The Reducing REVISITS Study: A Cluster RCT
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Chicago
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Factorial
Treatments tested in this trial
COPD Transitions of Care Intervention Bundle: Virtual Interventions
BehavioralThe 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
BehavioralThe 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.
Treatment groups
24 Participants
are divided into 4 treatment groupsGroup A: In-person intervention delivery with virtual mentoringExperimental treatment 1 intervention
Group B: In-person intervention delivery with virtual mentoring and co-designExperimental treatment 1 intervention
Group C: Virtual intervention delivery with virtual mentoringExperimental treatment 1 intervention
Group D: Virtual intervention delivery with virtual mentoring with co-designExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Immediately Post-Program Implementation (12 months after enrollment in Aim 2)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.
Time frame
Immediately Post-Intervention (12 months after enrollment in Aim 2)3
Sustainability of effectiveness: 30-day revisits
Composite of all emergency department visits and/or re-hospitalizations within 30-days post index hospitalization.
Time frame
Quarterly for 24 months Post-Intervention initial enrollment (Aim 3)4
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.
Time frame
Quarterly for 24 months Post-Intervention initial enrollment (Aim 3)Secondary outcomes
1
Delivery of care transition program individual interventions: penetration
Proportion of patients with documented individual care transition interventions including: on admission and/or upon discharge medication reconciliation \[yes/no\]; self-management education, e.g., inhaler technique including baseline and/or post-education technique documentation \[scores/descriptive\] and/or whether education was provided \[yes/no\]; documentation that post-discharge communication occurred (Y/N); other site-specific care transition interventions (site-specific).
Time frame
Immediately Post-Intervention (12 months after enrollment in Aim 2)2
Cost/savings evaluation
To evaluate hospital-level program costs and savings.
Time frame
At completion of 12- months of Intervention (Aim 3)3
Cost/savings evaluation
To evaluate hospital-level program costs and savings.
Time frame
At 24 months Post-Intervention (Aim 3)4
Healthcare Utilization: 30-day acute care revisits for COPD during intervention
Composite of all emergency department visits and/or re-hospitalizations within 30-days for COPD post index hospitalization across all enrolled sites.
Time frame
Immediately Post-Program Implementation (12 months after enrollment in Aim 2)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Chicago
Lead sponsor
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
Source ClinicalTrials.gov