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Nudging Guideline-concordant Antibiotic Prescribing Using Public Commitments

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01767064
Recruitment Status : Completed
First Posted : January 11, 2013
Results First Posted : August 10, 2017
Last Update Posted : August 10, 2017
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Jason Doctor, University of Southern California

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition Acute Respiratory Infections (ARIs)
Intervention Other: Posted commitment letter
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Posted Commitment Letter Control
Hide Arm/Group Description

The poster-sized (18x24 inches) commitment letter, written at the 8th grade reading-level and displayed in English and Spanish, emphasize clinician commitment to guidelines for appropriate antibiotic prescribing and explain why antibiotics are not appropriate in many cases. These letters, featuring clinician photographs and signatures, are displayed in clinician exam rooms for a 16-week period.

Posted commitment letter

Usual care with no posted letters.
Period Title: Overall Study
Started 7 7
Completed 7 7
Not Completed 0 0
Arm/Group Title Posted Commitment Letter Control Total
Hide Arm/Group Description

The poster-sized (18x24 inches) commitment letter, written at the 8th grade reading-level and displayed in English and Spanish, emphasize clinician commitment to guidelines for appropriate antibiotic prescribing and explain why antibiotics are not appropriate in many cases. These letters, featuring clinician photographs and signatures, are displayed in clinician exam rooms for a 16-week period.

Posted commitment letter

Usual care with no posted letters. Total of all reporting groups
Overall Number of Baseline Participants 7 7 14
Hide Baseline Analysis Population Description
Clinicians
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 7 participants 14 participants
53  (12.9) 55  (9.5) 54.3  (10.64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 14 participants
Female
5
  71.4%
6
  85.7%
11
  78.6%
Male
2
  28.6%
1
  14.3%
3
  21.4%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 7 participants 14 participants
7 7 14
1.Primary Outcome
Title Inappropriate Antibiotic Prescribing for Patients With Acute Respiratory Infections (ARI)
Hide Description Using data from electronic health records, we will calculate clinician antibiotic prescribing rates for antibiotic-inappropriate ARI diagnoses: acute nasopharyngitis (ICD-9 460.x), acute laryngitis without obstruction (465.8), acute laryngopharyngitis (465.0), acute bronchitis (466.x), acute upper respiratory infections of other multiple sites (465.8), acute upper respiratory infections not otherwise specified (465.9), bronchitis not specified as acute or chronic (490.x), non-streptococcal pharyngitis (462.xx), and influenza with other respiratory manifestations (487.1). To control for temporal trends in antibiotic prescribing and provider-fixed effects, we will fit a logistic mixed effects model that predicts inappropriate antibiotic prescribing as a function of study arm and an indicator for baseline versus intervention period (a difference-in-differences regression).
Time Frame up to 12 months post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
clinicians
Arm/Group Title Posted Commitment Letter Control
Hide Arm/Group Description:

The poster-sized (18x24 inches) commitment letter, written at the 8th grade reading-level and displayed in English and Spanish, emphasize clinician commitment to guidelines for appropriate antibiotic prescribing and explain why antibiotics are not appropriate in many cases. These letters, featuring clinician photographs and signatures, are displayed in clinician exam rooms for a 16-week period.

Posted commitment letter

Usual care with no posted letters.
Overall Number of Participants Analyzed 7 7
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: inappropriate prescribing events
33.7
(25.1 to 43.1)
52.7
(44.2 to 61.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Posted Commitment Letter Control
Hide Arm/Group Description

The poster-sized (18x24 inches) commitment letter, written at the 8th grade reading-level and displayed in English and Spanish, emphasize clinician commitment to guidelines for appropriate antibiotic prescribing and explain why antibiotics are not appropriate in many cases. These letters, featuring clinician photographs and signatures, are displayed in clinician exam rooms for a 16-week period.

Posted commitment letter

Usual care with no posted letters.
All-Cause Mortality
Posted Commitment Letter Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Posted Commitment Letter Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/7 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Posted Commitment Letter Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/7 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jason Doctor
Organization: USCalifornia
Phone: 213.821.8142
EMail: jdoctor@usc.edu
Layout table for additonal information
Responsible Party: Jason Doctor, University of Southern California
ClinicalTrials.gov Identifier: NCT01767064    
Other Study ID Numbers: USCalifornia
RC4AG039115 ( U.S. NIH Grant/Contract )
First Submitted: January 10, 2013
First Posted: January 11, 2013
Results First Submitted: March 30, 2017
Results First Posted: August 10, 2017
Last Update Posted: August 10, 2017