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Enrolling by Invitation

NCT Number: NCT05897125

Telehealth Education Leveraging Electronic Transitions Of Care for COPD Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Patients younger than 18 years of age

Treatment and study plan

Virtual at Home Medication Reconciliation Visit(s)

Other

Patients will have their medications reviewed by the TELE-TOC interventionalist, a member of the pharmacy team (anticipated)

Other names: Virtual At Home Medication Reconciliation

Virtual At Home Medication Education Visit(s)

Behavioral

Patients will be provided with inhaler education by the TELE-TOC interventionalist, a member of the pharmacy team (anticipated)

Other names: Virtual At Home Inhaler Education

COPD advanced practice nurse Inpatient Consult

Other

Patients will receive a COPD consult by an advanced practice nurse as part of standard of care

Other names: Inpatient consult

Inpatient Medication Reconciliation

Other

Patients will have their medications reviewed by member(s) of the clinical care team as part of standard of care

Post-discharge nurse 48 hour phone follow-up call

Other

Patients will receive a post-discharge nurse 48 hour phone follow-up call as part of standard of care

Post-discharge follow-up advanced practice nurse outpatient visit

Other

Patients will be scheduled for a 1-2 week post-discharge visit with the COPD advanced practice nurse as part of standard of care

Primary outcomes

  1. Correct inhaler technique 30 days post discharge

    Time frame: 30 days post discharge

    Correct inhaler technique within 30 days post-discharge compared to baseline technique in hospital based on standardized checklists (<75% correct steps = misuse)

  2. Reach of the TELE-TOC intervention

    Time frame: 1-2 weeks post discharge

    Proportion of patients receiving at home inhaler education within 1-2 weeks post discharge

Secondary outcomes

  1. 30 day revisits

    Time frame: 30 -days

    proportion of patients with any emergency department visit and/or re-hospitalization within 30 days of index admission

  2. 90 day revisits

    Time frame: 90 -days

    proportion of patients with any emergency department visit and/or re-hospitalization within 90 days of index admission

  3. 180 day revisits

    Time frame: 180 -days

    proportion of patients with any emergency department visit and/or re-hospitalization within 180 days of index admission

  4. Medication errors

    Time frame: Within 30 days

    Proportion of patients with medication errors at TELE-TOC visit medication reconciliation

  5. COPD Symptoms option 1

    Time frame: Within 30 days

    Evaluation of COPD symptoms using COPD Assessment Test (CAT)

  6. COPD Symptoms option 2

    Time frame: Within 30 days

    Evaluation of COPD symptoms using the modified medical Research Council Scale (mmRC) [Scale = 0 to 4; 0 (better) = Breathlessness only on strenuous exercise; 4 (worse)= too breathless to leave the house or breathless when dressing or undressing]

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)
  • COPD Foundation
  • Hospital Medicine Reengineering Network (HOMERuN)
  • Society of Hospital Medicine
  • The American Telemedicine Association
  • Washington University School of Medicine

Registry information

Official study title

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

Acronym: TELE-TOC

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 9, 2023
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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