Browsing by Author "Edelman, David"

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    ItemOpen Access
    Characteristics and Delivery of Diabetes Shared Medical Appointments in North Carolina.
    (North Carolina medical journal, 2019-09) Drake, Connor; Kirk, Julienne K; Buse, John B; Edelman, David; Shea, Christopher M; Spratt, Susan; Young, Laura A; Kahkoska, Anna R
    BACKGROUND Successful diabetes care requires patient engagement and health self-management. Diabetes shared medical appointments (SMAs) are an evidence-based approach that enables peer support, diabetes group education, and medication management to improve outcomes. The purpose of this study is to learn how diabetes SMAs are being delivered in North Carolina, including the characteristics of diabetes SMAs across the state.METHOD Twelve health systems in the state of North Carolina were contacted to explore clinical workflow and intervention characteristics with a member of the SMA care delivery team. Surveys were used to assess intervention characteristics and delivery.RESULTS Diabetes SMAs were offered in 10 clinics in 5 of the 12 health systems contacted with considerable heterogeneity across sites. The majority of SMAs were open cohorts (80%), offered monthly (60%) for 1.5 hours (60%). SMAs included a mean of 7.5 ± 3.4 patients with a maximum of 11.2 ± 2.7 patients. Survey data revealed barriers (cost-sharing and provider buy-in) to, and facilitators (leadership support and clinical champions) of, clinical adoption and sustained implementation.LIMITATIONS External validity is limited due to the small sample size and geographic clustering.CONCLUSION There is significant heterogeneity in the delivery and characteristics of diabetes SMAs in North Carolina with only modest uptake across the health systems. Further research to determine best practices and effectiveness in diverse, real-world clinical settings is required to inform implementation and dissemination efforts.
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    Clinical factors associated with persistently poor diabetes control in the Veterans Health Administration: A nationwide cohort study.
    (PloS one, 2019-01) Alexopoulos, Anastasia-Stefania; Jackson, George L; Edelman, David; Smith, Valerie A; Berkowitz, Theodore SZ; Woolson, Sandra L; Bosworth, Hayden B; Crowley, Matthew J

    Objective

    Patients with persistent poorly-controlled diabetes mellitus (PPDM) despite engagement in clinic-based care are at particularly high risk for diabetes complications and costs. Understanding this population's demographics, comorbidities and care utilization could guide strategies to address PPDM. We characterized factors associated with PPDM in a large sample of Veterans with type 2 diabetes.

    Methods

    We identified a cohort of Veterans with medically treated type 2 diabetes, who received Veterans Health Administration primary care during fiscal years 2012 and 2013. PPDM was defined by hemoglobin A1c levels uniformly >8.5% during fiscal year (FY) 2012, despite engagement with care during this period. We used FY 2012 demographic, comorbidity and medication data to describe PPDM in relation to better-controlled diabetes patients and created multivariable models to examine associations between clinical factors and PPDM. We also constructed multivariable models to explore the association between PPDM and FY 2013 care utilization.

    Results

    In our cohort of diabetes patients (n = 435,820), 12% met criteria for PPDM. Patients with PPDM were younger than better-controlled patients, less often married, and more often Black/African-American and Hispanic or Latino/Latina. Of included comorbidities, only retinopathy (OR 1.68, 95% confidence interval (CI): 1.63,1.73) and nephropathy (OR 1.26, 95% CI: 1.19,1.34) demonstrated clinically significant associations with PPDM. Complex insulin regimens such as premixed (OR 10.80, 95% CI: 10.11,11.54) and prandial-containing regimens (OR 18.74, 95% CI: 17.73,19.81) were strongly associated with PPDM. Patients with PPDM had higher care utilization, particularly endocrinology care (RR 3.56, 95% CI: 3.47,3.66); although only 26.4% of patients saw endocrinology overall.

