NCT01454960

Brief Summary

Bacteria resistant to antibiotic therapy are a major public health problem. The evolution of multi-drug resistant pathogens may be encouraged by provider prescribing behavior. Inappropriate use of antibiotics for nonbacterial infections and overuse of broad spectrum antibiotics can lead to the development of resistant strains. Though providers are adequately trained to know when antibiotics are and are not comparatively effective, this has not been sufficient to affect critical provider practices. The intent of this study is to apply behavioral economic theory to reduce the rate of antibiotic prescriptions for acute respiratory diagnoses for which guidelines do not call for antibiotics. Specifically targeted are infections that are likely to be viral. The objective of this study is to improve provider decisions around treatment of acute respiratory infections. The participants are practicing attending physicians or advanced practice nurses (i.e. providers) at participating clinics who see acute respiratory infection patients. A maximum of 550 participants will be recruited for this study. Providers consenting to participate will fill out a baseline questionnaire online. Subsequent to baseline data collection and enrollment, participating clinic sites will be randomized to the study arms, as described below. There will be a control arm, with clinic sites randomized in a multifactorial design to up to three interventions that leverage the electronic medical record: Order Sets that are triggered by EHR workflow containing exclusively guideline concordant choices (SA, for Suggested Alternatives); Accountable Justification (AJ) triggered by discordant prescriptions that populate the note with provider's rationale for guideline exceptions ; and performance feedback that benchmarks providers' own performance to that of their peers (PC, for Peer Comparison). The outcomes of interest are antibiotic prescribing patterns, including prescribing rates and changes in prescribing rates over time. The intervention period will be over one year, with a one-year follow up period to measure persistence of the effect after EHR features are returned to the original state and providers no longer receive email alerts.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2011

Typical duration for not_applicable

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

Study Start

First participant enrolled

July 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 4, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 19, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

1.6 years

First QC Date

August 4, 2011

Last Update Submit

March 31, 2017

Conditions

Keywords

AntibioticsInappropriate PrescribingRespiratory Tract InfectionsBehavioral Research

Outcome Measures

Primary Outcomes (1)

  • Antibiotic Prescribing Rate for 5 Specific Acute Respiratory Infection Diagnoses

    Changes in antibiotic prescribing rate for the following ICD-9 diagnoses: 460 Acute nasopharyngitis (common cold) 465 Acute laryngeopharyngitis/acute upper respiratory infection 466 Acute bronchitis 490 Bronchitis not specified as acute or chronic 487 Flu

    2 years

Secondary Outcomes (1)

  • Antibiotic Prescribing Rates for Expanded List of Acute Respiratory Infection Diagnoses

    2 years

Study Arms (8)

SA, AJ, PC

EXPERIMENTAL

Participants are given all 3 interventions: Suggested Alternatives, Accountable Justification, and Peer Comparison.

Behavioral: Clinical Decision Support: Accountable JustificationBehavioral: Audit and Feedback: Peer ComparisonBehavioral: CDS Order Sets: Suggested Alternatives

SA, AJ

EXPERIMENTAL

Participants receive the Suggested Alternatives and Accountable Justification interventions, but not the Peer Comparison intervention.

Behavioral: Clinical Decision Support: Accountable JustificationBehavioral: CDS Order Sets: Suggested Alternatives

SA, PC

EXPERIMENTAL

Participants receive the Suggested Alternatives and Peer Comparison interventions, but not the Accountable Justification intervention.

Behavioral: Audit and Feedback: Peer ComparisonBehavioral: CDS Order Sets: Suggested Alternatives

AJ, PC

EXPERIMENTAL

Participants receive the Accountable Justification and Peer Comparison interventions, but not the Suggested Alternatives intervention.

Behavioral: Clinical Decision Support: Accountable JustificationBehavioral: Audit and Feedback: Peer Comparison

Peer Comparison

EXPERIMENTAL

Participants receive the Peer Comparison intervention, but do not receive the Suggested Alternatives or Accountable Justification interventions.

Behavioral: Audit and Feedback: Peer Comparison

Suggested Alternatives

EXPERIMENTAL

Participants receive the Suggested Alternatives intervention, but not the Accountable Justification or Peer Comparison interventions.

Behavioral: CDS Order Sets: Suggested Alternatives

Accountable Justification

EXPERIMENTAL

Participants receive the Accountable Justification intervention, but do not receive the Suggested Alternatives or Peer Comparison interventions.

Behavioral: Clinical Decision Support: Accountable Justification

Control

NO INTERVENTION

Participants do not receive any of the 3 interventions.

Interventions

Accountable Justification is triggered by discordant prescriptions that populate the EHR note with provider's rationale for guideline exceptions (AJ).

Also known as: AJ, Accountable Justification
AJ, PCAccountable JustificationSA, AJSA, AJ, PC

Performance feedback that benchmarks providers' own performance to that of their peers (PC, for Peer Comparison).

Also known as: PC, Peer Comparison
AJ, PCPeer ComparisonSA, AJ, PCSA, PC

Order Sets that are triggered by EHR workflow containing exclusively guideline concordant choices (SA, for Suggested Alternatives).

Also known as: SA, Suggested Alternatives
SA, AJSA, AJ, PCSA, PCSuggested Alternatives

Eligibility Criteria

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

You may qualify if:

  • A practicing attending physician or advanced practice nurse ("provider") at Northwestern University's NMFF GIM Clinic in 2011-2013 who sees acute respiratory infection patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Medical Faculty Foundation General Internal Medicine Clinic

Chicago, Illinois, 60611-2923, United States

Location

Related Publications (1)

  • Persell SD, Doctor JN, Friedberg MW, Meeker D, Friesema E, Cooper A, Haryani A, Gregory DL, Fox CR, Goldstein NJ, Linder JA. Behavioral interventions to reduce inappropriate antibiotic prescribing: a randomized pilot trial. BMC Infect Dis. 2016 Aug 5;16:373. doi: 10.1186/s12879-016-1715-8.

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Study Officials

  • Stephen Persell, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR
  • Jason N Doctor, PhD

    University of Southern California

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 4, 2011

First Posted

October 19, 2011

Study Start

July 1, 2011

Primary Completion

February 1, 2013

Study Completion

September 1, 2014

Last Updated

April 4, 2017

Record last verified: 2017-03

Locations