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Acute Respiratory InfectionNCT05138874

Improving Safe Antibiotic Prescribing in Telehealth

A study testing Trending Feedback, Benchmark Peer Comparison Feedback and Private Commitment in people with Acute Respiratory Infection and Telehealth, run by University of Southern California at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Respiratory Infection, Telehealth
What is being tested?
Trending Feedback, Benchmark Peer Comparison Feedback and Private Commitment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6,581 participants
Where
1 siteUnited States
Study dates
3 Mar 2022to 21 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Teladoc Health

    Dallas, Texas, 75244

Other trials in United States

About this study

Official title: Improving Safe Antibiotic Prescribing in Telehealth: Evaluation of a Randomized Trial

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).

Read the 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:

  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.

Being tested
Trending Feedback, Benchmark Peer Comparison Feedback, Private Commitment, Public Commitment
Keywords
antibiotics, behavioral economics, social norms, performance feedback

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trending FeedbackBehavioural

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

  • Benchmark Peer Comparison FeedbackBehavioural

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

  • Private CommitmentBehavioural

    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.

  • Public CommitmentBehavioural

    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.

Study groups in NCT05138874
Study groupRoleWhat they receive
Trending Feedback + Private CommitmentExperimentalClinicians receive both Trending Feedback + Private Commitment interventions.
Receives: Behavioral: Trending Feedback; Behavioral: Private Commitment
Trending Feedback + Public CommitmentExperimentalClinicians receive both Trending Feedback + Public Commitment interventions.
Receives: Behavioral: Trending Feedback; Behavioral: Public Commitment
Trending Feedback + Commitment ControlExperimentalClinicians receive Trending Feedback intervention + Commitment Control.
Receives: Behavioral: Trending Feedback
Benchmark Peer Comparison Feedback + Private CommitmentExperimentalClinicians receive both Benchmark Peer Comparison Feedback + Private Commitment interventions.
Receives: Behavioral: Benchmark Peer Comparison Feedback; Behavioral: Private Commitment
Benchmark Peer Comparison Feedback + Public CommitmentExperimentalClinicians receive both Benchmark Peer Comparison Feedback + Public Commitment interventions.
Receives: Behavioral: Benchmark Peer Comparison Feedback; Behavioral: Public Commitment
Benchmark Peer Comparison Feedback + Commitment ControlExperimentalClinicians receive Benchmark Peer Comparison Feedback intervention + Commitment Control.
Receives: Behavioral: Benchmark Peer Comparison Feedback
Public Commitment + Feedback ControlExperimentalClinicians receive Public Commitment intervention + Feedback Control.
Receives: Behavioral: Public Commitment
Private Commitment + Feedback ControlExperimentalClinicians receive Private Commitment intervention + Feedback Control.
Receives: Behavioral: Private Commitment
Commitment Control + Feedback ControlNo interventionClinicians receive no intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (1)
  1. 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)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2021
  2. Study start3 Mar 2022
  3. Primary completion21 Mar 2023
  4. Study completion21 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Factorial
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
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
6,581 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05138874
Sponsor's protocol ID
R01HS026506
Status last verified
Jan 2024
First submitted
20 Oct 2021
Last updated
18 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 30651273
  • 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.

    PubMed 24474434
  • 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.

    PubMed 26864410
  • 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.

    PubMed 27832047
  • 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.

    PubMed 29049577
  • 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.

    PubMed 35724841

Questions about this trial

What is this clinical trial studying?

A study testing Trending Feedback, Benchmark Peer Comparison Feedback and Private Commitment in people with Acute Respiratory Infection and Telehealth, run by University of Southern California at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in antibiotic prescribing rate for Acute Respiratory Infections (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05138874, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.

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