Community Healthcare for Asthma Management and Prevention of Symptoms (CHAMPS)
A Study of the Feasibility and Effectiveness of Implementing and Diffusing an Evidence-based Childhood Asthma Management Intervention in Community Health Centers
A tanulmány áttekintése
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
-
-
District of Columbia
-
Washington, District of Columbia, Egyesült Államok, 20052
- Milken Institute School of Public Health
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Megelőzés
- Kiosztás: Nem véletlenszerű
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Egyéb: CHAMPS Intervention
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
|
|
|
Nincs beavatkozás: Usual Care
Usual asthma care and management
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Asthma symptoms
Időkeret: In the past 4 weeks
|
Reduction in asthma symptom days in the past 4 weeks as measured by the Asthma Symptoms and Utilization (ASU) questionnaire
|
In the past 4 weeks
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Utilization of health care services
Időkeret: In the past year
|
Reduction of utilization of Emergency Departments and hospitalizations in the past 12 months as measured by the Asthma Symptom and Utilization (ASU) questionnaire
|
In the past year
|
Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Success of implementation
Időkeret: 5 years
|
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
|
5 years
|
|
Success of implementation
Időkeret: 5 years
|
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
|
5 years
|
|
Success of implementation
Időkeret: 5 years
|
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
|
5 years
|
|
Success of implementation
Időkeret: 5 years
|
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
|
5 years
|
|
Success of implementation
Időkeret: 5 years
|
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
|
5 years
|
|
Success of implementation
Időkeret: 5 years
|
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
|
5 years
|
|
Success of implementation
Időkeret: 5 years
|
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
|
5 years
|
Együttműködők és nyomozók
Szponzor
Együttműködők
Nyomozók
- Kutatásvezető: Anne R Markus, JD, PhD, MHS, George Washington University
- Kutatásvezető: Herman Mitchell, PhD, Rho, Inc.
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Becslés)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Becslés)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 31993
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .