COPD Care Transition Programs for Chronic Obstructive Pulmonary Disease

(REVISITS Trial)

Overseen By Valerie G Press, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which COPD (chronic obstructive pulmonary disease) care transition programs best reduce hospital visits. It compares virtual and in-person programs, both featuring mentoring, with some also incorporating co-design (a collaborative approach to improving care methods). The focus is on maximizing the effectiveness and sustainability of these programs. This study targets individuals who frequently experience hospitalizations due to COPD. As an unphased trial, it offers a unique opportunity to contribute to innovative care solutions that could enhance the quality of life for COPD patients.

Do I need to stop taking my current medications for this trial?

The trial protocol does not specify whether participants need to stop taking their current medications.

What prior data suggests that these COPD care transition programs are safe?

Research has shown that both online and in-person programs for managing COPD are generally safe and well-received. Patients in similar programs have experienced positive outcomes, such as reduced COPD-related hospital visits and improved management of this chronic lung condition.

For online programs, studies have found that telehealth (remote healthcare services) is effective and safe for COPD patients. These programs often include virtual visits, where patients and healthcare providers connect through video calls. This method has been linked to fewer hospitalizations and better self-management of the disease.

In-person programs also show promise by offering face-to-face support, which can be beneficial for some patients. Research indicates that these programs improve care by providing easy access to health information and support.

Overall, both types of programs have been used safely in previous studies. They aim to enhance COPD management and reduce hospital visits, offering encouragement for patients considering such programs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these COPD care transition programs because they utilize innovative delivery methods that could significantly enhance patient outcomes. Unlike standard treatments that often rely on medications and intermittent doctor visits, these programs offer personalized care through virtual and in-person interventions, combined with virtual mentoring and co-design support. The use of tele-conferencing technology allows for continuous two-way interaction, which can improve adherence and provide real-time support tailored to individual needs. By incorporating a mentored implementation model, these programs aim to make hospital-based quality improvements more sustainable and effective over the long term. This approach could revolutionize how COPD patients transition through different stages of care, potentially leading to better health outcomes and quality of life.

What evidence suggests that this trial's COPD care transition programs could be effective?

Research has shown that programs designed to help people with COPD (Chronic Obstructive Pulmonary Disease) transition from hospital to home can reduce hospital readmissions and improve health outcomes. This trial will compare different approaches to these programs. One arm will focus on virtual intervention delivery with virtual mentoring, which studies have found reduces hospital readmissions for COPD patients within 7 and 30 days after discharge. Another arm will test in-person intervention delivery with virtual mentoring, linked to better management during the transition from hospital to home, potentially lowering death rates and aiding recovery. Both types of support use mentoring and involve patients in planning to enhance effectiveness and longevity. Overall, these programs aim to smooth the transition and keep patients healthier. ^{6 7 8 9 10}

Who Is on the Research Team?

Valerie G Press, MD, MPH

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for US hospital sites, not individuals. It's designed to compare the effectiveness of virtual versus in-person care transition programs for patients with Chronic Obstructive Pulmonary Disease (COPD).

Inclusion Criteria

Specific individuals who meet these criteria are not applicable since Aim 2 will only enroll hospital sites, not individuals

The sites the investigators enroll will represent diverse patient populations and geographical locations across the US.

Enrollment for Aim 2 will occur on a site/system-level

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of COPD care transition programs via virtual or in-person delivery with virtual mentoring over a one-year period

12 months

Monthly virtual mentoring sessions

Follow-up

Participants are monitored for sustainability of intervention and implementation outcomes at 6, 12, 18, and 24 months post-implementation

24 months

What Are the Treatments Tested in This Trial?

Interventions

• COPD Transitions of Care Intervention Bundle: In-Person Interventions
• COPD Transitions of Care Intervention Bundle: Virtual Interventions

Trial Overview The study tests two COPD care transition interventions: one delivered in person and the other virtually. Both are supported by mentoring, with some sites also using co-design methods to implement these programs.

How Is the Trial Designed?

Group I: Virtual intervention delivery with virtual mentoring with co-design Experimental Treatment 1 Intervention

The implemented interventions will be virtual and will include virtual mentoring and co-design support with our study partner, Onda Collective. The mentored implementation model (MIM) is an evidence-based strategy to promote the success and sustainability of hospital-based quality improvement (QI) initiatives. After completing the contextual assessments and pre-implementation planning in Aim 1, the investigators will collaborate with the SHM to harness their expertise with the MIM to implement the COPD Program over a one-year period during Aim 2 (implementation). Virtual Mentored Implementation involves implementing their assigned care transition program intervention delivery method using an innovative virtual mentored implementation approach using tele-conferencing technology (i.e., video-conferences) for two-way visualization of individuals in different locations for educational purposes. Monthly mentoring sessions will occur to maximize mentors' input.

