Community Healthcare for Asthma Management and Prevention of Symptoms (CHAMPS)
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CHAMPS
Sponsored by

About this trial
This is an interventional prevention trial for Asthma focused on measuring Evidence-based intervention, Implementation, Underserved communities
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of asthma
- Currently receiving long-term asthma control therapy and either has symptoms consistent with persistent asthma or has evidence of uncontrolled disease or is not currently receiving long-term asthma control therapy and has symptoms consistent with persistent asthma and also has evidence of uncontrolled disease
- Caretaker speaks English or Spanish
Exclusion Criteria:
- Younger or older children
- Mild, intermittent asthma
Sites / Locations
- Milken Institute School of Public Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
CHAMPS Intervention
Usual Care
Arm Description
Tailored asthma education and counseling for children with moderate to severe asthma who have confirmed allergies to environmental triggers present in their homes provided through a combination of clinic and home visits
Usual asthma care and management
Outcomes
Primary Outcome Measures
Asthma symptoms
Reduction in asthma symptom days in the past 4 weeks as measured by the Asthma Symptoms and Utilization (ASU) questionnaire
Secondary Outcome Measures
Utilization of health care services
Reduction of utilization of Emergency Departments and hospitalizations in the past 12 months as measured by the Asthma Symptom and Utilization (ASU) questionnaire
Full Information
NCT ID
NCT02454192
First Posted
April 29, 2015
Last Updated
April 5, 2016
Sponsor
George Washington University
Collaborators
Rho, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02454192
Brief Title
Community Healthcare for Asthma Management and Prevention of Symptoms
Acronym
CHAMPS
Official Title
A Study of the Feasibility and Effectiveness of Implementing and Diffusing an Evidence-based Childhood Asthma Management Intervention in Community Health Centers
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
George Washington University
Collaborators
Rho, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to systematically investigate across health center study sites participating in this study the process of adopting, integrating, implementing, and diffusing a minimum set of evidence-based interventions for the management of childhood asthma. Investigators hypothesized that an intervention that is evidence- and consensus-based (i.e., minimum elements to be integrated into existing practice, dosing of each element) would be implemented effectively, as measured by health center performance improvement on child health outcomes, health care utilization, and other measures (e.g., avoidable costs).
Detailed Description
In this study, investigators combined childhood asthma counseling and environmental interventions proven effective in previous NIH-funded clinical trials, the National Cooperative Inner-City Asthma Study (NCICAS) and the Inner-City Asthma Study (ICAS), and a third study, Head-off Environmental Asthma in Louisiana (HEAL). These studies demonstrated that participant-tailored interventions reduce asthma morbidity. Through a process of consensus building, investigators adapted a hybrid of these interventions for use in primary care clinics located in medically underserved areas (FQHCs). Investigators recruited participants ages 5-12 years with poorly controlled, moderate-to-severe asthma to ensure comparability with previous studies. Unlike the earlier clinical trials, which limited eligibility to inner-city children in stable housing, CHAMPS enrolled participants regardless of housing situation (e.g., temporary/shared homes) and location (e.g., urban/rural). Investigators collaborated with 3 FQHCs in Arizona, Michigan, and Porto Rico to enroll children and implement the CHAMPS intervention but otherwise granted them discretion to make decisions about staffing, patient flow and other process determinations, while tracking what those entailed. Investigators also invited 3 additional FQHCs to recruit and enroll children in a comparison group that did not receive the intervention.
The primary aim is to identify and understand barriers and solutions to the adaptation of an evidence-based asthma intervention at the system-level. The evaluation consists of determining how a system makes room for an intervention, identifying stakeholders to make it happen, documenting the process for replication, and monitoring processes and outcomes to ensure the integrity of the intervention remains intact. The process of implementation in the unique clinical settings presented by health centers will be described, including the facilitators and the barriers to the systematic adoption of an evidence-based childhood asthma intervention into routine practice. Of particular importance are those determinants related to in-home and community-based environmental risks, the limits of understanding on the part of parents and caretakers, and community-wide policies and practices that may create health risks.
The secondary aim is to assess the effectiveness and cost-effectiveness of the evidence-based asthma intervention as implemented in health centers.
The third and final aim is to develop a dissemination strategy and some tools for further take up of the intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Evidence-based intervention, Implementation, Underserved communities
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
599 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CHAMPS Intervention
Arm Type
Other
Arm Description
Tailored asthma education and counseling for children with moderate to severe asthma who have confirmed allergies to environmental triggers present in their homes provided through a combination of clinic and home visits
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual asthma care and management
Intervention Type
Behavioral
Intervention Name(s)
CHAMPS
Primary Outcome Measure Information:
Title
Asthma symptoms
Description
Reduction in asthma symptom days in the past 4 weeks as measured by the Asthma Symptoms and Utilization (ASU) questionnaire
Time Frame
In the past 4 weeks
Secondary Outcome Measure Information:
Title
Utilization of health care services
Description
Reduction of utilization of Emergency Departments and hospitalizations in the past 12 months as measured by the Asthma Symptom and Utilization (ASU) questionnaire
Time Frame
In the past year
Other Pre-specified Outcome Measures:
Title
Success of implementation
Description
Successful implementation of the CHAMPS intervention at health centers during the study period as measured by different aspects of implementation (see Outcomes 4-9) as measured by different instruments, including fidelity index, ASU, modified CAHPS and attitude patient surveys, provider interviews, leadership interviews, and Medicaid health plan claims data
Time Frame
5 years
Title
Success of implementation
Description
Successful implementation of the CHAMPS intervention at health centers during the study period as measured by close fidelity to intervention protocol as measured by fidelity index
Time Frame
5 years
Title
Success of implementation
Description
Successful implementation of the CHAMPS intervention at health centers during the study period as measured by improvement in clinical outcomes (i.e., reduction in asthma symptom days) as measured by ASU
Time Frame
5 years
Title
Success of implementation
Description
Successful implementation of the CHAMPS intervention at health centers during the study period as measured by high satisfaction/change in attitudes about home visits among caretakers as measured by modified Consumer Assessment of Healthcare Providers and Systems (CAHPS) and patient attitude surveys
Time Frame
5 years
Title
Success of implementation
Description
Successful implementation of the CHAMPS intervention at health centers during the study period as measured by change in providers' perceptions of benefit of CHAMPS as measured by provider interviews
Time Frame
5 years
Title
Success of implementation
Description
Successful implementation of the CHAMPS intervention at health centers during the study period as measured by leadership intent to sustain services included in CHAMPS as measured by leadership interviews
Time Frame
5 years
Title
Success of implementation
Description
Successful implementation of the CHAMPS intervention at health centers during the study period as measured by decrease in costs, especially among high users, as measured by ASU questionnaire and Medicaid health plan claims data
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of asthma
Currently receiving long-term asthma control therapy and either has symptoms consistent with persistent asthma or has evidence of uncontrolled disease or is not currently receiving long-term asthma control therapy and has symptoms consistent with persistent asthma and also has evidence of uncontrolled disease
Caretaker speaks English or Spanish
Exclusion Criteria:
Younger or older children
Mild, intermittent asthma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne R Markus, JD, PhD, MHS
Organizational Affiliation
George Washington University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Herman Mitchell, PhD
Organizational Affiliation
Rho, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Milken Institute School of Public Health
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20052
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Community Healthcare for Asthma Management and Prevention of Symptoms
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