    Conclusion

    PPDM is strongly associated with complex diabetes regimens, although heterogeneity in care utilization exists. While there is evidence of underutilization, inadequacy of available care may also contribute to PPDM. Our findings should inform tailored approaches to meet the needs of PPDM, who are among the highest-risk, highest-cost patients with diabetes.
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    Do the benefits of participation in a hypertension self-management trial persist after patients resume usual care?
    (Circulation. Cardiovascular quality and outcomes, 2014-03) Maciejewski, Matthew L; Bosworth, Hayden B; Olsen, Maren K; Smith, Valerie A; Edelman, David; Powers, Benjamin J; Kaufman, Miriam A; Oddone, Eugene Z; Jackson, George L

    Background

    Hypertension self-management has been shown to improve systolic blood pressure (BP) control, but longer-term economic and clinical impacts are unknown. The purpose of this article is to examine clinical and economic outcomes 18 months after completion of a hypertension self-management trial.

    Methods and results

    This study is a follow-up analysis of an 18-month, 4-arm, hypertension self-management trial of 591 veterans with hypertension who were randomized to usual care or 1 of 3 interventions. Clinic-derived systolic blood pressure obtained before, during, and after the trial were estimated using linear mixed models. Inpatient admissions, outpatient expenditures, and total expenditures were estimated using generalized estimating equations. The 3 telephone-based interventions were nurse-administered health behavior promotion, provider-administered medication adjustments based on hypertension treatment guidelines, or a combination of both. Intervention calls were triggered by home BP values transmitted via telemonitoring devices. Clinical and economic outcomes were examined 12 months before, 18 months during, and 18 months after trial completion. Compared with usual care, patients randomized to the combined arm had greater improvement in proportion of BP control during and after the 18-month trial and estimated proportion of BP control improved 18 months after trial completion for patients in the behavioral and medication management arms. Among the patients with inadequate baseline BP control, estimated mean systolic BP was significantly lower in the combined arm as compared with usual care during and after the 18-month trial. Utilization and expenditure trends were similar for patients in all 4 arms.

    Conclusions

    Behavioral and medication management can generate systolic BP improvements that are sustained 18 months after trial completion.

    Clinical trial registration

    URL: http://www.clinicaltrials.gov. Unique identifier: NCT00237692.
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    Effect of a Comprehensive Telehealth Intervention vs Telemonitoring and Care Coordination in Patients With Persistently Poor Type 2 Diabetes Control: A Randomized Clinical Trial.
    (JAMA internal medicine, 2022-07-25) Crowley, Matthew J; Tarkington, Phillip E; Bosworth, Hayden B; Jeffreys, Amy S; Coffman, Cynthia J; Maciejewski, Matthew L; Steinhauser, Karen; Smith, Valerie A; Dar, Moahad S; Fredrickson, Sonja K; Mundy, Amy C; Strawbridge, Elizabeth M; Marcano, Teresa J; Overby, Donna L; Majette Elliott, Nadya T; Danus, Susanne; Edelman, David

    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.
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    Factors associated with persistent poorly controlled diabetes mellitus: clues to improving management in patients with resistant poor control.
    (Chronic illness, 2014-12) Crowley, Matthew J; Holleman, Rob; Klamerus, Mandi L; Bosworth, Hayden B; Edelman, David; Heisler, Michele

    Objectives

    Patients with persistent poorly controlled diabetes mellitus (PPDM), defined as an uninterrupted hemoglobin A1c >8.0% for ≥1 year despite standard care, are at high risk for complications. Additional research to define patient factors associated with PPDM could suggest barriers to improvement in this group and inform the development of targeted strategies to address these patients' resistant diabetes.

    Methods

    We analyzed patients with type 2 diabetes from a multi-site randomized trial. We characterized patients with PPDM relative to other patients using detailed survey data and multivariable modeling.

    Results

    Of 963 patients, 118 (12%) had PPDM, 265 (28%) were intermittently poorly controlled, and 580 (60%) were well-controlled. Patients with PPDM had younger age, earlier diabetes diagnosis, insulin use, higher antihypertensive burden, higher low-density lipoprotein cholesterol, and lower statin use relative to well-controlled patients. Among patients with objective adherence data (Veterans Affairs patients), a larger oral diabetes medication refill gap was associated with PPDM.

