Informational Postcards Increase Engagement with Remote Monitoring Among Veterans with Pacemakers and Implantable Cardioverter-Defibrillators: a Stepped-Wedge Randomized Controlled Trial.

BACKGROUND: Remote monitoring (RM) of pacemakers and implantable cardioverter-defibrillators (ICDs) reduces morbidity and mortality. However, many patients are not adherent to RM. OBJECTIVE: To test the effect of informational postcards on RM adherence. DESIGN/PATIENTS: Stepped-wedge randomized controlled trial among Veterans with pacemakers and ICDs. INTERVENTION: In wave 1, Veterans who had sent at least 1 transmission within the past 2 years but had become non-adherent were randomly assigned to receive a postcard or no postcard. Those receiving postcards were randomized to 1 of 2 messages: (1) a"warning" postcard describing risks of non-adherence or (2) an "encouraging" postcard describing benefits of adherence. In wave 2, Veterans who had either not received a postcard in wave 1 or had since become non-adherent were mailed a postcard (again, randomized to 1 of 2 messages). Patients who did not send an RM transmission within 1 month were mailed a second, identical postcard. MAIN MEASURES: Transmission within 70 days. KEY RESULTS: Overall, 6351 Veterans were included. In waves 1 and 2, postcards were mailed to 5657 Veterans (2821 "warning" messages and 2836 "encouraging" messages). Wave 1 included 2178 Veterans as controls (i.e., not mailed a postcard), some of whom received a postcard in wave 2 if they remained non-adherent. In wave 2, 3473 postcards were sent. Of the 5657 patients mailed a postcard, 2756 (48.7%) sent an RM transmission within 70 days, compared to 530 (24.3%) of 2178 controls (absolute difference 24.4%, 95% confidence interval [CI] 22.2%, 26.6%). Of those who sent a transmission, 71.8% did so after the first postcard. Transmission rates at 70 days did not significantly differ between "warning" and "encouraging" messages (odds ratio 1.04, 95% CI 0.92, 1.18). CONCLUSIONS: Informational postcards led to a 24.4% absolute increase in adherence at 70 days among Veterans with pacemakers and ICDs who were non-adherent to RM.

An Electronic Dashboard to Improve Dosing of Hydroxychloroquine Within the Veterans Health Care System: Time Series Analysis.

BACKGROUND: Hydroxychloroquine (HCQ) is commonly used for patients with autoimmune conditions. Long-term use of HCQ can cause retinal toxicity, but this risk can be reduced if high doses are avoided. OBJECTIVE: We developed and piloted an electronic health record-based dashboard to improve the safe prescribing of HCQ within the Veterans Health Administration (VHA). We observed pilot facilities over a 1-year period to determine whether they were able to improve the proportion of patients receiving inappropriate doses of HCQ. METHODS: Patients receiving HCQ were identified from the VHA corporate data warehouse. Using PowerBI (Microsoft Corp), we constructed a dashboard to display patient identifiers and the most recent HCQ dose and weight (flagged if ≥5.2 mg/kg/day). Six VHA pilot facilities were enlisted to test the dashboard and invited to participate in monthly webinars. We performed an interrupted time series analysis using synthetic controls to assess changes in the proportion of patients receiving HCQ ≥5.2 mg/kg/day between October 2020 and November 2021. RESULTS: At the start of the study period, we identified 18,525 total users of HCQ nationwide at 128 facilities in the VHA, including 1365 patients at the 6 pilot facilities. Nationwide, at baseline, 19.8% (3671/18,525) of patients were receiving high doses of HCQ. We observed significant improvements in the proportion of HCQ prescribed at doses ≥5.2 mg/kg/day among pilot facilities after the dashboard was deployed (-0.06; 95% CI -0.08 to -0.04). The difference in the postintervention linear trend for pilot versus synthetic controls was also significant (-0.06; 95% CI -0.08 to -0.05). CONCLUSIONS: The use of an electronic health record-based dashboard reduced the proportion of patients receiving higher than recommended doses of HCQ and significantly improved performance at 6 VHA facilities. National roll-out of the dashboard will enable further improvements in the safe prescribing of HCQ.

