Validating a tool to measure spiritual beliefs, needs and resources in serious illness: The I-SPIRIT.

BACKGROUND: Seriously ill patients rely on spiritual and existential beliefs to support coping and approach crucial treatment and healthcare decisions. Yet, we lack gold standard, validated approaches to gathering information on those spiritual beliefs. Therefore, we developed I-SPIRIT, a spiritual needs and beliefs inventory for those with serious illness (IIR-10-050). METHODS: In prior work to develop measure content, we interviewed a total of 74 participants: 20 patients (veterans with Stage IV cancer, CHF, COPD, ESRD), 19 caregivers, 14 chaplains, 10 social workers, 12 nurses, and 5 physicians. Using directed content analyses, we identified over 50 attributes of spiritual experience comprising five domains: overall importance of spirituality; affiliations and practices; impact on decisions; spiritual needs; and spiritual resources. We then translated these attributes into individual items with Likert response scales. In the quantitative validation of I-SPIRIT, we administered the instrument and a battery of comparison measures to 249 seriously ill veterans. The comparison measures captured general spiritual well-being, religious coping, and emotional functioning. Convergent and discriminant validity was examined with the FACIT-sp (faith, meaning, and purpose), BMMRS (religious/spirituality), POMS and PHQ-8 (emotional function), and FACT-G (quality of life). We administered the I-SPIRIT a week later, for test-retest reliability. RESULTS: Psychometric analyses yielded a final I-SPIRIT Tool including 30 items. Results demonstrated reliability and validity and yielded a tool with three main components: Spiritual Beliefs (seven items); Spiritual Needs (nine items); and Spiritual Resources (14 items). The Spiritual Beliefs items include key practices and affiliations, and impact of beliefs on healthcare. Higher levels of Spiritual Needs were associated with higher anxiety and depression. CONCLUSION: The I-Spirit measures relevance of spirituality, spiritual needs and spiritual resources and demonstrates validity, reliability, and acceptability for patients with serious illness.

Evaluating Therapeutic Inertia in Two Telehealth Interventions for Type 2 Diabetes: Secondary Analyses of a Randomized Trial.

Introduction: Although therapeutic inertia is a known driver of suboptimal type 2 diabetes control, little is known about how to combat this phenomenon. We analyzed randomized trial data to determine whether a comprehensive telehealth intervention was more effective than a less structured telehealth approach (telemonitoring and care coordination) at promoting treatment intensification in poorly controlled diabetes. Methods: Patients with poorly controlled type 2 diabetes were randomized 1:1 to telemonitoring/care coordination or a comprehensive telehealth intervention, which included an active, study provider-guided medication management component. Prospectively collected medication lists were used to determine whether treatment intensification occurred for each patient during 3-month intervals throughout the study period. To examine between-arm differences in treatment intensification over time, we fit a generalized estimation equation model. In each arm, hemoglobin A1c levels at the beginning and end of each 3-month interval were used to distinguish between therapeutic inertia and potentially appropriate nonintensification of treatment. Results: The mean, model-estimated likelihood of treatment intensification during 3-month intervals was 61.3% in the comprehensive telehealth group versus 48.6% for telemonitoring/care coordination (odds ratio 1.7, 95% confidence interval 1.2-2.2; p = 0.0007), with no evidence that treatment effect varied over time (p = 0.54). Treatment intervals with observed therapeutic inertia were more common in the telemonitoring/care coordination arm than the comprehensive telehealth arm (116/300, 39% vs. 57/275, 21%). Conclusions: A comprehensive telehealth approach that integrated protocol-guided medication management increased treatment intensification and reduced therapeutic inertia compared with a less structured telehealth approach. The studied approaches may serve as examples of how systems might use telehealth to combat therapeutic inertia. Clinical Trial Registration: ClinicalTrials.gov NCT03520413.

Diabetes distress in Veterans with type 2 diabetes mellitus: Qualitative descriptive study.

