Telehealth Education Leveraging Electronic Transitions Of Care for COPD Patients

NCT ID: NCT05897125

Last Updated: 2026-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

218 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-19

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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COPD Exacerbation Care Transitions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1:1 randomization
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators
Investigators will remain masked to treatment group and data

Study Groups

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TELE-TOC plus Usual Care

Patients randomized to this arm will receive the TELE-TOC intervention as well as the standard COPD care via the institution's COPD readmission reduction program.

Group Type EXPERIMENTAL

Virtual at Home Medication Reconciliation Visit(s)

Intervention Type OTHER

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

Virtual At Home Medication Education Visit(s)

Intervention Type BEHAVIORAL

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

COPD advanced practice nurse Inpatient Consult

Intervention Type OTHER

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

Inpatient Medication Reconciliation

Intervention Type 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

Intervention Type 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

Intervention Type 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

Usual Care

Patients randomized to this arm will receive standard COPD care via the institution's COPD readmission reduction program.

Group Type ACTIVE_COMPARATOR

COPD advanced practice nurse Inpatient Consult

Intervention Type OTHER

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

Inpatient Medication Reconciliation

Intervention Type 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

Intervention Type 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

Intervention Type 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

Interventions

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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)

Intervention Type OTHER

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)

Intervention Type BEHAVIORAL

COPD advanced practice nurse Inpatient Consult

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

Intervention Type OTHER

Inpatient Medication Reconciliation

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

Other Intervention Names

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Virtual At Home Medication Reconciliation Virtual At Home Inhaler Education Inpatient consult

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role collaborator

Society of Hospital Medicine

OTHER

Sponsor Role collaborator

COPD Foundation

OTHER

Sponsor Role collaborator

Hospital Medicine Reengineering Network (HOMERuN)

UNKNOWN

Sponsor Role collaborator

The American Telemedicine Association

UNKNOWN

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Valerie G Press, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 21471497 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30016216 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28720676 (View on PubMed)

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. Erratum In: N Engl J Med. 2011 Apr 21;364(16):1582.

Reference Type BACKGROUND
PMID: 19339721 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30707066 (View on PubMed)

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.

Reference Type DERIVED
PMID: 41193196 (View on PubMed)

Related Links

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https://www.ncbi.nlm.nih.gov/books/NBK196199

Contextual Frameworks for Research on the Implementation of Complex System Interventions

https://www.cms.gov/medicare/medicare-fee-for-service-payment/acuteinpatientpps/readmissions-reduction-program

Centers for Medicare and Medicaid Services Hospital Readmission Reduction Program (HRRP)

Other Identifiers

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IRB21-1325

Identifier Type: -

Identifier Source: org_study_id

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