Matthew J. Crowley, Allison A. Lewinski, Qing Yang, Daniel Hatch, Anushka Palipana, Hayden B. Bosworth, Brystana G. Kaufman, Ranee Chatterjee, Gina Pennington, Doreen Matters, D M Lee, Diana Urlichich, Hailey Miller, Jashalynn German, Somin Sang, Benjamin Smith, Sarah Kokosa, Patrick Gregory, Cindy Leslie Roberson, Holly Canupp, RYAN J. SHAW
BACKGROUND: Comprehensive telehealth is used effectively for treatment-resistant chronic diseases in certain integrated health systems but has seldom been implemented in systems that provide mainly fee-for-service (FFS) care. OBJECTIVE: To examine the effectiveness and implementation of comprehensive telehealth delivered in an FFS environment for patients with uncontrolled type 2 diabetes (T2D) and comorbid hypertension. DESIGN: Pragmatic, randomized, effectiveness-implementation trial. (ClinicalTrials.gov: NCT05120544). SETTING: 6 academic primary care or endocrinology clinics. PARTICIPANTS: ) persistently at 8.0% or higher for at least 6 months and hypertension with at least 1 systolic blood pressure (BP) above 140 mm Hg or diastolic BP above 90 mm Hg in the past year. INTERVENTION: Two 12-month, mobile monitoring-enabled interventions: a self-monitoring control program and a nurse-delivered, comprehensive telehealth program incorporating self-management support and medication management. MEASUREMENTS: ) and secondary outcomes were evaluated at 12 months. Implementation analyses evaluated fidelity and barriers to intervention delivery. RESULTS: change at 12 months was -0.4 percentage points (95% CI, -1.0 to 0.3 percentage points). Between-group differences in change in secondary outcomes did not reach statistical significance, except for diabetes self-care (0.4 [CI, 0.0 to 0.9], favoring comprehensive telehealth). The comprehensive program was delivered with suboptimal fidelity (median encounters per participant, 9; fidelity threshold, ≥12); analyses identified barriers to program delivery. LIMITATION: Generalizability to dissimilar populations and systems lacking telehealth infrastructure may be limited. CONCLUSION: relative to control in this study. Population factors, intervention and control program design, and barriers to FFS implementation of comprehensive telehealth may have contributed to these findings. PRIMARY FUNDING SOURCE: National Institute of Nursing Research and Duke Clinical & Translational Science Institute.