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Clinical Trial Summary

Transitions of Care (TOC) between hospital, ambulatory, and home settings for high-risk, frequently hospitalized adults with chronic diseases, such as chronic obstructive pulmonary disease (COPD) are complex, costly, and vulnerable to safety threats and poor health outcomes. One potential solution to address this gap in care is the Transitional Care Model (TCM), which utilizes a patient-centered approach with in-home interventions; since in-person in-home visits are costly, using innovative telehealth, such as virtual visits via teleconferencing may be just as effective with greater feasibility, scalability, and sustainability, particularly in the post-COVID-19 era as has been seen the rapid expansion of these technologies. With a transdisciplinary team of experts from cognitive science, care transitions/handoffs, human factors engineering, design, implementation science, and health services research, the study team proposes to implement and evaluate via a randomized clinical trial the "TELE-TOC: Telehealth Education: Leveraging Electronic Transitions Of Care for COPD patients," intervention which includes a virtual visit, pharmacy-based, in-home intervention for COPD patients to improve medication use and patient outcomes among a population at high risk for readmission and medication safety events.


Clinical Trial Description

Transitions of Care (TOC) for high-risk, frequently hospitalized adults with chronic diseases are complex, costly, and vulnerable to safety threats and poor health outcomes. Communication breakdowns, information lapses, and IT-induced unintended consequences can result in poor follow-up and medication non-adherence, both of which contribute to preventable readmissions or emergency room (ER) visits. The Transitional Care Model (TCM) aims to reduce such risks through a holistic, collaborative, patient-centered approach with in-home interventions. Prior to the coronavirus disease 2019 (COVID-19) pandemic, most in- home interventions relied on in-person visits, which can be cost-prohibitive and unsustainable. One potential sustainable and scalable solution is to use telehealth for in-home virtual visits; however, use of telehealth for post-discharge TOC interventions has not been routinely implemented. In the post-COVID-19 era, given the rapid expansion of telehealth, hospitals are well-positioned to initiate this virtual care. In-home virtual visits may be particularly promising for patients with chronic obstructive pulmonary disease (COPD), who are often hospitalized, have multiple comorbidities, and require intensive medication teaching due to rampant inhaler misuse. COPD affects more than 16 million US adults, many of whom are older, contribute ~$50 billion to healthcare costs annually, experience high rates of acute care revisits, often due to care coordination failures. For this reason, Medicare's Hospital Readmission Reduction Program (HRRP) aims to incentivize hospitals to implement TOC programs for increased quality and value of care for COPD patients. However, currently, such programs fall short of aligning with the full TCM. In-home interventions may be particularly salient for improving medication skills and outcomes for patients with COPD given rampant inhaler misuses, the effectiveness of in- hospital inhaler education, and evidence showing the need for inhaler education reinforcement post discharge. Thus, our trans-disciplinary team proposes to implement and evaluate "TELE-TOC: Telehealth Education: Leveraging Electronic Transitions Of Care for COPD patients," which seeks to integrate virtual, pharmacy-based, in-home visits for COPD patients within our hospital's existing COPD HRRP. The central hypotheses are that virtual visits with pharmacists will be feasible to implement and will result in improved medication use and outcomes among COPD patients at high risk for readmission. The investigator aims to iteratively design TELE-TOC using participatory study design and stakeholder input. The study team will then test the effectiveness of adding TELE-TOC virtual visits in a randomized controlled trial among COPD patients enrolled in the HRRP program. Lastly, the study team will develop a plan for a dissemination strategy and roadmap with national stakeholders to facilitate wide scale adoption of TELE-TOC nation wide. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05897125
Study type Interventional
Source University of Chicago
Contact Leah Traeger
Phone 773-834-4489
Email ltraeger@bsd.uchicago.edu
Status Not yet recruiting
Phase N/A
Start date September 1, 2024
Completion date December 31, 2025

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