Improving Safe Antibiotic Prescribing in Telehealth

NCT ID: NCT05138874

Last Updated: 2024-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6581 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-03

Study Completion Date

2023-09-21

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Acute Respiratory Infection Telehealth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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".
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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.

Study Groups

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Trending Feedback + Private Commitment

Clinicians receive both Trending Feedback + Private Commitment interventions.

Group Type EXPERIMENTAL

Trending Feedback

Intervention Type BEHAVIORAL

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

Private Commitment

Intervention Type BEHAVIORAL

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.

Trending Feedback + Public Commitment

Clinicians receive both Trending Feedback + Public Commitment interventions.

Group Type EXPERIMENTAL

Trending Feedback

Intervention Type BEHAVIORAL

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

Public Commitment

Intervention Type BEHAVIORAL

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.

Trending Feedback + Commitment Control

Clinicians receive Trending Feedback intervention + Commitment Control.

Group Type EXPERIMENTAL

Trending Feedback

Intervention Type BEHAVIORAL

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

Benchmark Peer Comparison Feedback + Private Commitment

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

Group Type EXPERIMENTAL

Benchmark Peer Comparison Feedback

Intervention Type BEHAVIORAL

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

Private Commitment

Intervention Type BEHAVIORAL

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 + Public Commitment

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

Group Type EXPERIMENTAL

Benchmark Peer Comparison Feedback

Intervention Type BEHAVIORAL

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

Public Commitment

Intervention Type BEHAVIORAL

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 + Commitment Control

Clinicians receive Benchmark Peer Comparison Feedback intervention + Commitment Control.

Group Type EXPERIMENTAL

Benchmark Peer Comparison Feedback

Intervention Type BEHAVIORAL

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

Public Commitment + Feedback Control

Clinicians receive Public Commitment intervention + Feedback Control.

Group Type EXPERIMENTAL

Public Commitment

Intervention Type BEHAVIORAL

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.

Private Commitment + Feedback Control

Clinicians receive Private Commitment intervention + Feedback Control.

Group Type EXPERIMENTAL

Private Commitment

Intervention Type BEHAVIORAL

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.

Commitment Control + Feedback Control

Clinicians receive no intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Trending Feedback

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

Intervention Type BEHAVIORAL

Benchmark Peer Comparison Feedback

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

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

Teladoc Health

INDUSTRY

Sponsor Role collaborator

University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Daniella Meeker

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniella Meeker, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

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Teladoc Health

Dallas, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 30651273 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24474434 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26864410 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27832047 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29049577 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35724841 (View on PubMed)

Other Identifiers

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R01HS026506

Identifier Type: AHRQ

Identifier Source: org_study_id

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