Implementation of an Intensive Telehealth Intervention for Rural Patients with Clinic-Refractory Diabetes.

BACKGROUND: Rural patients with type 2 diabetes (T2D) may experience poor glycemic control due to limited access to T2D specialty care and self-management support. Telehealth can facilitate delivery of comprehensive T2D care to rural patients, but implementation in clinical practice is challenging. OBJECTIVE: To examine the implementation of Advanced Comprehensive Diabetes Care (ACDC), an evidence-based, comprehensive telehealth intervention for clinic-refractory, uncontrolled T2D. ACDC leverages existing Veterans Health Administration (VHA) Home Telehealth (HT) infrastructure, making delivery practical in rural areas. DESIGN: Mixed-methods implementation study. PARTICIPANTS: 230 patients with clinic-refractory, uncontrolled T2D. INTERVENTION: ACDC bundles telemonitoring, self-management support, and specialist-guided medication management, and is delivered over 6 months using existing VHA HT clinical staffing/equipment. Patients may continue in a maintenance protocol after the initial 6-month intervention period. MAIN MEASURES: Implementation was evaluated using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. The primary effectiveness outcome was hemoglobin A1c (HbA1c). KEY RESULTS: From 2017 to 2020, ACDC was delivered to 230 patients across seven geographically diverse VHA sites; on average, patients were 59 years of age, 95% male, 80% white, and 14% Hispanic/Latinx. Patients completed an average of 10.1 of 12 scheduled encounters during the 6-month intervention period. Model-estimated mean baseline HbA1c was 9.56% and improved to 8.14% at 6 months (- 1.43%, 95% CI: - 1.64, - 1.21; P < .001). Benefits persisted at 12 (- 1.26%, 95% CI: - 1.48, - 1.05; P < .001) and 18 months (- 1.08%, 95% CI - 1.35, - 0.81; P < .001). Patients reported increased engagement in self-management and awareness of glycemic control, while clinicians and HT nurses reported a moderate workload increase. As of this submission, some sites have maintained delivery of ACDC for up to 4 years. CONCLUSIONS: When strategically designed to leverage existing infrastructure, comprehensive telehealth interventions can be implemented successfully, even in rural areas. ACDC produced sustained improvements in glycemic control in a previously refractory population.

Longitudinal assessment of colonoscopy adverse events in the prospective Cooperative Studies Program no. 380 colorectal cancer screening and surveillance cohort.

BACKGROUND AND AIMS: Data are limited regarding colonoscopy risk during long-term, programmatic colorectal cancer screening and follow-up. We aimed to describe adverse events during follow-up in a colonoscopy screening program after the baseline examination and examine factors associated with increased risk. METHODS: Cooperative Studies Program no. 380 includes 3121 asymptomatic veterans aged 50 to 75 years who underwent screening colonoscopy between 1994 and 1997. Periprocedure adverse events requiring significant intervention were defined as major events (other events were minor) and were tracked during follow-up for at least 10 years. Multivariable odds ratios (ORs) were calculated for factors associated with risk of follow-up adverse events. RESULTS: Of 3727 follow-up examinations in 1983 participants, adverse events occurred in 105 examinations (2.8%) in 93 individuals, including 22 major and 87 minor events (examinations may have had >1 event). Incidence of major events (per 1000 examinations) remained relatively stable over time, with 6.1 events at examination 2, 4.8 at examination 3, and 7.2 at examination 4. Examinations with major events included 1 perforation, 3 GI bleeds requiring intervention, and 17 cardiopulmonary events. History of prior colonoscopic adverse events was associated with increased risk of events (major or minor) during follow-up (OR, 2.7; 95% confidence interval, 1.6-4.6). CONCLUSIONS: Long-term programmatic screening and surveillance was safe, as major events were rare during follow-up. However, serious cardiopulmonary events were the most common major events. These results highlight the need for detailed assessments of comorbid conditions during routine clinical practice, which could help inform individual decisions regarding the utility of ongoing colonoscopy follow-up.

Heterogeneity of Treatment Effects Among Patients With Type 2 Diabetes and Elevated Body Mass Index in a Study Comparing Group Medical Visits Focused on Weight Management and Medication Intensification.

BACKGROUND: Illuminating heterogeneity of treatment effect (HTE) within trials is important for identifying target populations for implementation. OBJECTIVE: The aim of this study was to examine HTE in a trial of group medical visits (GMVs) for patients with type 2 diabetes and elevated body mass index. RESEARCH DESIGN AND MEASURES: Participants (n=263) were randomized to GMV-based medication management plus low carbohydrate diet-focused weight management (WM/GMV; n=127) or GMV-based medication management alone (GMV; n=136) for diabetes control. We used QUalitative INteraction Trees, a tree-based clustering method, to identify subgroups with greater improvement in hemoglobin A1c (HbA1c) and weight from either WM/GMV or GMV. Subgroup predictors included 32 baseline demographic, clinical, and psychosocial factors. Internal validation was conducted to estimate bias in the range of mean outcome differences between arms. RESULTS: QUalitative INteraction Trees analyses indicated that for patients who had not previously attempted weight loss, WM/GMV resulted in better glycemic control than GMV (mean difference in HbA1c improvement=1.48%). For patients who had previously attempted weight loss and had lower cholesterol and blood urea nitrogen, GMV was better than WM/GMV (mean difference in HbA1c improvement=1.51%). No treatment-subgroup effects were identified for weight. Internal validation resulted in moderate corrections in mean HbA1c differences between arms; however, differences remained in the clinically significant range. CONCLUSION: This work represents a novel step toward targeting care approaches for patients to maximize benefit based on individual patient characteristics.

Racial Differences in the Effectiveness of a Multifactorial Telehealth Intervention to Slow Diabetic Kidney Disease.

BACKGROUND: African Americans are significantly more likely than non-African Americans to have diabetes, chronic kidney disease, and uncontrolled hypertension, increasing their risk for kidney function decline. OBJECTIVE: The objective of this study was to compare how African Americans and non-African Americans with diabetes responded to a multifactorial telehealth intervention designed to slow kidney function decline. RESEARCH DESIGN: Secondary analysis of a randomized trial. Primary care patients (N=281, 56% African American) were allocated to either: (1) a multifactorial, pharmacist-delivered phone-based telehealth intervention focused on behavioral and medication management of diabetic kidney disease; or (2) an education control. MEASURES: The primary study outcome was change in estimated glomerular filtration rate (eGFR). Linear mixed models were used to explore the moderating effect of race on the relationship between study arm and eGFR decline over time; the mean annual rate of eGFR decline was estimated by race and study arm. RESULTS: Findings demonstrated a differential intervention effect on kidney function over time by race (Pinteraction=0.005). Among African Americans, the intervention arm had significantly greater preservation of eGFR over time than the control arm (difference in the annual rate of eGFR decline=1.5 mL/min/1.73 m; 95% confidence interval: 0.04, 3.02). For non-African Americans, the intervention arm had a faster decline in eGFR over time than the control arm (difference in the annual rate of eGFR decline=-1.7 mL/min/1.73 m; 95% confidence interval: -3.3, -0.02). CONCLUSION: A multifactorial, pharmacist-delivered telehealth intervention for diabetic kidney disease may be more effective for slowing eGFR decline among African Americans than non-African Americans.

Patient-specific Hip Fracture Strength Assessment with Microstructural MR Imaging-based Finite Element Modeling.

Purpose To describe a nonlinear finite element analysis method by using magnetic resonance (MR) images for the assessment of the mechanical competence of the hip and to demonstrate the reproducibility of the tool. Materials and Methods This prospective study received institutional review board approval and fully complied with HIPAA regulations for patient data. Written informed consent was obtained from all subjects. A nonlinear finite element analysis method was developed to estimate mechanical parameters that relate to hip fracture resistance by using MR images. Twenty-three women (mean age ± standard deviation, 61.7 years ± 13.8) were recruited from a single osteoporosis center. To thoroughly assess the reproducibility of the finite element method, three separate analyses were performed: a test-retest reproducibility analysis, where each of the first 13 subjects underwent MR imaging on three separate occasions to determine longitudinal variability, and an intra- and interoperator reproducibility analysis, where a single examination was performed in each of the next 10 subjects and four operators independently performed the analysis two times in each of the subjects. Reproducibility of parameters that reflect fracture resistance was assessed by using the intraclass correlation coefficient and the coefficient of variation. Results For test-retest reproducibility analysis and inter- and intraoperator analyses for proximal femur stiffness, yield strain, yield load, ultimate strain, ultimate load, resilience, and toughness in both stance and sideways-fall loading configurations each had an individual median coefficient of variation of less than 10%. Additionally, all measures had an intraclass correlation coefficient higher than 0.99. Conclusion This experiment demonstrates that the finite element analysis model can consistently and reliably provide fracture risk information on correctly segmented bone images. © RSNA, 2016 Online supplemental material is available for this article.

Heart Failure Remote Monitoring: A Review and Implementation How-To.

Heart failure (HF) is a significant clinical and financial burden worldwide. Remote monitoring (RM) devices capable of identifying early physiologic changes in decompensation have the potential to reduce the HF burden. However, few trials have discussed at length the practical aspects of implementing RM in real-world clinical practice. The present paper reviews current RM devices and clinical trials, focusing on patient populations, outcomes, data collection, storage, and management, and describes the implementation of an RM device in clinical practice, providing a pragmatic and adaptable framework.

Factors Associated With Diabetes Distress Among Patients With Poorly Controlled Type 2 Diabetes.

Objective: Examine factors associated with increased diabetes distress (DD) among patients with type 2 diabetes with DD assessed by Diabetes Distress Scale (DDS) total and subscale scores (emotional burden, physician-related distress, regimen-related distress, and interpersonal distress). Methods: Cross-sectional analysis of data from veterans with persistently poorly controlled diabetes mellitus. Multivariable linear regression models included baseline patient characteristics (independent variables) and DDS total and subscale scores (dependent variable). Results: The cohort's (N = 248) mean age was 58 years (SD 8.3); 21% were female, 79% were non-White, and 5% were Hispanic/Latinx. Mean hemoglobin A1c (HbA1c) was 9.8%, and 37.5% had moderate to high DD. Hispanic/Latinx ethnicity (ß=0.41; 95% CI 0.01, 0.80), baseline HbA1c (0.07; 95% CI 0.01,0.13), and higher Personal Health Questionnaire-8 (PHQ-8) scores (0.07; 95% CI 0.05, 0.09) were associated with higher total DD. Hispanic/Latinx ethnicity (0.79; 95% CI 0.25, 1.34) and higher PHQ-8 (0.05; 95% CI 0.03, 0.08) were associated with higher interpersonal-related distress. Higher HbA1c (0.15; 95% CI 0.06, 0.23) and higher PHQ-8 scores (0.10; 95% CI 0.07, 0.13) were associated with higher regimen-related distress. The use of basal insulin (0.28; 95% CI 0.001, 0.56) and higher PHQ-8 (0.02; 95% CI 0.001, 0.05) were associated with higher physician-related distress. Higher PHQ-8 (0.10; 95% CI 0.07, 0.12) was associated with higher emotional burden. Conclusion: Hispanic/Latinx ethnicity, depressive symptoms, uncontrolled hyperglycemia, and insulin use were associated with higher risk for DD. Future research should explore these relationships, and interventions designed to reduce diabetes distress should consider accounting for these factors.

Underrecognition of Nonalcoholic Fatty Liver Disease in Poorly Controlled Diabetes: A Call to Action in Diabetes Care.

Individuals with type 2 diabetes (T2DM) are at high risk for nonalcoholic fatty liver disease (NAFLD), and evidence suggests that poor glycemic control is linked to heightened risk of progressive NAFLD. We conducted an observational study based on data from a telehealth trial conducted in 2018-2020. Our objectives were to (1) characterize patterns of NAFLD testing/care in a cohort of individuals with poorly controlled T2DM; and (2) explore how laboratory based measures of NAFLD (eg, liver enzymes, fibrosis-4 [FIB-4]) vary by glycemic control. We included individuals with poorly controlled T2DM (n = 228), defined as hemoglobin A1c (HbA1c) ≥ 8.5% despite clinic-based care. Two groups of interest were (1) T2DM without known NAFLD; and (2) T2DM with known NAFLD. Demographics, medical history, medication use, glycemic control (HbA1c), and NAFLD testing/care patterns were obtained by chart review. Among those without known NAFLD (n = 213), most were male (78.4%) and self-identified as Black race (68.5%). Mean HbA1c was 9.8%. Most had liver enzymes (85.4%) and platelets (84.5%) ordered in the outpatient department over a 2-year period that would allow for FIB-4 calculation, yet only 2 individuals had FIB-4 documented in clinical notes. Approximately one-third had abnormal liver enzymes at least once over a 2-year period, yet only 7% had undergone liver ultrasound and 4.7% had referral to hepatology. Among those with known NAFLD (n = 15), mean HbA1c was 9.5%. Only 4 individuals had undergone transient elastography, half of whom had advanced fibrosis. NAFLD is underrecognized in poorly controlled T2DM, even though this is a high-risk group for NAFLD and its complications.

