NCT01454947

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 electronic health record (EHR) workflow containing exclusively guideline concordant choices (SA, for Suggested Alternatives); Accountable Justifications triggered by discordant prescriptions that populate the note with provider's rationale for guideline exceptions (AJ); and performance feedback that benchmarks providers' own performance to that of their peers (PC, for Peer Comparisons). 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
248

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable

Geographic Reach
1 country

55 active sites

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

August 1, 2011

Completed
3 days 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
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

June 20, 2017

Completed
Last Updated

May 23, 2024

Status Verified

May 1, 2024

Enrollment Period

2.7 years

First QC Date

August 4, 2011

Results QC Date

July 20, 2015

Last Update Submit

May 22, 2024

Conditions

Keywords

AntibioticsInappropriate PrescribingRespiratory Tract InfectionsBehavioral Research

Outcome Measures

Primary Outcomes (1)

  • Inappropriate Antibiotic Prescribing Rate for Qualifying Acute Respiratory Infection Diagnoses

    Assess inappropriate antibiotic prescribing rates (relative to all practices that did not receive the intervention) for antibiotic-inappropriate acute respiratory tract infection visits and no concomitant reason for antibiotic prescribing. based on the following non-antibiotic-appropriate International Statistical Classification of Diseases, version 9 (ICD-9) diagnoses: 460 Acute nasopharyngitis (common cold) 465 Acute laryngopharyngitis/acute upper respiratory infection 466 Acute bronchitis 490 Bronchitis not specified as acute or chronic 487 Flu

    18 months

Secondary Outcomes (1)

  • Encounters Closely Following the Index Encounter for Serious Diagnoses

    18 months

Study Arms (8)

SA, AJ, PC

EXPERIMENTAL

Participants are given all 3 interventions.

Behavioral: Clinical Decision Support (CDS): Accountable JustificationsBehavioral: 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 (CDS): Accountable JustificationsBehavioral: CDS Order Sets: Suggested Alternatives

SA, PC

EXPERIMENTAL

Participants receive the Suggested Alternative 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 Alternative intervention.

Behavioral: Clinical Decision Support (CDS): Accountable JustificationsBehavioral: Audit and Feedback: Peer Comparison

Peer Comparison (PC)

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 (SA)

EXPERIMENTAL

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

Behavioral: CDS Order Sets: Suggested Alternatives

Accountable Justification (AJ)

EXPERIMENTAL

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

Behavioral: Clinical Decision Support (CDS): Accountable Justifications

Education Control

NO INTERVENTION

Participants do not receive any of the 3 interventions.

Interventions

Accountable Justifications triggered by discordant prescriptions that populate the electronic health record (EHR) note with provider's rationale for guideline exceptions (AJ).

Also known as: AJ, Accountable Justification
AJ, PCAccountable Justification (AJ)SA, 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 Comparison (PC)SA, 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 (SA)

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 a participating clinic in 2011-2013 who sees acute respiratory infection patients.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (55)