    Discussion

    Strategies are needed to target-specific barriers to improvement among patients whose diabetes is resistant to standard diabetes care. Our data suggest that strategies for targeting PPDM should accommodate younger patients' lifestyles, include medication management for insulin titration and comorbid disease conditions, and address barriers to self-management adherence.
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    Group physical therapy for veterans with knee osteoarthritis: study design and methodology.
    (Contemporary clinical trials, 2013-03) Allen, Kelli D; Bongiorni, Dennis; Walker, Tessa A; Bartle, John; Bosworth, Hayden B; Coffman, Cynthia J; Datta, Santanu K; Edelman, David; Hall, Katherine S; Hansen, Gloria; Jennings, Caroline; Lindquist, Jennifer H; Oddone, Eugene Z; Senick, Margaret J; Sizemore, John C; St John, Jamie; Hoenig, Helen
    Physical therapy (PT) is a key component of treatment for knee osteoarthritis (OA) and can decrease pain and improve function. Given the expected rise in prevalence of knee OA and the associated demand for treatment, there is a need for models of care that cost-effectively extend PT services for patients with this condition. This manuscript describes a randomized clinical trial of a group-based physical therapy program that can potentially extend services to more patients with knee OA, providing a greater number of sessions per patient, at lower staffing costs compared to traditional individual PT. Participants with symptomatic knee OA (n = 376) are randomized to either a 12-week group-based PT program (six 1 h sessions, eight patients per group, led by a physical therapist and physical therapist assistant) or usual PT care (two individual visits with a physical therapist). Participants in both PT arms receive instruction in an exercise program, information on joint care and protection, and individual consultations with a physical therapist to address specific functional and therapeutic needs. The primary outcome is the Western Ontario and McMasters Universities Osteoarthritis Index (self-reported pain, stiffness, and function), and the secondary outcome is the Short Physical Performance Test Protocol (objective physical function). Outcomes are assessed at baseline and 12-week follow-up, and the primary outcome is also assessed via telephone at 24-week follow-up to examine sustainability of effects. Linear mixed models will be used to compare outcomes for the two study arms. An economic cost analysis of the PT interventions will also be conducted.
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    Group Versus Individual Physical Therapy for Veterans With Knee Osteoarthritis: Randomized Clinical Trial.
    (Physical therapy, 2016-05) Allen, Kelli D; Bongiorni, Dennis; Bosworth, Hayden B; Coffman, Cynthia J; Datta, Santanu K; Edelman, David; Hall, Katherine S; Lindquist, Jennifer H; Oddone, Eugene Z; Hoenig, Helen

    Background

    Efficient approaches are needed for delivering nonpharmacological interventions for management of knee osteoarthritis (OA).

    Objective

    This trial compared group-based versus individual physical therapy interventions for management of knee OA.

    Design and methods

    Three hundred twenty patients with knee OA at the VA Medical Center in Durham, North Carolina, (mean age=60 years, 88% male, 58% nonwhite) were randomly assigned to receive either the group intervention (group physical therapy; six 1-hour sessions, typically 8 participants per group) or the individual intervention (individual physical therapy; two 1-hour sessions). Both programs included instruction in home exercise, joint protection techniques, and individual physical therapist evaluation. The primary outcome measure was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC; range=0-96, higher scores indicate worse symptoms), measured at baseline, 12 weeks, and 24 weeks. The secondary outcome measure was the Short Physical Performance Battery (SPPB; range=0-12, higher scores indicate better performance), measured at baseline and 12 weeks. Linear mixed models assessed the difference in WOMAC scores between arms.

