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Improving Safe Antibiotic Prescribing in Telehealth

Primary Purpose

Acute Respiratory Infection, Telehealth

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trending Feedback
Benchmark Peer Comparison Feedback
Private Commitment
Public Commitment
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acute Respiratory Infection focused on measuring antibiotics, behavioral economics, social norms, performance feedback

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Teladoc Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

No Intervention

Arm Label

Trending Feedback + Private Commitment

Trending Feedback + Public Commitment

Trending Feedback + Commitment Control

Benchmark Peer Comparison Feedback + Private Commitment

Benchmark Peer Comparison Feedback + Public Commitment

Benchmark Peer Comparison Feedback + Commitment Control

Public Commitment + Feedback Control

Private Commitment + Feedback Control

Commitment Control + Feedback Control

Arm Description

Clinicians receive both Trending Feedback + Private Commitment interventions.

Clinicians receive both Trending Feedback + Public Commitment interventions.

Clinicians receive Trending Feedback intervention + Commitment Control.

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

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

Clinicians receive Benchmark Peer Comparison Feedback intervention + Commitment Control.

Clinicians receive Public Commitment intervention + Feedback Control.

Clinicians receive Private Commitment intervention + Feedback Control.

Clinicians receive no intervention.

Outcomes

Primary Outcome Measures

Change in antibiotic prescribing rate for Acute Respiratory Infections
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

Change in inappropriate antibiotic prescribing rate for Acute Respiratory Infections
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)

Full Information

First Posted
October 20, 2021
Last Updated
April 5, 2023
Sponsor
University of Southern California
Collaborators
Agency for Healthcare Research and Quality (AHRQ), Teladoc Health
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1. Study Identification

Unique Protocol Identification Number
NCT05138874
Brief Title
Improving Safe Antibiotic Prescribing in Telehealth
Official Title
Improving Safe Antibiotic Prescribing in Telehealth: Evaluation of a Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 3, 2022 (Actual)
Primary Completion Date
March 21, 2023 (Actual)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
Agency for Healthcare Research and Quality (AHRQ), Teladoc Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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 (Teladoc®), each with two levels of intensity. Teladoc® 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).
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 (Teladoc®), 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: 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." 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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Infection, Telehealth
Keywords
antibiotics, behavioral economics, social norms, performance feedback

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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".
Masking
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
6581 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Trending Feedback + Private Commitment
Arm Type
Experimental
Arm Description
Clinicians receive both Trending Feedback + Private Commitment interventions.
Arm Title
Trending Feedback + Public Commitment
Arm Type
Experimental
Arm Description
Clinicians receive both Trending Feedback + Public Commitment interventions.
Arm Title
Trending Feedback + Commitment Control
Arm Type
Experimental
Arm Description
Clinicians receive Trending Feedback intervention + Commitment Control.
Arm Title
Benchmark Peer Comparison Feedback + Private Commitment
Arm Type
Experimental
Arm Description
Clinicians receive both Benchmark Peer Comparison Feedback + Private Commitment interventions.
Arm Title
Benchmark Peer Comparison Feedback + Public Commitment
Arm Type
Experimental
Arm Description
Clinicians receive both Benchmark Peer Comparison Feedback + Public Commitment interventions.
Arm Title
Benchmark Peer Comparison Feedback + Commitment Control
Arm Type
Experimental
Arm Description
Clinicians receive Benchmark Peer Comparison Feedback intervention + Commitment Control.
Arm Title
Public Commitment + Feedback Control
Arm Type
Experimental
Arm Description
Clinicians receive Public Commitment intervention + Feedback Control.
Arm Title
Private Commitment + Feedback Control
Arm Type
Experimental
Arm Description
Clinicians receive Private Commitment intervention + Feedback Control.
Arm Title
Commitment Control + Feedback Control
Arm Type
No Intervention
Arm Description
Clinicians receive no intervention.
Intervention Type
Behavioral
Intervention Name(s)
Trending Feedback
Intervention Description
Clinicians randomized to Trending Feedback will receive monthly feedback on the provider dashboard page.
Intervention Type
Behavioral
Intervention Name(s)
Benchmark Peer Comparison Feedback
Intervention Description
Clinicians randomized to Benchmark Peer Comparison Feedback will receive monthly feedback on the provider dashboard page.
Intervention Type
Behavioral
Intervention Name(s)
Private Commitment
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Public Commitment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in antibiotic prescribing rate for Acute Respiratory Infections
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in inappropriate antibiotic prescribing rate for Acute Respiratory Infections
Description
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)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniella Meeker, PhD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Teladoc Health
City
Dallas
State/Province
Texas
ZIP/Postal Code
75244
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30651273
Citation
Chua KP, Fischer MA, Linder JA. Appropriateness of outpatient antibiotic prescribing among privately insured US patients: ICD-10-CM based cross sectional study. BMJ. 2019 Jan 16;364:k5092. doi: 10.1136/bmj.k5092.
Results Reference
background
PubMed Identifier
24474434
Citation
Meeker D, Knight TK, Friedberg MW, Linder JA, Goldstein NJ, Fox CR, Rothfeld A, Diaz G, Doctor JN. Nudging guideline-concordant antibiotic prescribing: a randomized clinical trial. JAMA Intern Med. 2014 Mar;174(3):425-31. doi: 10.1001/jamainternmed.2013.14191.
Results Reference
background
PubMed Identifier
26864410
Citation
Meeker D, Linder JA, Fox CR, Friedberg MW, Persell SD, Goldstein NJ, Knight TK, Hay JW, Doctor JN. Effect of Behavioral Interventions on Inappropriate Antibiotic Prescribing Among Primary Care Practices: A Randomized Clinical Trial. JAMA. 2016 Feb 9;315(6):562-70. doi: 10.1001/jama.2016.0275.
Results Reference
background
PubMed Identifier
27832047
Citation
Sanchez GV, Fleming-Dutra KE, Roberts RM, Hicks LA. Core Elements of Outpatient Antibiotic Stewardship. MMWR Recomm Rep. 2016 Nov 11;65(6):1-12. doi: 10.15585/mmwr.rr6506a1.
Results Reference
background
PubMed Identifier
29049577
Citation
Linder JA, Meeker D, Fox CR, Friedberg MW, Persell SD, Goldstein NJ, Doctor JN. Effects of Behavioral Interventions on Inappropriate Antibiotic Prescribing in Primary Care 12 Months After Stopping Interventions. JAMA. 2017 Oct 10;318(14):1391-1392. doi: 10.1001/jama.2017.11152.
Results Reference
background
PubMed Identifier
35724841
Citation
McCabe BK, Linder JA, Doctor JN, Friedberg M, Fox CR, Goldstein NJ, Knight TK, Kaiser K, Tibbels J, Haenchen S, Persell SD, Warberg R, Meeker D. The protocol of improving safe antibiotic prescribing in telehealth: A randomized trial. Contemp Clin Trials. 2022 Aug;119:106834. doi: 10.1016/j.cct.2022.106834. Epub 2022 Jun 18. Erratum In: Contemp Clin Trials. 2022 Sep 22;:106927.
Results Reference
derived

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Improving Safe Antibiotic Prescribing in Telehealth

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