Altamed Anaheim Lincoln

Anaheim, California, 92801, United States

Location

Altamed Anaheim West

Anaheim, California, 92801, United States

Location

Altamed Bell Clinic

Bell, California, 90201, United States

Location

Altamed Mobile Unit Primary Care

Commerce, California, 90040, United States

Location

Altamed DVL El Monte

El Monte, California, 91731, United States

Location

Altamed El Monte Clinic

El Monte, California, 91731, United States

Location

Altamed Garden Grove Harbor

Garden Grove, California, 92840, United States

Location

Altamed Huntington Beach Clinic

Huntington Beach, California, 92647, United States

Location

Altamed PACE Rugby

Huntington Park, California, 90255, United States

Location

The Children's Clinic Family Health Center at Cesar Chavez Elementary School

Long Beach, California, 90802, United States

Location

The Children's Clinic Family Health Center at Hamilton Middle School

Long Beach, California, 90805, United States

Location

The S. Mark Taper Foundation Children's Clinic Family Health Center

Long Beach, California, 90806, United States

Location

The Children's Clinic at the Long Beach Multi-Service Center for the Homeless

Long Beach, California, 90813, United States

Location

The Vasek Polak Children's Clinic Family Health Center

Long Beach, California, 90813, United States

Location

Altamed PACE Grand Plaza

Los Angeles, California, 90012, United States

Location

Altamed William Mead Homes

Los Angeles, California, 90012, United States

Location

Altamed Commerce Clinic

Los Angeles, California, 90022, United States

Location

Altamed DVL Commerce

Los Angeles, California, 90022, United States

Location

Altamed PACE Pomona

Los Angeles, California, 90022, United States

Location

Altamed Boyle Heights Clinic

Los Angeles, California, 90023, United States

Location

Altamed Estrada Courts

Los Angeles, California, 90023, United States

Location

Altamed Ramona Gardens

Los Angeles, California, 90023, United States

Location

AltaMed 1st St Boyle Heights Clinic

Los Angeles, California, 90033, United States

Location

Altamed Zonal Clinic

Los Angeles, California, 90033, United States

Location

Altamed Montebello Clinic

Montebello, California, 90640, United States

Location

Altamed El Modena Clinic

Orange, California, 92869, United States

Location

Altamed Pico Clinic

Pico Rivera, California, 90060, United States

Location

Altamed DVL Pico

Pico Rivera, California, 90660, United States

Location

Altamed Santa Ana Main

Santa Ana, California, 92701, United States

Location

Altamed Clinic For Women

Santa Ana, California, 92706, United States

Location

Altamed Santa Ana Broadway

Santa Ana, California, 92707, United States

Location

Altamed Santa Ana Central

Santa Ana, California, 92707, United States

Location

Brigham and Women's Primary Care Associates at Foxborough

Boston, Massachusetts, 02035, United States

Location

MGH Downtown

Boston, Massachusetts, 02108, United States

Location

Mass General Medial Group

Boston, Massachusetts, 02114, United States

Location

MGH Beacon Hill

Boston, Massachusetts, 02114, United States

Location

MGH Senior Health

Boston, Massachusetts, 02114, United States

Location

Women's Health Associates

Boston, Massachusetts, 02114, United States

Location

Brigham Circle Medical Associates

Boston, Massachusetts, 02115, United States

Location

Brigham Internal Medicine Associates

Boston, Massachusetts, 02115, United States

Location

Spanish Clinic

Boston, Massachusetts, 02115, United States

Location

MGH Back Bay

Boston, Massachusetts, 02228, United States

Location

Brigham and Women's Primary Care Associates of Brookline

Brookline, Massachusetts, 02446, United States

Location

MGH Charlestown HealthCare Center

Charlestown, Massachusetts, 02129, United States

Location

MGH Chelsea HealthCare Center

Chelsea, Massachusetts, 02150, United States

Location

Brigham and Women's Physician Group

Chestnut Hill, Massachusetts, 02467, United States

Location

Gretchen and Edward Fish Center for Women's Health

Chestnut Hill, Massachusetts, 02467, United States

Location

Everett Family Practice

Everett, Massachusetts, 02149, United States

Location

Brigham Primary Physicians at Faulkner

Jamaica Plain, Massachusetts, 02130, United States

Location

Brookside Community Health Center

Jamaica Plain, Massachusetts, 02130, United States

Location

Faulkner Community Physicians

Jamaica Plain, Massachusetts, 02130, United States

Location

Southern Jamaica Plain Health Center

Jamaica Plain, Massachusetts, 02130, United States

Location

Brigham and Women's Primary Care Associates of Newton Corner

Newton, Massachusetts, 02458, United States

Location

Mass General Revere HealthCare Center

Revere, Massachusetts, 02151, United States

Location

Mass General West Medical Group

Waltham, Massachusetts, 02451, United States

Location

Related Publications (5)

  • 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
  • Doctor JN, Goldstein NJ, Fox CR, Linder JA, Persell SD, Stewart EP, Knight TK, Meeker D. Clinician Job Satisfaction After Peer Comparison Feedback: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2317379. doi: 10.1001/jamanetworkopen.2023.17379.

  • Gong CL, Zangwill KM, Hay JW, Meeker D, Doctor JN. Behavioral Economics Interventions to Improve Outpatient Antibiotic Prescribing for Acute Respiratory Infections: a Cost-Effectiveness Analysis. J Gen Intern Med. 2019 Jun;34(6):846-854. doi: 10.1007/s11606-018-4467-x. Epub 2018 May 8.

  • Gong CL, Hay JW, Meeker D, Doctor JN. Prescriber preferences for behavioural economics interventions to improve treatment of acute respiratory infections: a discrete choice experiment. BMJ Open. 2016 Sep 22;6(9):e012739. doi: 10.1136/bmjopen-2016-012739.

  • Persell SD, Friedberg MW, Meeker D, Linder JA, Fox CR, Goldstein NJ, Shah PD, Knight TK, Doctor JN. Use of behavioral economics and social psychology to improve treatment of acute respiratory infections (BEARI): rationale and design of a cluster randomized controlled trial [1RC4AG039115-01]--study protocol and baseline practice and provider characteristics. BMC Infect Dis. 2013 Jun 27;13:290. doi: 10.1186/1471-2334-13-290.

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Results Point of Contact

Title
Jason N. Doctor
Organization
University of Southern California

Study Officials

  • Jason N Doctor, PhD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

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

August 1, 2011

Primary Completion

April 1, 2014

Study Completion

September 1, 2014

Last Updated

May 23, 2024

Results First Posted

June 20, 2017

Record last verified: 2024-05

Locations