    Results

    At 12 weeks, WOMAC scores were 2.7 points lower in the group physical therapy arm compared with the individual physical therapy arm (95% confidence interval [CI]=-5.9, 0.5; P=.10), indicating no between-group difference. At 24 weeks, WOMAC scores were 1.3 points lower in the group physical therapy arm compared with the individual physical therapy arm (95% CI=-4.6, 2.0; P=.44), indicating no significant between-group difference. At 12 weeks, SPPB scores were 0.1 points lower in the group physical therapy arm compared with the individual physical therapy arm (95% CI=-0.5, 0.2; P=.53), indicating no difference between groups.

    Limitations

    This study was conducted in one VA medical center. Outcome assessors were blinded, but participants and physical therapists were not blinded.

    Conclusions

    Group physical therapy was not more effective than individual physical therapy for primary and secondary study outcomes. Either group physical therapy or individual physical therapy may be a reasonable delivery model for health care systems to consider.
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    ItemOpen Access
    How Views of the Organization of Primary Care Among Patients with Hypertension Vary by Race or Ethnicity.
    (Military medicine, 2018-09) Jackson, George L; Stechuchak, Karen M; Weinberger, Morris; Bosworth, Hayden B; Coffman, Cynthia J; Kirshner, Miriam A; Edelman, David

    Introduction

    We assessed potential racial or ethnic differences in the degree to which veterans with pharmaceutically treated hypertension report experiences with their primary care system that are consistent with optimal chronic illness care as suggested by Wagner's Chronic Care Model (CCM).

    Materials and methods

    A cross-sectional analysis of the results of the Patient Assessment of Chronic Illness Care (PACIC), which measured components of the care system suggested by the CCM and was completed at baseline by participants in a hypertension disease management clinical trial. Participants had a recent history of uncontrolled systolic blood pressure.

    Results

    Among 377 patients, non-Hispanic African American veterans had almost twice the odds of indicating that their primary care experience is consistent with CCM features when compared with non-Hispanic White patients (odds ratio (OR) = 1.86; 95% confidence interval (CI) = 1.16-2.98). Similar statistically significant associations were observed for follow-up care (OR = 2.59; 95% CI = 1.49-4.50), patient activation (OR = 1.80; 95% CI = 1.13-2.87), goal setting (OR = 1.65; 95% CI = 1.03-2.64), and help with problem solving (OR = 1.62; 95% CI = 1.00-2.60).

    Conclusions

    Non-Hispanic African Americans with pharmaceutically treated hypertension report that the primary care system more closely approximates the Wagner CCM than non-Hispanic White patients.
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    Implementation of an Intensive Telehealth Intervention for Rural Patients with Clinic-Refractory Diabetes.
    (Journal of general internal medicine, 2022-09) Kobe, Elizabeth A; Lewinski, Allison A; Jeffreys, Amy S; Smith, Valerie A; Coffman, Cynthia J; Danus, Susanne M; Sidoli, Elisabeth; Greck, Beth D; Horne, Leanne; Saxon, David R; Shook, Susan; Aguirre, Lina E; Esquibel, Mary G; Evenson, Clarene; Elizagaray, Christopher; Nelson, Vivian; Zeek, Amanda; Weppner, William G; Scodellaro, Stephanie; Perdew, Cassie J; Jackson, George L; Steinhauser, Karen; Bosworth, Hayden B; Edelman, David; Crowley, Matthew J