Practical telehealth to improve control and engagement for patients with clinic-refractory diabetes mellitus (PRACTICE-DM): Protocol and baseline data for a randomized trial.

BACKGROUND: Persistent poorly-controlled type 2 diabetes mellitus (PPDM), or maintenance of a hemoglobin A1c (HbA1c) ≥8.5% despite receiving clinic-based diabetes care, contributes disproportionately to the national diabetes burden. Comprehensive telehealth interventions may help ameliorate PPDM, but existing approaches have rarely been designed with clinical implementation in mind, limiting use in routine practice. We describe a study testing a novel telehealth intervention that comprehensively targets clinic-refractory PPDM, and was explicitly developed for practical delivery using existing Veterans Health Administration (VHA) clinical infrastructure. METHODS: Practical Telehealth to Improve Control and Engagement for Patients with Clinic-Refractory Diabetes Mellitus (PRACTICE-DM) is an ongoing randomized controlled trial comparing two 12-month interventions: 1) standard VHA Home Telehealth (HT) telemonitoring/care coordination; or 2) the PRACTICE-DM intervention, a comprehensive HT-delivered intervention combining telemonitoring, self-management support, diet/activity support, medication management, and depression management. The primary outcome is HbA1c. Secondary outcomes include diabetes distress, self-care, self-efficacy, weight, depressive symptoms, implementation barriers/facilitators, and costs. We hypothesize that the PRACTICE-DM intervention will reduce HbA1c by >0.6% versus standard HT over 12 months. RESULTS: Enrollment for this ongoing trial concluded in January 2020; 200 patients were randomized (99 to standard HT and 101 to the PRACTICE-DM intervention). The cohort has a mean age of 58 and is 23% female and 72% African American. Mean baseline HbA1c and BMI were 10.2% and 34.8 kg/m2. CONCLUSIONS: Because it comprehensively targets factors underlying PPDM using existing clinical infrastructure, the PRACTICE-DM intervention may be well suited to lower the complications and costs of PPDM in routine practice.

Accuracy of MRI-based finite element assessment of distal tibia compared to mechanical testing.

High-resolution MRI-derived finite element analysis (FEA) has been used in translational research to estimate the mechanical competence of human bone. However, this method has yet to be validated adequately under in vivo imaging spatial resolution or signal-to-noise conditions. We therefore compared MRI-based metrics of bone strength to those obtained from direct, mechanical testing. The study was conducted on tibiae from 17 human donors (12 males and five females, aged 33 to 88years) with no medical history of conditions affecting bone mineral homeostasis. A 25mm segment from each distal tibia underwent MR imaging in a clinical 3-Tesla scanner using a fast large-angle spin-echo (FLASE) sequence at 0.137mm×0.137mm×0.410mm voxel size, in accordance with in vivo scanning protocol. The resulting high-resolution MR images were processed and used to generate bone volume fraction maps, which served as input for the micro-level FEA model. Simulated compression was applied to compute stiffness, yield strength, ultimate strength, modulus of resilience, and toughness, which were then compared to metrics obtained from mechanical testing. Moderate to strong positive correlations were found between computationally and experimentally derived values of stiffness (R2=0.77, p<0.0001), yield strength (R2=0.38, p=0.0082), ultimate strength (R2=0.40, p=0.0067), and resilience (R2=0.46, p=0.0026), but only a weak, albeit significant, correlation was found for toughness (R2=0.26, p=0.036). Furthermore, experimentally derived yield strength and ultimate strength were moderately correlated with MRI-derived stiffness (R2=0.48, p=0.0022 and R2=0.58, p=0.0004, respectively). These results suggest that high-resolution MRI-based finite element (FE) models are effective in assessing mechanical parameters of distal skeletal extremities.

