CommunicationNCT03037112
Resetting the Default: Improving Provider-patient Communication to Reduce Antibiotic Misuse
A study testing Education and Communication Skills in people with Communication and Anti-Bacterial Agents, run by Children's Mercy Hospital Kansas City at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Communication, Anti-Bacterial Agents, Decision Making
- What is being tested?
- Education and Communication Skills
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Mar 2017to 30 Apr 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parent or guardian of a child 1-5 years of age with suspected respiratory tract infection who are English or Spanish speaking
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Heartland Primary Care
Kansas City, Kansas, 66109
Children's Mercy Pediatric Care Clinic
Kansas City, Missouri, 64111
Heartland Primary Care
Lenexa, Kansas, 66227
About this study
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).
Read the detailed description
Significance: Antibiotic overuse and misuse contribute to the development of antibiotic resistant infections that kill at least 23,000 Americans and cause an additional 2 million infections annually. If left unchecked, antibiotic resistant infections are estimated to cause 10 million deaths worldwide by 2050. Antibiotic associated adverse drug reactions (e.g., rash, diarrhea, nausea, and vomiting) also result in over 140,000 Emergency Department visits annually.
The majority of all antibiotic prescribing occurs in outpatient settings where children receive 49 million prescriptions annually. Over 70% of these are for respiratory infections and nearly 8.5 million of these prescriptions are inappropriate (i.e., either an unnecessary broad-spectrum antibiotic or to treat a viral illness). There are many factors that lead to overprescribing, but chief among them is inadequate parent-provider communication.
Innovation: This study is the first US multi-site randomized controlled trial comparing the effectiveness an education vs. communication skills provider intervention to stimulate high quality parent-provider communication and judicious use of antibiotics.
Approach: 1,600 eligible parents (or caregivers) of children between the ages of 1 and 5 will be enrolled and exposed to one of the interventions based on the provider they see for their visit. English and Spanish speaking parents will be recruited from the Children's Mercy Hospital Primary Care Clinic (CMH PCC) in Kansas City, Missouri and the Heartland Primary Care Clinics in Kansas City, KS and Lenexa, KS. Parents in both arms will receive identical brief negatively behavioral framed antibiotic education via tablet computers. Providers will be randomized to the parent-provider education or communication skills intervention arm and trained accordingly. The primary outcome is rate of inappropriate antibiotic prescribing. Secondary outcomes are parental ratings of shared decision-making and satisfaction, re-visits and adverse drug reactions. Data will be collected via a tablet computer administered 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).
Public Health Impact: This study could have significant public health implications and meet the goals outlined in the 2014 Executive Order on Combating Antibiotic Resistance, which seeks to slow the emergence of resistant bacteria and prevent the spread of resistant infections through the judicious and appropriate use of antibiotics.
- Being tested
- Education, Communication Skills
- Medical subject headings
- Communication, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
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.
Communication SkillsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Education | Active comparator | All 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. Receives: Behavioral: Education |
| Communication Skills | Active comparator | Providers 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. Receives: Behavioral: Communication Skills |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (4)
Revisits
All parents will be called 2 weeks following the initial visit to determine if any revisits to the same office or to another health care facility were made after the initial visit for either clinical worsening or lack of clinical improvement, or due to an adverse drug reaction.
Measured: 18 months
Adverse drug reactions
All parents will be called 2 weeks following the visit to determine if the patient developed an adverse drug reaction to antibiotics.
Measured: 18 months
Shared decision-making
Parents will rate the quality of the shared decision-making using validated survey instruments
Measured: 18 months
Parent Satisfaction with visit
Parents will rate the their satisfaction with the visit using validated measures.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start3 Mar 2017
- Primary completion20 Mar 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CommunicationStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- Heartland Primary Care of Sunflower Medical Group, Washington University School of Medicine, Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Kathy Goggin, Children's Mercy Hospital Kansas City
- Investigators
- Kathy Goggin, PhD, Principal investigator, Childrens Mercy HospitalJason G. Newland, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037112
- Sponsor's protocol ID
- PCORI150731759
- Status last verified
- Jun 2019
- First submitted
- 27 Jan 2017
- Last updated
- 26 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 36410835Goggin 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.
