24 Participants Needed

COPD Care Transition Programs for Chronic Obstructive Pulmonary Disease

(REVISITS 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?

This type II hybrid effectiveness-implementation trial will concurrently study the comparative effectiveness of virtual vs. in-person COPD care transition programs implemented via virtual mentored implementation approaches with and without co-design methods. The investigators will enroll up to 24 randomized sites (with a goal minimum of 16 sites) to: * Deliver the COPD programs implemented via mentored support in collaboration with SHM Center for Quality Improvement. * Compare the effectiveness and penetration of virtual versus in-person COPD care transition programs implemented along with mentoring support with or without co-design. The investigators aim to determine which combined approach(es) is/are the most effective at implementing evidence-based COPD program interventions and decreasing COPD acute care revisits with the greatest overall impact and sustainability.

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 data supports the idea that COPD Care Transition Programs for Chronic Obstructive Pulmonary Disease is an effective treatment?

The available research shows that COPD Care Transition Programs can effectively reduce hospital readmissions for patients with chronic obstructive pulmonary disease. For example, the BREATHE study developed a program to help patients and their families manage COPD at home, which is crucial for preventing future hospital visits. Another study found that using a transition care bundle led to fewer hospital readmissions compared to usual care. Additionally, these programs can improve the quality of life for patients by providing comprehensive care that addresses not only the respiratory issues but also other related health problems. This approach is more effective than just using medication alone, as it includes education, personalized treatment plans, and support for both patients and their families.12345

What safety data exists for COPD care transition programs?

The safety data for COPD care transition programs, including discharge care bundles, suggest that these interventions can improve patient outcomes, such as reducing hospital readmissions and mortality rates. Studies like the BREATHE study and systematic reviews indicate that these programs are effective in managing COPD post-discharge, although there is a need for more research to standardize the interventions and address care gaps.25678

Is the COPD Transitions of Care Intervention Bundle a promising treatment for COPD?

Yes, the COPD Transitions of Care Intervention Bundle is a promising treatment. It helps reduce hospital readmissions, improves patient health, and can lower healthcare costs. It focuses on better care coordination and patient education, which empowers patients and their families to manage COPD more effectively at home.12345

Research Team

VP

Valerie G Press, MD, MPH

Principal Investigator

University of Chicago

Eligibility Criteria

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

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

Treatment Details

Interventions

  • COPD Transitions of Care Intervention Bundle: In-Person Interventions
  • COPD Transitions of Care Intervention Bundle: Virtual Interventions
Trial OverviewThe 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.
Participant Groups
4Treatment groups
Experimental Treatment
Group I: Virtual intervention delivery with virtual mentoring with co-designExperimental Treatment1 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 mentoringExperimental Treatment1 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-designExperimental Treatment1 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 mentoringExperimental Treatment1 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

Find a Clinic Near You

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+

Society of Hospital Medicine

Collaborator

Trials
6
Recruited
24,200+

Findings from Research

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.
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]
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.
Decreasing Hospital Readmissions Utilizing an Evidence-Based COPD Care Bundle.Kendra, M., Mansukhani, R., Rudawsky, N., et al.[2022]
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.
Models of care across the continuum of exacerbations for patients with chronic obstructive pulmonary disease.Bourbeau, J., Echevarria, C.[2021]

References

Cost Analysis of a Transition Care Bundle Compared with Usual Care for COPD Patients Being Discharged from Hospital: Evaluation of a Randomized Controlled Trial. [2023]
Decreasing Hospital Readmissions Utilizing an Evidence-Based COPD Care Bundle. [2022]
Models of care across the continuum of exacerbations for patients with chronic obstructive pulmonary disease. [2021]
Integrated Care in Chronic Obstructive Pulmonary Disease and Rehabilitation. [2019]
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. [2019]
A systematic review of the effectiveness of discharge care bundles for patients with COPD. [2022]
A care-bundles approach to improving standard of care in AECOPD admissions: results of a national project. [2019]
Care Bundles after Discharging Patients with Chronic Obstructive Pulmonary Disease Exacerbation from the Emergency Department. [2023]