Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-05 @ 1:05 AM
Study NCT ID:
NCT02435394
Status:
WITHDRAWN
Last Update Posted:
2016-04-21
First Post:
2015-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Web System for Engaging Families & Doctors in Continuous Asthma Quality Improvement
Sponsor:
Total Child Health, Inc.
Organization:
Study Overview
Official Title:
Web System for Engaging Families & Doctors in Continuous Asthma Quality Improvement
Status:
WITHDRAWN
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
After IRB review, this study is no longer considered a clinical trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Asthma
Brief Summary:
Asthma, one of the most common pediatric illnesses, is optimally managed according to National Heart Lung and Blood Institute (NHLBI) guidelines yet this is not often done in primary care. This project is to develop and test the effects of using a module for guideline based care in the Child Health and Development Interactive System (CHADIS) online system by prompting and incorporating patient symptom/control and adherence data from standard questionnaires to inform visits and providing automated patient specific education and Asthma Action Plans in individual Care Portals.
Detailed Description:
We will complete the formative work collecting professional opinion to create and pilot the initial CHADIS Asthma Intervention module (CHADIS-AI), an innovative decision support system. CHADIS-AI content will be assembled and vetted by asthma experts and primary care providers (PCPs). Parent and teen focus groups will vet the content and language of the adherence materials and Care Portal. A system will also be established for points for patient participation, to give clinicians Maintenance of Certification (MOC) credit, and ongoing run chart reports of their patients' asthma status for continual Quality Improvement (QI) feedback. The resulting system will be pilot tested and refined by clinician feedback. Practices will be randomly assigned to intervention vs control. Control practices will use CHADIS for asthma care without the A-I module. Intervention practices will be further randomized to have remote coach support for patients or not. Outcomes will be examined of asthma severity/control, match of severity with guideline based medication management, numbers of Emergency Department (ED) visits, hospitalizations and oral steroid use. Effect of remote coaching will also be assessed.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: