Associations between alcohol and cigarette use and type 1 and 2 myocardial infarction among people with HIV.

OBJECTIVES: People with HIV have a higher risk of myocardial infarction (MI) than the general population, with a greater proportion of type 2 MI (T2MI) due to oxygen demand-supply mismatch compared with type 1 (T1MI) resulting from atherothrombotic plaque disruption. People living with HIV report a greater prevalence of cigarette and alcohol use than do the general population. Alcohol use and smoking as risk factors for MI by type are not well studied among people living with HIV. We examined longitudinal associations between smoking and alcohol use patterns and MI by type among people living with HIV. DESIGN AND METHODS: Using longitudinal data from the Centers for AIDS Research Network of Integrated Clinical Systems cohort, we conducted time-updated Cox proportional hazards models to determine the impact of smoking and alcohol consumption on adjudicated T1MI and T2MI. RESULTS: Among 13 506 people living with HIV, with a median 4 years of follow-up, we observed 177 T1MI and 141 T2MI. Current smoking was associated with a 60% increase in risk of both T1MI and T2MI. In addition, every cigarette smoked per day was associated with a 4% increase in risk of T1MI, with a suggestive, but not significant, 2% increase for T2MI. Cigarette use had a greater impact on T1MI for men than for women and on T2MI for women than for men. Increasing alcohol use was associated with a lower risk of T1MI but not T2MI. Frequency of heavy episodic alcohol use was not associated with MI. CONCLUSIONS: Our findings reinforce the prioritization of smoking reduction, even without cessation, and cessation among people living with HIV for MI prevention and highlight the different impacts on MI type by gender.

Intervention to Promote Communication About Goals of Care for Hospitalized Patients With Serious Illness: A Randomized Clinical Trial.

Importance: Discussions about goals of care are important for high-quality palliative care yet are often lacking for hospitalized older patients with serious illness. Objective: To evaluate a communication-priming intervention to promote goals-of-care discussions between clinicians and hospitalized older patients with serious illness. Design, Setting, and Participants: A pragmatic, randomized clinical trial of a clinician-facing communication-priming intervention vs usual care was conducted at 3 US hospitals within 1 health care system, including a university, county, and community hospital. Eligible hospitalized patients were aged 55 years or older with any of the chronic illnesses used by the Dartmouth Atlas project to study end-of-life care or were aged 80 years or older. Patients with documented goals-of-care discussions or a palliative care consultation between hospital admission and eligibility screening were excluded. Randomization occurred between April 2020 and March 2021 and was stratified by study site and history of dementia. Intervention: Physicians and advance practice clinicians who were treating the patients randomized to the intervention received a 1-page, patient-specific intervention (Jumpstart Guide) to prompt and guide goals-of-care discussions. Main Outcomes and Measures: The primary outcome was the proportion of patients with electronic health record-documented goals-of-care discussions within 30 days. There was also an evaluation of whether the effect of the intervention varied by age, sex, history of dementia, minoritized race or ethnicity, or study site. Results: Of 3918 patients screened, 2512 were enrolled (mean age, 71.7 [SD, 10.8] years and 42% were women) and randomized (1255 to the intervention group and 1257 to the usual care group). The patients were American Indian or Alaska Native (1.8%), Asian (12%), Black (13%), Hispanic (6%), Native Hawaiian or Pacific Islander (0.5%), non-Hispanic (93%), and White (70%). The proportion of patients with electronic health record-documented goals-of-care discussions within 30 days was 34.5% (433 of 1255 patients) in the intervention group vs 30.4% (382 of 1257 patients) in the usual care group (hospital- and dementia-adjusted difference, 4.1% [95% CI, 0.4% to 7.8%]). The analyses of the treatment effect modifiers suggested that the intervention had a larger effect size among patients with minoritized race or ethnicity. Among 803 patients with minoritized race or ethnicity, the hospital- and dementia-adjusted proportion with goals-of-care discussions was 10.2% (95% CI, 4.0% to 16.5%) higher in the intervention group than in the usual care group. Among 1641 non-Hispanic White patients, the adjusted proportion with goals-of-care discussions was 1.6% (95% CI, -3.0% to 6.2%) higher in the intervention group than in the usual care group. There was no evidence of differential treatment effects of the intervention on the primary outcome by age, sex, history of dementia, or study site. Conclusions and Relevance: Among hospitalized older adults with serious illness, a pragmatic clinician-facing communication-priming intervention significantly improved documentation of goals-of-care discussions in the electronic health record, with a greater effect size in racially or ethnically minoritized patients. Trial Registration: ClinicalTrials.gov Identifier: NCT04281784.

Tobacco smoking and binge alcohol use are associated with incident venous thromboembolism in an HIV cohort.

