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Resetting the Default: Improving Provider-patient Communication to Reduce Antibiotic Misuse

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ClinicalTrials.gov Identifier: NCT03037112
Recruitment Status : Completed
First Posted : January 31, 2017
Last Update Posted : June 26, 2019
Sponsor:
Collaborators:
Heartland Primary Care of Sunflower Medical Group
Washington University School of Medicine
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Kathy Goggin, Children's Mercy Hospital Kansas City

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).

Condition or disease Intervention/treatment Phase
Communication Anti-Bacterial Agents Decision Making Personal Satisfaction Behavioral: Education Behavioral: Communication Skills Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: 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.
Primary Purpose: Health Services Research
Official Title: Resetting the Default: Improving Provider-patient Communication to Reduce Antibiotic Misuse
Actual Study Start Date : March 3, 2017
Actual Primary Completion Date : March 20, 2019
Actual Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Active Comparator: Education
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.
Behavioral: Education
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.

Active Comparator: Communication Skills
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.
Behavioral: Communication Skills
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Revisits [ Time Frame: 18 months ]
    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.

  2. Adverse drug reactions [ Time Frame: 18 months ]
    All parents will be called 2 weeks following the visit to determine if the patient developed an adverse drug reaction to antibiotics.

  3. Shared decision-making [ Time Frame: 18 months ]
    Parents will rate the quality of the shared decision-making using validated survey instruments

  4. Parent Satisfaction with visit [ Time Frame: 18 months ]
    Parents will rate the their satisfaction with the visit using validated measures.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: \

  • Parent or guardian of a child 1-5 years of age with suspected respiratory tract infection who are English or Spanish speaking

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037112


Locations
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United States, Kansas
Heartland Primary Care
Kansas City, Kansas, United States, 66109
Heartland Primary Care
Lenexa, Kansas, United States, 66227
United States, Missouri
Children's Mercy Pediatric Care Clinic
Kansas City, Missouri, United States, 64111
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Heartland Primary Care of Sunflower Medical Group
Washington University School of Medicine
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Kathy Goggin, PhD Childrens Mercy Hospital
Principal Investigator: Jason G. Newland, MD Washington University School of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kathy Goggin, Ernest L. Glasscock, MD, Chair in Pediatric Education and Research, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT03037112     History of Changes
Other Study ID Numbers: PCORI150731759
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents