Clinical trial NCT02454192: Community Healthcare for Asthma Management and Prevention of Symptoms
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
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Evidence-based intervention
Implementation
Underserved communities
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: Rho, Inc.
First posted: 2015-05-27
Enrollment: 599
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Asthma symptoms
timeFrame: In the past 4 weeks
Secondary outcomes:
measure: Utilization of health care services
timeFrame: In the past year
Other outcomes:
measure: Success of implementation
timeFrame: 5 years
measure: Success of implementation
timeFrame: 5 years
measure: Success of implementation
timeFrame: 5 years
measure: Success of implementation
timeFrame: 5 years
measure: Success of implementation
timeFrame: 5 years
measure: Success of implementation
timeFrame: 5 years
measure: Success of implementation
timeFrame: 5 years
Locations:
city: Washington
country: United States
facility: Milken Institute School of Public Health
state: District of Columbia
Study officials:
affiliation: George Washington University
name: Anne R Markus, JD, PhD, MHS
role: PRINCIPAL_INVESTIGATOR
affiliation: Rho, Inc.
name: Herman Mitchell, PhD
role: PRINCIPAL_INVESTIGATOR
References: