218 Participants Needed

Virtual Care Transition for COPD

(TELE-TOC Trial)

LT
VG
Overseen ByValerie G Press, MD, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Chicago
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on improving medication use, so it's possible you may continue your current regimen.

What data supports the effectiveness of this treatment for COPD?

Research shows that a COPD care service can improve access to follow-up care and patient education when transitioning from hospital to home, which is a key part of the virtual care transition treatment. Additionally, advanced nurse practitioners play a crucial role in enhancing rehabilitation programs for COPD, suggesting that their involvement in the treatment could be beneficial.12345

Is the Virtual Care Transition for COPD generally safe for humans?

The research suggests that medication reconciliation, a key part of the Virtual Care Transition for COPD, can help prevent medication errors and improve safety during care transitions. However, there were some potential adverse drug events noted, with nearly 50% classified as serious, indicating the importance of careful monitoring.678910

How does the Virtual Care Transition for COPD treatment differ from other treatments for COPD?

The Virtual Care Transition for COPD treatment is unique because it combines virtual at-home visits for medication education and reconciliation with advanced practice nurse consultations, aiming to improve care transitions from hospital to home. This approach is different from traditional treatments as it emphasizes virtual support and nurse-led care, which has been shown to reduce rehospitalizations and improve patient outcomes.311121314

Research Team

VG

Valerie G Press, MD, MPH

Principal Investigator

University of Chicago

Eligibility Criteria

This trial is for adults aged 40 or older who have been hospitalized with a COPD exacerbation and are part of the COPD Hospital Readmission Reduction Program. It's designed to help those at high risk for readmission and medication issues.

Inclusion Criteria

I am over 40 and hospitalized for a COPD flare-up.
Enrolled/seen by our COPD Hospital Readmission Reduction Program

Exclusion Criteria

I am younger than 40 years old.
I am currently in the intensive care unit.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the TELE-TOC intervention, which includes virtual, pharmacy-based, in-home visits for COPD patients to improve medication use and patient outcomes.

4 weeks
1 virtual visit

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of COPD symptoms and medication errors.

30 days

Long-term Follow-up

Participants are monitored for emergency department visits and/or re-hospitalization within 90 to 180 days of index admission.

180 days

Treatment Details

Interventions

  • COPD advanced practice nurse Inpatient Consult
  • Inpatient Medication Reconciliation
  • Post-discharge follow-up advanced practice nurse outpatient visit
  • Post-discharge nurse 48 hour phone follow-up call
  • Virtual At Home Medication Education Visit(s)
  • Virtual at Home Medication Reconciliation Visit(s)
Trial Overview The study tests a telehealth intervention called TELE-TOC, which includes virtual visits and pharmacy-based in-home support after hospital discharge, aiming to improve medication use and health outcomes in COPD patients.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: TELE-TOC plus Usual CareExperimental Treatment6 Interventions
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 II: Usual CareActive Control4 Interventions
Patients randomized to this arm will receive standard COPD care via the institution's COPD readmission reduction program.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials
1,086
Recruited
844,000+

Society of Hospital Medicine

Collaborator

Trials
6
Recruited
24,200+

COPD Foundation

Collaborator

Trials
18
Recruited
238,000+

Washington University School of Medicine

Collaborator

Trials
2,027
Recruited
2,353,000+

Hospital Medicine Reengineering Network (HOMERuN)

Collaborator

Trials
1
Recruited
200+

The American Telemedicine Association

Collaborator

Trials
1
Recruited
200+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials
415
Recruited
6,777,000+

Findings from Research

A chronic obstructive pulmonary disease (COPD) care service enhances timely access to follow-up care for patients transitioning from hospital to home, which is crucial for their recovery.
This service also improves patient education during the transition, helping patients better understand their condition and manage their health effectively.
Reducing COPD Readmission Rates: Using a COPD Care Service During Care Transitions.Portillo, EC., Wilcox, A., Seckel, E., et al.[2023]
The electronic medication reconciliation module significantly improved the accuracy of identifying and resolving medication discrepancies compared to the traditional paper-based method, with participants leaving fewer discrepancies unaddressed (0.45 vs. 1.55 discrepancies).
Although the electronic system did not reduce the time taken for reconciliation, it was highly rated for usability, with 17 out of 19 physicians preferring it over the paper method, indicating a positive reception for future integration into electronic medical records.
Evaluation of an Electronic Module for Reconciling Medications in Home Health Plans of Care.Kramer, HS., Gibson, B., Livnat, Y., et al.[2018]

References

Order Set to Improve the Care of Patients Hospitalized for an Exacerbation of Chronic Obstructive Pulmonary Disease. [2018]
Development of a patient-centred, evidence-based and consensus-based discharge care bundle for patients with acute exacerbation of chronic obstructive pulmonary disease. [2023]
Reducing COPD Readmission Rates: Using a COPD Care Service During Care Transitions. [2023]
[Nurse practitioners as key actors in pulmonary rehabilitation for chronic obstructive pulmonary disease]. [2022]
Nursing Outcomes and Risk Factors of Patients with Chronic Obstructive Pulmonary Disease After Discharge. [2022]
Engaging patients in medication reconciliation via a patient portal following hospital discharge. [2022]
Aligning medication reconciliation and secure messaging: qualitative study of primary care providers' perspectives. [2021]
Nurse-pharmacist collaboration on medication reconciliation prevents potential harm. [2022]
Reducing errors through discharge medication reconciliation by pharmacy services. [2022]
Evaluation of an Electronic Module for Reconciling Medications in Home Health Plans of Care. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
Transfer of care for outpatients with stable chronic obstructive pulmonary disease from respiratory care physician to respiratory nurse--a randomized controlled study. [2022]
Transitional care quality indicators to assess quality of care following hospitalisation for chronic obstructive pulmonary disease and heart failure: a systematic review protocol. [2020]
13.United Statespubmed.ncbi.nlm.nih.gov
APN-directed transitional home care model: achieving positive outcomes for patients with COPD. [2019]
The E-Coach technology-assisted care transition system: a pragmatic randomized trial. [2019]