    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.
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    Is there a nonadherent subtype of hypertensive patient? A latent class analysis approach.
    (Patient preference and adherence, 2010-07) Trivedi, Ranak B; Ayotte, Brian J; Thorpe, Carolyn T; Edelman, David; Bosworth, Hayden B
    To determine subtypes of adherence, 636 hypertensive patients (48% White, 34% male) reported adherence to medications, diet, exercise, smoking, and home blood pressure monitoring. A latent class analysis approach was used to identify subgroups that adhere to these five self-management behaviors. Fit statistics suggested two latent classes. The first class (labeled "more adherent") included patients with greater probability of adhering to recommendations compared with the second class (labeled "less adherent") with regard to nonsmoking (97.7% versus 76.3%), medications (75.5% versus 49.5%), diet (70.7% versus 46.9%), exercise (63.4% versus 27.2%), and blood pressure monitoring (32% versus 3.4%). Logistic regression analyses used to characterize the two classes showed that "more adherent" participants were more likely to report full-time employment, adequate income, and better emotional and physical well-being. Results suggest the presence of a less adherent subtype of hypertensive patients. Behavioral interventions designed to improve adherence might best target these at-risk patients for greater treatment efficiency.
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    Nurse-led behavioral management of diabetes and hypertension in community practices: a randomized trial.
    (J Gen Intern Med, 2015-05) Edelman, David; Dolor, Rowena J; Coffman, Cynthia J; Pereira, Katherine C; Granger, Bradi B; Lindquist, Jennifer H; Neary, Alice M; Harris, Amy J; Bosworth, Hayden B
    BACKGROUND: Several trials have demonstrated the efficacy of nurse telephone case management for diabetes (DM) and hypertension (HTN) in academic or vertically integrated systems. Little is known about the real-world potency of these interventions. OBJECTIVE: To assess the effectiveness of nurse behavioral management of DM and HTN in community practices among patients with both diseases. DESIGN: The study was designed as a patient-level randomized controlled trial. PARTICIPANTS: Participants included adult patients with both type 2 DM and HTN who were receiving care at one of nine community fee-for-service practices. Subjects were required to have inadequately controlled DM (hemoglobin A1c [A1c] ≥ 7.5%) but could have well-controlled HTN. INTERVENTIONS: All patients received a call from a nurse experienced in DM and HTN management once every two months over a period of two years, for a total of 12 calls. Intervention patients received tailored DM- and HTN- focused behavioral content; control patients received non-tailored, non-interactive information regarding health issues unrelated to DM and HTN (e.g., skin cancer prevention). MAIN OUTCOMES AND MEASURES: Systolic blood pressure (SBP) and A1c were co-primary outcomes, measured at 6, 12, and 24 months; 24 months was the primary time point. RESULTS: Three hundred seventy-seven subjects were enrolled; 193 were randomized to intervention, 184 to control. Subjects were 55% female and 50% white; the mean baseline A1c was 9.1% (SD = 1%) and mean SBP was 142 mmHg (SD = 20). Eighty-two percent of scheduled interviews were conducted; 69% of intervention patients and 70% of control patients reached the 24-month time point. Expressing model estimated