Diabetes distress (DD) is a negative psychosocial response to living with type 2 diabetes mellitus (T2DM). We sought insight into Veterans' experiences with DD in the context of T2DM self-management. The four domains in the Diabetes Distress Scale (i.e. regimen, emotional, interpersonal, healthcare provider) informed the interview guide and analysis (structural coding using thematic analysis). The mean age of the cohort (n = 36) was 59.1 years (SD 10.4); 8.3% of patients were female and 63.9% were Black or Mixed Race; mean A1C was 8.8% (SD 2.0); and mean DDS score was 2.4 (SD 1.1), indicating moderate distress. Veterans described DD and challenges to T2DM self-management across the four domains in the Diabetes Distress Scale. We found that (1) Veterans' challenges with their T2DM self-management routines influenced DD and (2) Veterans experienced DD across a wide range of domains, indicating that clinical interventions should take a "whole-person" approach.Trial Registration: NCT04587336.

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.

Veterans Health Administration National TeleOncology Service.

PURPOSE: As the largest integrated health care system in the United States, the Veterans Health Administration (VA) is a leader in telehealth-delivered care. All 10 million Veterans cared for within the VA are eligible for telehealth. The VA cares for approximately 46,000 Veteran patients with newly diagnosed cancer and an estimated 400,000 prevalent cases annually. With nearly 38% of VA health care system users residing in rural areas and only 44% of rural counties having an oncologist, many Veterans lack local access to specialized cancer services. METHODS: We describe the VA's National TeleOncology (NTO) Service. NTO was established to provide Veterans with the opportunity for specialized treatment regardless of geographical location. Designed as a hub-and-spoke model, VA oncologists from across the country can provide care to patients at spoke sites. Spoke sites are smaller and rural VA medical centers that are less able to independently provide the full range of services available at larger facilities. In addition to smaller rural spoke sites, NTO also provides subspecialized oncology care to Veterans located in larger VA medical facilities that do not have subspecialties available or that have limited capacity. RESULTS: As of fiscal year 2021, 23 clinics are served by or engaged in planning for delivery of NTO and there are 24 physicians providing care through the NTO virtual hub. Most NTO physicians continue to provide patient care in separate traditional in-person clinics. Approximately 4,300 unique Veterans have used NTO services. Approximately half (52%) of Veterans using NTO lived in rural areas. Most of these Veterans had more than one remote visit through NTO. CONCLUSION: NTO is a state-of-the-art model that has the potential to revolutionize the way cancer care is delivered, which should improve the experience of Veterans receiving cancer care.

Provider-supported self-management cognitive behavioral therapy for insomnia (Tele-Self CBTi): Protocol for a randomized controlled trial.

BACKGROUND: Cognitive Behavioral Therapy for Insomnia (CBTi) is recommended as first-line treatment for insomnia, yet patient access to CBTi is limited. Self-help CBTi could increase patient access. Self-help CBTI with provider sup]port is more effective and is preferred by patients. Self-help CBTi has not been evaluated in veterans; a population with greater medical and mental health morbidity and more severe sleep difficulties than non-veterans. Moreover, those with mental health conditions have been largely excluded from prior CBTi self-help trials. Stablishing the efficacy of provider-supported Self-help CBTi is an important first step for expanding veteran access to CBTi. METHODS: In a 2-armed randomized controlled trial, a provider-supported self-help CBTi (Tele-Self CBTi) is compared to Health Education for improving insomnia severity (primary outcome) among treatment-seeking veterans with insomnia disorder. Tele-Self CBTi is comprised of two treatment components: self-help CBTi via a professionally designed manual developed using an iterative process of expert review and patient input; and 6 telephone-based support sessions lasting >20 min. Outcomes are assessed at baseline, 8 weeks, and 6 months after baseline. The primary outcome, insomnia severity, is measured using the Insomnia Severity Index. Secondary outcomes include self-reported and actigraphy-assessed sleep, fatigue, depression symptoms, and sleep-related quality of life. CONCLUSION: Innovative approaches are essential to improving overall health among veterans; a population with highly prevalent insomnia disorder. If effective, Tele-Self CBTi may bridge the gap between unavailable resources and high demand for CBTi and serve as the entry level intervention in a stepped model of care. GOV IDENTIFIER: NCT03727438.