BACKGROUND: People with HIV (PWH) are at increased risk of cardiovascular comorbidities and substance use is a potential predisposing factor. We evaluated associations of tobacco smoking and alcohol use with venous thromboembolism (VTE) in PWH. METHODS: We assessed incident, centrally adjudicated VTE among 12 957 PWH within the Centers for AIDS Research Network of Integrated Clinical Systems (CNICS) cohort between January 2009 and December 2018. Using separate Cox proportional hazards models, we evaluated associations of time-updated alcohol and cigarette use with VTE, adjusting for demographic and clinical characteristics. Smoking was evaluated as pack-years and never, former, or current use with current cigarettes per day. Alcohol use was parameterized using categorical and continuous alcohol use score, frequency of use, and binge frequency. RESULTS: During a median of 3.6 years of follow-up, 213 PWH developed a VTE. One-third of PWH reported binge drinking and 40% reported currently smoking. In adjusted analyses, risk of VTE was increased among both current (HR: 1.44, 95% CI: 1.02-2.03) and former (HR: 1.44, 95% CI: 0.99-2.07) smokers compared to PWH who never smoked. Additionally, total pack-years among ever-smokers (HR: 1.10 per 5 pack-years; 95% CI: 1.03-1.18) was associated with incident VTE in a dose-dependent manner. Frequency of binge drinking was associated with incident VTE (HR: 1.30 per 7 days/month, 95% CI: 1.11-1.52); however, alcohol use frequency was not. Severity of alcohol use was not significantly associated with VTE. CONCLUSIONS: Current smoking and pack-year smoking history were dose-dependently associated with incident VTE among PWH in CNICS. Binge drinking was also associated with VTE. Interventions for smoking and binge drinking may decrease VTE risk among PWH.

Changes in on-time vaccination following the introduction of an electronic immunization registry, Tanzania 2016-2018: interrupted time-series analysis.

BACKGROUND: Digital health interventions (DHI) have the potential to improve the management and utilization of health information to optimize health care worker performance and provision of care. Despite the proliferation of DHI projects in low-and middle-income countries, few have been evaluated in an effort to understand their impact on health systems and health-related outcomes. Although more evidence is needed on their impact and effectiveness, the use of DHIs among immunization programs has become more widespread and shows promise for improving vaccination uptake and adherence to immunization schedules. METHODS: Our aim was to assess the impact of an electronic immunization registry (EIR) using an interrupted time-series analysis to analyze the effect on proportion of on-time vaccinations following introduction of an EIR in Tanzania. We hypothesized that the introduction of the EIR would lead to statistically significant changes in vaccination timeliness at 3, 6, and > 6 months post-introduction. RESULTS: For our primary analysis, we observed a decrease in the proportion of on-time vaccinations following EIR introduction. In contrast, our sensitivity analysis estimated improvements in timeliness among those children with complete vaccination records. However, we must emphasize caution interpreting these findings as they are likely affected by implementation challenges. CONCLUSIONS: This study highlights the complexities of using digitized individual-level routine health information system data for evaluation and research purposes. EIRs have the potential to improve vaccination timeliness, but analyses using EIR data can be complicated by data quality issues and inconsistent data entry leading to difficulties interpreting findings.

Drug and alcohol use among people living with HIV in care in the United States by geographic region.

Substance use in the U.S. varies by geographic region. Opioid prescribing practices and marijuana, heroin, and methamphetamine availability are evolving differently across regions. We examined self-reported substance use among people living with HIV (PLWH) in care at seven sites from 2017-2019 to understand current regional substance use patterns. We calculated the percentage and standardized percentage of PLWH reporting current drug use and at-risk and binge alcohol use by U.S. Census Bureau geographic region and examined associations in adjusted logistic regression analyses. Among 7,686 PLWH, marijuana use was the most prevalent drug (30%), followed by methamphetamine/crystal (8%), cocaine/crack (7%), and illicit opioids (3%). One-third reported binge alcohol use (32%). Differences in percent of current use by region were seen for marijuana (24-41%) and methamphetamine/crystal (2-15%), with more use in the West and Northeast, and binge alcohol use (26-40%). In adjusted analyses, PLWH in the Midwest were significantly less likely to use methamphetamine/crystal (aOR: 0.13;0.06-0.25) or illicit opioids (aOR:0.16;0.05-0.53), and PLWH in the Northeast were more likely to use cocaine/crack (aOR:1.59;1.16-2.17), compared to PLWH in the West. Understanding differences in substance use patterns in the current era, as policies continue to evolve, will enable more targeted interventions in clinical settings among PLWH.

Association of Physician Orders for Life-Sustaining Treatment With ICU Admission Among Patients Hospitalized Near the End of Life.

