NCT05138874

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,581

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 1, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

March 3, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2023

Completed
Last Updated

January 18, 2024

Status Verified

January 1, 2024

Enrollment Period

1 year

First QC Date

October 20, 2021

Last Update Submit

January 17, 2024

Conditions

Keywords

antibioticsbehavioral economicssocial normsperformance feedback

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (1)

  • Change in inappropriate antibiotic prescribing rate for Acute Respiratory Infections

    12 months

Study Arms (9)

Trending Feedback + Private Commitment

EXPERIMENTAL

Clinicians receive both Trending Feedback + Private Commitment interventions.

Behavioral: Trending FeedbackBehavioral: Private Commitment

Trending Feedback + Public Commitment

EXPERIMENTAL

Clinicians receive both Trending Feedback + Public Commitment interventions.

Behavioral: Trending FeedbackBehavioral: Public Commitment

Trending Feedback + Commitment Control

EXPERIMENTAL

Clinicians receive Trending Feedback intervention + Commitment Control.

Behavioral: Trending Feedback

Benchmark Peer Comparison Feedback + Private Commitment

EXPERIMENTAL

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

Behavioral: Benchmark Peer Comparison FeedbackBehavioral: Private Commitment

Benchmark Peer Comparison Feedback + Public Commitment

EXPERIMENTAL

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

Behavioral: Benchmark Peer Comparison FeedbackBehavioral: Public Commitment

Benchmark Peer Comparison Feedback + Commitment Control

EXPERIMENTAL

Clinicians receive Benchmark Peer Comparison Feedback intervention + Commitment Control.

Behavioral: Benchmark Peer Comparison Feedback

Public Commitment + Feedback Control

EXPERIMENTAL

Clinicians receive Public Commitment intervention + Feedback Control.

Behavioral: Public Commitment

Private Commitment + Feedback Control

EXPERIMENTAL

Clinicians receive Private Commitment intervention + Feedback Control.

Behavioral: Private Commitment

Commitment Control + Feedback Control

NO INTERVENTION

Clinicians receive no intervention.

Interventions

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

Trending Feedback + Commitment ControlTrending Feedback + Private CommitmentTrending Feedback + Public Commitment

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

Benchmark Peer Comparison Feedback + Commitment ControlBenchmark Peer Comparison Feedback + Private CommitmentBenchmark Peer Comparison Feedback + Public 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.

Benchmark Peer Comparison Feedback + Private CommitmentPrivate Commitment + Feedback ControlTrending Feedback + Private 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.

Benchmark Peer Comparison Feedback + Public CommitmentPublic Commitment + Feedback ControlTrending Feedback + Public Commitment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Teladoc Health

Dallas, Texas, 75244, United States

Location

Related Publications (6)

  • 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.

    PMID: 30651273BACKGROUND
  • 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.

    PMID: 24474434BACKGROUND
  • 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.

    PMID: 26864410BACKGROUND
  • 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.

    PMID: 27832047BACKGROUND
  • 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.

    PMID: 29049577BACKGROUND
  • 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.

Study Officials

  • Daniella Meeker, PhD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Model Details: 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".
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 20, 2021

First Posted

December 1, 2021

Study Start

March 3, 2022

Primary Completion

March 21, 2023

Study Completion

September 21, 2023

Last Updated

January 18, 2024

Record last verified: 2024-01

Locations