Cardiovascular implantable electronic device lead safety: Harnessing real-world remote monitoring data for medical device evaluation.

BACKGROUND: Current methods to identify cardiovascular implantable electronic device lead failure include postapproval studies, which may be limited in scope, participant numbers, and attrition; studies relying on administrative codes, which lack specificity; and voluntary adverse event reporting, which cannot determine incidence or attribution to the lead. OBJECTIVE: The purpose of this study was to determine whether adjudicated remote monitoring (RM) data can address these limitations and augment lead safety evaluation. METHODS: Among 48,191 actively monitored patients with a cardiovascular implantable electronic device, we identified RM transmissions signifying incident lead abnormalities and, separately, identified all leads abandoned or extracted between April 1, 2019, and April 1, 2021. We queried electronic health record and Medicare fee-for-service claims data to determine whether patients had administrative codes for lead failure. We verified lead failure through manual electronic health record review. RESULTS: Of the 48,191 patients, 1170 (2.4%) had incident lead abnormalities detected by RM. Of these, 409 patients had administrative codes for lead failure, and 233 of these 409 patients (57.0%) had structural lead failure verified through chart review. Of the 761 patients without administrative codes, 167 (21.9%) had structural lead failure verified through chart review. Thus, 400 patients with RM transmissions suggestive of lead abnormalities (34.2%) had structural lead failure. In addition, 200 patients without preceding abnormal RM transmissions had leads abandoned or extracted for structural failure, making the total lead failure cohort 600 patients (66.7% with RM abnormalities, 33.3% without). Patients with isolated right atrial or left ventricular lead failure were less likely to have lead replacement and administrative codes reflective of lead failure. CONCLUSION: RM may strengthen real-world assessment of lead failure, particularly for leads where patients do not undergo replacement.

Screening for Latent Infections Among Users of High-Risk Immunosuppressants: A Cross-Sectional Analysis From the Veterans Health Administration Healthcare System.

OBJECTIVES: Guidelines recommend screening for latent hepatitis B virus (HBV), hepatitis C virus (HCV), and tuberculosis (TB) before initiating biologics or targeted synthetic disease-modifying antirheumatic drugs (b/ts DMARDs) to avoid reactivation of life-threatening infections. The extent to which such screening occurs in the national Veterans Health Administration (VA) healthcare system is unknown. METHODS: Using data from the Veterans Affairs' (VA) Corporate Data Warehouse, we performed a cross-sectional analysis of veterans receiving b/ts DMARDs between October 1, 2017, and September 30, 2019. We calculated the proportion of patients with screening completed for latent HBV, HCV, and TB between October 1, 1999 and September 30, 2019. Patient characteristics associated with complete screening were evaluated using mixed-effects multivariate logistic regression models. We also examined facility-level factors associated with high versus lower performance. RESULTS: A total of 51,764 unique patients from 129 VA facilities received b/ts DMARDs from 2017 to 2019. Of these, 63% had complete screening. Among the 11,006 patients identified as new users, 64% had complete screening. Higher screening rates were observed among Hispanic/Latinx and Black/African American patients, users of B-cell therapies, and patients who had seen oncology subspecialists. Substantial variation was observed across facilities, with complete screening ranging from 13% to 98% of patients. Higher screening rates were associated with highly complex, urban, and higher-volume facilities. CONCLUSIONS: Approximately two-thirds of veterans taking b/ts DMARDs have received guideline-recommended screening for HBV, HCV, and TB, but substantial facility variation was observed. Performance measures, robust multidisciplinary workflows, and electronic health record-based tools to feed information back to providers may improve screening rates for low-performing facilities.

Factors associated with remote monitoring adherence for cardiovascular implantable electronic devices.

BACKGROUND: Professional societies strongly recommend remote monitoring (RM) of all cardiac implantable electronic devices, and higher RM adherence is associated with improved patient outcomes. However, adherence with RM is suboptimal. OBJECTIVE: The purpose of this study was to better understand factors associated with RM adherence. METHODS: We linked RM data from the Veterans Affairs National Cardiac Device Surveillance Program to clinical data for patients monitored between October 25, 2018, and October 24, 2020. RM adherence was defined as the percentage of days covered by an RM transmission during the study period. Patients were classified into 3 categories: complete (100% of days covered by an RM transmission), intermediate (above median in patients with <100% adherence), and low (below median in patients with <100% adherence) adherence. We used multivariable logistic regression to examine patient, device, and facility characteristics associated with adherence. RESULTS: In 52,574 patients, average RM adherence was 71.9%. Only 30.9% (16,224) of patients had complete RM adherence. Black or African American patients had a lower odds of complete RM adherence than white patients (odds ratio 0.88; 95% confidence interval 0.82-0.94), and Hispanic or Latino patients had a lower odds of complete RM adherence (odds ratio 0.79; 95% confidence interval 0.70-0.89) than non-Hispanic or Latino patients. Dementia, depression, and posttraumatic stress disorder were associated with a lower odds of RM adherence. CONCLUSION: There are significant disparities in RM adherence by race, ethnicity, and neuropsychiatric comorbidities. These findings can inform strategies to improve health equity and ensure that all patients with cardiac implantable electronic devices receive the evidence-based clinical benefits of RM.

Implantable cardioverter-defibrillator placement among patients with left ventricular ejection fraction ≤35 % at least 40 days after acute myocardial infarction.

Background: Implantable cardioverter-defibrillators (ICDs) reduce the risk of sudden cardiac death among patients with persistently reduced (≤35 %) left ventricular ejection fraction (LVEF) at least 40 days following acute myocardial infarction (AMI). Few prior studies have used LVEF measured after the 40-day waiting period to examine primary prevention ICD placement. Methods: We sought to determine factors associated with ICD placement among patients who met LVEF criteria post-MI within a large integrated health care system in the U.S by conducting a retrospective cohort study of Veteran patients hospitalized for AMI from 2004 to 2017 who had documented LVEF ≤35 % from echocardiograms performed between 40 and 455 (90 days +1 year) days post-MI. We used multivariable logistic regression to examine factors associated with ICD placement. Results: Of 12,893 patients with LVEF ≤35 % at least 40 days post-MI, 2176 (16.9 %) received an ICD between 91- and 455-days post-MI. Younger age, fewer comorbidities, revascularization with PCI, and greater use of GDMT were associated with increased odds of receiving an ICD. However, half of patients treated with a beta-blocker, ACE inhibitor or angiotensin receptor blocker, and mineralocorticoid receptor antagonist prior to LVEF assessment did not receive an ICD. Eligible Black patients were less likely (odds ratio 0.80, 95 % confidence interval 0.69-0.92) to receive an ICD than White patients. Conclusion: Many factors affect ICD placement among Veteran patients with a confirmed LVEF ≤35 % at least 40 days post-MI. Greater understanding of factors influencing ICD placement would help clinicians ensure guideline-concordant care.

Effects of Home-Based Cardiac Rehabilitation on Time to Enrollment and Functional Status in Patients With Ischemic Heart Disease.

Background Cardiac rehabilitation is an established performance measure for adults with ischemic heart disease, but patient participation is remarkably low. Home-based cardiac rehabilitation (HBCR) may be more practical and feasible, but evidence regarding its efficacy is limited. We sought to compare the effects of HBCR versus facility-based cardiac rehabilitation (FBCR) on functional status in patients with ischemic heart disease. Methods and Results This was a pragmatic trial of 237 selected patients with a recent ischemic heart disease event, who enrolled in HBCR or FBCR between August 2015 and September 2017. The primary outcome was 3-month change in distance completed on a 6-minute walk test. Secondary outcomes included rehospitalization as well as patient-reported physical activity, quality of life, and self-efficacy. Characteristics of the 116 patients enrolled in FBCR and 121 enrolled in HBCR were similar, except the mean time from index event to enrollment was shorter for HBCR (25 versus 77 days; P<0.001). As compared with patients undergoing FBCR, those in HBCR achieved greater 3-month gains in 6-minute walk test distance (+95 versus +41 m; P<0.001). After adjusting for demographics, comorbid conditions, and indication, the mean change in 6-minute walk test distance remained significantly greater for patients enrolled in HBCR (+101 versus +40 m; P<0.001). HBCR participants reported greater improvements in quality of life and physical activity but less improvement in exercise self-efficacy. There were no deaths or cardiovascular hospitalizations. Conclusions Patients enrolled in HBCR achieved greater 3-month functional gains than those enrolled in FBCR. Our data suggest that HBCR may safely derive equivalent benefits in exercise capacity and overall program efficacy in selected patients. Registration URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT02105246.