Importance: Patients with chronic illness frequently use Physician Orders for Life-Sustaining Treatment (POLST) to document treatment limitations. Objectives: To evaluate the association between POLST order for medical interventions and intensive care unit (ICU) admission for patients hospitalized near the end of life. Design, Setting, and Participants: Retrospective cohort study of patients with POLSTs and with chronic illness who died between January 1, 2010, and December 31, 2017, and were hospitalized 6 months or less before death in a 2-hospital academic health care system. Exposures: POLST order for medical interventions ("comfort measures only" vs "limited additional interventions" vs "full treatment"), age, race/ethnicity, education, days from POLST completion to admission, histories of cancer or dementia, and admission for traumatic injury. Main Outcomes and Measures: The primary outcome was the association between POLST order and ICU admission during the last hospitalization of life; the secondary outcome was receipt of a composite of 4 life-sustaining treatments: mechanical ventilation, vasopressors, dialysis, and cardiopulmonary resuscitation. For evaluating factors associated with POLST-discordant care, the outcome was ICU admission contrary to POLST order for medical interventions during the last hospitalization of life. Results: Among 1818 decedents (mean age, 70.8 [SD, 14.7] years; 41% women), 401 (22%) had POLST orders for comfort measures only, 761 (42%) had orders for limited additional interventions, and 656 (36%) had orders for full treatment. ICU admissions occurred in 31% (95% CI, 26%-35%) of patients with comfort-only orders, 46% (95% CI, 42%-49%) with limited-interventions orders, and 62% (95% CI, 58%-66%) with full-treatment orders. One or more life-sustaining treatments were delivered to 14% (95% CI, 11%-17%) of patients with comfort-only orders and to 20% (95% CI, 17%-23%) of patients with limited-interventions orders. Compared with patients with full-treatment POLSTs, those with comfort-only and limited-interventions orders were significantly less likely to receive ICU admission (comfort only: 123/401 [31%] vs 406/656 [62%], aRR, 0.53 [95% CI, 0.45-0.62]; limited interventions: 349/761 [46%] vs 406/656 [62%], aRR, 0.79 [95% CI, 0.71-0.87]). Across patients with comfort-only and limited-interventions POLSTs, 38% (95% CI, 35%-40%) received POLST-discordant care. Patients with cancer were significantly less likely to receive POLST-discordant care than those without cancer (comfort only: 41/181 [23%] vs 80/220 [36%], aRR, 0.60 [95% CI, 0.43-0.85]; limited interventions: 100/321 [31%] vs 215/440 [49%], aRR, 0.63 [95% CI, 0.51-0.78]). Patients with dementia and comfort-only orders were significantly less likely to receive POLST-discordant care than those without dementia (23/111 [21%] vs 98/290 [34%], aRR, 0.44 [95% CI, 0.29-0.67]). Patients admitted for traumatic injury were significantly more likely to receive POLST-discordant care (comfort only: 29/64 [45%] vs 92/337 [27%], aRR, 1.52 [95% CI, 1.08-2.14]; limited interventions: 51/91 [56%] vs 264/670 [39%], aRR, 1.36 [95% CI, 1.09-1.68]). In patients with limited-interventions orders, older age was significantly associated with less POLST-discordant care (aRR, 0.93 per 10 years [95% CI, 0.88-1.00]). Conclusions and Relevance: Among patients with POLSTs and with chronic life-limiting illness who were hospitalized within 6 months of death, treatment-limiting POLSTs were significantly associated with lower rates of ICU admission compared with full-treatment POLSTs. However, 38% of patients with treatment-limiting POLSTs received intensive care that was potentially discordant with their POLST.

Mortality following myocardial infarction among HIV-infected persons: the Center for AIDS Research Network Of Integrated Clinical Systems (CNICS).

BACKGROUND: Persons with human immunodeficiency virus (HIV) have higher risks for myocardial infarction (MI) than the general population. This is driven in part by higher type 2 MI (T2MI, due to coronary supply-demand mismatch) rates among persons with HIV (PWH). In the general population, T2MI has higher mortality than type 1 MI (T1MI, spontaneous and generally due to plaque rupture and thrombosis). PWH have a greater burden of comorbidities and may therefore have an even greater excess risk for complication and death in the setting of T2MI. However, mortality patterns after T1MI and T2MI in HIV are unknown. METHODS: We analyzed mortality after MI among PWH enrolled in the multicenter, US-based Centers for AIDS Research Network of Integrated Clinical Systems (CNICS) cohort (N = 28,186). Incident MIs occurring between January 1, 1996, and December 31, 2014, were centrally adjudicated and classified as T1MI or T2MI. We first compared mortality following T1MI vs. T2MI among PWH. Cox survival analyses and Bayesian model averaging were then used to evaluate pre-MI covariates associated with mortality following T1MI and T2MI. RESULTS: Among the 596 out of 28,186 PWH who experienced MI (2.1%; 293 T1MI and 303 T2MI), mortality rates were significantly greater after T2MI (22.2/100 person-years; 1-, 3-, and 5-year mortality 39%, 52%, and 62%) than T1MI (8.2/100 person-years; 1-, 3-, and 5-year mortality 15%, 22%, and 30%). Significant mortality predictors after T1MI were higher HIV viral load, renal dysfunction, and older age. Significant predictors of mortality after T2MI were low body-mass index (BMI) and detectable HIV viral load. CONCLUSIONS: Mortality is high following MI for PWH and substantially greater after T2MI than T1MI. Predictors of death after MI differed by type of MI, reinforcing the different clinical scenarios associated with each MI type and the importance of considering MI types separately.

