Improving Safe Antibiotic Prescribing in Telehealth

Sponsor
University of Southern California (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05138874
Collaborator
Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed), Teladoc Health (Industry)
6,581
1
9
18
366.2

Study Details

Study Description

Brief Summary

Appropriate use of antibiotics reduces resistance and protects patients from unnecessary harm. Important advances in antibiotic stewardship have been achieved in outpatient settings, but little is known about stewardship in the rapidly growing telehealth sector. Prior pragmatic randomized trials have shown that Centers for Disease Control (CDC) Core Element interventions constructed using insights from decision and social psychology can greatly reduce inappropriate prescribing in outpatient settings.

In a randomized trial, the investigators will adapt and test two aspects of CDC Core Elements in a telehealth environment (TeladocĀ®), each with two levels of intensity. TeladocĀ® clinicians will be randomized to the following interventions: 1) Performance Feedback (Trending, Benchmark Peer Comparison), 2) Commitment (Private, Public), or 3) Control. All randomization occurs at the provider level, with the exception of the Public Commitment arm, which requires patient-facing content that is determined by patient state. Clinicians and members will see the same messages across all pages, all channels & all consults during the 12-month study period. The primary outcome is to assess change in antibiotic prescribing rate for qualifying acute respiratory infection visits (ARIs).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Trending Feedback
  • Behavioral: Benchmark Peer Comparison Feedback
  • Behavioral: Private Commitment
  • Behavioral: Public Commitment
N/A

Detailed Description

In a 3 x 3 (Performance Feedback x Commitment) randomized trial, the investigators will adapt and test two aspects of Core Elements in a telehealth environment (TeladocĀ®), each with two variations. Qualifying visits include pediatric and adult telehealth visits for acute respiratory infections, including sinusitis, bronchitis, influenza, otitis media, pharyngitis, nonspecific upper respiratory infections, and COVID-19.

All randomization occurs at the provider level, with the exception of the Public Commitment arm, which requires patient-facing content that is determined by patient state. Allocation will be stratified to ensure balance across baseline characteristics including visit volume (consults per year), antibiotic prescribing rate for acute respiratory infections and COVID-19, and average member satisfaction (percent of responses "Outstanding" or "Good").

Performance Feedback (Trending, Benchmark Peer Comparison, Control). Performance Feedback is based on regional performance benchmarks; physicians with antibiotic prescribing rates in the lowest 3 deciles are designated top performers. The electronic health record (EHR) metrics and messaging are designed to align with enterprise-wide performance feedback practices. A minimum of 8 qualifying visits is required for a provider to see a message.

Providers randomized to Performance Feedback interventions will see one of two feedback messages in the EHR:

  1. Trending Feedback Message: If the clinician's mean monthly antibiotic prescribing rate for acute respiratory infections is below the 3rd decile, where better performance is indicated by a position in a lower decile, providers will see the following message with a link to the clinical practice guidelines: "Your antibiotic prescribing rate is X%. Stay in the growing number of providers in your group that have stopped inappropriate antibiotic prescribing." If the clinician's mean monthly antibiotic prescribing rate for ARIs is above the 3rd decile where better performance is indicated by a position in a lower decile, providers will see the following message with a link to the clinical practice guidelines: "Your antibiotic prescribing rate is Y% (where Y% is the prescribing rate of the third decile). Don't be left behind! Join the growing number of providers in your group who prescribe antibiotics only when clearly indicated."

  2. Benchmark Peer Comparison Feedback Message: If the clinician's mean monthly antibiotic prescribing rate for ARIs is below the 3rd decile, where better performance is indicated by a position in a lower decile, providers will receive the following message: "You are a Top Performer. Your antibiotic prescribing rate is X%. Top performers in your group typically prescribe antibiotics in X% of visits." If the clinician prescribing rate is above the 3rd decile, where better performance is indicated by a position in a lower decile, providers will receive the following message: "You are not a Top Performer. Top performers in your group typically prescribe antibiotics in Y% of visits."

Commitment (Private, Public, Control). Clinicians assigned to the Private Commitment arm will make a personal commitment to evidence-based use of antibiotics that is not shared with their patients, while those assigned to Public Commitment will make a commitment to evidence-based use of antibiotics that is shared with their patients. For both arms, this commitment is displayed on the clinician's personal provider dashboard.

Providers randomized to the Commitment interventions will be asked to complete one of two commitments:

  1. Private Commitment: Providers will be given the following options:1) Record my commitment or 2) Do not include me in the commitment, followed by a text box to type their name. For clinicians who choose option 1, their commitment is displayed on their personal provider dashboard at the time of each login.

  2. Public Commitment: Providers will be given the following options:1) Record and share my commitment with my patients OR 2) I am not committed to the new guidelines, followed by a text box to type their name. For clinicians who opt in, the commitment is displayed on their personal dashboard at each login.

Patients in states assigned to Public Commitment will see the clinician's commitment at the end of their visit request. Patients will select: 1) I understand the provider's commitment OR 2) I do not understand and need more information. Clinicians in this arm will be notified about the patient response in the EHR during the visit.

