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COPD ExacerbationTELE-TOCNCT05897125

Telehealth Education Leveraging Electronic Transitions Of Care for COPD Patients

A study testing Virtual at Home Medication Reconciliation Visit(s), Virtual At Home Medication Education Visit(s) and COPD advanced practice nurse Inpatient Consult in people with COPD Exacerbation and Care Transitions, run by University of Chicago at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COPD Exacerbation, Care Transitions
What is being tested?
Virtual at Home Medication Reconciliation Visit(s), Virtual At Home Medication Education Visit(s) and COPD advanced practice nurse Inpatient Consult
Could I receive a placebo?
No, everyone receives an active treatment
How many people
218 participants
Where
1 siteUnited States
Study dates
19 Feb 2025to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Patients younger than 18 years of age

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site
  • University of Chicago

    Chicago, Illinois, 60637

Other trials in United States

About this study

Official title: TELE-TOC: 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.

Read the 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.

Being tested
Virtual at Home Medication Reconciliation Visit(s), Virtual At Home Medication Education Visit(s), COPD advanced practice nurse Inpatient Consult, Inpatient Medication Reconciliation, Post-discharge nurse 48 hour phone follow-up call
Keywords
Medication education, Medication reconciliation, Medication Adherence
Medical subject headings
Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual at Home Medication Reconciliation Visit(s)Other

    Also called Virtual At Home Medication Reconciliation

    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)Behavioural

    Also called Virtual At Home Inhaler Education

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

  • COPD advanced practice nurse Inpatient ConsultOther

    Also called Inpatient consult

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

  • Inpatient Medication ReconciliationOther

    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 callOther

    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 visitOther

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

Study groups in NCT05897125
Study groupRoleWhat they receive
TELE-TOC plus Usual CareExperimentalPatients 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.
Receives: Other: Virtual at Home Medication Reconciliation Visit(s); Behavioral: Virtual At Home Medication Education Visit(s); Other: COPD advanced practice nurse Inpatient Consult; Other: Inpatient Medication Reconciliation; Other: Post-discharge nurse 48 hour phone follow-up call; Other: Post-discharge follow-up advanced practice nurse outpatient visit
Usual CareActive comparatorPatients randomized to this arm will receive standard COPD care via the institution's COPD readmission reduction program.
Receives: Other: COPD advanced practice nurse Inpatient Consult; Other: Inpatient Medication Reconciliation; Other: Post-discharge nurse 48 hour phone follow-up call; Other: Post-discharge follow-up advanced practice nurse outpatient visit

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correct inhaler technique 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)

    Measured: 30 days post discharge

  2. Reach of the TELE-TOC intervention

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

    Measured: 1-2 weeks post discharge

Secondary outcomes (6)
  1. 30 day revisits

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

    Measured: 30 -days

  2. 90 day revisits

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

    Measured: 90 -days

  3. 180 day revisits

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

    Measured: 180 -days

  4. Medication errors

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

    Measured: Within 30 days

  5. COPD Symptoms option 1

    Evaluation of COPD symptoms using COPD Assessment Test (CAT)

    Measured: Within 30 days

  6. COPD Symptoms option 2

    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]

    Measured: Within 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2023
  2. Study start19 Feb 2025
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
1:1 randomization
Masking
Single blind
Who is masked
Investigator
Enrolment
218 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05897125
Sponsor's protocol ID
IRB21-1325
Acronym
TELE-TOC
Status last verified
Jan 2026
First submitted
10 May 2023
Last updated
14 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified participant data, associated documentation, and study materials will be made available to other researchers following publication of the primary results. Data will be shared in accordance with institutional policies and data use agreements.

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 41193196

Questions about this trial

What is this clinical trial studying?

A study testing Virtual at Home Medication Reconciliation Visit(s), Virtual At Home Medication Education Visit(s) and COPD advanced practice nurse Inpatient Consult in people with COPD Exacerbation and Care Transitions, run by University of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correct inhaler technique 30 days post discharge (time frame: 30 days post discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05897125, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.

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