Improving Communication During Pediatric Visits for Acute Respiratory Illness

Upper Respiratory Infection Clinical Trial

Official title:

Improving Communication During Pediatric Visits for Acute Respiratory Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01168778
• Other study ID #: 32542-A
• Secondary ID: 61-5957
• Status: Completed
• Phase: N/A
• First received: July 21, 2010
• Last updated: July 21, 2010
• Start date: September 2007
• Est. completion date: April 2009

Study information

• Verified date: July 2010
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1313
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Respiratory Tract Infections
• Upper Respiratory Infection

Intervention

Behavioral:
• Physician Workshop
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	12 months	No
Secondary	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	12 months	No
Secondary	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	12 months	No
Secondary	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.	12 months	No