Resetting the Default: Improving Provider-patient Communication to Reduce Antibiotic Misuse
1 other identifier
interventional
1,600
1 country
3
Brief Summary
Antibiotic overuse and misuse contributes to the development of antibiotic resistant infections and adverse drug reactions. The majority of all antibiotic prescribing occurs in outpatient settings; most of which are for respiratory illnesses. It is estimated that 50% of these prescriptions are unnecessary. The most important factor that leads to overprescribing is inadequate parent-provider communication. This study will recruit providers and eligible parents of children 1-5 years of age. Parents in both arms will receive identical brief antibiotic education via tablet computers. Providers will be randomized to the parent-provider education or communication skills intervention arm and trained accordingly. Parent data will be collected via a tablet computer RedCap survey administered in the exam room prior and immediately following the child's visit. Additional data will be garnered from the medical record (antibiotic prescribing) and a 2-week follow-up telephone call with parents (re-visits and adverse drug reactions).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2017
Typical duration for not_applicable
3 active sites
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
First Submitted
Initial submission to the registry
January 27, 2017
CompletedFirst Posted
Study publicly available on registry
January 31, 2017
CompletedStudy Start
First participant enrolled
March 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2019
CompletedJune 26, 2019
June 1, 2019
2 years
January 27, 2017
June 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Inappropriate antibiotic use
Patient medical records will be reviewed 2 weeks after the visit to determine the clinical diagnosis and whether or not antibiotics were given. Determination will be made regarding the appropriateness of the diagnosis and prescribing using current clinical practice guidelines.
18 months
Secondary Outcomes (4)
Revisits
18 months
Adverse drug reactions
18 months
Shared decision-making
18 months
Parent Satisfaction with visit
18 months
Study Arms (2)
Education
ACTIVE COMPARATORAll providers will receive identical training on the appropriate prescribing of antibiotics for ARTIs in a 20 minute presentation. Follow up refresher video clips will also be available for all providers to view at their convenience throughout the study. Parents in both arms will receive identical high quality education on the pros and cons of antibiotics and tips for communicating with their provider.
Communication Skills
ACTIVE COMPARATORProviders randomized to the communication intervention will receive additional training on communication skills in a 40 minute communication skills training session. This training session will include good and bad communication examples, training on positive and negative behavioral framing, and education regarding key drivers of patient satisfaction.
Interventions
The first intervention is an educational intervention regarding appropriate diagnosis and treatment of common respiratory infections. This education will be delivered in an interactive lecture format for providers with follow up short informational video clips available over the course of the project.
The second intervention is an education plus communication skills training intervention. This training session will include identical antibiotic education training, good and bad communication examples, training on negative behavioral framing, and education regarding key drivers of patient satisfaction. Additionally providers will be informed of parent's desire for antibiotics rating prior to their consultation with the patient.
Eligibility Criteria
You may qualify if:
- Parent or guardian of a child 1-5 years of age with suspected respiratory tract infection who are English or Spanish speaking
You may not qualify if:
- Parents of children who require hospitalization
- Received antibiotics in the last 30 days
- Have concurrent bacterial infection, an immune compromising condition or chronic medical condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Heartland Primary Care
Kansas City, Kansas, 66109, United States
Heartland Primary Care
Lenexa, Kansas, 66227, United States
Children's Mercy Pediatric Care Clinic
Kansas City, Missouri, 64111, United States
Related Publications (3)
Goggin K, Hurley EA, Lee BR, Bradley-Ewing A, Bickford C, Pina K, Donis de Miranda E, Yu D, Weltmer K, Linnemayr S, Butler CC, Newland JG, Myers AL. Let's Talk About Antibiotics: a randomised trial of two interventions to reduce antibiotic misuse. BMJ Open. 2022 Nov 21;12(11):e049258. doi: 10.1136/bmjopen-2021-049258.
PMID: 36410835DERIVEDGoggin K, Hurley EA, Bradley-Ewing A, Bickford C, Lee BR, Pina K, De Miranda ED, Mackenzie A, Yu D, Weltmer K, Linnemayr S, Butler CC, Miller M, Newland JG, Myers AL. Reductions in Parent Interest in Receiving Antibiotics following a 90-Second Video Intervention in Outpatient Pediatric Clinics. J Pediatr. 2020 Oct;225:138-145.e1. doi: 10.1016/j.jpeds.2020.06.027. Epub 2020 Jun 15.
PMID: 32553835DERIVEDGoggin K, Bradley-Ewing A, Myers AL, Lee BR, Hurley EA, Delay KB, Schlachter S, Ramphal A, Pina K, Yu D, Weltmer K, Linnemayr S, Butler CC, Newland JG. Protocol for a randomised trial of higher versus lower intensity patient-provider communication interventions to reduce antibiotic misuse in two paediatric ambulatory clinics in the USA. BMJ Open. 2018 May 9;8(5):e020981. doi: 10.1136/bmjopen-2017-020981.
PMID: 29743330DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathy Goggin, PhD
Childrens Mercy Hospital
- PRINCIPAL INVESTIGATOR
Jason G. Newland, MD
Washington University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Providers will be randomly assigned to the education or communication skills intervention study arms. Both groups will receive identical training on the appropriate prescribing of antibiotics for ARTIs, but only those in the communication intervention will receive additional training on communication skills. Once providers have been randomized and trained, eligible patients will be enrolled and exposed to one of the interventions based on the provider they see for their visit. Patients will not be informed of their provider's study arm.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ernest L. Glasscock, MD, Chair in Pediatric Education and Research
Study Record Dates
First Submitted
January 27, 2017
First Posted
January 31, 2017
Study Start
March 3, 2017
Primary Completion
March 20, 2019
Study Completion
April 30, 2019
Last Updated
June 26, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will share
We will create a clean, de-identified copy of our final dataset that will be available to other researcher groups, upon request, within 9 months of the end of the final year of funding. Prior to data sharing, we will remove or convert all identifying information (date of birth will be converted to age and other identifiers will be removed). There may remain the possibility of deductive disclosure of subjects with unusual characteristics. Thus, we will make the data and associated documentation available to users under a data-sharing agreement.