Group II: Virtual intervention delivery with virtual mentoring Experimental Treatment 1 Intervention

The implemented interventions will be virtual and will include virtual mentoring. The mentored implementation model (MIM) is an evidence-based strategy to promote the success and sustainability of hospital-based quality improvement (QI) initiatives. After completing the contextual assessments and pre-implementation planning in Aim 1, the investigators will collaborate with the SHM to harness their expertise with the MIM to implement the COPD Program over a one-year period during Aim 2 (implementation). Virtual Mentored Implementation involves implementing their assigned care transition program intervention delivery method using an innovative virtual mentored implementation approach using tele-conferencing technology (i.e., video-conferences) for two-way visualization of individuals in different locations for educational purposes. Monthly mentoring sessions will occur to maximize mentors' input.

Group III: In-person intervention delivery with virtual mentoring and co-design Experimental Treatment 1 Intervention

The implemented interventions will be in-person and will include virtual mentoring and co-design support with our study partner, Onda Collective. The mentored implementation model (MIM) is an evidence-based strategy to promote the success and sustainability of hospital-based quality improvement (QI) initiatives. After completing the contextual assessments and pre-implementation planning in Aim 1, the investigators will collaborate with the SHM to harness their expertise with the MIM to implement the COPD Program over a one-year period during Aim 2 (implementation). Virtual Mentored Implementation involves implementing their assigned care transition program intervention delivery method using an innovative virtual mentored implementation approach using tele-conferencing technology (i.e., video-conferences) for two-way visualization of individuals in different locations for educational purposes. Monthly mentoring sessions will occur to maximize mentors' input.

Group IV: In-person intervention delivery with virtual mentoring Experimental Treatment 1 Intervention

The implemented interventions will be in-person and will include virtual mentoring. The mentored implementation model (MIM) is an evidence-based strategy to promote the success and sustainability of hospital-based quality improvement (QI) initiatives. After completing the contextual assessments and pre-implementation planning in Aim 1, the investigators will collaborate with the SHM to harness their expertise with the MIM to implement the COPD Program over a one-year period during Aim 2 (implementation). Virtual Mentored Implementation involves implementing their assigned care transition program intervention delivery method using an innovative virtual mentored implementation approach using tele-conferencing technology (i.e., video-conferences) for two-way visualization of individuals in different locations for educational purposes. Monthly mentoring sessions will occur to maximize mentors' input.

COPD Transitions of Care Intervention Bundle: In-Person Interventions is already approved in United States, European Union for the following indications:

Approved in United States as COPD Management Programs for:

• Chronic Obstructive Pulmonary Disease

Approved in European Union as COPD Care Transition Programs for:

• Chronic Obstructive Pulmonary Disease

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

The Hospital Medicine Reengineering Network (HOMERuN)

Collaborator

Trials

1

Recruited

20+

Onda Collective

Collaborator

Trials

1

Recruited

20+

COPD Foundation

Collaborator

Trials

18

Recruited

238,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Society of Hospital Medicine

Collaborator

Trials

6

Recruited

24,200+

Published Research Related to This Trial

Chronic obstructive pulmonary disease (COPD) leads to high rates of emergency department admissions, with nearly one-third of patients experiencing re-admissions within 28 days after discharge, indicating a critical need for improved post-discharge care.

Implementing a COPD discharge bundle, which consists of evidence-based practices, could potentially reduce hospital readmissions, but there is currently no consensus on which specific interventions should be included, highlighting the need for further research to optimize these care strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Care Bundles after Discharging Patients with Chronic Obstructive Pulmonary Disease Exacerbation from the Emergency Department. Gómez-Angelats, E., Sánchez, C.[2023]

The implementation of care bundles for patients with acute exacerbations of COPD (AECOPD) in a study involving 11,748 patients led to a significant reduction in both mortality and length of hospital stay.

Better outcomes, including higher completion rates of care bundles, were associated with specialist respiratory reviews, suggesting that expert involvement enhances the effectiveness of care for AECOPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A care-bundles approach to improving standard of care in AECOPD admissions: results of a national project. Turner, AM., Lim, WS., Rodrigo, C., et al.[2019]

Individuals with advanced COPD require comprehensive care that goes beyond medication to effectively manage both respiratory issues and related health problems, especially during the critical peri-exacerbation period.

Pulmonary rehabilitation and integrated care models, which focus on patient-centered and coordinated approaches, are essential for improving outcomes in COPD patients, particularly after hospital discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated Care in Chronic Obstructive Pulmonary Disease and Rehabilitation. Nici, L., ZuWallack, R.[2019]

The transition care bundle (TCB) for managing COPD patients after hospital discharge significantly reduced hospital readmission rates and emergency department visits compared to usual care, indicating its efficacy in improving patient outcomes.