The primary outcome is to assess the change in antibiotic prescribing rate for qualifying acute respiratory infection visits.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
6581 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Intervention Model Description:
Participants are randomly assigned to one of three levels of commitment interventions and one of three levels of feedback interventions, for a total of 9 study arms (3 X 3). One level in each factor is "control" which entails "no intervention".Participants are randomly assigned to one of three levels of commitment interventions and one of three levels of feedback interventions, for a total of 9 study arms (3 X 3). One level in each factor is "control" which entails "no intervention".
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
Patients are blinded to all study arms with the exception of Public Commitment where, by design, patients are exposed to physicians' commitment. Physicians cannot be blinded to interventions that, by design, impact the electronic medical record display.
Primary Purpose:
Health Services Research
Official Title:
Improving Safe Antibiotic Prescribing in Telehealth: Evaluation of a Randomized Trial
Actual Study Start Date :
Mar 3, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Trending Feedback + Private Commitment

Clinicians receive both Trending Feedback + Private Commitment interventions.

Behavioral: Trending Feedback
Clinicians randomized to Trending Feedback will receive monthly feedback on the provider dashboard page.

Behavioral: Private Commitment
Clinicians assigned to the Private Commitment will be prompted in the provider dashboard to make a personal commitment to evidence-based use of antibiotics that will not be shared with their patients.

Experimental: Trending Feedback + Public Commitment

Clinicians receive both Trending Feedback + Public Commitment interventions.

Behavioral: Trending Feedback
Clinicians randomized to Trending Feedback will receive monthly feedback on the provider dashboard page.

Behavioral: Public Commitment
Clinicians assigned to Public Commitment will be prompted in the provider dashboard to make a commitment to evidence-based use of antibiotics that will be shared with their patients.

Experimental: Trending Feedback + Commitment Control

Clinicians receive Trending Feedback intervention + Commitment Control.

Behavioral: Trending Feedback
Clinicians randomized to Trending Feedback will receive monthly feedback on the provider dashboard page.

Experimental: Benchmark Peer Comparison Feedback + Private Commitment

Clinicians receive both Benchmark Peer Comparison Feedback + Private Commitment interventions.

Behavioral: Benchmark Peer Comparison Feedback
Clinicians randomized to Benchmark Peer Comparison Feedback will receive monthly feedback on the provider dashboard page.

Behavioral: Private Commitment
Clinicians assigned to the Private Commitment will be prompted in the provider dashboard to make a personal commitment to evidence-based use of antibiotics that will not be shared with their patients.

Experimental: Benchmark Peer Comparison Feedback + Public Commitment

Clinicians receive both Benchmark Peer Comparison Feedback + Public Commitment interventions.

Behavioral: Benchmark Peer Comparison Feedback
Clinicians randomized to Benchmark Peer Comparison Feedback will receive monthly feedback on the provider dashboard page.

Behavioral: Public Commitment
Clinicians assigned to Public Commitment will be prompted in the provider dashboard to make a commitment to evidence-based use of antibiotics that will be shared with their patients.

Experimental: Benchmark Peer Comparison Feedback + Commitment Control

Clinicians receive Benchmark Peer Comparison Feedback intervention + Commitment Control.

Behavioral: Benchmark Peer Comparison Feedback
Clinicians randomized to Benchmark Peer Comparison Feedback will receive monthly feedback on the provider dashboard page.

Experimental: Public Commitment + Feedback Control

Clinicians receive Public Commitment intervention + Feedback Control.

Behavioral: Public Commitment
Clinicians assigned to Public Commitment will be prompted in the provider dashboard to make a commitment to evidence-based use of antibiotics that will be shared with their patients.

Experimental: Private Commitment + Feedback Control

Clinicians receive Private Commitment intervention + Feedback Control.

Behavioral: Private Commitment
Clinicians assigned to the Private Commitment will be prompted in the provider dashboard to make a personal commitment to evidence-based use of antibiotics that will not be shared with their patients.

No Intervention: Commitment Control + Feedback Control

Clinicians receive no intervention.

Outcome Measures

Primary Outcome Measures

  1. Change in antibiotic prescribing rate for Acute Respiratory Infections [12 months]

    Change in antibiotic prescribing rate for acute respiratory infection visits based on the International Statistical Classification of Diseases, version 10 (ICD-10) codes including: non-specific upper respiratory infections, otitis media, sinusitis, pharyngitis, bronchitis, influenza, and COVID-19.

Secondary Outcome Measures

  1. Change in inappropriate antibiotic prescribing rate for Acute Respiratory Infections [12 months]

    Change in inappropriate antibiotic prescribing rate for acute respiratory infections where antibiotics are never appropriate based on International Statistical Classification of Diseases, version 10 (ICD-10) codes as well as COVID-19 (U07.1)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Clinicians with prescribing privileges and one or more Acute Respiratory Infection visit

  • Eligible encounters include pediatric and adult telehealth visits for Acute Respiratory Infections, including Sinusitis, Bronchitis, Influenza, Otitis Media, Nasopharyngitis, Upper Respiratory Infections, and COVID-19.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Teladoc Health Dallas Texas United States 75244

Sponsors and Collaborators

  • University of Southern California
  • Agency for Healthcare Research and Quality (AHRQ)
  • Teladoc Health

Investigators

  • Principal Investigator: Daniella Meeker, PhD, University of Southern California

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Daniella Meeker, Associate Professor, University of Southern California
ClinicalTrials.gov Identifier:
NCT05138874
Other Study ID Numbers:
  • R01HS026506
First Posted:
Dec 1, 2021
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Daniella Meeker, Associate Professor, University of Southern California
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 31, 2022