differences as (intervention--control), at 24 months, intervention patients had similar A1c [diff = 0.1 %, 95 % CI (-0.3, 0.5), p = 0.51] and SBP [diff = -0.9 mmHg, 95% CI (-5.4, 3.5), p = 0.68] values compared to control patients. Likewise, DBP (diff = 0.4 mmHg, p = 0.76), weight (diff = 0.3 kg, p = 0.80), and physical activity levels (diff = 153 MET-min/week, p = 0.41) were similar between control and intervention patients. Results were also similar at the 6- and 12-month time points. CONCLUSIONS: In nine community fee-for-service practices, telephonic nurse case management did not lead to improvement in A1c or SBP. Gains seen in telephonic behavioral self-management interventions in optimal settings may not translate to the wider range of primary care settings.
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    ItemOpen Access
    Open-label randomized trial of titrated disease management for patients with hypertension: Study design and baseline sample characteristics.
    (Contemporary clinical trials, 2016-09) Jackson, George L; Weinberger, Morris; Kirshner, Miriam A; Stechuchak, Karen M; Melnyk, Stephanie D; Bosworth, Hayden B; Coffman, Cynthia J; Neelon, Brian; Van Houtven, Courtney; Gentry, Pamela W; Morris, Isis J; Rose, Cynthia M; Taylor, Jennifer P; May, Carrie L; Han, Byungjoo; Wainwright, Christi; Alkon, Aviel; Powell, Lesa; Edelman, David
    Despite the availability of efficacious treatments, only half of patients with hypertension achieve adequate blood pressure (BP) control. This paper describes the protocol and baseline subject characteristics of a 2-arm, 18-month randomized clinical trial of titrated disease management (TDM) for patients with pharmaceutically-treated hypertension for whom systolic blood pressure (SBP) is not controlled (≥140mmHg for non-diabetic or ≥130mmHg for diabetic patients). The trial is being conducted among patients of four clinic locations associated with a Veterans Affairs Medical Center. An intervention arm has a TDM strategy in which patients' hypertension control at baseline, 6, and 12months determines the resource intensity of disease management. Intensity levels include: a low-intensity strategy utilizing a licensed practical nurse to provide bi-monthly, non-tailored behavioral support calls to patients whose SBP comes under control; medium-intensity strategy utilizing a registered nurse to provide monthly tailored behavioral support telephone calls plus home BP monitoring; and high-intensity strategy utilizing a pharmacist to provide monthly tailored behavioral support telephone calls, home BP monitoring, and pharmacist-directed medication management. Control arm patients receive the low-intensity strategy regardless of BP control. The primary outcome is SBP. There are 385 randomized (192 intervention; 193 control) veterans that are predominately older (mean age 63.5years) men (92.5%). 61.8% are African American, and the mean baseline SBP for all subjects is 143.6mmHg. This trial will determine if a disease management program that is titrated by matching the intensity of resources to patients' BP control leads to superior outcomes compared to a low-intensity management strategy.
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    Patient perceptions of a comprehensive telemedicine intervention to address persistent poorly controlled diabetes.
    (Patient preference and adherence, 2017-01) Andrews, Sara M; Sperber, Nina R; Gierisch, Jennifer M; Danus, Susanne; Macy, Stephanie L; Bosworth, Hayden B; Edelman, David; Crowley, Matthew J

