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Educational Video for Improving Follow-up After an Emergency Department Visit for Asthma

3. März 2014 aktualisiert von: Children's Hospital of Philadelphia

A Three-part Intervention to Improve Regular Care for Asthma After a Pediatric Emergency Department Visit: A Randomized Clinical Trial

The study will assess the efficacy of a three-part Emergency Department (ED)-based "Asthma Belief and Control" intervention on healthcare utilization, asthma controller medication use, symptoms, and quality of life during the 6 months following an Emergency Department visit.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Inner-city children are particularly at risk for poor asthma treatment outcomes and frequently obtain their asthma care in the ED. Prior studies have had limited success in improving primary care follow-up, quality of care, and long-term outcomes after a pediatric ED visit for asthma. Prior ED-based interventions have been designed to address barriers to follow-up with a primary care provider (PCP) such as an inability to obtain a follow-up appointment or lack of transportation. Focus groups and surveys of inner-city families have found that beliefs about the benefits of follow-up care and the role of preventive asthma medications have a strong impact on adherence to therapy.

This study will develop a brief educational video about the benefits of follow-up asthma care using a multi-disciplinary panel of experts at the Children's Hospital of Philadelphia and focus groups of parents of children with asthma. This educational video will then be combined into an intervention along with symptom screening and a reminder phone call that has been demonstrated to improve follow-up rates in a previous study. The combined intervention will be tested using a randomized trial design to determine its efficacy on healthcare utilization, asthma controller medication use, symptoms, and quality of life during the 6 months following an ED visit. The research is conducted as part of a research career development award.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

439

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Pennsylvania
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
        • Children's Hospital of Philadelphia

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

1 Jahr bis 18 Jahre (Kind, Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Age 1-18 years
  • History of Asthma:
  • At least 2 prior episodes of bronchodilator treatment
  • No underlying cardiac disease
  • No other chronic lung disease
  • Residence within Philadelphia city limits
  • Discharged from ED after treatment for asthma

Exclusion Criteria:

  • Prior study enrollment
  • Parent unable to speak English
  • No telephone to be reachable for follow-up calls

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: Control Subjects
These subjects will receive standard discharge instructions that recommend follow-up with a PCP within 3-5 days.
Experimental: Intervention Subjects
As part of the intervention, the family will view a brief educational video about asthma control and therapy developed using provider and patient focus groups. For children reporting persistent asthma symptoms, a letter will be given to the family to bring to their PCP stating that screening revealed symptoms that may require further treatment with controller medications. A mailed reminder to schedule a follow-up appointment will be sent to the family.
Verhalten: Intervention Subjects
The subject's family will view a brief educational video about asthma control and therapy developed using provider and patient focus groups; a mailed reminder will be sent to the family to schedule a follow-up appointment.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Follow-up with a Primary Care Physician (PCP)
Zeitfenster: 4 weeks, 3 months and 6 months after Emergency Department visit
At baseline, all subjects will complete the Parental Impressions of the Benefits (pros) and barriers (cons) of Follow-Up Care Scale (24-item instrument designed to measure perceived benefits and barriers to follow-up after an ED visit). Follow-up telephone contact will be made by the Primary Investigator or a research assistant after the initial Emergency Department visit. The person making the call will be unaware of the subjects group assignment (control or intervention). Families will be asked about the number of asthma-related follow-up visits which have been made to the Primary Care Physician. Information provided by families will be verified by medical record review.
4 weeks, 3 months and 6 months after Emergency Department visit

