search
Back to results

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

Primary Purpose

Asthma

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Remote Coach plus Asthma Module
Asthma Module- No Coach
CHADIS- no Asthma Module
Sponsored by
Total Child Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

undefined - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Asthma diagnosis

Exclusion Criteria:

  • Not English or Spanish speaking

Sites / Locations

  • Total Child Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Remote Coach plus Asthma Module

Asthma Module- No Coach

CHADIS- no Asthma module

Arm Description

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.

The intervention is for practices to use CHADIS-Asthma module to improve patient care without a remote coach assisting patient adherence.

Practices using CHADIS but no Asthma module as a control condition.

Outcomes

Primary Outcome Measures

NHLBI recommended controller meds used
match between severity rating and NHLBI recommended med mgt

Secondary Outcome Measures

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

Full Information

First Posted
April 28, 2015
Last Updated
April 19, 2016
Sponsor
Total Child Health, Inc.
Collaborators
University of California, Los Angeles
search

1. Study Identification

Unique Protocol Identification Number
NCT02435394
Brief Title
Web System for Engaging Families & Doctors in Continuous Asthma Quality Improvement
Acronym
Asthma
Official Title
Web System for Engaging Families & Doctors in Continuous Asthma Quality Improvement
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Withdrawn
Why Stopped
After IRB review, this study is no longer considered a clinical trial
Study Start Date
July 2015 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Total Child Health, Inc.
Collaborators
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remote Coach plus Asthma Module
Arm Type
Experimental
Arm Description
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.
Arm Title
Asthma Module- No Coach
Arm Type
Experimental
Arm Description
The intervention is for practices to use CHADIS-Asthma module to improve patient care without a remote coach assisting patient adherence.
Arm Title
CHADIS- no Asthma module
Arm Type
Active Comparator
Arm Description
Practices using CHADIS but no Asthma module as a control condition.
Intervention Type
Behavioral
Intervention Name(s)
Remote Coach plus Asthma Module
Other Intervention Name(s)
Remote Coach
Intervention Description
The intervention is for a remote coach to assist patients with asthma for practices which will use Asthma module for guidance for asthma care.
Intervention Type
Behavioral
Intervention Name(s)
Asthma Module- No Coach
Intervention Description
The intervention is for practices to use the Asthma module for guidance for asthma care without assistance by a remote coach.
Intervention Type
Behavioral
Intervention Name(s)
CHADIS- no Asthma Module
Intervention Description
The practices will use the general CHADIS tool without access to the Asthma Module add-on to assist in asthma care.
Primary Outcome Measure Information:
Title
NHLBI recommended controller meds used
Description
match between severity rating and NHLBI recommended med mgt
Time Frame
3-12 months
Secondary Outcome Measure Information:
Title
Emergency department visits
Description
Self reported interval ED visits
Time Frame
3-12 months
Title
Asthma trigger mitigation
Description
self-reported efforts to reduce asthma triggers
Time Frame
3-12 months
Title
Hospitalizations for asthma
Description
Self reported hospitalizations
Time Frame
3-12 months
Title
Steroid bursts
Description
Self reported use of steroid bursts for asthma exacerbations
Time Frame
3-12 months
Title
Influenza vaccine receipt
Description
self reported receipt of flu vaccine for this season
Time Frame
3-12 months
Title
asthma symptom control
Description
severity/control ratings
Time Frame
3-12 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Asthma diagnosis Exclusion Criteria: Not English or Spanish speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara J Howard, MD
Organizational Affiliation
Total Child Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Total Child Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21210
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs