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.

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.

Can group medical clinics improve lipid management in diabetes?

BACKGROUND: Group medical clinics may improve diabetes and hypertension control, but data about dyslipidemia are limited. We examined the impact of group medical clinics on lipids among patients with uncontrolled diabetes and hypertension. METHODS: Prespecified secondary analysis of 239 veterans randomized to group medical clinics or usual care. Lipids were assessed at study baseline, midpoint, and end. We used linear mixed models to compare lipid levels between arms and generalized estimating equation models to compare low-density lipoprotein cholesterol (LDL-C) goal attainment. An additional post hoc analysis examined intensification of cholesterol-lowering medications in both arms. RESULTS: At baseline, mean total cholesterol was 169.7 mg/dL (SD 47.8), LDL-C 98.2 mg/dL (SD 41.7), and high-density lipoprotein cholesterol (HDL-C) 39.3 mg/dL (SD 13.0). Median baseline triglycerides were 131 mg/dL (interquartile range 122). By study end, mean total cholesterol and LDL-C in group medical clinics were 14.2 mg/dL (P = .01) and 9.2 mg/dL (P = .02) lower than usual care, respectively; 76% of group medical clinic patients met goals for LDL-C, versus 61% of usual care patients (P = .02). Triglycerides and HDL-C remained similar between study arms. Treatment intensification occurred in 52% of group medical clinic patients, versus 37% of usual care patients between study baseline and end (P = .04). The mean statin dose was higher in group medical clinic patients at study midpoint and end. CONCLUSIONS: Group medical clinics appear to enhance lipid management among patients with diabetes and hypertension. This may be a result of greater intensification of cholesterol-lowering medications in group medical clinics relative to usual care.

Metformin for obesity and glucose dysregulation in patients with schizophrenia receiving antipsychotic drugs.

Antipsychotic drug-induced weight gain and glucose dysregulation add to the cardiovascular risk of patients with schizophrenia and contribute to their early mortality. The currently recommended interventions to address the metabolic complications of antipsychotic drug treatment are to switch the patient from an antipsychotic drug with high metabolic liability to one with a lower liability and to implement lifestyle changes. These interventions can be quite challenging to carry out. So far the progress in improving the metabolic and cardiovascular outcome of patients with major mental illness has been disappointing. We offer an overview of the literature on metformin for antipsychotic drug-induced weight gain and glucose dysregulation and pertinent literature from the Diabetes Prevention Program. We conclude that young adults with schizophrenia newly exposed to antipsychotic drugs, who show a pattern of rapid weight gain and/or glucose dysregulation, are prime candidates for metformin if switching the antipsychotic medication to one with a lower metabolic burden is not an option or does not curtail the weight gain and/or adverse metabolic effects. Metformin therapy should not preclude healthy lifestyle interventions.

Medical clinics versus usual care for patients with both diabetes and hypertension: a randomized trial.

BACKGROUND: Group medical clinics (GMCs) are widely used in the management of diabetes and hypertension, but data on their effectiveness are limited. OBJECTIVE: To test the effectiveness of GMCs in the management of comorbid diabetes and hypertension. DESIGN: Randomized, controlled trial. (ClinicalTrials.gov registration number: NCT00286741) SETTING: 2 Veterans Affairs Medical Centers in North Carolina and Virginia. PATIENTS: 239 patients with poorly controlled diabetes (hemoglobin A(1c) [HbA(1c)] level > or =7.5%) and hypertension (systolic blood pressure >140 mm Hg or diastolic blood pressure >90 mm Hg). INTERVENTION: Patients were randomly assigned within each center to either attend a GMC or receive usual care. Clinics comprised 7 to 8 patients and a care team that consisted of a primary care general internist, a pharmacist, and a nurse or other certified diabetes educator. Each session included structured group interactions moderated by the educator. The pharmacist and physician adjusted medication to manage each patient's HbA(1c) level and blood pressure. MEASUREMENTS: Hemoglobin A(1c) level and systolic blood pressure, measured by blinded research personnel at baseline, study midpoint (median, 6.8 months), and study completion (median follow-up, 12.8 months). Linear mixed models, adjusted for clustering within GMCs, were used to compare HbA(1c) levels and systolic blood pressure between the intervention and control groups. RESULTS: Mean baseline systolic blood pressure and HbA(1c) level were 152.9 mm Hg (SD, 14.2) and 9.2% (SD, 1.4), respectively. At the end of the study, mean systolic blood pressure improved by 13.7 mm Hg in the GMC group and 6.4 mm Hg in the usual care group (P = 0.011 by linear mixed model), whereas mean HbA(1c) level improved by 0.8% in the GMC group and 0.5% in the usual care group (P = 0.159). LIMITATION: Measurements of effectiveness may have been limited by concomitant improvements in the usual care group that were due to co-intervention. CONCLUSION: Group medical clinics are a potent strategy for improving blood pressure but not HbA(1c) level in diabetic patients. PRIMARY FUNDING SOURCE: U.S. Department of Veterans Affairs Health Services Research and Development Service.

Metabolic syndrome associated with schizophrenia and atypical antipsychotics.

Patients with schizophrenia are at increased risk for developing the metabolic syndrome or its individual components due to their lifestyle, suspected genetic predisposition, and exposure to antipsychotic medications that can cause weight gain and other metabolic side effects. Despite the availability of clinical guidelines, screening for and monitoring of metabolic problems in this patient population continue to be suboptimal. We provide an overview specifically addressing 1) why patients with schizophrenia are at increased risk for metabolic problems; 2) how commonly used antipsychotic medications vary in terms of their metabolic liability; 3) how to effectively screen for and monitor metabolic problems in patients receiving antipsychotic medications; 4) what interventions can prevent, limit, or reverse the metabolic side effects of antipsychotic drug treatment; and 5) what are the barriers to the care of these patients.

Metformin for atypical antipsychotic-induced weight gain and glucose metabolism dysregulation: review of the literature and clinical suggestions.

Individuals receiving certain atypical antipsychotic medications are at risk of gaining weight and developing metabolic problems. There are no established drug treatments to prevent or counter these problems. However, the antihyperglycaemic agent metformin appears promising in some recent studies and we review the literature that evaluates metformin for limiting or reversing atypical antipsychotic drug-induced weight gain and glucose metabolism dysregulation. These studies suggest that metformin is beneficial if started early in antipsychotic drug treatment. Metformin has also been shown to prevent or delay the onset of type 2 diabetes mellitus in high-risk individuals from the general population. Based on these findings, we identify antipsychotic drug-treated patients who might benefit from metformin therapy and offer clinical guidelines for its use. Further long-term studies are needed to extend our observations and improve this strategy.

Clinical monitoring and management of the metabolic syndrome in patients receiving atypical antipsychotic medications.

Individuals with major mental illness are a high-risk group for cardio-metabolic derangements due to genetic predisposition, developmental and environmental stressors, and lifestyle. This risk is compounded when they receive antipsychotic medications. Guidelines for screening, monitoring, and managing these patients for metabolic problems have been in place for several years. Despite this, recent reports document that this population continues to receive poor care in this regard. In this article, we review the metabolic profile of atypical antipsychotic medications and offer guidelines to reduce the metabolic complications of these agents.

Psychotropic drug considerations in depressed patients with metabolic disturbances.

Depression, obesity, diabetes mellitus, and the metabolic syndrome are conditions commonly treated in primary care. The prevalence of each condition separately does not explain the frequency of their co-occurrence. Depression may lead to or exacerbate these endocrine and metabolic conditions. Conversely, these medical conditions may lead to or exacerbate depression. Psychotropic drugs that treat depression may increase appetite with resultant weight gain. Rarely, such agents may be associated with weight loss. We review the potential for psychotropic drugs to alter body weight and provide a table as a guide to drug selection. Unless circumstances dictate otherwise, clinicians should select psychotropic drugs least likely to induce weight gain when treating depressed patients with obesity, diabetes mellitus, or the metabolic syndrome. Even drugs generally thought to be "weight neutral" may occasionally be associated with weight gain. Thus, alerting patients to this potential and due diligence form the cornerstone of weight management in the depressed patient.