Wound Care Follow-Up From the Emergency Department Using a Mobile Application: A Pilot Study.

BACKGROUND: Many patients presenting to emergency departments (EDs) do not have primary care and risk being lost to follow-up. Technology has been used successfully in surgical populations for wound care follow-up yet this is not well studied in ED populations. OBJECTIVE: We aimed to conduct a pilot study demonstrating "smartphone" application-based follow-up after wound care in the ED. METHODS: We enrolled participants in 2 urban EDs using a smartphone application called Mobile Post-Operative Wound Evaluator (mPOWEr) and defined participation as photographic submission at any time during the study period. We collected demographic data, frequency of use of mPOWEr, number of photographs uploaded, and timing of uploads. RESULTS: We approached patients for study enrollment, and 67 patients (28%) were not enrolled because they had no access to a smartphone. Seventy-one patients (30%) declined to enroll, leaving 100 (42%) successfully enrolled. Smartphone ownership was more common among patients <40 years of age (81% vs. 64%, p = 0.004), more common among white patients than nonwhite patients (75% vs. 15%, p = 0.046), more common among patients approached at the university medical center than the trauma center (84% vs. 66%, p = 0.003), and among patients with commercial or other insurance than those with Medicare or Medicaid (92% vs. 54%, p < 0.001). Of those enrolled, 58% submitted a photograph. CONCLUSIONS: Patients presenting for wound care to the ED will participate in smartphone-based app communication for wound care follow-up and are satisfied with this option. Disparities in smartphone access must be considered when using this follow-up method.

Development and Content Validation of a Patient-Reported Sexual Risk Measure for Use in Primary Care.

BACKGROUND: Patient-provider sexual risk behavior discussions occur infrequently but may be facilitated by high-quality sexual risk screening tools. OBJECTIVE: To develop the Sexual Risk Behavior Inventory (SRBI), a brief computer-administered patient-reported measure. DESIGN: Qualitative item development/quantitative instrument validation. PARTICIPANTS: We developed SRBI items based on patient interviews (n = 128) at four geographically diverse US primary care clinics. Patients were diverse in gender identity, sex, sexual orientation, age, race/ethnicity, and HIV status. We compared sexual risk behavior identified by the SRBI and the Risk Assessment Battery (RAB) among patients (n = 422). APPROACH: We constructed an item pool based on validated measures of sexual risk, developed an in-depth interview guide based on pool content, and used interviews to elicit new sexual risk concepts. We coded concepts, matched them to item pool content, and developed new content where needed. A provider team evaluated item clinical relevance. We conducted cognitive interviews to assess item comprehensibility. We administered the SRBI and the RAB to patients. KEY RESULTS: Common, clinically relevant concepts in the SRBI included number of sex partners; partner HIV status; partner use of antiretroviral medication (ART)/pre-exposure prophylaxis (PrEP); and recent sex without barrier protection, direction of anal sex, and concern regarding HIV/STI exposure. While 90% reported inconsistent condom use on the RAB, same-day SRBI administration revealed that for over one third, all their partners were on ART/PrEP. CONCLUSION: The SRBI is a brief, skip-patterned, clinically relevant measure that ascertains sexual risk behavior across sex, sexual orientation, gender identity, partner HIV serostatus, and partner treatment status, furnishing providers with context to determine gradations of risk for HIV/STI.

HIV Provider Documentation and Actions Following Patient Reports of At-risk Behaviors and Conditions When Identified by a Web-Based Point-of-Care Assessment.

We compared same-day provider medical record documentation and interventions addressing depression and risk behaviors before and after delivering point-of-care patient-reported outcomes (PROs) feedback for patients who self-reported clinically relevant levels of depression or risk behaviors. During the study period (1 January 2006-15 October 2010), 2289 PRO assessments were completed by HIV-infected patients. Comparing the 8 months before versus after feedback implementation, providers were more likely to document depression (74% before vs. 87% after feedback, p = 0.02) in patients with moderate-to-severe depression (n = 317 assessments), at-risk alcohol use (41 vs. 64%, p = 0.04, n = 155) and substance use (60 vs. 80%, p = 0.004, n = 212). Providers were less likely to incorrectly document good adherence among patients with inadequate adherence after feedback (42 vs. 24%, p = 0.02, n = 205). While PRO feedback of depression and adherence were followed by increased provider intervention, other domains were not. Further investigation of factors associated with the gap between awareness and intervention are needed in order to bridge this divide.

The electronic self report assessment and intervention for cancer: promoting patient verbal reporting of symptom and quality of life issues in a randomized controlled trial.

BACKGROUND: The electronic self report assessment - cancer (ESRA-C), has been shown to reduce symptom distress during cancer therapy The purpose of this analysis was to evaluate aspects of how the ESRA-C intervention may have resulted in lower symptom distress (SD). METHODS: Patients at two cancer centers were randomized to ESRA-C assessment only (control) or the Web-based ESRA-C intervention delivered to patients' homes or to a tablet in clinic. The intervention allowed patients to self-monitor symptom and quality of life (SxQOL) between visits, receive self-care education and coaching to report SxQOL to clinicians. Summaries of assessments were delivered to clinicians in both groups. Audio-recordings of clinic visits made 6 weeks after treatment initiation were coded for discussions of 26 SxQOL issues, focusing on patients'/caregivers' coached verbal reports of SxQOL severity, pattern, alleviating/aggravating factors and requests for help. Among issues identified as problematic, two measures were defined for each patient: the percent SxQOL reported that included a coached statement, and an index of verbalized coached statements per SxQOL. The Wilcoxon rank test was used to compare measures between groups. Clinician responses to problematic SxQOL were compared. A mediation analysis was conducted, exploring the effect of verbal reports on SD outcomes. RESULTS: 517 (256 intervention) clinic visits were audio-recorded. General discussion of problematic SxQOL was similar in both groups. Control group patients reported a median 75% of problematic SxQOL using any specific coached statement compared to a median 85% in the intervention group (p = .0009). The median report index of coached statements was 0.25 for the control group and 0.31 for the intervention group (p = 0.008). Fatigue, pain and physical function issues were reported significantly more often in the intervention group (all p < .05). Clinicians' verbalized responses did not differ between groups. Patients' verbal reports did not mediate final SD outcomes (p = .41). CONCLUSIONS: Adding electronically-delivered, self-care instructions and communication coaching to ESRA-C promoted specific patient descriptions of problematic SxQOL issues compared with ESRA-C assessment alone. However, clinician verbal responses were no different and subsequent symptom distress group differences were not mediated by the patients' reports. TRIAL REGISTRATION: NCT00852852; 26 Feb 2009.

Use of Digital COVID-19 Exposure Notifications at a Large Gathering: Survey Analysis of Public Health Conference Attendees.

BACKGROUND: WA Notify was Washington State's smartphone-based COVID-19 digital exposure notification (EN) tool, which was used to help limit the spread of COVID-19 between November 30, 2020, and May 11, 2023. Following the 2022 Washington State Public Health Association Annual Conference, attendees who had WA Notify activated began receiving ENs alerting them to a possible COVID-19 exposure during the conference. A survey was emailed to all conference attendees to measure WA Notify adoption, mechanisms through which attendees received ENs, and self-reported engagement in protective behaviors postexposure. OBJECTIVE: This study aimed to learn more about the experiences of WA Notify adopters and nonadopters who may have been exposed to COVID-19 at a large group gathering. METHODS: A web-based survey administered through REDCap (Research Electronic Data Capture; Vanderbilt University) was sent to all attendees of the Washington State Public Health Association conference. Self-reported demographic information and characteristics of respondents were summarized. Regression models were used to estimate relative risks to compare WA Notify adoption and testing behaviors between groups. RESULTS: Of the 464 total registered attendees who were sent the survey, 205 (44%) responses were received; 201 eligible attendees were included in this analysis. Of those, 149 (74%) respondents reported having WA Notify activated on their phones at the time of the conference. Among respondents with WA Notify activated, 54% (n=77) reported learning of their potential exposure from a WA Notify EN. Respondents who reported that they did not have WA Notify activated and learned of their potential exposure via the event-wide email from conference organizers were 39% less likely to test for COVID-19 compared to respondents with WA Notify activated who learned of their potential exposure from the email (relative risk 0.61, 95% CI 0.40-0.93; P=.02), and this gap was even larger when compared to respondents who learned of their exposure from a WA Notify EN. The most commonly cited reason for not having WA Notify activated was privacy concerns (n=17, 35%), followed by not wanting to receive ENs (n=6, 12%) and being unaware of WA Notify (n=5, 10%). CONCLUSIONS: Digital EN systems are an important tool to directly and anonymously notify close contacts of potential exposures and provide guidance on the next steps in a timely manner. Given the privacy concerns, there is still a need for increasing transparency surrounding EN technology to increase uptake by the public if this technology were to be used in the future to slow the spread of communicable diseases.

Venous Thromboembolism Among People With HIV: Design, Implementation, and Findings of a Centralized Adjudication System in Clinical Care Sites Across the United States.

BACKGROUND: People with HIV (PWH) are at increased risk for venous thromboembolism (VTE). We conducted this study to characterize VTE including provoking factors among PWH in the current treatment era. METHODS: We included PWH with VTE between 2010 and 2020 at 6 sites in the CFAR Network of Integrated Clinical Systems cohort. We ascertained for possible VTE using diagnosis, VTE-related imaging, and VTE-related procedure codes, followed by centralized adjudication of primary data by expert physician reviewers. We evaluated sensitivity and positive predictive value of VTE ascertainment approaches. VTEs were classified by type and anatomic location. Reviewers identified provoking factors such as hospitalizations, infections, and other potential predisposing factors such as smoking. RESULTS: We identified 557 PWH with adjudicated VTE: 239 (43%) had pulmonary embolism with or without deep venous thrombosis, and 318 (57%) had deep venous thrombosis alone. Ascertainment with clinical diagnoses alone missed 6% of VTEs identified with multiple ascertainment approaches. DVTs not associated with intravenous lines were most often in the proximal lower extremities. Among PWH with VTE, common provoking factors included recent hospitalization (n = 134, 42%), infection (n = 133, 42%), and immobilization/bed rest (n = 78, 25%). Only 57 (10%) PWH had no provoking factor identified. Smoking (46%), HIV viremia (27%), and injection drug use (22%) were also common. CONCLUSIONS: We conducted a robust adjudication process that demonstrated the benefits of multiple ascertainment approaches followed by adjudication. Provoked VTEs were more common than unprovoked events. Nontraditional and modifiable potential predisposing factors such as viremia and smoking were common.

Assessment of Natural Language Processing of Electronic Health Records to Measure Goals-of-Care Discussions as a Clinical Trial Outcome.

Importance: Many clinical trial outcomes are documented in free-text electronic health records (EHRs), making manual data collection costly and infeasible at scale. Natural language processing (NLP) is a promising approach for measuring such outcomes efficiently, but ignoring NLP-related misclassification may lead to underpowered studies. Objective: To evaluate the performance, feasibility, and power implications of using NLP to measure the primary outcome of EHR-documented goals-of-care discussions in a pragmatic randomized clinical trial of a communication intervention. Design, Setting, and Participants: This diagnostic study compared the performance, feasibility, and power implications of measuring EHR-documented goals-of-care discussions using 3 approaches: (1) deep-learning NLP, (2) NLP-screened human abstraction (manual verification of NLP-positive records), and (3) conventional manual abstraction. The study included hospitalized patients aged 55 years or older with serious illness enrolled between April 23, 2020, and March 26, 2021, in a pragmatic randomized clinical trial of a communication intervention in a multihospital US academic health system. Main Outcomes and Measures: Main outcomes were natural language processing performance characteristics, human abstractor-hours, and misclassification-adjusted statistical power of methods of measuring clinician-documented goals-of-care discussions. Performance of NLP was evaluated with receiver operating characteristic (ROC) curves and precision-recall (PR) analyses and examined the effects of misclassification on power using mathematical substitution and Monte Carlo simulation. Results: A total of 2512 trial participants (mean [SD] age, 71.7 [10.8] years; 1456 [58%] female) amassed 44 324 clinical notes during 30-day follow-up. In a validation sample of 159 participants, deep-learning NLP trained on a separate training data set identified patients with documented goals-of-care discussions with moderate accuracy (maximal F1 score, 0.82; area under the ROC curve, 0.924; area under the PR curve, 0.879). Manual abstraction of the outcome from the trial data set would require an estimated 2000 abstractor-hours and would power the trial to detect a risk difference of 5.4% (assuming 33.5% control-arm prevalence, 80% power, and 2-sided α = .05). Measuring the outcome by NLP alone would power the trial to detect a risk difference of 7.6%. Measuring the outcome by NLP-screened human abstraction would require 34.3 abstractor-hours to achieve estimated sensitivity of 92.6% and would power the trial to detect a risk difference of 5.7%. Monte Carlo simulations corroborated misclassification-adjusted power calculations. Conclusions and Relevance: In this diagnostic study, deep-learning NLP and NLP-screened human abstraction had favorable characteristics for measuring an EHR outcome at scale. Adjusted power calculations accurately quantified power loss from NLP-related misclassification, suggesting that incorporation of this approach into the design of studies using NLP would be beneficial.

Preliminary Efficacy of Let's Talk Tech: Technology Use Planning for Dementia Care Dyads.

Background and Objective: Care partners of people living with dementia require support to knowledgeably navigate decision making about how and when to use monitoring technologies for care purposes. We conducted a pilot study of a novel self-administered intervention, "Let's Talk Tech," for people living with mild dementia and their care partners. This paper presents preliminary efficacy findings of this intervention designed to educate and facilitate dyadic communication about a range of technologies used in dementia care and to document the preferences of the person living with dementia. It is the first-of-its-kind decision-making and planning tool with a specific focus on technology use. Research Design and Methods: We used a 1-group pretest-post-test design and paired t tests to assess change over 2 time periods in measures of technology comprehension, care partner knowledge of the participant living with mild Alzheimer's disease's (AD) preferences, care partner preparedness to make decisions about technology use, and mutual understanding. Thematic analysis was conducted on postintervention interview transcripts to elucidate mechanisms and experiences with Let's Talk Tech. Results: Twenty-nine mild AD dementia care dyads who live together completed the study. There was statistically significant improvement with medium and large effect sizes on outcome measures of care partners' understanding of each technology, care partners' perceptions of the person living with dementia's understanding of each technology, knowledge of the person living with dementia's preferences, decision-making preparedness, and care partners' feelings of mutual understanding. Participants reported that it helped them have important and meaningful conversations about using technology. Discussion and Implications: Let's Talk Tech demonstrated promising preliminary efficacy on targeted measures that can lead to informed, shared decision making about technologies used in dementia care. Future studies should assess efficacy with larger samples and more diverse sample populations in terms of race, ethnicity, and dementia type.

