Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Pediatric Asthma Alert Intervention for Minority Children With Asthma (PAAL)

31. august 2015 oppdatert av: Arlene M. Butz, Johns Hopkins University

Pediatric Asthma Alert Intervention for Minority Children

Young inner-city children with asthma have the highest emergency department (ED) visit rates. Relying on the emergency department for asthma care can be a dangerous sign of poorly controlled asthma. This research will focus on whether having a specialized asthma nurse join the family at a child's doctor visit after an ED visit for asthma to make sure the child and parent keep the follow-up appointment and have the nurse remind the child's doctor to prescribe preventive asthma medicines and an asthma action plan for home (PAAL intervention) will result in young children with asthma having fewer days with wheezing and cough.

The investigators hypothesize that:

  1. Significantly more children receiving the PAAL intervention will attend greater than 2 non-urgent visits and greater than 6 refills for the child's anti-inflammatory medications over 12 months when compared to children in the control or standard asthma education group.
  2. Children in the PAAL intervention group will experience less morbidity and caregivers will experience increased quality of life compared to children in the control of standard asthma education group.

Studieoversikt

Detaljert beskrivelse

Asthma is the number one cause of pediatric emergency department (ED) visits in young children and results in a significant economic impact on society and use of health resources. Reliance on the ED for asthma care is not only costly but it is also a dangerous index of poorly controlled asthma. Recent updated national asthma guidelines recommend daily inhaled corticosteroids (ICS) as the cornerstone of treatment for patients with persistent asthma. When properly used ICS prevent exacerbations, ED visits and hospitalizations and maintain asthma control. However, > 50% of inner city minority children with asthma do not receive or use recommended anti-inflammatory preventive medications. In fact, many children encounter repeated ED visits with no provision of appropriate preventive medications or other components of guideline-based preventive care because of inconsistent follow-up with their primary care provider (PCP). The overall goal of this study is to evaluate whether a standardized caregiver and physician prompting intervention, Pediatric Asthma Alert Leader (PAAL), can improve guideline-based preventive asthma care including increased anti-inflammatory use and preventive PCP visits in children with frequent ED visits. This study builds on the experience with our parent-child-PCP communication intervention ("Improving Asthma Communication in Minority Families", ACE) in which we found that teaching parent and child asthma communication skills resulted in increased anti-inflammatory medication use at 6 months for children with persistent asthma. However, the beneficial effects of this intervention were seen primarily when caregivers and children were reminded by the nurse interventionist to relay specific health information to the PCP. Furthermore, the intervention was not associated with decreased ED visits or appropriate PCP follow-up to sustain preventive care. The proposed PAAL intervention has the potential to substantially improve care for children at highest risk for asthma morbidity and we propose to establish (1) whether the positive effects of the ACE study can be replicated in a specific group of high-risk children with repeat ED visits; 2) whether the effects of the intervention can be enhanced by incorporating consistent clinician prompting to assure the provision of each component of guideline-based asthma care (ICS use, asthma action plan, and sustaining regular follow-up care to monitor asthma control); and 3)whether families not achieving optimal care will respond to a more intensive tiered intervention. We propose a caregiver and clinician prompting/feedback intervention using a pediatric asthma alert leader (PAAL) nurse to 1) organize and relay critical, individualized child health information from the ED and home setting to the PCP in a feedback letter, 2) ensure child and caregiver attendance at the follow-up visit with the PCP and 3) empower the family and prompt the PCP for guideline-based treatment decisions at the PCP visit. We hypothesize that the PAAL intervention will improve preventive care and reduce morbidity and health care costs for high-risk children with asthma compared to a Standard Asthma Education (SAE) control group.

Studietype

Intervensjonell

Registrering (Faktiske)

350

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Maryland
      • Baltimore, Maryland, Forente stater, 21287
        • Johns Hopkins University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

3 år til 10 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

All 6 criteria must be met:

  1. Physician-diagnosed asthma (based on caregiver report with validation from the child's physician)
  2. > 2 ED visits or > 1 hospitalization for asthma within past 12 months
  3. Mild persistent to severe persistent asthma based on NHLBI guidelines criteria (7-9) having any 1 of the following:

    • An average of > 2 days per week of asthma symptoms
    • > 2 days per week with rescue medication use (albuterol, xopenex) OR
    • > 2 days per month of nighttime symptoms
  4. Age > 3 and < 10 years
  5. Reside in Baltimore Metropolitan area
  6. Not currently participating in another asthma study or sibling enrolled in PAAL study

Exclusion Criteria:

  1. Inability to speak and understand English
  2. No access to a working phone or alternate phone for follow-up surveys
  3. Co-morbid respiratory condition including cystic fibrosis, chronic lung disease (BPD), lung cancer, tracheostomy that could interfere with the assessment of asthma-related outcome measures.
  4. Children residing in foster care or where consent cannot be obtained from a legal guardian.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 1
Standard asthma education delivered during 2 home visits by a nurse.
Standard asthma education during 2 home visits.
Andre navn:
  • Astma utdanning
Eksperimentell: 2 PAAL
PAAL
Asthma nurse conducts 2 home visits and accompanies the child to primary care provider visit after ED visits
Andre navn:
  • Pediatric Asthma Alert Leader (Nurse)

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Number of primary care appointments kept over 12 months
Tidsramme: 12 months
12 months

Sekundære resultatmål

Resultatmål
Tidsramme
Number of refills for anti-inflammatory medications prescribed over 12 months
Tidsramme: 12 months
12 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Arlene M Butz, ScD, RN, Johns Hopkins University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2008

Primær fullføring (Faktiske)

1. juni 2013

Studiet fullført (Faktiske)

1. juni 2013

Datoer for studieregistrering

Først innsendt

11. mars 2009

Først innsendt som oppfylte QC-kriteriene

11. mars 2009

Først lagt ut (Anslag)

12. mars 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

2. september 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. august 2015

Sist bekreftet

1. juni 2011

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Standard asthma education

3
Abonnere