Digital Medicine System in Veterans With Severe Mental Illness: Feasibility and Acceptability Study.

BACKGROUND: Suboptimal medication adherence is a significant problem for patients with serious mental illness. Measuring medication adherence through subjective and objective measures can be challenging, time-consuming, and inaccurate. OBJECTIVE: The primary purpose of this feasibility and acceptability study was to evaluate the impact of a digital medicine system (DMS) among Veterans (patients) with serious mental illness as compared with treatment as usual (TAU) on medication adherence. METHODS: This open-label, 2-site, provider-randomized trial assessed aripiprazole refill adherence in Veterans with schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder. We randomized 26 providers such that their patients either received TAU or DMS for a period of 90 days. Semistructured interviews with patients and providers were used to examine the feasibility and acceptability of using the DMS. RESULTS: We enrolled 46 patients across 2 Veterans Health Administration sites: 21 (46%) in DMS and 25 (54%) in TAU. There was no difference in the proportion of days covered by medication refill over 3 and 6 months (0.82, SD 0.24 and 0.75, SD 0.26 in DMS vs 0.86, SD 0.19 and 0.82, SD 0.21 in TAU, respectively). The DMS arm had 0.85 (SD 0.20) proportion of days covered during the period they were engaged with the DMS (mean 144, SD 100 days). Interviews with patients (n=14) and providers (n=5) elicited themes salient to using the DMS. Patient findings described the positive impact of the DMS on medication adherence, challenges with the DMS patch connectivity and skin irritation, and challenges with the DMS app that affected overall use. Providers described an overall interest in using a DMS as an objective measure to support medication adherence in their patients. However, providers described challenges with the DMS dashboard and integrating DMS data into their workflow, which decreased the usability of the DMS for providers. CONCLUSIONS: There was no observed difference in refill rates. Among those who engaged in the DMS arm, the proportion of days covered by refills were relatively high (mean 0.85, SD 0.20). The qualitative analyses highlighted areas for further refinement of the DMS. TRIAL REGISTRATION: ClinicalTrials.gov NCT03881449; https://clinicaltrials.gov/ct2/show/NCT03881449.

Effect of a Comprehensive Telehealth Intervention vs Telemonitoring and Care Coordination in Patients With Persistently Poor Type 2 Diabetes Control: A Randomized Clinical Trial.

Importance: Persistently poorly controlled type 2 diabetes (PPDM) is common and causes poor outcomes. Comprehensive telehealth interventions could help address PPDM, but effectiveness is uncertain, and barriers impede use in clinical practice. Objective: To address evidence gaps preventing use of comprehensive telehealth for PPDM by comparing a practical, comprehensive telehealth intervention to a simpler telehealth approach. Design, Setting, and Participants: This active-comparator, parallel-arm, randomized clinical trial was conducted in 2 Veterans Affairs health care systems. From December 2018 to January 2020, 1128 outpatients with PPDM were assessed for eligibility and 200 were randomized; PPDM was defined as maintenance of hemoglobin A1c (HbA1c) level of 8.5% or higher for 1 year or longer despite engagement with clinic-based primary care and/or diabetes specialty care. Data analyses were preformed between March 2021 and May 2022. Interventions: Each 12-month intervention was nurse-delivered and used only clinical staffing/resources. The comprehensive telehealth group (n = 101) received telemonitoring, self-management support, diet/activity support, medication management, and depression support. Patients assigned to the simpler intervention (n = 99) received telemonitoring and care coordination. Main Outcomes and Measures: Primary (HbA1c) and secondary outcomes (diabetes distress, diabetes self-care, self-efficacy, body mass index, depression symptoms) were analyzed over 12 months using intent-to-treat linear mixed longitudinal models. Sensitivity analyses with multiple imputation and inclusion of clinical data examined the impact of missing HbA1c measurements. Adverse events and intervention costs were examined. Results: The population (n = 200) had a mean (SD) age of 57.8 (8.2) years; 45 (22.5%) were women, 144 (72.0%) were of Black race, and 11 (5.5%) were of Hispanic/Latinx ethnicity. From baseline to 12 months, HbA1c change was -1.59% (10.17% to 8.58%) in the comprehensive telehealth group and -0.98% (10.17% to 9.19%) in the telemonitoring/care coordination group, for an estimated mean difference of -0.61% (95% CI, -1.12% to -0.11%; P = .02). Sensitivity analyses showed similar results. At 12 months, patients receiving comprehensive telehealth had significantly greater improvements in diabetes distress, diabetes self-care, and self-efficacy; no differences in body mass index or depression were seen. Adverse events were similar between groups. Comprehensive telehealth cost an additional $1519 per patient per year to deliver. Conclusions and Relevance: This randomized clinical trial found that compared with telemonitoring/care coordination, comprehensive telehealth improved multiple outcomes in patients with PPDM at a reasonable additional cost. This study supports consideration of comprehensive telehealth implementation for PPDM in systems with appropriate infrastructure and may enhance the value of telehealth during the COVID-19 pandemic and beyond. Trial Registration: ClinicalTrials.gov Identifier: NCT03520413.

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.

Factors associated with non-adherence to insulin and non-insulin medications in patients with poorly controlled diabetes.

OBJECTIVES: To evaluate differences in factors associated with self-reported medication non-adherence to insulin and non-insulin medications in patients with uncontrolled type 2 diabetes. METHODS: In this secondary analysis of a randomized trial in patients with obesity and uncontrolled type 2 diabetes, multivariable logistic regression was used to evaluate associations between several clinical factors (measured with survey questionnaires at study baseline) and self-reported non-adherence to insulin and non-insulin medications. RESULTS: Among 263 patients, reported non-adherence was 62% (52% for insulin, 55% for non-insulin medications). Reported non-adherence to non-insulin medications was less likely in white versus non-white patients (odds ratio (OR) = 0.42; 95%CI: 0.22,0.80) and with each additional medication taken (OR = 0.75; 95%CI: 0.61,0.93). Non-adherence to non-insulin medications was more likely with each point increase in a measure of diabetes medication intensity (OR = 1.43; 95%CI: 1.01,2.03), the Problem Areas in Diabetes (PAID) score (OR = 1.06; 95%CI: 1.02,1.12), and in men versus women (OR = 3.03; 95%CI: 1.06,8.65). For insulin, reporting non-adherence was more likely (OR = 1.02; 95%CI: 1.00,1.04) with each point increase in the PAID. DISCUSSION: Despite similar overall rates of reported non-adherence to insulin and non-insulin medications, factors associated with reported non-adherence to each medication type differed. These findings may help tailor approaches to supporting adherence in patients using different types of diabetes medications.

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.

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.

Veterans' Interpretation of Diabetes Distress in Diabetes Self-Management: Findings From Cognitive Interviews.

PURPOSE: The purpose of this project was to identify additional facets of diabetes distress (DD) in veterans that may be present due to the veteran's military-related experience. METHODS: The study team completed cognitive interviews with veterans with type 2 diabetes mellitus (T2DM) to examine how they answered the Diabetes Distress Scale (DD Scale), a tool that assesses DD. The DD Scale was used because of its strong associations with self-management challenges, physician-related distress, and clinical outcomes. RESULTS: The veterans sample (n= 15) was 73% male, mean age of 61 (SD = 8.6), 53% Black, 53% with glycosylated hemoglobin level <9%, and 67% with prescribed insulin. The DD Scale is readily understood by veterans and interpreted. Thematic analysis indicated additional domains affecting DD and T2DM self-management, including access to care, comorbidities, disruptions in routine, fluctuations in emotions and behaviors, interactions with providers, lifelong nature of diabetes, mental health concerns, military as culture, personal characteristics, physical limitations, physical pain, sources of information and support, spirituality, and stigma. CONCLUSIONS: This study describes how a veteran's military experience may contribute to DD in the context of T2DM self-management. Findings indicate clinicians and researchers should account for additional domains when developing self-management interventions and discussing self-management behaviors with individuals with T2DM.

Clinical associations of an updated medication effect score for measuring diabetes treatment intensity.

OBJECTIVES: The medication effect score reflects overall intensity of a diabetes regimen by consolidating dosage and potency of agents used. Little is understood regarding how medication intensity relates to clinical factors. We updated the medication effect score to account for newer agents and explored associations between medication effect score and patient-level clinical factors. METHODS: Cross-sectional analysis of baseline data from a randomized controlled trial involving 263 Veterans with type 2 diabetes and hemoglobin A1c levels ≥8.0% (≥7.5% if under age 50). Medication effect score was calculated for all patients at baseline, alongside additional measures including demographics, comorbid illnesses, hemoglobin A1c, and self-reported psychosocial factors. We used multivariable regression to explore associations between baseline medication effect score and patient-level clinical factors. RESULTS: Our sample had a mean age of 60.7 (SD = 8.2) years, was 89.4% male, and 57.4% non-White. Older age and younger onset of diabetes were associated with a higher medication effect score, as was higher body mass index. Higher medication effect score was significantly associated with medication nonadherence, although not with hemoglobin A1c, self-reported hypoglycemia, diabetes-related distress, or depression. DISCUSSION: We observed several expected associations between an updated medication effect score and patient-level clinical factors. These associations support the medication effect score as an appropriate measure of diabetes regimen intensity in clinical and research contexts.

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.

Comparison of Group Medical Visits Combined With Intensive Weight Management vs Group Medical Visits Alone for Glycemia in Patients With Type 2 Diabetes: A Noninferiority Randomized Clinical Trial.

Importance: Traditionally, group medical visits (GMVs) for persons with diabetes improved glycemia by intensifying medications, which infrequently led to weight loss. Incorporating GMVs with intensive dietary change could enable weight loss and improve glycemia while decreasing medication intensity. Objective: To examine whether a program of GMVs combined with intensive weight management (WM) is noninferior to GMVs alone for change in glycated hemoglobin (HbA1c) level at 48 weeks (prespecified margin of 0.5%) and superior to GMVs alone for hypoglycemic events, diabetes medication intensity, and weight loss. Design, Setting, and Participants: This randomized clinical trial identified via the electronic medical record 2814 outpatients with type 2 diabetes, uncontrolled HbA1c, and body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) of 27 or higher from Veterans Affairs Medical Center clinics in Durham and Greenville, North Carolina. Between January 12, 2015, and May 30, 2017, 263 outpatients started the intervention. Interventions: Participants randomized to the GMV group (n = 136) received counseling about diabetes-related topics with medication optimization every 4 weeks for 16 weeks, then every 8 weeks (9 visits). Participants randomized to the WM/GMV group (n = 127) received low-carbohydrate diet counseling with baseline medication reduction and subsequent medication optimization every 2 weeks for 16 weeks followed by an abbreviated GMV intervention every 8 weeks (13 visits). Main Outcomes and Measures: Outcomes included HbA1c level, hypoglycemic events, diabetes medication effect score, and weight at 48 weeks analyzed using hierarchical generalized mixed models to account for clustering within group sessions. Results: Among 263 participants (mean [SD] age, 60.7 [8.2] years; 235 [89.4%] men; 143 [54.4%] black), baseline HbA1c level was 9.1% (1.3%) and BMI was 35.3 (5.1). At 48 weeks, HbA1c level was improved in both study arms (8.2% in the WM/GMV arm and 8.3% in the GMV arm; mean difference, -0.1%; 95% CI, -0.5% to 0.2%; upper 95% CI, <0.5% threshold; P = .44). The WM/GMV arm had lower diabetes medication use (mean difference in medication effect score, -0.5; 95% CI, -0.6 to -0.3; P < .001) and greater weight loss (mean difference, -3.7 kg; 95% CI, -5.5 to -1.9 kg; P < .001) than did the GMV arm at 48 weeks and approximately 50% fewer hypoglycemic events (incidence rate ratio, 0.49; 95% CI, 0.27 to 0.71; P < .001) during the 48-week period. Conclusions and Relevance: In GMVs for diabetes, addition of WM using a low-carbohydrate diet was noninferior for lowering HbA1c levels compared with conventional medication management and showed advantages in other clinically important outcomes. Trial Registration: ClinicalTrials.gov identifier: NCT01973972.

A feasibility study to develop and test a Spanish patient and provider intervention for managing osteoarthritis in Hispanic/Latino adults (PRIMO-Latino).

BACKGROUND: Arthritis affects approximately 50 million adults in the USA. Hispanics/Latinos have a higher prevalence of arthritis-attributed activity limitations primarily related to osteoarthritis (OA). Hispanic/Latinos are less likely to receive hip replacement independent of health care access, and they are less likely to receive knee replacement. There have been few interventions to improve OA treatment among the Hispanic/Latino population in the USA. In our study, we aimed to develop and test a telephone delivered culturally appropriate Spanish behavioral intervention for the management of OA in Hispanic/Latino adults. METHODS: We conducted a feasibility study in an academic health center and local community in Durham, North Carolina. We enrolled self-identified Spanish speaking overweight/obese adults (≥ 18) with OA of the knee and/or hip under the care of a primary health care provider. The 12-month patient intervention focused on physical activity, weight management, and cognitive behavioral pain management skills. The patient intervention was delivered via telephone with calls scheduled twice per month for the first 6 months, then monthly for the last 6 months (18 sessions). The one-time provider intervention included delivery of patient-specific OA treatment recommendations, based on patients' baseline data and published guidelines. The primary measures were metrics of feasibility, including recruitment and intervention delivery. We also assessed pain, stiffness, and function using the Spanish-Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). RESULTS: A total of 1879 participants were identified for potential enrollment. Of those, 1864 did not meet inclusion criteria, were not able to be reached or refused. Fifteen participants enrolled in the intervention. The mean number of phone calls completed was 14.7. Eighty percent completed more than 16 calls. The mean WOMAC baseline score (SD) was 39 (20); mean improvement in WOMAC scores between baseline and 12 months, among 11 participants who completed the study, was - 13.27 [95% CI, - 25.09 to - 1.46] points. CONCLUSION: Recruitment of Hispanics/Latinos, continues to be a major challenge. A Spanish-based telephone delivering lifestyle intervention for OA management in Hispanic/Latino adults is feasible to deliver and may lead to improved OA symptoms. Future research is needed to further test the feasibility and effectiveness of this type of intervention in this segment of the population. TRIAL REGISTRATION: NCT01782417.

Prevalence of and characteristics associated with insomnia and obstructive sleep apnea among veterans with knee and hip osteoarthritis.

BACKGROUND: Few studies have examined patterns of specific sleep problems among individuals with osteoarthritis (OA). The primary objective of this study was to examine prevalence of symptoms of insomnia and obstructive sleep apnea (OSA) among Veterans with OA. Secondary objectives were to assess proportions of individuals with insomnia and OSA symptoms who may have been undiagnosed and to examine Veterans' characteristics associated with insomnia and OSA symptoms. METHODS: Veterans (n = 300) enrolled in a clinical trial completed the Insomnia Severity Index (ISI) and the Berlin Questionnaire (BQ) at baseline; proportions of participants with symptoms consistent with insomnia and OSA were calculated, using standard cut-offs for ISI and BQ. For Veterans with insomnia and OSA symptoms, electronic medical records were searched to identify whether there was a diagnosis code for these conditions. Multivariable linear (ISI) and logistic (BQ) regression models examined associations of the following characteristics with symptoms of insomnia and OSA: age, gender, race, self-reported general health, body mass index (BMI), diagnosis of post-traumatic stress disorder (PTSD), pain severity, depressive symptoms, number of joints with arthritis symptoms and opioid use. RESULTS: Symptoms consistent with insomnia and OSA were found in 53 and 66% of this sample, respectively. Among participants screening positive for insomnia and OSA, diagnosis codes for these disorders were present in the electronic medical record for 22 and 51%, respectively. Characteristics associated with insomnia were lower age (ß (SE) = - 0.09 (0.04), 95% confidence interval [CI] = - 0.16, - 0.02), having a PTSD diagnosis (ß (SE) = 1.68 (0.73), CI = 0.25, 3.11), greater pain severity (ß (SE) = 0.36 (0.09), CI = 0.17, 0.55), and greater depressive symptoms (ß (SE) = 0.84 (0.07), CI = 0.70, 0.98). Characteristics associated with OSA were higher BMI (odds ratio [OR] = 1.13, CI = 1.06, 1.21), greater depressive symptoms (OR = 1.12, CI = 1.05, 1.20), and opioid use (OR = 0.51, CI = 0.26, 0.99). CONCLUSIONS: Insomnia and OSA symptoms were very common in Veterans with OA, and a substantial proportion of individuals with symptoms may have been undiagnosed. Characteristics associated with insomnia and OSA symptoms were consistent with prior studies. TRIAL REGISTRATION: NCT01130740 .