The TCB was also associated with lower healthcare costs, with an average cost of CAN$10,172 compared to CAN$15,588 for usual care, demonstrating that this approach is not only effective but also economically beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost Analysis of a Transition Care Bundle Compared with Usual Care for COPD Patients Being Discharged from Hospital: Evaluation of a Randomized Controlled Trial. Yan, C., Round, J., Akpinar, I., et al.[2023]

Self-management strategies, including written action plans and patient coaching, can significantly reduce hospital admissions for COPD exacerbations, improve quality of life, and are cost-effective.

Domiciliary care and discharge care bundles, which include personalized treatments and support, can help prevent readmissions and improve the transition from hospital to home for COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Models of care across the continuum of exacerbations for patients with chronic obstructive pulmonary disease. Bourbeau, J., Echevarria, C.[2021]

A study involving 363 patients with COPD showed that implementing an evidence-based care bundle significantly reduced 30-day readmission rates from 38.3% to 22.4%.

The care bundle also led to substantial decreases in 60-day and 90-day readmission rates, indicating that this approach effectively improves patient management and reduces hospitalizations for COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decreasing Hospital Readmissions Utilizing an Evidence-Based COPD Care Bundle. Kendra, M., Mansukhani, R., Rudawsky, N., et al.[2022]

COPD discharge bundles, which are sets of evidence-based practices, have been shown to significantly reduce hospital readmissions for patients after an exacerbation, with a pooled risk ratio of 0.80 based on data from four clinical trials.

However, the review found insufficient evidence to suggest that these discharge bundles improve long-term mortality or quality of life for COPD patients, indicating that while they help with readmissions, their impact on overall health outcomes may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the effectiveness of discharge care bundles for patients with COPD. Ospina, MB., Mrklas, K., Deuchar, L., et al.[2022]

The BREATHE study developed a comprehensive transitional care program for COPD patients, involving 240 participants, aimed at improving their management of the disease after hospital discharge and reducing hospital readmissions.

This program not only addresses immediate post-discharge needs but also focuses on long-term self-management, potentially offering a significant solution to reduce COPD-related hospitalizations and improve patients' quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Better Respiratory Education and Treatment Help Empower (BREATHE) study: Methodology and baseline characteristics of a randomized controlled trial testing a transitional care program to improve patient-centered care delivery among chronic obstructive pulmonary disease patients. Aboumatar, H., Naqibuddin, M., Chung, S., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11745471/

Improving COPD Management at Transitions of Care - PMC This includes implementing interventions that reduce CV and all-cause mortality in COPD, such as smoking cessation, early initiation of pulmonary rehabilitation ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9166333/

Evaluation of COPD Chronic Care Management ... While COPD can be managed with effective interventions, patients often do not receive appropriate or timely treatment, leading to worse clinical outcomes, high ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0012369222005943

Optimizing COPD Acute Care Patient Outcomes Using a ... The COPD transition bundle reduced 7- and 30-day hospital readmissions while increasing LOS and ED revisits. The care coordinator did not improve outcomes.

4. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2752467

Effect of a Hospital-Initiated Program Combining ... This randomized clinical trial compares the effects of a hospital-initiated, nurse-delivered program combining transition of care and ...

5. journal.copdfoundation.org journal.copdfoundation.org/jcopdf/id/1548/Impact-of-an-Inpatient-COPD-Care-Pathway-on-Hospital-Care-Process-and-Outcome-Metrics

Impact of Inpatient COPD Care Pathway on Outcomes Kim N, Teng W, Akande O, Rhodes D, Rochester CL. Impact of an inpatient COPD care pathway on hospital care process and outcome metrics.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8094214/

Digital interventions for the management of chronic obstructive ... Digital technology can help to improve care for people with long‐term conditions such as COPD by providing health information that is easily accessible, and may ...

7. bmjopenquality.bmj.com bmjopenquality.bmj.com/content/12/1/e002074

Evaluation of an implementation package to deliver the ... This evaluation considers the process of scaling the COPD CARE service across medical facilities using an implementation package designed for service expansion.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8815630/

Telehealth in chronic obstructive pulmonary disease This review describes the use of telehealth for the care of people with chronic obstructive pulmonary disease (COPD) at various points before and after the ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT05897125

Telehealth Education Leveraging Electronic Transitions Of ... In-home virtual visits may be particularly promising for patients with chronic obstructive pulmonary disease (COPD), who are often hospitalized, have multiple ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S0142694X25000092

Transition design: Co-creating system solutions for chronic ... We proposed a Transition Design model to identify and deliver sustainable solutions for complex healthcare problems.