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

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.

Study Overview

• Status: Withdrawn
• Conditions: Asthma
• Intervention / Treatment: Behavioral: Remote Coach plus Asthma Module; Behavioral: Asthma Module- No Coach; Behavioral: CHADIS- no Asthma Module

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21210
      • Total Child Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Asthma diagnosis

Exclusion Criteria:

• Not English or Spanish speaking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remote Coach plus Asthma Module; The intervention is for practices to have remote coach support for patients with asthma in addition to doctors using CHADIS-Asthma module. Practices will start sequentially for a time series analysis.	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.; Other Names: Remote Coach
Experimental: Asthma Module- No Coach; The intervention is for practices to use CHADIS-Asthma module to improve patient care without a remote coach assisting patient adherence.	Behavioral: 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.
Active Comparator: CHADIS- no Asthma module; Practices using CHADIS but no Asthma module as a control condition.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NHLBI recommended controller meds used	match between severity rating and NHLBI recommended med mgt	3-12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergency department visits	Self reported interval ED visits	3-12 months
Asthma trigger mitigation	self-reported efforts to reduce asthma triggers	3-12 months
Hospitalizations for asthma	Self reported hospitalizations	3-12 months
Steroid bursts	Self reported use of steroid bursts for asthma exacerbations	3-12 months
Influenza vaccine receipt	self reported receipt of flu vaccine for this season	3-12 months
asthma symptom control	severity/control ratings	3-12 months

Collaborators and Investigators

• Sponsor: Total Child Health, Inc.
• Collaborators: University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: April 28, 2015
• First Submitted That Met QC Criteria: April 30, 2015
• First Posted (Estimate): May 6, 2015

Study Record Updates

• Last Update Posted (Estimate): April 21, 2016
• Last Update Submitted That Met QC Criteria: April 19, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 1R44HL117482 (U.S. NIH Grant/Contract)