Cognitive Mediators of Change in Physical Functioning in Response to a Multifaceted Intervention for Managing Osteoarthritis.

PURPOSE: Although non-pharmacological interventions have been shown to improve physical functioning in individuals with osteoarthritis (OA), the mechanisms by which this occurs are often unclear. This study assessed whether changes in arthritis self-efficacy, perceived pain control, and pain catastrophizing mediated changes in physical functioning following an osteoarthritis intervention involving weight management, physical activity, and cognitive-behavioral pain management. METHOD: Three hundred Veteran patients of 30 primary care providers with knee and/or hip OA were cluster randomized to an OA intervention group or usual care. The OA intervention included a 12-month phone-based patient behavioral protocol (weight management, physical activity, and cognitive-behavioral pain management) plus patient-specific OA treatment recommendations delivered to primary care providers. RESULTS: Using linear mixed models adjusted for provider clustering, we observed that baseline to 6-month changes in arthritis self-efficacy and pain control partially mediated baseline to 12-month physical functioning improvements for the intervention group; catastrophizing did not. CONCLUSION: Findings of a mediating role of arthritis self-efficacy and pain control in intervention-related functional changes are consistent with hypotheses and align with theoretical assertions of the role of cognitions in cognitive and behavioral interventions for chronic pain. However, contrary to hypotheses, catastrophizing was not found to be a mediator of these changes.

Demographic and Clinical Factors Associated With Nonsurgical Osteoarthritis Treatment Among Patients in Outpatient Clinics.

OBJECTIVE: To identify patient demographic and clinical characteristics associated with osteoarthritis (OA) treatment use. METHODS: This was a secondary data analysis of 3 clinical trials among patients with hip or knee OA conducted in Duke Primary Care practices, the Durham Veterans Affairs (VA) Health Care System, and the University of North Carolina-Chapel Hill (UNC). At baseline, participants reported sociodemographic characteristics, OA-related pain and function, and OA treatment use, including oral analgesics, topical creams, joint injections, and physical therapy. Separate, multivariable logistic models (adjusted for clustering of clinics and providers for the Duke and VA cohorts) were used to estimate odds ratios (ORs) and 95% confidence intervals (95% CIs) for the associations between participant characteristics and each type of OA treatment. RESULTS: Oral analgesic use was reported by 70-82% of participants across the 3 cohorts. Physical therapy, knee injections, and topical creams were used by 39-52%, 55-60%, and 25-39% of Duke, VA, and UNC participants, respectively. In multivariable models, worse pain, stiffness, and function, per 5-unit increase, were associated with greater odds of using any oral analgesic for the cohorts from Duke (OR 1.18 [95% CI 1.08-1.28]) and UNC (OR 1.14 [95% CI 1.05-1.24]), but not for the VA cohort (OR 1.04 [95% CI 0.95-1.14]). For all 3 cohorts, nonwhites had higher odds of using topical creams compared to whites. CONCLUSION: Results suggest potential underutilization of therapies other than oral analgesics. Patient characteristics may affect OA treatment use, and understanding the relationship between these factors and OA treatment preferences may improve adherence to OA treatment guidelines.