    Objective

    We studied a telemedicine intervention for persistent poorly controlled diabetes mellitus (PPDM) that combined telemonitoring, self-management support, and medication management. The intervention was designed for practical delivery using existing Veterans Affairs (VA) telemedicine infrastructure. To refine the intervention and inform the delivery of the intervention in other settings, we examined participants' experiences.

    Methods

    We conducted semistructured interviews with 18 Veterans who completed the intervention. We analyzed interview text using directed content analysis and categorized themes by hemoglobin A1c (HbA1c) improvement (<1% or ≥1%).

    Results

    Participants generally reported greater awareness of their blood glucose levels; however, they described dissatisfaction with the telemonitoring interface and competing demands during the intervention. Participants with <1% HbA1c improvement reported that these challenges interfered with their engagement. Participants with ≥1% HbA1c improvement reported new self-management routines despite challenges.

    Conclusion

    Despite competing demands and frustration with the telemonitoring interface, many participants demonstrated intervention engagement and substantial improvement in HbA1c ($1%). Differences in engagement may reflect differing capacity to manage treatment burden. Because it relies on existing infrastructure, this intervention is a promising model for addressing PPDM within VA. Future work should focus on optimizing systems' telemedicine infrastructure; while reliance on existing infrastructure may facilitate practical delivery, and it may also limit intervention engagement by excessively contributing to treatment burden.
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    Potassium Measures and Their Associations with Glucose and Diabetes Risk: The Multi-Ethnic Study of Atherosclerosis (MESA).
    (PLoS One, 2016) Chatterjee, Ranee; Zelnick, Leila; Mukamal, Kenneth J; Nettleton, Jennifer A; Kestenbaum, Bryan R; Siscovick, David S; Ix, Joachim H; Tracy, Russell; Hoofnagle, Andrew N; Svetkey, Laura P; Edelman, David; de Boer, Ian H
    BACKGROUND: Recent studies have found low-normal potassium (K) to be associated with increased diabetes risk. We sought to verify these associations in a multi-ethnic US cohort; and to determine if these associations extend to US Hispanics and Asian-Americans. METHODS: We analyzed data from Multi-Ethnic Study of Atherosclerosis (MESA) participants who were free-of-diabetes at baseline. We examined cross-sectional associations between measures of K-serum, dietary, and urine-with fasting glucose and HOMA-IR. We examined longitudinal associations between K and diabetes risk over 8 years. FINDINGS: In multivariable models, compared to those with higher serum K (≥4.5mmol/L), those with lower serum K (<4.0mmol/L) had significantly higher fasting glucose [1.3 mg/dL (95%CI 0.2, 2.4), P-value = 0.03]. Incident diabetes developed in 1281 of 5415 at-risk participants. In minimally-adjusted models, we found inverse associations between serum and dietary K and diabetes risk. Compared to those with higher serum K, those with lower serum K had an HR (95% CI) of incident diabetes of 1.23 (1.04, 1.47), P-value = 0.02. However, these associations were attenuated in fully-adjusted models. We found no significant interaction between potassium and ethnicity. CONCLUSIONS: In this multi-ethnic cohort, we found a significant inverse association between serum K and fasting glucose but no significant association with longer-term diabetes risk. This inverse association between potassium and glucose must be studied further to understand the physiology and its potential impact on chronic health.
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    Practical telehealth to improve control and engagement for patients with clinic-refractory diabetes mellitus (PRACTICE-DM): Protocol and baseline data for a randomized trial.
    (Contemporary clinical trials, 2020-11) Kobe, Elizabeth A; Edelman, David; Tarkington, Phillip E; Bosworth, Hayden B; Maciejewski, Matthew L; Steinhauser, Karen; Jeffreys, Amy S; Coffman, Cynthia J; Smith, Valerie A; Strawbridge, Elizabeth M; Szabo, Steven T; Desai, Shivan; Garrett, Mary P; Wilmot, Theresa C; Marcano, Teresa J; Overby, Donna L; Tisdale, Glenda A; Durkee, Melissa; Bullard, Susan; Dar, Moahad S; Mundy, Amy C; Hiner, Janette; Fredrickson, Sonja K; Majette Elliott, Nadya T; Howard, Teresa; Jeter, Deborah H; Danus, Susanne; Crowley, Matthew J

    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.
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    ItemOpen Access
    Serum potassium is a predictor of incident diabetes in African Americans with normal aldosterone: the Jackson Heart Study
    (AMERICAN JOURNAL OF CLINICAL NUTRITION, 2017-02) Chatterjee, Ranee; Davenport, Clemontina A; Svetkey, Laura P; Batch, Bryan C; Lin, Pao-Hwa; Ramachandran, Vasan S; Fox, Ervin R; Harman, Jane; Yeh, Hsin-Chieh; Selvin, Elizabeth; Correa, Adolfo; Butler, Kenneth; Edelman, David
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    Tailored Case Management for Diabetes and Hypertension (TEACH-DM) in a community population: study design and baseline sample characteristics.
    (Contemporary clinical trials, 2013-09) Crowley, Matthew J; Bosworth, Hayden B; Coffman, Cynthia J; Lindquist, Jennifer H; Neary, Alice M; Harris, Amy C; Datta, Santanu K; Granger, Bradi B; Pereira, Katherine; Dolor, Rowena J; Edelman, David

    Background

    Despite recognition of the benefits associated with well-controlled diabetes and hypertension, control remains suboptimal. Effective interventions for these conditions have been studied within academic settings, but interventions targeting both conditions have rarely been tested in community settings. We describe the design and baseline results of a trial evaluating a behavioral intervention among community patients with poorly-controlled diabetes and comorbid hypertension.

    Methods

    Tailored Case Management for Diabetes and Hypertension (TEACH-DM) is a 24-month randomized, controlled trial evaluating a telephone-delivered behavioral intervention for diabetes and hypertension versus attention control. The study recruited from nine community practices. The nurse-administered intervention targets 3 areas: 1) cultivation of healthful behaviors for diabetes and hypertension control; 2) provision of fundamentals to support attainment of healthful behaviors; and 3) identification and correction of patient-specific barriers to adopting healthful behaviors. Hemoglobin A1c and blood pressure measured at 6, 12, and 24 months are co-primary outcomes. Secondary outcomes include self-efficacy, self-reported medication adherence, exercise, and cost-effectiveness.

