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

Communication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03037112
• Other study ID #: PCORI150731759
• Status: Completed
• Phase: N/A
• Start date: March 3, 2017
• Est. completion date: April 30, 2019

Study information

• Verified date: June 2019
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1600
• Est. completion date: April 30, 2019
• Est. primary completion date: March 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anti-Bacterial Agents
• Communication
• Decision Making
• Personal Satisfaction

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Children's Mercy Pediatric Care Clinic	Kansas City	Missouri
United States	Heartland Primary Care	Kansas City	Kansas
United States	Heartland Primary Care	Lenexa	Kansas

Sponsors (4)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City	Heartland Primary Care of Sunflower Medical Group, Patient-Centered Outcomes Research Institute, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	18 months
Secondary	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.	18 months
Secondary	Shared decision-making	Parents will rate the quality of the shared decision-making using validated survey instruments	18 months
Secondary	Parent Satisfaction with visit	Parents will rate the their satisfaction with the visit using validated measures.	18 months