Skip to main content
Clinical Trials/NCT05897125
NCT05897125
Enrolling By Invitation
Not Applicable

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

University of Chicago1 site in 1 country218 target enrollmentFebruary 19, 2025

Overview

Phase
Not Applicable
Intervention
Virtual at Home Medication Reconciliation Visit(s)
Conditions
COPD Exacerbation
Sponsor
University of Chicago
Enrollment
218
Locations
1
Primary Endpoint
Correct inhaler technique 30 days post discharge
Status
Enrolling By Invitation
Last Updated
3 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 19, 2025
End Date
December 31, 2026
Last Updated
3 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

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.

Intervention: Virtual at Home Medication Reconciliation Visit(s)

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.

Intervention: Virtual At Home Medication Education Visit(s)

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.

Intervention: COPD advanced practice nurse Inpatient Consult

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.

Intervention: Inpatient Medication Reconciliation

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.

Intervention: Post-discharge nurse 48 hour phone follow-up call

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.

Intervention: Post-discharge follow-up advanced practice nurse outpatient visit

Usual Care

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

Intervention: COPD advanced practice nurse Inpatient Consult

Usual Care

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

Intervention: Inpatient Medication Reconciliation

Usual Care

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

Intervention: Post-discharge nurse 48 hour phone follow-up call

Usual Care

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

Intervention: Post-discharge follow-up advanced practice nurse outpatient visit

Outcomes

Primary Outcomes

Correct inhaler technique 30 days post discharge

Time Frame: 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)

Reach of the TELE-TOC intervention

Time Frame: 1-2 weeks post discharge

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

Secondary Outcomes

  • COPD Symptoms option 1(Within 30 days)
  • 90 day revisits(90 -days)
  • 30 day revisits(30 -days)
  • Medication errors(Within 30 days)
  • COPD Symptoms option 2(Within 30 days)
  • 180 day revisits(180 -days)

Study Sites (1)

Loading locations...

Similar Trials