The Efficacy of Low-intensity Vibration to Improve Bone Health in Patients with End-stage Renal Disease Is Highly Dependent on Compliance and Muscle Response.

RATIONAL AND OBJECTIVES: Low intensity vibration (LIV) may represent a nondrug strategy to mitigate bone deficits in patients with end-stage renal disease. MATERIALS AND METHODS: Thirty end-stage renal patients on maintenance hemodialysis were randomized to stand for 20 minutes each day on either an active or placebo LIV device. Analysis at baseline and completion of 6-month intervention included magnetic resonance imaging (tibia and fibula stiffness; trabecular thickness, number, separation, bone volume fraction, plate-to-rod ratio; and cortical bone porosity), dual-energy X-ray absorptiometry (hip and spine bone mineral density [BMD]), and peripheral quantitative computed tomography (tibia trabecular and cortical BMD; calf muscle cross-sectional area). RESULTS: Intention-to-treat analysis did not show any significant changes in outcomes associated with LIV. Subjects using the active device and with greater than the median adherence (70%) demonstrated an increase in distal tibia stiffness (5.3%), trabecular number (1.7%), BMD (2.3%), and plate-to-rod ratio (6.5%), and a decrease in trabecular separation (-1.8%). Changes in calf muscle cross-sectional area were associated with changes in distal tibia stiffness (R = 0.85), trabecular bone volume/total volume (R = 0.91), number (R = 0.92), and separation (R = -0.94) in the active group but not in the placebo group. Baseline parathyroid hormone levels were positively associated with increased cortical bone porosity over the 6-month study period in the placebo group (R = 0.55) but not in the active group (R = 0.01). No changes were observed in the nondistal tibia locations for either group except a decrease in hip BMD in the placebo group (-1.7%). CONCLUSION: Outcomes and adherence thresholds identified from this pilot study could guide future longitudinal studies involving vibration therapy.

Analog Method for Radiographic Assessment of Heterotopic Bone in Fibrodysplasia Ossificans Progressiva.

RATIONALE AND OBJECTIVES: Severe progressive multifocal heterotopic ossification (HO) is a rare occurrence seen predominantly in patients who have fibrodysplasia ossificans progressiva (FOP) and is difficult to quantitate owing to patient-, disease-, logistical-, and radiation-related issues. The purpose of this study was to develop and validate a scoring system based on plain radiographs for quantitative assessment of HO lesions in patients with FOP. MATERIALS AND METHODS: Institutional review board approval was obtained from the University of Pennsylvania, and all data comply with Health Insurance Portability and Accountability Act regulations. The University of Pennsylvania Institutional Animal Care and Use Committee approved the use of mice in this study. First, we used a mouse model of FOP-like HO to validate a semiquantitative analog scale for estimating relative heterotopic bone volume. Second, we used this validated scale to estimate the relative amount of HO from a retrospective analysis of plain radiographs from 63 patients with classic FOP. Finally, the scale was applied to a retrospective analysis of computed tomographic images from three patients with FOP. RESULTS: In the FOP-mouse model, the observed rating on the analog scale is highly correlated to heterotopic bone volumes measured by microcomputed tomography (R2 = 0.89). The scoring system that was applied to radiographs of patients with FOP captured the clinical range of HO typically present at all axial and appendicular sites. Analysis of computed tomographic scans of patients with FOP found that observed radiograph ratings were highly correlated with HO volume (R2 = 0.80). CONCLUSIONS: The scoring system described here could enable practical, quantitative assessment of HO in clinical trials to evaluate new treatment modalities, especially for FOP. The development of the six-point analog scale described here provides and validates a much-needed, reproducible, and quantifiable method for describing and assessing HO in patients with FOP. This scale has the potential to be a key descriptor that can inform patients with FOP and clinicians about disease progression and response of HO lesions to interventions and treatments.