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Improving Communication During Pediatric Visits for Acute Respiratory Illness

21 juli 2010 bijgewerkt door: University of Washington

The excessive use of outpatient antibiotics in the pediatric population has contributed to the rapid development of resistance in many strains of Streptococcus pneumoniae. Research has shown that community-based interventions may have a modest impact on reducing the injudicious use of antibiotics in children. However, since the actual prescribing of antibiotics is done by physicians and research has shown that physician-parent communication patterns during pediatric visits for acute respiratory tract infections (ARTI) strongly influence antibiotic prescription rate, it is crucial to develop effective interventions aimed specifically at them.

The overall goal of this study is to improve physician-parent communication patterns during visits for pediatric ARTI and, ultimately, to decrease rates of antibiotic prescribing for these illnesses in children.

Studie Overzicht

Toestand

Voltooid

Interventie / Behandeling

Gedetailleerde beschrijving

The overall goal of this study is to test a novel communication-based intervention aimed at decreasing rates of prescribing antibiotics for ARTI in children. We propose a randomized controlled trial involving a sample of 34 primary care pediatricians drawn from 8 practices in the Puget Sound Pediatric Research Network (PSPRN). Our research design incorporates a novel physician intervention that teaches the importance of specific physician communication behaviors. The primary physician outcomes for the study will be changes in the utilization of communication behaviors as reported by parents, and antibiotic prescribing rates for children presenting with ARTI symptoms. The primary parent outcome measure for the study will be satisfaction with care. Changes in the primary outcomes for the intervention physicians will be compared to changes in these outcomes for control physicians. The trial has five specific aims and five major hypotheses.

  1. To evaluate the effectiveness of the proposed intervention in achieving its stated goals of changing physician communication behaviors.

    • We hypothesize that physicians in the intervention group will have increased reported use of desirable communication behaviors and decreased reported use of undesirable communication behaviors relative to control group physicians.
  2. To determine the antibiotic prescribing rates for children aged 6 months to 10 years presenting with ARTI symptoms and assess how these rates change as a function of the intervention.

    • We hypothesize that physicians in the intervention group will decrease antibiotic prescribing rates for ARTI relative to the control group physicians.
  3. To determine visit-specific satisfaction levels for parents of children seen by study physicians and assess how satisfaction levels change as a function of the intervention.

    • We hypothesize that parents who take their children to physicians in the intervention group will report increased satisfaction with care, relative to control group physicians.
  4. To identify the factors (e.g., physician communication behaviors) that mediate the relationships between physicians being in the intervention group, decreased antibiotic prescribing, and increased parent satisfaction with care.

    • We hypothesize that increased use of desirable communication behaviors and decreased use of undesirable communication behaviors will partially mediate the relationships between being an intervention group physician, decreased inappropriate prescribing, and increased parent satisfaction with care.
  5. To perform a validation study of the Physician Communication Behavior Inventory (PCBI) survey items. Using a standardized approach, specific physician communication behaviors will be coded through review of 100 video taped physician-parent encounters. The behaviors coded will be compared to parent responses on the PCBI surveys from these encounters.

    • We hypothesize that parent reports of physician communication behaviors on the PCBI will be highly correlated with actual physician communication behaviors coded from video tape data.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

1313

Fase

  • Niet toepasbaar

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

19 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Parents: the parent must present with a child between the ages of 6 months and 10 years old, who has not received antibiotics for any reason in the prior two weeks and who has any of the following symptoms: cough, runny nose/congestion, sore throat, ear pain, or ear tugging. Parents must be able to read English or Spanish; the visit must occur during one of the three data collection periods for the participating physician; and parents must have not previously participated in teh study.
  • Physicians: physician must be a member of Puget Sound Pediatric research Network (PSPRN).

Exclusion Criteria:

  • Parents: parents who are 18 years of age or less
  • Physicians: physicians who are not members of PSPRN

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Interventie
Physicians that were assigned to the intervention group attended a 3.5 hour intervention workshop where they were trained in skills to communicate information about physical examination findings, treatment, and follow-up that will ultimately facilitate appropriate antibiotic prescribing and increase parent satisfaction with care.
Geen tussenkomst: Controle

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Effectiveness of intervention in changing physician communication behaviors
Tijdsspanne: 12 months
To evaluate the effectiveness of the proposed intervention in achieving its stated goals of changing physician communication behavoirs
12 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Antibiotic prescribing rates as a function of the intervention
Tijdsspanne: 12 months
To determine the antibiotic prescribing rates for children aged 6 months to 10 years presenting with ARTI symptoms and assess how these rates change as a function of the intervention
12 months
Satisfaction levels for parents as a function of the intervention
Tijdsspanne: 12 months
To determine visit-specific satisfaction levels for parents of children seen by study physicians and assess how satisfaction levels change as a function of the intervention
12 months
Factor identification
Tijdsspanne: 12 months
To identify the factors (e.g., physician communication behaviors) that mediate the relationships between physicians being in the intervention group, decreased antibiotic prescribing, and increased parent satisfaction with care
12 months
Validation study of the PCBI
Tijdsspanne: 12 months
To perform a validation study of the Physician Communication Behavior Inventory (PCBI) survey items. Using a standardized approach, specific physician communication behaviors will be coded through review of 100 video taped physician-parent encounters. The behaviors coded will be compared to parent responses on the PCBI surveys from these encounters.
12 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Rita Mangione-Smith, MD, MPH, University of Washington/ Seattle Children's Hospital
  • Hoofdonderzoeker: James A Taylor, MD, MPH, University of Washington

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2007

Primaire voltooiing (Werkelijk)

1 april 2009

Studie voltooiing (Werkelijk)

1 april 2009

Studieregistratiedata

Eerst ingediend

21 juli 2010

Eerst ingediend dat voldeed aan de QC-criteria

21 juli 2010

Eerst geplaatst (Schatting)

23 juli 2010

Updates van studierecords

Laatste update geplaatst (Schatting)

23 juli 2010

Laatste update ingediend die voldeed aan QC-criteria

21 juli 2010

Laatst geverifieerd

1 juli 2010

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 32542-A
  • 61-5957 (Andere identificatie: Children's IRB application number)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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