Telehealth Education Leveraging Electronic Transitions Of Care for COPD Patients

Официальное название

TELE-TOC: Telehealth Education Leveraging Electronic Transitions Of Care for COPD Patients

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Virtual at Home Medication Reconciliation Visit(s)
  Patients will have their medications reviewed by the TELE-TOC interventionalist, a member of the pharmacy team (anticipated)
• Поведенческое Virtual At Home Medication Education Visit(s)
  Patients will be provided with inhaler education by the TELE-TOC interventionalist, a member of the pharmacy team (anticipated)
• Другое COPD advanced practice nurse Inpatient Consult
  Patients will receive a COPD consult by an advanced practice nurse as part of standard of care
• Другое Inpatient Medication Reconciliation
  Patients will have their medications reviewed by member(s) of the clinical care team as part of standard of care
• Другое Post-discharge nurse 48 hour phone follow-up call
  Patients will receive a post-discharge nurse 48 hour phone follow-up call as part of standard of care
• Другое Post-discharge follow-up advanced practice nurse outpatient visit
  Patients will be scheduled for a 1-2 week post-discharge visit with the COPD advanced practice nurse as part of standard of care

Первичные конечные точки

• Correct inhaler technique 30 days post discharge [Срок оценки: 30 days post discharge]
• Reach of the TELE-TOC intervention [Срок оценки: 1-2 weeks post discharge]

Вторичные конечные точки (6)

• 30 day revisits [Срок оценки: 30 -days]
• 90 day revisits [Срок оценки: 90 -days]
• 180 day revisits [Срок оценки: 180 -days]
• Medication errors [Срок оценки: Within 30 days]
• COPD Symptoms option 1 [Срок оценки: Within 30 days]
• COPD Symptoms option 2 [Срок оценки: Within 30 days]

Критерии участия

Критерии включения

• Adults 18 years or older
• Admitted to the hospital on a general inpatient ward with a COPD Exacerbation
• Enrolled/seen by our COPD Hospital Readmission Reduction Program

Критерии исключения

• Patients younger than 18 years of age

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• University of Chicago — Chicago

Публикации

• Naylor MD, Aiken LH, Kurtzman ET, Olds DM, Hirschman KB. The care span: The importance of transitional care in achieving health reform. Health Aff (Millwood). 2011 Apr;30(4):746-54. doi: 10.1377/hlthaff.2011.0041. PMID 21471497
• Locke ER, Thomas RM, Woo DM, Nguyen EHK, Tamanaha BK, Press VG, Reiber GE, Kaboli PJ, Fan VS. Using Video Telehealth to Facilitate Inhaler Training in Rural Patients with Obstructive Lung Disease. Telemed J E Health. 2019 Mar;25(3):230-236. doi: 10.1089/tmj.2017.0330. Epub 2018 Jul 17. PMID 30016216
• Thomas RM, Locke ER, Woo DM, Nguyen EHK, Press VG, Layouni TA, Trittschuh EH, Reiber GE, Fan VS. Inhaler Training Delivered by Internet-Based Home Videoconferencing Improves Technique and Quality of Life. Respir Care. 2017 Nov;62(11):1412-1422. doi: 10.4187/respcare.05445. Epub 2017 Jul 18. PMID 28720676
• Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009 Apr 2;360(14):1418-28. doi: 10.1056/NEJMsa0803563. PMID 19339721
• Press VG, Au DH, Bourbeau J, Dransfield MT, Gershon AS, Krishnan JA, Mularski RA, Sciurba FC, Sullivan J, Feemster LC. Reducing Chronic Obstructive Pulmonary Disease Hospital Readmissions. An Official American Thoracic Society Workshop Report. Ann Am Thorac Soc. 2019 Feb;16(2):161-170. doi: 10.1513/AnnalsATS.201811-755WS. PMID 30707066
• Ramadurai D, Lee CT, Traeger L, Pucci G, Jackson-Sagredo A, Shah S, Abraham J, Arora VM, Press VG. 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. BMJ Open. 2025 Nov 4;15(11):e105521. doi: 10.1136/bmjopen-2025-105521. PMID 41193196

Идентификаторы

NCT: NCT05897125 · IRB21-1325

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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