Integration of a Digital Health Intervention Into Immunization Clinic Workflows in Kenya: Qualitative, Realist Evaluation of Technology Usability.

BACKGROUND: In an effort to increase vaccination coverage in low-resource settings, digital tools have been introduced to better track immunization records, improve data management practices, and provide improved access to vaccination coverage data for decision-making. Despite the potential of these electronic systems to improve the provision of health services, few digital health interventions have been institutionalized at scale in low- and middle-income countries. OBJECTIVE: In this paper, we aimed to describe how health care workers in Kenya had integrated an electronic immunization registry into their immunization clinic workflows and to use these findings to inform the development of a refined program theory on the registry's usability. METHODS: Informed by realist methodology, we developed a program theory to explain usability of the electronic immunization registry. We designed a qualitative study based on our theory to describe the barriers and facilitators influencing data entry and use. Qualitative data were collected through semistructured interviews with users and workflow observations of immunization clinic sessions. Our findings were summarized by context-mechanism-outcome relationships formed after analyzing our key themes across interviews and workflow observations. Using these relationships, we were able to identify common rules for future implementers. RESULTS: Across the 12 facilities included in our study, 19 health care workers were interviewed, and 58 workflow sessions were observed. The common rules developed from our qualitative findings are as follows: rule 1-ensure that the users complete training to build familiarity with the system, understand the value of the system and data, and know where to find support; rule 2-confirm that the system captures all data needed for users to provide routine health care services and is easy to navigate; rule 3-identify work-arounds for poor network, system performance, and too few staff or resources; and rule 4-make users aware of expected changes to their workflow, and how these changes might differ over time and by facility size or number of patients. Upon study completion, we revised the program theory to reflect the importance of the goals and workflows of electronic immunization registries aligning with reality. CONCLUSIONS: We created a deeper understanding of the underlying mechanisms for usability of the registry. We found that the electronic immunization registry had high acceptability among users; however, there were numerous barriers to using the system, even under ideal conditions, causing a misalignment between the system and the reality of the users' workflows and their environment. Human-centered design and human-factors methods can assist during pilot stages to better align systems with users' needs and again after scale-up to ensure that interventions are suitable for all user settings.

Time Utilization Among Immunization Clinics Using an Electronic Immunization Registry (Part 2): Time and Motion Study of Modified User Workflows.

BACKGROUND: Digital health interventions have the potential to improve the provision of health care services through digitized data collection and management. Low- and middle-income countries are beginning to introduce electronic immunization registries (EIRs) into their routine immunization services to better capture and store childhood vaccination information. Especially in Africa, where 25% of children remain unimmunized or underimmunized, technologies that can help identify children due for a vaccination are particularly important for improving vaccination coverage. However, an improved understanding of the effectiveness of these systems is needed to develop and deploy sustainable EIRs in low- and middle-income countries. OBJECTIVE: We conducted an interventional pretest-posttest design study that sought to improve time efficiency through workflow modifications in Kenyan immunization clinics. Our aim was to describe how activity times differed after introducing workflow modifications that could potentially reduce the time needed to perform routine data entry activities. Our intent was to demonstrate changes in efficiency when moving from the existing dual-data entry workflow to a future paperless workflow by health facility size and experience length of health care workers (HCWs). METHODS: We tested how 3 workflow modifications would affect time utilization among HCWs using the EIR at the point of care compared with baseline immunization clinic workflows. Our outcome of interest was the time taken to complete individual activities and a patient's total time in the clinic where we compared the time spent during the baseline workflow with that during the modified workflow. We used a standardized tool to observe and document the immunization clinic workflow. To estimate differences in time utilization, we used bivariate analyses and fit multivariate linear mixed-effects models. RESULTS: Our study found that for HCWs using an EIR, the introduction of modified workflows decreased the amount of time needed to provide services to children seen in the immunization clinic. With a baseline mean time of 10 minutes spent per child, this decreased by about 3 minutes when the preparation modification was introduced and almost 5 minutes for the paperless and combined modifications. Results pertaining to the EIR's performance and ability to connect to the internet were particularly insightful about potential causes of delays. CONCLUSIONS: We were able to conduct a concise clinical simulation exercise by introducing modified workflows and estimating their impact on time utilization in immunization clinics using an EIR. We found that the paperless workflow provided the largest time savings when delivering services, although this was threatened by poor EIR performance and internet connectivity. This study demonstrated that not only should digital health interventions be built and adapted for particular use cases but existing user workflows also need to adapt to new technology.

Predictors of Documented Goals-of-Care Discussion for Hospitalized Patients With Chronic Illness.

CONTEXT: Goals-of-care discussions are important for patient-centered care among hospitalized patients with serious illness. However, there are little data on the occurrence, predictors, and timing of these discussions. OBJECTIVES: To examine the occurrence, predictors, and timing of electronic health record (EHR)-documented goals-of-care discussions for hospitalized patients. METHODS: This retrospective cohort study used natural language processing (NLP) to examine EHR-documented goals-of-care discussions for adults with chronic life-limiting illness or age ≥80 hospitalized 2015-2019. The primary outcome was NLP-identified documentation of a goals-of-care discussion during the index hospitalization. We used multivariable logistic regression to evaluate associations with baseline characteristics. RESULTS: Of 16,262 consecutive, eligible patients without missing data, 5,918 (36.4%) had a documented goals-of-care discussion during hospitalization; approximately 57% of these discussions occurred within 24 hours of admission. In multivariable analysis, documented goals-of-care discussions were more common for women (OR=1.26, 95%CI 1.18-1.36), older patients (OR=1.04 per year, 95%CI 1.03-1.04), and patients with more comorbidities (OR=1.11 per Deyo-Charlson point, 95%CI 1.10-1.13), cancer (OR=1.88, 95%CI 1.72-2.06), dementia (OR=2.60, 95%CI 2.29-2.94), higher acute illness severity (OR=1.12 per National Early Warning Score point, 95%CI 1.11-1.14), or prior advance care planning documents (OR=1.18, 95%CI 1.08-1.30). Documentation of these discussions was less common for racially or ethnically minoritized patients (OR=0.823, 95%CI 0.75-0.90). CONCLUSION: Among hospitalized patients with serious illness, documented goals-of-care discussions identified by NLP were more common among patients with older age and increased burden of acute or chronic illness, and less common among racially or ethnically minoritized patients. This suggests important disparities in goals-of-care discussions.

Tobacco Smoking and Pack-Years Are Associated With Frailty Among People With HIV.

BACKGROUND: Tobacco smoking increases frailty risk among the general population and is common among people with HIV (PWH) who experience higher rates of frailty at younger ages than the general population. METHODS: We identified 8608 PWH across 6 Centers for AIDS Research Network of Integrated Clinical Systems sites who completed ≥2 patient-reported outcome assessments, including a frailty phenotype measuring unintentional weight loss, poor mobility, fatigue, and inactivity, and scored 0-4. Smoking was measured as baseline pack-years and time-updated never, former, or current use with cigarettes/day. We used Cox models to associate smoking with risk of incident frailty (score ≥3) and deterioration (frailty score increase by ≥2 points), adjusted for demographics, antiretroviral medication, and time-updated CD4 count. RESULTS: The mean follow-up of PWH was 5.3 years (median: 5.0), the mean age at baseline was 45 years, 15% were female, and 52% were non-White. At baseline, 60% reported current or former smoking. Current (HR: 1.79; 95% confidence interval: 1.54 to 2.08) and former (HR: 1.31; 95% confidence interval: 1.12 to 1.53) smoking were associated with higher incident frailty risk, as were higher pack-years. Current smoking (among younger PWH) and pack-years, but not former smoking, were associated with higher risk of deterioration. CONCLUSIONS: Among PWH, smoking status and duration are associated with incident and worsening frailty.

Development of Frail RISC-HIV: a Risk Score for Predicting Frailty Risk in the Short-term for Care of People with HIV.

OBJECTIVE: Frailty is common among people with HIV (PWH), so we developed frail risk in the short-term for care (RISC)-HIV, a frailty prediction risk score for HIV clinical decision-making. DESIGN: We followed PWH for up to 2 years to identify short-term predictors of becoming frail. METHODS: We predicted frailty risk among PWH at seven HIV clinics across the United States. A modified self-reported Fried Phenotype captured frailty, including fatigue, weight loss, inactivity, and poor mobility. PWH without frailty were separated into training and validation sets and followed until becoming frail or 2 years. Bayesian Model Averaging (BMA) and five-fold-cross-validation Lasso regression selected predictors of frailty. Predictors were selected by BMA if they had a greater than 45% probability of being in the best model and by Lasso if they minimized mean squared error. We included age, sex, and variables selected by both BMA and Lasso in Frail RISC-HIV by associating incident frailty with each selected variable in Cox models. Frail RISC-HIV performance was assessed in the validation set by Harrell's C and lift plots. RESULTS: Among 3170 PWH (training set), 7% developed frailty, whereas among 1510 PWH (validation set), 12% developed frailty. BMA and Lasso selected baseline frailty score, prescribed antidepressants, prescribed antiretroviral therapy, depressive symptomology, and current marijuana and illicit opioid use. Discrimination was acceptable in the validation set, with Harrell's C of 0.76 (95% confidence interval: 0.73-0.79) and sensitivity of 80% and specificity of 61% at a 5% frailty risk cutoff. CONCLUSIONS: Frail RISC-HIV is a simple, easily implemented tool to assist in classifying PWH at risk for frailty in clinics.