PubMed 32553835Goggin 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.
PubMed 29743330
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resetting the Default: Improving Provider-patient Communication to Reduce Antibiotic Misuse
- ClinicalTrials.gov ID
- NCT03037112
- Acronym / sponsor ID
- PCORI150731759
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,600 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Collaborators
- Heartland Primary Care of Sunflower Medical Group, Washington University School of Medicine, Patient-Centered Outcomes Research Institute
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- 20 Mar 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 31 Jan 2017 (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.
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).
Detailed description
Significance: Antibiotic overuse and misuse contribute to the development of antibiotic resistant infections that kill at least 23,000 Americans and cause an additional 2 million infections annually. If left unchecked, antibiotic resistant infections are estimated to cause 10 million deaths worldwide by 2050. Antibiotic associated adverse drug reactions (e.g., rash, diarrhea, nausea, and vomiting) also result in over 140,000 Emergency Department visits annually.
The majority of all antibiotic prescribing occurs in outpatient settings where children receive 49 million prescriptions annually. Over 70% of these are for respiratory infections and nearly 8.5 million of these prescriptions are inappropriate (i.e., either an unnecessary broad-spectrum antibiotic or to treat a viral illness). There are many factors that lead to overprescribing, but chief among them is inadequate parent-provider communication.
Innovation: This study is the first US multi-site randomized controlled trial comparing the effectiveness an education vs. communication skills provider intervention to stimulate high quality parent-provider communication and judicious use of antibiotics.
Approach: 1,600 eligible parents (or caregivers) of children between the ages of 1 and 5 will be enrolled and exposed to one of the interventions based on the provider they see for their visit. English and Spanish speaking parents will be recruited from the Children's Mercy Hospital Primary Care Clinic (CMH PCC) in Kansas City, Missouri and the Heartland Primary Care Clinics in Kansas City, KS and Lenexa, KS. Parents in both arms will receive identical brief negatively behavioral framed antibiotic education via tablet computers. Providers will be randomized to the parent-provider education or communication skills intervention arm and trained accordingly. The primary outcome is rate of inappropriate antibiotic prescribing. Secondary outcomes are parental ratings of shared decision-making and satisfaction, re-visits and adverse drug reactions. Data will be collected via a tablet computer administered 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).
Public Health Impact: This study could have significant public health implications and meet the goals outlined in the 2014 Executive Order on Combating Antibiotic Resistance, which seeks to slow the emergence of resistant bacteria and prevent the spread of resistant infections through the judicious and appropriate use of antibiotics.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education | Active comparator | Behavioral: EducationAll 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 comparator | Behavioral: Communication SkillsProviders 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Parent or guardian of a child 1-5 years of age with suspected respiratory tract infection who are English or Spanish speaking
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| EducationThe 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. | Behavioural | Education |
| Communication SkillsThe 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. | Behavioural | Communication Skills |
Primary outcome
Inappropriate antibiotic use
Time frame: 18 months
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.
4 secondary outcomes
Revisits
Time frame: 18 months
Adverse drug reactions
Time frame: 18 months
Shared decision-making
Time frame: 18 months
Parent Satisfaction with visit
Time frame: 18 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 26 Jun 2019.
- Derived from this study: PubMed 36410835Goggin 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.
- Derived from this study: PubMed 32553835Goggin 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.
- Derived from this study: PubMed 29743330Goggin 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.
- Individual participant dataSharing planned: Yes. 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.
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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.
Kathy Goggin, PhD principal investigator
Childrens Mercy Hospital
Jason G. Newland, MD principal investigator
Washington University School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and Communication Skills in people with Communication and Anti-Bacterial Agents, run by Children's Mercy Hospital Kansas City at 3 sites in United States.
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 1 inclusion and 3 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 26 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Inappropriate antibiotic use (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03037112, which also lists 3 linked publications.
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 26 Jun 2019.