A Double-blind, Placebo-controlled, Randomized, Single Ascending, and Multiple Dose Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Dose Isomyosamine Capsules in Healthy Adult Subjects.

BACKGROUND: Aging is tightly linked to chronic disease, frailty, and death. Multi-morbidity, defined as the presence in the same patient of three or more conditions such as neoplastic, cardiovascular, neurodegenerative, metabolic, or autoimmune diseases, becomes more common with age. METHODS: The study was performed in a double-blind fashion. Subjects within each dose cohort (Cohorts 1, 2, 3, and 4) were randomly assigned to receive Isomyosamine doses (between 150 mg to 600 mg or placebo) or placebo in a 3:1 ratio (6 active: 2 placebo). RESULTS: Isomyosamine single daily doses each of 150 mg, 300 mg, and 450 mg for 3 days and multiple daily doses of 600 mg for 6 days were safe and well tolerated in healthy subjects. In one dose group, there was a decrease in TNF-α levels found in Isomyosamine treated subjects, but no change in the levels in subjects given placebo. The increase in Isomyosamine exposure was proportional to dose across the dose range of 300 mg to 600 mg when administered as a single dose. There was minimal accumulation of Isomyosamine following 5 days of once daily dosing of Isomyosamine 600 mg. Isomyosamine half-life ranged from approximately 15 minutes to 45 minutes across all doses in the single ascending dose and multiple ascending dose portion of the study. Elimination of Isomyosamine included the renal pathway as a minor route. CONCLUSION: Isomyosamine will continue to be investigated in phase 2 clinical trials for the treatment of sarcopenia/frailty, hashimoto's thyroiditis and rheumatoid arthritis.

Colocating Teleophthalmology Within Primary Care Settings to Improve Access to Diabetic Retinopathy Screening: Retrospective Descriptive Evaluation.

BACKGROUND: Annual retinal exams for patients with diabetes are critical as diabetic retinopathy is the number one cause of preventable blindness in working-age adults in the United States. Currently, most patients with diabetes in the United States receive a referral from their primary care provider to see an ophthalmologist for their annual dilated eye exam, which can be an added inconvenience and expense. As such, there is a need for alternative screening strategies within an outpatient network. The use of a telemedicine platform in a primary care setting serves as a novel strategy to increase diabetic retinopathy screening rates. In order to provide better access to diabetic retinopathy screening for our patients, cameras were placed in 3 primary care practices in October 2017 as part of an 8-month pilot program. Specialized cameras from Intelligent Retinal Imaging Systems (IRIS) were used to acquire images that could be interpreted remotely by ophthalmologists within the LifeBridge Health network for the diagnosis of diabetic retinopathy and the detection of other types of pathology (eg, macular edema). OBJECTIVE: The aim of this retrospective descriptive study was to examine whether a telemedicine platform can be used as a cost-effective way to increase diabetic retinopathy screening rates in the primary care setting. METHODS: Aggregate screening volume and diagnostic data were collected for each of the 3 practice locations for the 8-month pilot period (October 30, 2017, through June 30, 2018). Additionally, payor reimbursement data and equipment cost data were used to determine the payback period for each of the 3 practice locations. RESULTS: The pilot program proved the business case that implementation of the IRIS camera in 3 practice locations could result in enough patients being screened to pay for the cost of the camera within a maximum of 2 years. The 3 practices showed increased diabetic retinopathy screening rates of 1%, 6%, and 24%, respectively, and were all able to screen enough patients to be on track to pay off the cost of the camera within 2 years of implementation. Aggregate data from the pilot period showed that of the 1213 patients who were screened, approximately 17.1% (n=207) were diagnosed with diabetic retinopathy and an additional 17.7% (n=215) were suspected of having some other form of pathology. Of note, 10.1% (n=123) were also identified as being "IRIS saves," defined as having pathology identified that was severe enough to be considered an imminent threat to their vision. CONCLUSIONS: This retrospective descriptive study suggests that a telemedicine platform can be used to improve diabetic retinopathy screening rates in the primary care setting within a large health care system in a cost-effective way that allows for the cost of the equipment to be recouped through billing within a maximum of 2 years.

The Effect of an Automated Mobile Patient Engagement Application on Emergency Department Revisits: Prospective Observational Study.

BACKGROUND: Revisits within 30 days to an emergency department (ED), observation care unit, or inpatient setting following patient discharge continue to be a challenge, especially in urban settings. In addition to the consequences for the patient, these revisits have a negative impact on a health system's finances in a value-based care or global budget environment. LifeBridge Health, a community health system in Maryland, United States, implemented an automated mobile patient engagement application as part of our enterprise-wide digital health strategy to improve patient engagement and reduce revisits to the ED. OBJECTIVE: The aim of this paper was to evaluate the effectiveness of a customized automated digital patient engagement application (GetWell Loop) to reduce 30-day revisits after home discharge from an ED. METHODS: The LifeBridge Health Innovation Department and ED staff from 2 participating health system hospitals collaborated with GetWellNetwork to customize their patient engagement application with automated check-in questions and other on-demand resources (eg, streaming content explaining aspects of self-care during COVID-19). An application link was emailed to adult patients discharged home from the ED. A study of ED visits for patients treated for general medicine and cardiology conditions between August 1, 2018, and July 31, 2019, was conducted using CRISP (Chesapeake Regional Information System for our Patients), Maryland's state-designated health information exchange. We also used data within GetWell Loop (GetWellNetwork) to track patient activation and engagement. The primary outcome was the number of ED patients who experienced a 30-day revisit and who did or did not activate their GetWell Loop account. Secondary outcomes included the overall activation rate and the rate of engagement as measured by the number of logins, alerts, and comments generated by patients through the application. Bivariate analysis comparing outcomes among patients who activated the GetWell Loop application to patients who did not was conducted using the Fisher exact test. Multivariate logistic regression modeling with elastic net regularization was also performed to account for potential confounders and potential collinearity of covariates. RESULTS: During this 1-year study, 1062 (27.4%) of 3866 of all emergency patients treated for general medicine or cardiology conditions, who received an invite to use the digital application, activated their account. The patients discharged from the ED, who were treated for general medicine conditions (n=2087) and who activated their GetWell Loop account, experienced a 30-day revisit rate of 17.3% (n=101) compared with 24.6% (n=369) for those who did not activate their account (P<.001). Of the patients treated for cardiology conditions (n=1779), 12.8% (n=61) of those who activated their GetWell account experienced a 30-day revisit compared with 17.7% (n=231) of those who did not activate their account (P=.01). The significance of these findings persisted after adjustment for confounding variables including age, race, sex, and payor in logistic regression modeling (adjusted odds ratio 0.75, 95% CI 0.62-0.92; P=.006). CONCLUSIONS: Our results suggest that a significant percentage of patients are willing to utilize a digital application following ED discharge to better engage in their own care, and that usage of such digital applications may significantly reduce 30-day revisit rates. LifeBridge Health's experience demonstrates that health care systems can leverage automated mobile apps to improve patient engagement and successfully impact clinical outcomes at scale.

Low-Income Parents' Perceptions of and Engagement With a Digital Behavioral Parent Training Program: A Mixed-Methods Study.

BACKGROUND: Parent training is a method for strengthening parenting skills, reducing child behavior problems, and promoting positive parent-child relationships. However, few parents have access to these evidence-based programs. The ezParent program, a tablet-based delivery adaptation of the group-based Chicago Parent Program, is a parent training program designed to address the needs of families raising young children in urban poverty. AIMS: This study aimed to explore (a) parents' perceptions of the benefits and barriers associated with their use of the ezParent program and (b) the ways in which the ezParent components and perceived usability varied by program use (module completion). METHOD: An explanatory mixed-methods design was used with the overall intent to use the qualitative data to help explain in greater detail the quantitative results. RESULTS: Fifty-nine parents of 2- to 5-year-old children from two pediatric primary care clinics serving predominantly low-income and racial/ethnic minority families in Chicago (Cohort 1) and Baltimore (Cohort 2) participated in follow-up interviews. Among those interviewed, 23 (38.9.5%) parents completed all six modules and 12 parents (20.3%) completed none of the modules. However, of those 12, 8 (67%) logged in to the program and completed portions of Module 1. Parents who completed more modules reported more program benefits, and those who completed fewer modules reported more barriers. CONCLUSIONS: Exploring users' experience with current digital applications, researchers and application developers can better design future tablet-based interventions to be both effective and acceptable by consumers.

Psychometric Properties of the Person-Centered Version of the Alcohol and Alcohol Problems Perceptions Questionnaire (PC-AAPPQ).

AIMS: Given the importance of addressing provider attitudes toward individuals with unhealthy alcohol use and the current emphasis on person-centered language to help decrease stigma and mitigate negative attitudes, the aim of this study was to evaluate the psychometric properties of a contemporary version of the Alcohol and Alcohol Problems Perception Questionnaire (AAPPQ) that uses person-centered language and addresses the spectrum of alcohol use. METHODS: The authors created a person-centered version of the AAPPQ (PC-AAPPQ) and conducted a cross-sectional study of its psychometric properties in academic settings in the Northeastern United States. The PC-AAPPQ was administered to 651 nursing students. Reliability analysis of the new instrument was performed using the total sample. Only surveys with complete data (n = 637) were randomly split into two datasets, one used for the exploratory factor analysis (EFA) (n = 310) and the other for confirmatory factor analysis (CFA) (n = 327). RESULTS: Compared to all the models generated from the EFA, neither the original six-factor structure nor the five-factor structure was superior to any of the other models. The results indicate that a seven-factor structure with all 30 items is the best fit for the PC-AAPPQ. CONCLUSIONS: The PC-AAPPQ represents a positive effort to modernize the four-decade-old AAPPQ. This 30-item instrument, which adds one additional subscale, offers a means to assess providers' attitudes using respectful wording that avoids perpetuating negative biases and reinforces efforts to affirm the worth and dignity of the population being treated.

Informational Videos About Alcohol Use: Feasibility and Acceptability.

BACKGROUND: An estimated 15.1 million adults ages 18 years and older are classified with an alcohol use disorder, which includes 9.8 million men and 5.3 million women. A brief intervention is indicated for those identified to be at risk because of alcohol use. OBJECTIVE: To determine the feasibility and acceptability of informational videos about alcohol use. DESIGN: This feasibility study provided participants with the opportunity to choose one of two videos, Alcohol and the Brain or Rethinking Drinking. An online survey was administered to all study participants to identify alcohol-related risk, readiness to decrease use, and knowledge pertaining to alcohol use. RESULTS: The two videos provided in this study were feasibly delivered in an on-line format to 129 adults, including 115 males and 5 females identified to be at risk. Knowledge scores increased only slightly. There were mixed results for the readiness scores. CONCLUSIONS: Future research should examine the efficacy of these two alcohol brief interventions on alcohol-related outcomes.

Engagement and Adherence With ezPARENT, an mHealth Parent-Training Program Promoting Child Well-Being.

Mobile health (mHealth) interventions use mobile technology (tablets and smartphones) delivery platforms for interventions to improve health outcomes. Despite growing acceptance, there is little understanding of how consumers engage with and adhere to mHealth interventions. This study analyzes usage data from the intervention arm ( n = 42) of a randomized clinical trial testing the efficacy of the ezPARENT program and provides recommendations for using engagement and adherence metrics. Engagement was measured by parent usage (duration, frequency, and activity) of ezPARENT and adherence using an adherence index (the sum of individual modules completed, number of visits to ezPARENT, and maximum time between visits). Parents spent M = 37.15 min per module and had M = 13.55 program visits in the 3-month intervention period. Parents visited the program over a period of M = 69.5 days and completed 82% of the modules. These data provide support that parents will use intervention programs delivered digitally; engagement and adherence metrics are useful in evaluating program uptake.