    Results

    Of 377 randomized patients, 193 were allocated to the intervention and 184 to attention control. The cohort is balanced in terms of gender, race, education level, and income. The cohort's mean baseline hemoglobin A1c and blood pressure are above goal, and mean baseline body mass index falls in the obese range. Baseline self-reported non-adherence is high for diabetes and hypertension medications. Trial results are pending.

    Conclusions

    If effective, the TEACH-DM intervention's telephone-based delivery strategy and nurse administration make it well-suited for rapid implementation and broad dissemination in community settings.
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    Telemedicine cardiovascular risk reduction in veterans.
    (American heart journal, 2013-04) Melnyk, S Dee; Zullig, Leah L; McCant, Felicia; Danus, Susanne; Oddone, Eugene; Bastian, Lori; Olsen, Maren; Stechuchak, Karen M; Edelman, David; Rakley, Susan; Morey, Miriam; Bosworth, Hayden B

    Background

    Patients with co-occurrence of hypertension, hyperlipidemia, and diabetes have an increased risk of cardiovascular disease (CVD) events. Comprehensive programs addressing both tailored patient self-management and pharmacotherapy are needed to address barriers to optimal cardiovascular risk reduction. We are examining a Clinical pharmacy specialist-, telephone-administered intervention, relying on home monitoring, with a goal of providing tailored medication and behavioral intervention to Veterans with CVD risk.

    Methods

    Randomized controlled trial including patients with hypertension (blood pressure >150/100 mm Hg) or elevated low density liporotein (>130 mg/dL). Longitudinal changes in CVD risk profile and improvement in health behaviors over time will be examined.

    Conclusion

    Given the national prevalence of CVD and the dismal rates of risk factor control, intensive but easily disseminated interventions are required to treat this epidemic. This study will be an important step in testing the effectiveness of a behavioral and medication intervention to improve CVD control among Veterans.
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    Veterans Affairs Primary Care Provider Perceptions of Insomnia Treatment.
    (Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2017-08) Ulmer, Christi S; Bosworth, Hayden B; Beckham, Jean C; Germain, Anne; Jeffreys, Amy S; Edelman, David; Macy, Stephanie; Kirby, Angela; Voils, Corrine I

    Study objectives

    Insomnia is a widespread issue among United States adults and rates of insomnia among veterans are even higher than the general population. Prior research examining primary care provider (PCP) perspectives on insomnia treatment found that: sleep hygiene and pharmacotherapy are the primary treatments offered; PCPs tend to focus on perceived causes of insomnia rather than the insomnia itself; and neither patients nor providers are satisfied with insomnia treatment options. Although insomnia complaints are typically first reported to primary care providers, little research has focused on perspectives regarding insomnia treatment among PCPs working in the largest integrated health care system in the United States-the Veterans Affairs (VA) health care system. This study was conducted to examine VA PCP perceptions of the availability of insomnia treatments, identify specific strategies offered by PCPs, and examine perceptions regarding the importance of treating insomnia and the role of comorbid conditions.

    Methods

    A survey was conducted within the VA health care system. Primary care providers completed surveys electronically.

    Results

    A high percentage of veterans (modal response = 20% to 39%) seen in VA primary care settings report an insomnia complaint to their provider. Almost half of respondents do not consistently document insomnia in the medical record (46% endorsed "sometimes," "rarely," or "never"). PCPs routinely advise sleep hygiene recommendations for insomnia (ie, avoid stimulants before bedtime [84.3%], and keep the bedroom environment quiet and dark and comfortable [68.6%]) and many are uncertain if cognitive behavioral therapy for insomnia is available at their facility (43.1%).

    Conclusions

    Findings point to the need for systems-level changes within health care systems, including the adoption of evidence-based clinical practice standards for insomnia and PCP education about the processes that maintain insomnia.

    Commentary

    A commentary on this article appears in this issue on page 937.