The Reducing REVISITS Study: A Cluster RCT

NCT05568043 | Recruiting DMC

• 2 other identifiers: 20-03735R01HL146644-05
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COPD; COPD Exacerbation Acute

Outcome Measures

Primary Outcomes (4)

• Healthcare Utilization: 30-day acute care revisits for COPD

  Composite of all emergency department visits and/or re-hospitalizations within 30-days post index hospitalization across all enrolled sites for COPD

  Immediately Post-Program Implementation (12 months after enrollment in Aim 2)

• Delivery of overall care transition program: penetration

  Proportion of hospitalized patients with COPD receiving their assigned care transition program interventions (composite) as per documented in the electronic health record.

  Immediately Post-Intervention (12 months after enrollment in Aim 2)

• Sustainability of effectiveness: 30-day revisits

  Composite of all emergency department visits and/or re-hospitalizations within 30-days post index hospitalization.

  Quarterly for 24 months Post-Intervention initial enrollment (Aim 3)

• Sustainability of program delivery: penetration

  Proportion of hospitalized patients with COPD receiving their assigned care transition program interventions (composite) as per documented in the electronic health record.

  Quarterly for 24 months Post-Intervention initial enrollment (Aim 3)

Secondary Outcomes (39)

• Delivery of care transition program individual interventions: penetration

  Immediately Post-Intervention (12 months after enrollment in Aim 2)

• Cost/savings evaluation

  At completion of 12- months of Intervention (Aim 3)

• Cost/savings evaluation

  At 24 months Post-Intervention (Aim 3)

• Healthcare Utilization: 30-day acute care revisits for COPD during intervention

  Immediately Post-Program Implementation (12 months after enrollment in Aim 2)

• Healthcare Utilization: 30-day acute care revisits for COPD

  Post-Program Implementation (24 months after enrollment in Aim 3)

Study Arms (4)

In-person intervention delivery with virtual mentoring

EXPERIMENTAL

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.

Behavioral: COPD Transitions of Care Intervention Bundle: In-Person Interventions

In-person intervention delivery with virtual mentoring and co-design

EXPERIMENTAL

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.

Behavioral: COPD Transitions of Care Intervention Bundle: In-Person Interventions

Virtual intervention delivery with virtual mentoring

EXPERIMENTAL

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.

Behavioral: COPD Transitions of Care Intervention Bundle: Virtual Interventions

Virtual intervention delivery with virtual mentoring with co-design

EXPERIMENTAL

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.

Behavioral: COPD Transitions of Care Intervention Bundle: Virtual Interventions

Interventions

COPD Transitions of Care Intervention Bundle: Virtual Interventions BEHAVIORAL

The COPD Transitions of Care Intervention Bundle will be site-specific determined through Aim 1 contextual assessments and will consist of 2-3 evidence-based COPD transitions of care interventions. Virtual interventions included in the bundle may consist of: phone or e-consults for medication reconciliation, virtual teach-to-goal \[V-TTG\] or tele-TTG inhaler education, and post-discharge phone call communication and/or texts/ and/or electronic portal use, among others.

Also known as: COPD Transitions of Care Program: Virtual Interventions

Virtual intervention delivery with virtual mentoring; Virtual intervention delivery with virtual mentoring with co-design

COPD Transitions of Care Intervention Bundle: In-Person Interventions BEHAVIORAL

The COPD Transitions of Care Intervention Bundle will be site-specific determined through Aim 1 contextual assessments and will consist of 2-3 evidence-based COPD transitions of care interventions. In-person interventions include face-to-face general COPD education, inhaler education, medication reconciliation, post-discharge clinic visits, community health worker home visits, pulmonary rehabilitation, smoking cessation programs, among others.

Also known as: COPD Transitions of Care Program: In-Person Interventions

In-person intervention delivery with virtual mentoring; In-person intervention delivery with virtual mentoring and co-design

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Since enrollment for Aim 2 will occur on a site/system-level, the inclusion of 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Chicago: lead
• Society of Hospital Medicine: collaborator
• Onda Collective: collaborator
• The Hospital Medicine Reengineering Network (HOMERuN): collaborator
• COPD Foundation: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Related Publications (1)

• Lee CT, Traeger L, Akula M, Fegley AE, Goldstein J, Erwin K, Damschroder LJ, Rommes J, Pick H, Auerbach A, Lindenauer P, Wan W, Jackson Sagredo A, Press VG. Virtual Mentored Implementation to Improve Care Transitions in Chronic Obstructive Pulmonary Disease: Protocol for a Pragmatic Implementation Study. JMIR Res Protoc. 2026 Jan 13;15:e82043. doi: 10.2196/82043.

  PMID: 41529255 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Valerie Press

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leah Traeger

CONTACT

847-508-3011; LTraeger@bsd.uchicago.edu

Valerie G Press, MD, MPH

CONTACT

734-717-1131; vpress@bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2x2 with 2 intervention delivery methods (virtual vs. in-person) and 2 implementation support mechanisms (virtual mentoring vs. virtual mentoring plus co-design)

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: October 5, 2022
• Study Start: February 15, 2022
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)