- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07243652
I-DECIDE After Bronchiolitis Hospitalization (I-DECIDE)
Cluster Randomized Trial of a Moderate vs High Resource Implementation Strategy to Increase As-needed Post-hospitalization Follow-up for Children With Bronchiolitis
Although automatic follow-up is a nearly universal practice, research has shown that these visits are often unnecessary after hospitalizations caused by bronchiolitis. Despite endorsement by national pediatric authorities, robust evidence, and family enthusiasm for as-needed (PRN) follow-up, it remains substantially underutilized for children hospitalized for bronchiolitis.
The goal of I-DECIDE is to compare the effects of two multi-component implementation strategies, both of which aim to (a) increase PRN follow-up prescribing by hospitalists (physicians who care for hospitalized children) and (b) decrease unnecessary follow-up visit attendance by families.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eric Coon, MD, MS
- Phone Number: 206-884-1223
- Email: Eric.Coon@seattlechildrens.org
Study Contact Backup
- Name: Chris Bonafide, MD, MSCE
- Email: bonafide@chop.edu
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35233
- Recruiting
- Children's of Alabama
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Contact:
- Samantha Hanna, MD
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Arizona
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Glendale, Arizona, United States, 85308
- Recruiting
- Phoenix Children's Hospital - Arrowhead Campus
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Contact:
- Jared Kusma, MD
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Phoenix, Arizona, United States, 85016
- Recruiting
- Phoenix Children's Hospital
-
Contact:
- Jared Kusma, MD
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California
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Lodi, California, United States, 95240
- Recruiting
- Adventist Health Lodi Memorial
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Contact:
- Julia Marlow, MD
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Los Angeles, California, United States, 90027
- Recruiting
- Children's Hospital Los Angeles
-
Contact:
- Vivian Lee, MD
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Madera, California, United States, 93636
- Recruiting
- Valley Children's Hospital
-
Contact:
- Kerrilynn Rice, MD
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Orange, California, United States, 92868
- Recruiting
- Children's Hospital Orange County (CHOC)
-
Contact:
- Amanda Schafenacker, MD
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Sacramento, California, United States, 95817
- Recruiting
- University of California Davis Children's Hospital
-
Contact:
- Michelle Hamline, MD
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Colorado
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Aurora, Colorado, United States, 80045
- Recruiting
- Children's Hospital Colorado
-
Contact:
- Michael Tchou, MD
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Connecticut
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Hartford, Connecticut, United States, 06106
- Recruiting
- Connecticut Children's Medical Center
-
Contact:
- Alexander Hogan, MD
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New Haven, Connecticut, United States, 06511
- Recruiting
- Yale-New Haven Children's Hospital
-
Contact:
- Lyubina Yankova, MD
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District of Columbia
-
Washington D.C., District of Columbia, United States, 20010
- Recruiting
- Children's National Medical Center
-
Contact:
- Kristen Johnson, MD
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Florida
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St. Petersburg, Florida, United States, 33701
- Recruiting
- Johns Hopkins All Children's Hospital
-
Contact:
- John Morrison, MD
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Illinois
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Chicago, Illinois, United States, 60611
- Recruiting
- Ann & Robert H. Lurie Children's Hospital of Chicago
-
Contact:
- Shira Toister, MD
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Peoria, Illinois, United States, 61637
- Recruiting
- OSF Children's Hospital of Illinois
-
Contact:
- Shaista Shaik, MD
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Indiana
-
Indianapolis, Indiana, United States, 46202
- Recruiting
- Riley Hospital for Children
-
Contact:
- Melanie Butz, MD
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Maine
-
Bangor, Maine, United States, 04401
- Recruiting
- Northern Light Eastern Maine Medical Center
-
Contact:
- Julia Millikan, MD
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Maryland
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Baltimore, Maryland, United States, 21287
- Recruiting
- Johns Hopkins Children's Center
-
Contact:
- Rachel Cane, MD
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Recruiting
- Boston Children's Hospital
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Contact:
- Patty Stoeck, MD
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Springfield, Massachusetts, United States, 01199
- Recruiting
- Baystate Children's Hospital
-
Contact:
- David Fish, MD
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Missouri
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Kansas City, Missouri, United States, 64108
- Recruiting
- Children's Mercy Kansas City
-
Contact:
- Jessica Markham, MD
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Springfield, Missouri, United States, 65807
- Recruiting
- Cox Medical Center South
-
Contact:
- Kayce Morton, MD
-
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Nebraska
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Lincoln, Nebraska, United States, 68506
- Recruiting
- Bryan Medical Center - Children's Nebraska Community site
-
Contact:
- Magi Dickinson, MD
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Omaha, Nebraska, United States, 68114
- Recruiting
- Children's Nebraska
-
Contact:
- Magi Dickinson, MD
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New Hampshire
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Manchester, New Hampshire, United States, 03104
- Recruiting
- Children's Hospital at Dartmouth-Hitchcock
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Contact:
- Kristin Reese, MD
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Recruiting
- JM Sanzari Children's Hospital, Hackensack Meridian Children's Health
-
Contact:
- Alyssa Silver, MD
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Plainsboro, New Jersey, United States, 08536
- Recruiting
- CHOP Pediatric Care at Penn Medicine/Princeton Health
-
Contact:
- Alicia Brennan, MD
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New York
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Albany, New York, United States, 12208
- Recruiting
- Albany Medical Center
-
Contact:
- Philip Cook, MD
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Buffalo, New York, United States, 14203
- Recruiting
- Oishei Children's Hospital
