Telehealth Education Leveraging Electronic Transitions Of Care for COPD Patients (TELE-TOC): a study protocol for a type II hybrid effectiveness-implementation randomised, pragmatic clinical trial of a pharmacist-led intervention

利用电子化护理过渡流程进行远程医疗教育以改善慢性阻塞性肺病患者的护理(TELE-TOC):一项由药剂师主导的干预措施的II型混合效果-实施随机实用性临床试验的研究方案

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Abstract

INTRODUCTION: Transitions of care (TOC) between hospital, ambulatory and home settings for high-risk adults with chronic diseases are complex, costly and often result in poor health outcomes. Suboptimal care transitions lead to medication errors, non-adherence, decreased self-management skills and inadequate follow-up, all of which contribute to readmissions or emergency department visits. The Transitional Care Model aims to address these challenges through patient-centred, in-home interventions. We propose to implement and evaluate TELE-TOC: Telehealth Education Leveraging Electronic Transitions Of Care for Chronic Obstructive Pulmonary Disease (COPD) patients. This study will evaluate the added value of a virtual, pharmacy-based intervention integrated into an existing COPD TOC program within a single healthcare system. METHODS AND ANALYSIS: Informed by the Proctor Framework implementation, service and health outcome domains, we will conduct a randomised controlled trial comparing the addition of at-home pharmacy team-based virtual visits to the standard of care (ie, our existing COPD TOC programme). Adult patients hospitalised for a COPD exacerbation will be randomised to receive the standard COPD TOC programme alone or the standard programme plus TELE-TOC virtual at-home pharmacy visits. We will use a pragmatic type II hybrid effectiveness-implementation trial. The primary effectiveness outcome is inhaler technique at 30 days postdischarge, and the primary implementation outcome is the proportion of patients receiving the intervention. Intention-to-treat analysis will be applied to all outcomes with χ² and logistic regression models adjusting for demographic factors. Treatment effects through 30 days will be assessed with generalised estimating equations and generalised linear mixed models. ETHICS AND DISSEMINATION: This study, the waiver of consent and the opt-out flyer were approved by the University of Chicago Institutional Review Board (23-0934). Dissemination of the findings is planned for up to 4 years of completion of the study to local, regional and national conferences and peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT05897125.

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