Web System for Engaging Families & Doctors in Continuous Asthma Quality Improvement

Asthma Clinical Trial

— Asthma  

Official title:

Web System for Engaging Families & Doctors in Continuous Asthma Quality Improvement

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02435394
• Other study ID #: 1R44HL117482
• Status: Withdrawn
• Phase: N/A
• First received: April 28, 2015
• Last updated: April 19, 2016
• Start date: July 2015
• Est. completion date: July 2016

Study information

• Verified date: April 2016
• Source: Total Child Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 19 Years

Eligibility

Inclusion Criteria:

• Asthma diagnosis

Exclusion Criteria:

• Not English or Spanish speaking

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• Remote Coach plus Asthma Module
The intervention is for a remote coach to assist patients with asthma for practices which will use Asthma module for guidance for asthma care.
• Asthma Module- No Coach
The intervention is for practices to use the Asthma module for guidance for asthma care without assistance by a remote coach.
• CHADIS- no Asthma Module
The practices will use the general CHADIS tool without access to the Asthma Module add-on to assist in asthma care.

Locations

Country	Name	City	State
United States	Total Child Health	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Total Child Health, Inc.	University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NHLBI recommended controller meds used	match between severity rating and NHLBI recommended med mgt	3-12 months	No
Secondary	Emergency department visits	Self reported interval ED visits	3-12 months	No
Secondary	Asthma trigger mitigation	self-reported efforts to reduce asthma triggers	3-12 months	No
Secondary	Hospitalizations for asthma	Self reported hospitalizations	3-12 months	No
Secondary	Steroid bursts	Self reported use of steroid bursts for asthma exacerbations	3-12 months	No
Secondary	Influenza vaccine receipt	self reported receipt of flu vaccine for this season	3-12 months	No
Secondary	asthma symptom control	severity/control ratings	3-12 months	No