Upper Respiratory InfectionNCT01168778
Improving Communication During Pediatric Visits for Acute Respiratory Illness
A study testing Physician Workshop in people with Upper Respiratory Infection, run by University of Washington.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Upper Respiratory Infection
- What is being tested?
- Physician Workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,313 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Apr 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Parents: parents who are 18 years of age or less
- Physicians: physicians who are not members of PSPRN
About this study
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.
Read the 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.
- Conditions
- Upper Respiratory Infection
- Being tested
- Physician Workshop
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician WorkshopBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Intervention | Experimental | Not described Receives: Behavioral: Physician Workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (4)
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
Measured: 12 months
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
Measured: 12 months
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
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2010 (estimated)
- Study startSep 2007
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory InfectionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,313 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Investigators
- Rita Mangione-Smith, MD, MPH, Principal investigator, University of Washington/ Seattle Children's HospitalJames A Taylor, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01168778
- Sponsor's protocol ID
- 32542-A
- Other IDs
- 61-5957
- Status last verified
- Jul 2010
- First submitted
- 21 Jul 2010
- Last updated
- 23 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Communication During Pediatric Visits for Acute Respiratory Illness
- ClinicalTrials.gov ID
- NCT01168778
- Acronym / sponsor ID
- 32542-A
- Conditions
- Upper Respiratory Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,313 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 23 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Intervention | Experimental | Behavioral: Physician Workshop |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- Parents: parents who are 18 years of age or less
- Physicians: physicians who are not members of PSPRN
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physician WorkshopPhysicians 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. | Behavioural | Intervention |
Primary outcome
Effectiveness of intervention in changing physician communication behaviors
Time frame: 12 months
To evaluate the effectiveness of the proposed intervention in achieving its stated goals of changing physician communication behavoirs
4 secondary outcomes
Antibiotic prescribing rates as a function of the intervention
Time frame: 12 months
Satisfaction levels for parents as a function of the intervention
Time frame: 12 months
Factor identification
Time frame: 12 months
Validation study of the PCBI
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2010.
Related trials for Upper Respiratory Infection
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
Not yet recruiting
Evaluating Sucrose and Cold Oral Interventions for the Treatment of Oral Pruritus During Allergy Procedures.
Allergy, Food Allergies
RecruitingObservational study
A Study to Evaluate Treating Watery Noses With Cryotherapy in the Clinic Setting. This is Cold Therapy, Freezing the Issues at the Back of the Nose to Ease Symptoms.
Chronic Rhinitis
Recruiting
Vocxi Breath Analyzer Study in Pediatric Respiratory Infection
Acute Respiratory Illness, Viral Respiratory Infection
Active, not recruitingPhase 2
OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recurrent OC
Platinum-sensitive Ovarian Cancer, Relapsed Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rita Mangione-Smith, MD, MPH principal investigator
University of Washington/ Seattle Children's Hospital
James A Taylor, MD, MPH principal investigator
University of Washington
Questions about this trial
What is this clinical trial studying?
A study testing Physician Workshop in people with Upper Respiratory Infection, run by University of Washington.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of intervention in changing physician communication behaviors (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2010.