Browsing by Author "Steinhauser, Karen"

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    Applied Rapid Qualitative Analysis to Develop a Contextually Appropriate Intervention and Increase the Likelihood of Uptake.
    (Medical care, 2021-06) Lewinski, Allison A; Crowley, Matthew J; Miller, Christopher; Bosworth, Hayden B; Jackson, George L; Steinhauser, Karen; White-Clark, Courtney; McCant, Felicia; Zullig, Leah L

    Background

    Rapid approaches to collecting and analyzing qualitative interview data can accelerate discovery timelines and intervention development while maintaining scientific rigor. We describe the application of these methods to a program designed to improve care coordination between the Veterans Health Administration (VHA) and community providers.

    Methods

    Care coordination between VHA and community providers can be challenging in rural areas. The Telehealth-based Coordination of Non-VHA Care (TECNO Care) intervention was designed to improve care coordination among VHA and community providers. To ensure contextually appropriate implementation of TECNO Care, we conducted preimplementation interviews with veterans, VHA administrators, and VHA and community providers involved in community care. Using both a rapid approach and qualitative analysis, an interviewer and 1-2 note-taker(s) conducted interviews.

    Results

    Over 5 months, 18 stakeholders were interviewed and we analyzed these data to identify how best to deliver TECNO Care. Responses relevant to improving care coordination include health system characteristics; target population; metrics and outcomes; challenges with the current system; and core components. Veterans who frequently visit VHA or community providers and are referred for additional services are at risk for poor outcomes and may benefit from additional care coordination. Using these data, we designed TECNO Care to include information on VHA services and processes, assist in the timely completion of referrals, and facilitate record sharing.

    Conclusion

    Rapid qualitative analysis can inform near real-time intervention development and ensure relevant content creation while setting the stage for stakeholder buy-in. Rigorous and timely analyses support the delivery of contextually appropriate, efficient, high-value patient care.
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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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    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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    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.