-
Contact:
- Sheri Wagner, MD
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New York, New York, United States, 10016
- Recruiting
- Hassenfeld Children's Hospital at NYU Langone
-
Contact:
- Liliana Cruz, MD
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Rochester, New York, United States, 14642
- Recruiting
- University of Rochester Golisano Children's Hospital
-
Contact:
- Desiree Mohney, MD
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The Bronx, New York, United States, 10467
- Recruiting
- Children's Hospital at Montefiore
-
Contact:
- Elissa Gross, MD
-
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North Carolina
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Winston-Salem, North Carolina, United States, 27103
- Recruiting
- Wake Forest Baptist Medical Center
-
Contact:
- Melissa Baranay, MD
-
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Ohio
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Akron, Ohio, United States, 44308
- Recruiting
- Akron Children's Hospital
-
Contact:
- Prabi Rajbhandari, MD
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Cincinnati, Ohio, United States, 45229
- Recruiting
- Cincinnati Children's Hospital Medical Center
-
Contact:
- Danni Liang, MD
-
Cleveland, Ohio, United States, 44195
- Recruiting
- Cleveland Clinic Children's
-
Contact:
- Andrew Kern-Goldberger, MD
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Cleveland, Ohio, United States, 44106
- Recruiting
- University Hospitals Rainbow Babies and Children's Hospital
-
Contact:
- Grace Kim, MD
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Columbus, Ohio, United States, 43205
- Recruiting
- Nationwide Children's Hospital
-
Contact:
- Maria Widmann, MD
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Dayton, Ohio, United States, 45404
- Recruiting
- Dayton Children's Hospital
-
Contact:
- Roshani Agarwal, MD
-
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Recruiting
- Children's Hospital of Oklahoma
-
Contact:
- Matthew Le, MD
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- Children's Hospital of Philadelphia
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Contact:
- Christopher Bonafide
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Pittsburgh, Pennsylvania, United States, 15224
- Recruiting
- UPMC Children's Hospital of Pittsburgh
-
Contact:
- Tiffany Yang, MD
-
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Recruiting
- Hasbro Children's Hospital
-
Contact:
- Hareem Park, MD
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Texas
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Austin, Texas, United States, 78717
- Recruiting
- Texas Children's Hospital - North Campus
-
Contact:
- Julio Ortiz, MD
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Belton, Texas, United States, 76513
- Recruiting
- Baylor Scott and White Mclane Children's
-
Contact:
- Swetha Vanja, MD
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Houston, Texas, United States, 77030
- Recruiting
- Children's Memorial Hermann
-
Contact:
- Wan-Hsuan Chen, MD
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Houston, Texas, United States, 77030
- Recruiting
- Texas Children's Hospital - Main
-
Contact:
- Raymond Parlar-Chun, MD
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Houston, Texas, United States, 77094
- Recruiting
- Texas Children's Hosptial - West Campus
-
Contact:
- Rabbia Naeem, MD
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Lubbock, Texas, United States, 79410
- Recruiting
- Covenant Children's Hospital
-
Contact:
- Audra Bowman, MD
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The Woodlands, Texas, United States, 77384
- Recruiting
- Texas Children's Hospital The Woodlands
-
Contact:
- Stephen Edwards, MD
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Utah
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Lehi, Utah, United States, 84043
- Recruiting
- Primary Children's Hospital - Lehi Campus
-
Contact:
- Kristina McKinley, MD
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Salt Lake City, Utah, United States, 84113
- Recruiting
- Primary Children's Hospital
-
Contact:
- Kristina McKinley, MD
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Washington
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Seattle, Washington, United States, 98105
- Recruiting
- Seattle Children's Hospital
-
Contact:
- Eric Coon
- Phone Number: 206-884-1223
- Email: Eric.Coon@seattlechildrens.org
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West Virginia
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Morgantown, West Virginia, United States, 26506
- Recruiting
- WVU Children's Hospital
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Contact:
- Kamakshya Patra, MD
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Recruiting
- Children's Wisconsin
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Contact:
- Kaitlyn McQuistion, MD
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Neenah, Wisconsin, United States, 54956
- Recruiting
- Children's Wisconsin - Fox Valley
-
Contact:
- Casandra ZumMallen, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Primary diagnosis of bronchiolitis, discharged by a generalist inpatient service from a non-ICU, non-emergency department, non-step down unit
Exclusion Criteria:
- Children with a history of gestational age <28 weeks, chronic lung disease, complex or hemodynamically significant heart disease, immunodeficiency, or neuromuscular disease
- Children being discharged with home oxygen therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Moderate-Resource Implementation Strategy
|
The moderate-resource implementation strategy includes educational outreach (including family-facing materials to support follow-up decision making), audit and feedback (review of clinician performance, captured in a structured report), and materials for clinical decision support.
|
|
Experimental: High-Resource Implementation Strategy
|
The high-resource implementation strategy includes all of the moderate resource components, plus two forms of external facilitation: small-group facilitation and expert clinical decision support coach-led facilitation.
In total, the high-resource implementation strategy includes educational outreach (including family-facing materials to support follow-up decision-making), audit and feedback (review of clinician performance, captured in a structured report), materials for clinical decision support, small-group facilitation and expert clinical decision support coach-led facilitation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adoption
Time Frame: Within 7 days of hospital discharge
|
Proportion of participants who are prescribed PRN follow-up
|
Within 7 days of hospital discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sustainment
Time Frame: Within 7 days of hospital discharge
|
Proportion of participants who attend a follow-up visit
|
Within 7 days of hospital discharge
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BPS-2024C1-35425
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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