NCT01168778

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,313

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2007

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2010

Completed
Last Updated

July 23, 2010

Status Verified

July 1, 2010

Enrollment Period

1.6 years

First QC Date

July 21, 2010

Last Update Submit

July 21, 2010

Conditions

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of intervention in changing physician communication behaviors

    To evaluate the effectiveness of the proposed intervention in achieving its stated goals of changing physician communication behavoirs

    12 months

Secondary Outcomes (4)

  • Antibiotic prescribing rates as a function of the intervention

    12 months

  • Satisfaction levels for parents as a function of the intervention

    12 months

  • Factor identification

    12 months

  • Validation study of the PCBI

    12 months

Study Arms (2)

Control

NO INTERVENTION

Intervention

EXPERIMENTAL
Behavioral: Physician Workshop

Interventions

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.

Intervention

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Study Officials

  • Rita Mangione-Smith, MD, MPH

    University of Washington/ Seattle Children's Hospital

    PRINCIPAL INVESTIGATOR
  • James A Taylor, MD, MPH

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 21, 2010

First Posted

July 23, 2010

Study Start

September 1, 2007

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

July 23, 2010

Record last verified: 2010-07