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Improving Communication During Pediatric Visits for Acute Respiratory Illness

Primary Purpose

Upper Respiratory Infection

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physician Workshop
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Upper Respiratory Infection

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control

    Intervention

    Arm Description

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Antibiotic prescribing rates as a function of the intervention
    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
    Satisfaction levels for parents as a function of the intervention
    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
    Factor identification
    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
    Validation study of the PCBI
    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.

    Full Information

    First Posted
    July 21, 2010
    Last Updated
    July 21, 2010
    Sponsor
    University of Washington
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01168778
    Brief Title
    Improving Communication During Pediatric Visits for Acute Respiratory Illness
    Official Title
    Improving Communication During Pediatric Visits for Acute Respiratory Illness
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2007 (undefined)
    Primary Completion Date
    April 2009 (Actual)
    Study Completion Date
    April 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Washington

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    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. 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. 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. 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. 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Upper Respiratory Infection

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1313 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Title
    Intervention
    Arm Type
    Experimental
    Intervention Type
    Behavioral
    Intervention Name(s)
    Physician Workshop
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Effectiveness of intervention in changing physician communication behaviors
    Description
    To evaluate the effectiveness of the proposed intervention in achieving its stated goals of changing physician communication behavoirs
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Antibiotic prescribing rates as a function of the intervention
    Description
    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
    Time Frame
    12 months
    Title
    Satisfaction levels for parents as a function of the intervention
    Description
    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
    Time Frame
    12 months
    Title
    Factor identification
    Description
    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
    Time Frame
    12 months
    Title
    Validation study of the PCBI
    Description
    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.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rita Mangione-Smith, MD, MPH
    Organizational Affiliation
    University of Washington/ Seattle Children's Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    James A Taylor, MD, MPH
    Organizational Affiliation
    University of Washington
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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