

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Background Mobile health apps are promising vehicles for delivering scalable health behavior change interventions to populations that are otherwise difficult to reach and engage, such as young adults with psychiatric conditions. To improve uptake and sustain consumer engagement, mobile health interventions need to be responsive to individuals’ needs and preferences, which may change over time. We previously created an ecological daily needs assessment to capture microprocesses influencing user needs and preferences for mobile health treatment adaptation. Objective The objective of our study was to test the utility of a needs assessment anchored within a mobile app to capture individualized, contextually relevant user needs and preferences within the framework of a weight management mobile health app. Methods Participants with an iOS device could download the study app via the study website or links from social media. In this fully remote study, we screened, obtained informed consent from, and enrolled participants through the mobile app. The mobile health framework included daily health goal setting and self-monitoring, with up to 6 daily prompts to determine in-the-moment needs and preferences for mobile health–assisted health behavior change. Results A total of 24 participants downloaded the app and provided e-consent (22 female; 2 male), with 23 participants responding to at least one prompt over 2 weeks. The mean length of engagement was 5.6 (SD 4.7) days, with a mean of 2.8 (1.1) responses per day. We observed individually dynamic needs and preferences, illustrating daily variability within and between individuals. Qualitative feedback indicated preferences for self-adapting features, simplified self-monitoring, and the ability to personalize app-generated message timing and content. Conclusions The technique provided an individually dynamic and contextually relevant alternative and complement to traditional needs assessment for assessing individually dynamic user needs and preferences during treatment development or adaptation. The results of this utility study suggest the importance of personalization and learning algorithms for sustaining app engagement in young adults with psychiatric conditions. Further study in broader user populations is needed.

Objective:Evaluate whether the benefits of Mindfulness-Based Cognitive Therapy for Migraine (MBCT-M) on headache disability differs among people with episodic and chronic migraine.Methods:This is a planned secondary analysis of a randomized clinical trial. After a 30-day baseline, participants were stratified by episodic (6-14 days/month) and chronic migraine (15-30 days/month) and randomized to 8 weekly individual sessions of MBCT-M or wait list/treatment as usual (WL/TAU). Primary outcomes [Headache Disability Inventory; Severe Migraine Disability Assessment Scale (scores ≥ 21)] were assessed at Months 0, 1, 2, and 4. Mixed models for repeated measures tested moderation with fixed effects of treatment, time, chronic migraine and all interactions. Planned subgroup analyses evaluated treatment*time in episodic and chronic migraine.Results:Of 60 participants (MBCT-M N = 31, WL/TAU N = 29), 52% had CM. CM moderated the effect of MBCT-M on Severe Migraine Disability Assessment Scale, F(3, 205) = 3.68, p = .013; MBCT-M vs. WL/TAU reduced the proportion of people reporting severe disability to a greater extent among people with EM (-40.0% vs. -14.3%) than CM (-16.4% vs. +8.7%). Subgroup analysis revealed MBCT-M (vs WL/TAU) significantly reduced Headache Disability Inventory for episodic (p = .011) but not chronic migraine (p = .268).Conclusions:MBCT-M is a promising treatment for reducing headache-related disability, with greater benefits in episodic than chronic migraine.Classification of EvidenceThis study provides Class III evidence that MBCT-M reduces headache disability to a greater extent in people with episodic than chronic migraine. NCT02443519.