Bringing functional status into a big data world: Validation of national Veterans Affairs functional status data.

BACKGROUND: The ability to perform basic daily activities ("functional status") is key to older adults' quality of life and strongly predicts health outcomes. However, data on functional status are seldom collected during routine clinical care in a way that makes them available for clinical use and research. OBJECTIVES: To validate functional status data that Veterans Affairs (VA) medical centers recently started collecting during routine clinical care, compared to the same data collected in a structured research setting. DESIGN: Prospective validation study. SETTING: Seven VA medical centers that collected complete data on 5 activities of daily living (ADLs) and 8 instrumental activities of daily living (IADLs) from older patients attending primary care appointments. PARTICIPANTS: Randomly selected patients aged 75 and older who had new ADL and IADL data collected during a primary care appointment (N = 252). We oversampled patients with ADL dependence and applied these sampling weights to our analyses. MEASUREMENTS: Telephone-based interviews using a validated measure to assess the same 5 ADLs and 8 IADLs. RESULTS: Mean age was 83 years, 96% were male, and 75% were white. Of 85 participants whom VA data identified as dependent in 1 or more ADLs, 74 (87%) reported being dependent by interview; of 167 whom VA data identified as independent in ADLs, 149 (89%) reported being independent. The sample-weighted sensitivity of the VA data for identifying ADL dependence was 45% (95% CI, 29%, 62%) compared to the reference standard, the specificity was 99% (95% CI, 99%, >99%), and the positive predictive value was 87% (95% CI, 79%, 93%). The weighted kappa statistic was 0.55 (95% CI, 0.41, 0.68) for the agreement between VA data and research-collected data in identifying ADL dependence. CONCLUSION: Overall agreement of VA functional status data with a reference standard was moderate, with fair sensitivity but high specificity and positive predictive value.

Web-based PTSD training for primary care providers: a pilot study.

Veterans with posttraumatic stress disorder (PTSD) symptoms frequently present to primary care providers (PCPs) and are reluctant to seek out or accept referrals to specialty mental health care. Most PCPs have not been trained to assess for and manage symptoms of PTSD. Web-based programs are increasingly used for medical education, but there are no published evaluations of online PTSD trainings for PCPs. We developed a 70-min Web-based training that focused on military-related PTSD for PCPs practicing in Veterans Affairs (VA) hospitals, but was applicable to PCPs treating veterans and other trauma-exposed patients outside VA settings. The training consisted of four modules: (1) Detection and Assessment; (2) Comorbid Conditions and Related Problems; (3) Pharmacological Interventions; and (4) Psychotherapeutic Interventions. Clinical vignettes dramatized key training concepts. Seventy-three PCPs completed the training and assessments pre- and posttraining and 30 days later. Paired t tests compared change in PTSD-related knowledge and comfort with PTSD-related skills, and qualitative methods were used to summarize participant feedback. After the training, mean knowledge score improved from 46% to 75% items correct, with sustained improvement at 30 days. Thirty days posttraining, PCPs reported significantly greater comfort regarding PTSD-related skills assessed; 47% reported using training content in their clinical practice. Qualitatively, PCPs appreciated the flexibility of asynchronous, self-paced online modules, but suggested more interactive content. Given the numerous barriers to specialty mental health treatment, coupled with a preference among veterans with PTSD for accessing treatment through primary care, improving PTSD competency among PCPs may help better serve veterans' mental health needs.

A randomized controlled trial of telephone motivational interviewing to enhance mental health treatment engagement in Iraq and Afghanistan veterans.

