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Clinical Trials/NCT02435394
NCT02435394WithdrawnNot Applicable

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

Total Child Health, Inc.2 sites in 1 countryStarted: July 1, 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Sponsor
Locations
2
Primary Endpoint
NHLBI recommended controller meds used

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
— to 19 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Asthma diagnosis

Exclusion Criteria

  • Not English or Spanish speaking

Outcomes

Primary Outcomes

NHLBI recommended controller meds used

Time Frame: 3-12 months

match between severity rating and NHLBI recommended med mgt

Secondary Outcomes

  • Influenza vaccine receipt(3-12 months)
  • Emergency department visits(3-12 months)
  • Hospitalizations for asthma(3-12 months)
  • Steroid bursts(3-12 months)
  • Asthma trigger mitigation(3-12 months)
  • asthma symptom control(3-12 months)

Investigators

Sponsor
Total Child Health, Inc.
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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