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Community Healthcare for Asthma Management and Prevention of Symptoms (CHAMPS)

5 aprile 2016 aggiornato da: George Washington University

A Study of the Feasibility and Effectiveness of Implementing and Diffusing an Evidence-based Childhood Asthma Management Intervention in Community Health Centers

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).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

599

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • District of Columbia
      • Washington, District of Columbia, Stati Uniti, 20052
        • Milken Institute School of Public Health

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 5 anni a 12 anni (Bambino)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: 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
Comportamentale: CHAMPS
Nessun intervento: Usual Care
Usual asthma care and management

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Asthma symptoms
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Utilization of health care services
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Success of implementation
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

George Washington University

Collaboratori

Rho, Inc.

Investigatori

  • Investigatore principale: Anne R Markus, JD, PhD, MHS, George Washington University
  • Investigatore principale: Herman Mitchell, PhD, Rho, Inc.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 ottobre 2010

Completamento primario (Effettivo)

1 gennaio 2015

Completamento dello studio (Effettivo)

1 marzo 2016

Date di iscrizione allo studio

Primo inviato

29 aprile 2015

Primo inviato che soddisfa i criteri di controllo qualità

26 maggio 2015

Primo Inserito (Stima)

27 maggio 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

7 aprile 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 aprile 2016

Ultimo verificato

1 aprile 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 31993

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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