OBJECTIVE: To test the efficacy of telephone-administered motivational interviewing (MI) to enhance treatment engagement in Iraq and Afghanistan veterans with mental health (MH) problems. METHOD: Between April 23, 2008, and February 25, 2011, 73 Iraq and Afghanistan veterans who screened positive for ≥1 MH problem(s) on telephone-administered psychometric assessment, but were not engaged in treatment, were randomized to either personalized referral for MH services and four sessions of telephone MI or standard referral and four neutral telephone check-in sessions (control) at baseline, 2, 4 and 8 weeks. Blinded assessment occurred at 8 and 16 weeks. RESULTS: In intent-to-treat analyses, 62% assigned to telephone MI engaged in MH treatment compared to 26% of controls [relative risk (RR)=2.41, 95% confidence interval (CI)=1.33-4.37, P=.004], which represented a large effect size (Cohen's h=0.74). Participants in the MI group also demonstrated significantly greater retention in MH treatment than controls [MI mean visits (S.D.)=1.68 (2.73) and control mean visits (S.D.)=0.38 (0.81), incidence rate ratio (IRR)=4.36, 95% CI=1.96-9.68, P<.001], as well as significant reductions in stigma and marijuana use at 8 weeks (P<.05). CONCLUSIONS: Telephone MI enhances MH treatment engagement in Iraq and Afghanistan veterans with MH problems.

Prior night sleep duration is associated with psychomotor vigilance in a healthy sample of police academy recruits.

Aviation, military, police, and health care personnel have been particularly interested in the operational impact of sleep restriction and work schedules given the potential severe consequences of making fatigue-related errors. Most studies examining the impact of sleep loss or circadian manipulations have been conducted in controlled laboratory settings using small sample sizes. This study examined whether the relationship between prior night sleep duration and performance on the psychomotor vigilance task could be reliably detected in a field study of healthy police academy recruits. Subjects (N = 189) were medically and psychiatrically healthy. Sleep-wake activity was assessed with wrist actigraphy for 7 days. Subjects performed the psychomotor vigilance task (PVT) for 5 min on a personal digital assistant (PDA) device before and after their police academy workday and on comparable times during their days off. Mixed-effects logistic regression was used to estimate the probability of having > or =1 lapse on the PVT as a function of the previous night sleep duration during the 7 days of field testing. Valid estimates of sleep duration were obtained for 1082 nights of sleep. The probability of a lapse decreased by 3.5%/h sleep the night prior to testing. The overall probability of having a lapse decreased by 0.9%/h since awakening, holding hours of sleep constant. Perceived stress was not associated with sleep duration or probability of performance lapse. These findings demonstrate the feasibility of detecting sleep and circadian effects on cognitive performance in large field studies. These findings have implications regarding the daytime functioning of police officers.

Serum brain-derived neurotrophic factor predicts responses to escitalopram in chronic posttraumatic stress disorder.

INTRODUCTION: Some studies have found that antidepressants increase serum brain-derived neurotrophic factor (BDNF) levels in patients with major depression and the expression of BDNF mRNA in limbic structures of rats. OBJECTIVES: This study addressed whether the SSRI escitalopram increases serum BDNF levels in subjects with PTSD and whether BDNF levels are associated with treatment response. METHODS: Medically healthy male subjects (N=16) with chronic PTSD completed a 12 week open-label trial of flexible dose (5-20 mg/day) escitalopram monotherapy. BDNF levels were obtained at baseline, and at weeks 4, 8 and 12. RESULTS: PTSD symptoms significantly declined over the course of the 12 week escitalopram treatment. Despite a substantial improvement in PTSD symptoms, there was virtually no change in BDNF levels over time. Nevertheless, mean BDNF levels across the trial were strongly correlated with the slope of PTSD symptoms over the 12 weeks (r=0.58, p=0.018). Lower mean BDNF was associated with a greater decrease in PTSD symptoms over the course of the trial. CONCLUSIONS: PTSD subjects with low BDNF levels demonstrated the largest treatment response from an agent with putative neurotrophic effects.