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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.

ABSTRACT: 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.

SUBMITTER: Kobe EA

PROVIDER: S-EPMC7505207 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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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.

Kobe Elizabeth A EA Edelman David D Tarkington Phillip E PE Bosworth Hayden B HB Maciejewski Matthew L ML Steinhauser Karen K Jeffreys Amy S AS Coffman Cynthia J CJ Smith Valerie A VA Strawbridge Elizabeth M EM Szabo Steven T ST Desai Shivan S Garrett Mary P MP Wilmot Theresa C TC Marcano Teresa J TJ Overby Donna L DL Tisdale Glenda A GA Durkee Melissa M Bullard Susan S Dar Moahad S MS Mundy Amy C AC Hiner Janette J Fredrickson Sonja K SK Majette Elliott Nadya T NT Howard Teresa T Jeter Deborah H DH Danus Susanne S Crowley Matthew J MJ

Contemporary clinical trials 20200921

<h4>Background</h4>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 comprehe ...[more]

PMID: 32971277

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Project description: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. 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. Mixed-methods implementation study. 230 patients with clinic-refractory, uncontrolled T2D. 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. Implementation was evaluated using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. The primary effectiveness outcome was hemoglobin A1c (HbA1c). 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. 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.

Project description:PurposeTo improve cardiovascular care through supporting primary care practices' adoption of evidence-based guidelines.Study designA cluster randomized trial compared two approaches: (1) standard practice support (practice facilitation, practice assessment with feedback, health information technology assistance, and collaborative learning sessions) and (2) standard support plus patient engagement support.MethodsPrimary outcomes were cardiovascular clinical quality measures (CQMs) collected at baseline, 9 months, and 15 months. Implementation of the first 6 "Building Blocks of High-Performing Primary Care" was assessed by practice facilitators at baseline and 3, 6, and 9 months. CQMs from practices not involved in the study served as an external comparison.ResultsA total of 211 practices completed baseline surveys. There were no differences by study arm (odds ratio [95% confidence interval]) for aspirin use (1.03 [0.99, 1.06]), blood pressure (0.98 [0.95, 1.01]), cholesterol (0.96 [0.92, 1.00]), and smoking (1.01 [0.96, 1.07]); however, there were significant improvements over time in aspirin use (1.04 [1.01, 1.07]), cholesterol (1.05 [1.03, 1.08]), and smoking (1.03 [1.01, 1.06]), but not blood pressure (1.01 [0.998, 1.03]). Improvement in enrolled practices was greater than external comparison practices across all 4 measures (all P < .05). Implementation improved in both arms for Team-Based Care, Patient-Team Partnership, and Population Management, and improvement was greater in enhanced intervention practices (all P < .05). Leadership and Data-Driven Improvement (P < .05) improved significantly, with no difference by arm. A greater improvement in Building Block implementation was associated with a greater improvement in blood pressure measures (P < .05).ConclusionsPractice transformation support can assist practices with improving quality of care. Patient engagement in practice transformation can further enhance practices' implementation of aspects of new models of care.

Project description:Background Despite lower cancer incidence rates, cancer mortality is higher among rural compared to urban dwellers. Patient, provider, and institutional level factors contribute to these disparities. The overarching objective of this study is to leverage the multidisciplinary, multispecialty oncology team from an academic cancer center in order to provide comprehensive cancer care at both the patient and provider levels in rural healthcare centers. Our specific aims are to: 1) evaluate the clinical effectiveness of a multi-level telehealth-based intervention consisting of provider access to molecular tumor board expertise along with patient access to a supportive care intervention to improve cancer care delivery; and 2) identify the facilitators and barriers to future larger scale dissemination and implementation of the multi-level intervention. Methods Coordinated by a National Cancer Institute-designated comprehensive cancer center, this study will include providers and patients across several clinics in two large healthcare systems serving rural communities. Using a telehealth-based molecular tumor board, sequencing results are reviewed, predictive and prognostic markers are discussed, and treatment plans are formulated between expert oncologists and rural providers. Simultaneously, the rural patients will be randomized to receive an evidence-based 6-week self-management supportive care program, Cancer Thriving and Surviving, versus an education attention control. Primary outcomes will be provider uptake of the molecular tumor board recommendation and patient treatment adherence. A mixed methods approach guided by the Consolidated Framework for Implementation Research that combines qualitative key informant interviews and quantitative surveys will be collected from both the patient and provider in order to identify facilitators and barriers to implementing the multi-level intervention. Discussion The proposed study will leverage information technology-enabled, team-based care delivery models in order to deliver comprehensive, coordinated, and high-quality cancer care to rural and/or underserved populations. Simultaneous attention to institutional, provider, and patient level barriers to quality care will afford the opportunity for us to broadly share oncology expertise and develop dissemination and implementation strategies that will enhance the cancer care delivered to patients residing within underserved rural communities. Trial registration Clinicaltrials.gov, NCT04758338. Registered 17 February 2021 – Retrospectively registered, http://www.clinicaltrials.gov/ Supplementary Information The online version contains supplementary material available at 10.1186/s12885-021-08949-4.

Dataset Information

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

Publications

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

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