The Reducing REVISITS Study: A Cluster RCT

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT05568043
Status
Recruiting
Apply to this trial

Conditions

  • COPD
  • COPD Exacerbation Acute

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Feb 15, 2022
Status verified
Jun 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION

Arms

  • Experimental: In-person intervention delivery with virtual mentoring
    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.
  • Experimental: In-person intervention delivery with virtual mentoring and co-design
    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.
  • Experimental: Virtual intervention delivery with virtual mentoring
    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.
  • Experimental: Virtual intervention delivery with virtual mentoring with co-design
    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.

Primary Outcome Measure

Healthcare Utilization: 30-day acute care revisits for COPD [ Time Frame: Immediately Post-Program Implementation (12 months after enrollment in Aim 2) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of ChicagoChicagoIllinois60637
Valerie G Press, MD, MPH
[email protected]
773-702-5170
Leah Traeger
[email protected]
773-834-4489
Valerie G Press, MD, MPH (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By condition
COPD
By specialty
PulmonologyLung disease
By research site
University of Chicago· Chicago, IL

Related Studies