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Return to the Emergency Department for an asthma-related visit.
Zeitfenster: 4 weeks, 3 months and 6 months after Emergency Department visit.
Follow-up telephone contact will be made by the Primary Investigator or a research assistant after the initial Emergency Department visit. The person making the call will be unaware of the subjects group assignment (control or intervention). Families will be asked about the number of asthma-related visits which have been made to the Emergency Department. Information provided by families will be verified by medical record review.
4 weeks, 3 months and 6 months after Emergency Department visit.
Persistent asthma symptoms
Zeitfenster: 4 weeks, 3 months and 6 months after Emergency Department visit
At baseline, all subjects will complete a screening instrument to assess the symptoms of persistent asthma (including cough, wheeze, shortness of breath). Follow-up telephone contact will be made by the Primary Investigator or a research assistant after the initial Emergency Department visit. The person making the call will be unaware of the subjects group assignment (control or intervention). Families will be asked about asthma symptoms and information will be compared to baseline.
4 weeks, 3 months and 6 months after Emergency Department visit
Asthma Controller prescriptions by Primary Care Physician (PCP)
Zeitfenster: 4 weeks, 3 months and 6 months after Emergency Department visit
At baseline, all subjects will complete a screening interview which will assess asthma history, site of primary care physician and current therapies. Follow-up telephone contact will be made by the Primary Investigator or a research assistant after the initial Emergency Department visit. The person making the call will be unaware of the subjects group assignment (control or intervention). Families will be asked about the number of asthma controller medication prescriptions made by their Primary Care Physician. Information provided by families will be verified by medical record review.
4 weeks, 3 months and 6 months after Emergency Department visit
Asthma controller medication use
Zeitfenster: 4 weeks, 3 months and 6 months after Emergency Department visit
At baseline, all subjects will complete a screening interview which will assess asthma history, site of primary care physician and current therapies. Follow-up telephone contact will be made by the Primary Investigator or a research assistant after the initial Emergency Department visit. The person making the call will be unaware of the subjects group assignment (control or intervention). Families will be asked about current asthma controller controller medication use.
4 weeks, 3 months and 6 months after Emergency Department visit
Days of school/work missed
Zeitfenster: 4 weeks, 3 months and 6 months after Emergency Department visit
At baseline, all subjects will complete a screening interview which will assess asthma history. Follow-up telephone contact will be made by the Primary Investigator or a research assistant after the initial Emergency Department visit. The person making the call will be unaware of the subjects group assignment (control or intervention). Families will be asked about the number of missed work/school days due to asthma-related reasons.
4 weeks, 3 months and 6 months after Emergency Department visit
Peak expiratory flow
Zeitfenster: 4 weeks, 3 months and 6 months after Emergency Department visit
At baseline, all subjects over the age of 6 will receive a peak expiratory flow meter and instruction as per standard care in the Emergency Department. Follow-up telephone contact will be made by the Primary Investigator or a research assistant. The person making the call will be unaware of the subjects group assignment (control or intervention). Families will be asked about peak expiratory flow meter testing since the initial Emergency Department visit.
4 weeks, 3 months and 6 months after Emergency Department visit
Quality of life
Zeitfenster: 4 weeks, 3 months and 6 months after Emergency Department visit
At baseline, parents will be asked to complete the Integrated Therapeutics Group Child Asthma Short Form (8-item asthma-related quality of life questionnaire). Follow-up telephone contact will be made by the Primary Investigator or a research assistant. The person making the call will be unaware of the subjects group assignment (control or intervention). Families will be asked about the asthma-related quality of life since the initial Emergency Department visit.
4 weeks, 3 months and 6 months after Emergency Department visit

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Children's Hospital of Philadelphia

Mitarbeiter

National Heart, Lung, and Blood Institute (NHLBI)

Ermittler

  • Hauptermittler: Joseph J. Zorc, Children's Hospital of Philadelphia

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. September 2003

Primärer Abschluss (Tatsächlich)

1. Juni 2006

Studienabschluss (Tatsächlich)

1. Juni 2006

Studienanmeldedaten

Zuerst eingereicht

9. Juni 2005

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

9. Juni 2005

Zuerst gepostet (Schätzen)

10. Juni 2005

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

4. März 2014

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. März 2014

Zuletzt verifiziert

1. März 2014

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2004-12-4130
  • K23HL074250 (US NIH Stipendium/Vertrag)

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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