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Telehealth Education Leveraging Electronic Transitions Of Care for COPD Patients

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

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05897125
Acronym
TELE-TOC
Enrollment
218
Registered
2023-06-09
Start date
2025-02-19
Completion date
2026-12-31
Last updated
2026-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Care Transitions, COPD Exacerbation

Keywords

Medication education, Medication reconciliation, Medication Adherence

Brief 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.

Detailed 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.

Interventions

OTHERVirtual at Home Medication Reconciliation Visit(s)

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

BEHAVIORALVirtual 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)

OTHERCOPD advanced practice nurse Inpatient Consult

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

OTHERInpatient Medication Reconciliation

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

OTHERPost-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

OTHERPost-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

Sponsors

Agency for Healthcare Research and Quality (AHRQ)
CollaboratorFED
Washington University School of Medicine
CollaboratorOTHER
Society of Hospital Medicine
CollaboratorOTHER
COPD Foundation
CollaboratorOTHER
Hospital Medicine Reengineering Network (HOMERuN)
CollaboratorUNKNOWN
The American Telemedicine Association
CollaboratorUNKNOWN
University of Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Masking description

Investigators will remain masked to treatment group and data

Intervention model description

1:1 randomization

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Correct inhaler technique 30 days post discharge30 days post dischargeCorrect inhaler technique within 30 days post-discharge compared to baseline technique in hospital based on standardized checklists (\<75% correct steps = misuse)
Reach of the TELE-TOC intervention1-2 weeks post dischargeProportion of patients receiving at home inhaler education within 1-2 weeks post discharge

Secondary

MeasureTime frameDescription
180 day revisits180 -daysproportion of patients with any emergency department visit and/or re-hospitalization within 180 days of index admission
Medication errorsWithin 30 daysProportion of patients with medication errors at TELE-TOC visit medication reconciliation
30 day revisits30 -daysproportion of patients with any emergency department visit and/or re-hospitalization within 30 days of index admission
COPD Symptoms option 2Within 30 daysEvaluation of COPD symptoms using the modified medical Research Council Scale (mmRC) \[Scale = 0 to 4; 0 (better) = Breathlessness only on strenuous exercise; 4 (worse)= too breathless to leave the house or breathless when dressing or undressing\]
COPD Symptoms option 1Within 30 daysEvaluation of COPD symptoms using COPD Assessment Test (CAT)
90 day revisits90 -daysproportion of patients with any emergency department visit and/or re-hospitalization within 90 days of index admission

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026