Telehealth Education Leveraging Electronic Transitions Of Care for COPD Patients

NCT05897125 | Enrolling By Invitation DMC

• 1 other identifier: IRB21-1325
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

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.

Conditions

Care Transitions; COPD Exacerbation

Keywords

Medication education; Medication reconciliation; Medication Adherence

Outcome Measures

Primary Outcomes (2)

• 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)

  30 days post discharge

• Reach of the TELE-TOC intervention

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

  1-2 weeks post discharge

Secondary Outcomes (6)

• 30 day revisits

  30 -days

• 90 day revisits

  90 -days

• 180 day revisits

  180 -days

• Medication errors

  Within 30 days

• COPD Symptoms option 1

  Within 30 days

Study Arms (2)

TELE-TOC plus Usual Care

EXPERIMENTAL

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.

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 Care

ACTIVE COMPARATOR

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

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

Interventions

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

TELE-TOC plus Usual Care; Usual Care

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)

Also known as: Virtual At Home Medication Reconciliation

TELE-TOC plus Usual Care

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)

Also known as: Virtual At Home Inhaler Education

TELE-TOC plus Usual Care

COPD advanced practice nurse Inpatient Consult OTHER

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

Also known as: Inpatient consult

TELE-TOC plus Usual Care; Usual Care

Inpatient Medication Reconciliation OTHER

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

TELE-TOC plus Usual Care; Usual 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

TELE-TOC plus Usual Care; Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients younger than 18 years of age

Sponsors & Collaborators

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

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 DERIVED

Related Links

• Contextual Frameworks for Research on the Implementation of Complex System Interventions
• Centers for Medicare and Medicaid Services Hospital Readmission Reduction Program (HRRP)

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Valerie G Press, MD, MPH

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigators will remain masked to treatment group and data
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 randomization

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: June 9, 2023
• Study Start: February 19, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)