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.
12345What 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.
25678Is 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.
12345Eligibility 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
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
University of ChicagoChicago, IL
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Who Is Running the Clinical Trial?
University of ChicagoLead Sponsor
The Hospital Medicine Reengineering Network (HOMERuN)Collaborator
Onda CollectiveCollaborator
COPD FoundationCollaborator
Society of Hospital MedicineCollaborator
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]Appropriate management of chronic obstructive pulmonary disease (COPD) patients following acute exacerbations can reduce the risk of future exacerbations, improve health status, and lower care costs. While a transition care bundle (TCB) was associated with lower readmissions to hospitals than usual care (UC), it remains unclear whether the TCB was associated with cost savings.
Decreasing Hospital Readmissions Utilizing an Evidence-Based COPD Care Bundle. [2022]Chronic obstructive pulmonary disease (COPD) is a chronic condition that leads to significant morbidity and mortality. Management of COPD hospitalizations utilizing an evidence-based care bundle can provide consistent quality of care and may reduce readmissions.
Models of care across the continuum of exacerbations for patients with chronic obstructive pulmonary disease. [2021]Exacerbations of chronic obstructive pulmonary disease (COPD) are associated with significant morbidity and mortality, and treatments require a multidisciplinary approach to address patient needs. This review considers different models of care across the continuum of exacerbations (1) chronic care and self-management interventions with the action plan, (2) domiciliary care for severe exacerbation and the impact on readmission prevention and (3) the discharge care bundle for management beyond the acute exacerbation episode. Self-management strategies include written action plans and coaching with patient and family support. Self-management interventions facilitate the delivery of good care, can reduce exacerbations associated with admission, be cost-effective and improve quality of life. Hospitalization as a complication of exacerbation is not always unavoidable. Domiciliary care has been proposed as a solution to replace part, and perhaps even all, of the patient's in-hospital stay, and to reduce hospital bed days, readmission rates and costs; low-risk patients can be identified using risk stratification tools. A COPD discharge bundle is another potentially important approach that can be considered to improve the management of COPD exacerbations complicated by hospital admission; it comprised treatments that have demonstrated efficacy, such as smoking cessation, personalized pharmacotherapy and non-pharmacotherapy such as pulmonary rehabilitation. COPD bundles may also improve the transition of care from the hospital to the community following exacerbation and may reduce readmission rates. Future models of care should be personalized - providing patient education aiming at behaviour changes, identifying and treating co-morbidities, and including outcomes that measure quality of care rather than focusing only on readmission quantity within 30 days.
Integrated Care in Chronic Obstructive Pulmonary Disease and Rehabilitation. [2019]Individuals with advanced chronic obstructive pulmonary disease (COPD) often have complex medical problems that require more than simple pharmacological therapy to optimize outcomes. Comprehensive care is necessary to meet the substantial burdens, not just from the primary respiratory disease process itself, but also those imposed by its systemic manifestations and comorbidities. These problems are intensified in the peri-exacerbation period, especially for newly discharged patients. Pulmonary rehabilitation, with its interdisciplinary, patient-centered and holistic approach to management, and integrated care, adding coordination or transition of care to the chronic care model, are useful approaches to meeting these complex issues.
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]Chronic Obstructive Pulmonary Disease (COPD) is a leading cause of hospitalizations. Interventional studies focusing on the hospital-to-home transition for COPD patients are few. In the BREATHE (Better Respiratory Education and Treatment Help Empower) study, we developed and tested a patient and family-centered transitional care program that helps prepare hospitalized COPD patients and their family caregivers to manage COPD at home.
A systematic review of the effectiveness of discharge care bundles for patients with COPD. [2022]A COPD discharge bundle is a set of evidence-based practices aimed at improving patient outcomes after discharge from acute care settings following an exacerbation. We conducted a systematic review on the effectiveness of COPD discharge bundles and summarised their individual care elements.
A care-bundles approach to improving standard of care in AECOPD admissions: results of a national project. [2019]This report describes a care bundles implementation project for COPD undertaken during 2013 in England and Wales. High-level data were collected on outcomes of care for 11 748 patients admitted with an acute exacerbation of COPD (AECOPD). Patient-level data on processes and outcomes of care were collected on 3272 COPD admissions, among which 1174 bundles were delivered. Analysis demonstrated a statistically significant reduction in mortality and length of hospital stay from some bundle elements. Outcomes, including bundle completion rates, were better when specialist respiratory review occurred. The results support wider use of care bundles for AECOPD.
Care Bundles after Discharging Patients with Chronic Obstructive Pulmonary Disease Exacerbation from the Emergency Department. [2023]Chronic obstructive pulmonary disease (COPD) is the second leading cause of emergency department (ED) admissions to hospital, and nearly a third of patients with acute exacerbation (AE) of COPD are re-admitted to hospital within 28 days after discharge. It has been suggested that nearly a third of COPD admissions could be avoided through the implementation of evidence-based care interventions. A COPD discharge bundle is a set of evidence-based practices, aimed at improving patient outcomes after discharge from AE COPD; body of evidence supports the usefulness of discharge care bundles after AE of COPD, although there is a lack of consensus of what interventions should be implemented. On the other hand, the implementation of those interventions also involves different challenges. Important care gaps remain regarding discharge care bundles for patients with acute exacerbation of COPD discharged from EDs There is an urgent need for investigations to guide future implementation of care bundles for those patients discharged from EDs.