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Trial record 66 of 257 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND broad

Use of Behavioral Economics to Improve Treatment of Acute Respiratory Infections (Main Study) (BEARI)

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ClinicalTrials.gov Identifier: NCT01454947
Recruitment Status : Completed
First Posted : October 19, 2011
Results First Posted : June 20, 2017
Last Update Posted : June 20, 2017
Sponsor:
Collaborator:
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: Factorial Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Acute Respiratory Infections (ARIs)
Interventions Behavioral: Clinical Decision Support (CDS): Accountable Justifications
Behavioral: Audit and Feedback: Peer Comparison
Behavioral: CDS Order Sets: Suggested Alternatives
Enrollment 248
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Education Control Suggested Alternatives (SA) Accountable Justification (AJ) Peer Comparison (PC) SA, AJ SA, PC AJ, PC SA, AJ, PC
Hide Arm/Group Description Participants do not receive any of the 3 interventions. Participants receive the Suggested Alternatives intervention, but not the Accountable Justification or Peer Comparison interventions. Participants receive the Accountable Justification intervention, but do not receive the Suggested Alternatives or Peer Comparison interventions. Participants receive the Peer Comparison intervention, but do not receive the Suggested Alternatives or Accountable Justification interventions. Participants receive the Suggested Alternatives and Accountable Justification interventions, but not the Peer Comparison intervention. Participants receive the Suggested Alternative and Peer Comparison interventions, but not the Accountable Justification intervention. Participants receive the Accountable Justification and Peer Comparison interventions, but not the Suggested Alternative intervention. Participants are given all 3 interventions.
Period Title: Overall Study
Started 27 42 35 20 34 35 27 28
Completed 24 38 32 19 33 32 26 23
Not Completed 3 4 3 1 1 3 1 5
Arm/Group Title Education Control Suggested Alternatives (SA) Accountable Justification (AJ) Peer Comparison (PC) SA, AJ SA, PC AJ, PC SA, AJ, PC Total
Hide Arm/Group Description Participants do not receive any of the 3 interventions. Participants receive the Suggested Alternatives intervention, but not the Accountable Justification or Peer Comparison interventions. Participants receive the Accountable Justification intervention, but do not receive the Suggested Alternatives or Peer Comparison interventions. Participants receive the Peer Comparison intervention, but do not receive the Suggested Alternatives or Accountable Justification interventions. Participants receive the Suggested Alternatives and Accountable Justification interventions, but not the Peer Comparison intervention. Participants receive the Suggested Alternative and Peer Comparison interventions, but not the Accountable Justification intervention. Participants receive the Accountable Justification and Peer Comparison interventions, but not the Suggested Alternative intervention. Participants are given all 3 interventions. Total of all reporting groups
Overall Number of Baseline Participants 27 42 35 20 34 35 27 28 248
Hide Baseline Analysis Population Description
Enrolled Clinicians
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 42 participants 35 participants 20 participants 34 participants 35 participants 27 participants 28 participants 248 participants
47  (12) 49  (10) 49  (9) 46  (9) 48  (9) 51  (11) 48  (10) 46  (9) 48  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 42 participants 35 participants 20 participants 34 participants 35 participants 27 participants 28 participants 248 participants
Female
13
  48.1%
30
  71.4%
22
  62.9%
12
  60.0%
24
  70.6%
25
  71.4%
15
  55.6%
16
  57.1%
157
  63.3%
Male
14
  51.9%
12
  28.6%
13
  37.1%
8
  40.0%
10
  29.4%
10
  28.6%
12
  44.4%
12
  42.9%
91
  36.7%
1.Primary Outcome
Title Inappropriate Antibiotic Prescribing Rate for Qualifying Acute Respiratory Infection Diagnoses
Hide Description

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 laryngeopharyngitis/acute upper respiratory infection

466 Acute bronchitis

490 Bronchitis not specified as acute or chronic

487 Flu

Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
We identified a total of 16,959 non-antibiotic-appropriate acute respiratory infection (ARI) visits. Visits were categorized as inappropriate if there were diagnosis codes for non-specific upper respiratory infections, acute bronchitis, and/or influenza.
Arm/Group Title Control Suggested Alternatives (SA) Accountable Justification (AJ) Peer Comparison (PC) Suggested Alternatives + Accountable Justification Suggested Alternatives + Peer Comparison Accountable Justification + Peer Comparison SA+AJ+PC
Hide Arm/Group Description:
Participants received no study interventions
Participants receive the Suggested Alternatives intervention, but not the Accountable Justification or Peer Comparison interventions.
Participants receive the Accountable Justification intervention, but do not receive the Suggested Alternatives or Peer Comparison interventions.
Participants receive the Peer Comparison intervention, but do not receive the Suggested Alternatives or Accountable Justification interventions.
Participants receive the Suggested Alternatives and Accountable Justification interventions, but do not receive the Peer Comparison intervention
Participants receive the Suggested Alternatives and Peer Comparison interventions, but do not receive the Accountable Justification intervention
Participants receive the Accountable Justification and Peer Comparison interventions, but do not receive the Suggested Alternatives intervention
Participants receive all three interventions: Suggested Alternatives, Accountable Justification, and Peer Comparison interventions
Overall Number of Participants Analyzed 27 42 35 20 34 35 27 28
Overall Number of Units Analyzed
Type of Units Analyzed: Qualifying ARI visits
2095 2388 1979 1620 2131 2014 2240 2492
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: inappropriate prescribing rate
0.20
(0.10 to 0.31)
0.19
(0.06 to 0.66)
0.08
(0.03 to 0.23)
0.09
(0.03 to 0.31)
0.07
(0.02 to 0.24)
0.01
(0.00 to 0.08)
0.03
(0.00 to 0.18)
0.03
(0.00 to 0.22)
2.Secondary Outcome
Title Antibiotic Prescribing Rates for Expanded List of Acute Respiratory Infection Diagnoses
Hide Description We will monitor overall prescribing for the specified diagnoses and other acute respiratory infection diagnoses, including cough/fever and pneumonia.
Time Frame 18 months
Outcome Measure Data Not Reported
Time Frame For antibiotic-inappropriate visits in which no antibiotic was prescribed, we assessed return visits within 30 days for the presence of complications potentially attributable to untreated bacterial infections
Adverse Event Reporting Description Intervention-qualifying acute respiratory infections (ARI) encounters include all ARI visits eligible for the suggested alternatives and accountable justification interventions (not limited to the antibiotic-inappropriate ARI diagnoses that define the primary outcome). A Diagnosis of Concern (DoC) was based on International Classification of Diseases version 9 (ICD9) codes of concern at revisit.
 
Arm/Group Title Education Control Suggested Alternatives (SA) Accountable Justification (AJ) Peer Comparison (PC) SA, AJ SA, PC AJ, PC SA, AJ, PC
Hide Arm/Group Description Participants do not receive any of the 3 interventions. Participants receive the Suggested Alternatives intervention, but not the Accountable Justification or Peer Comparison interventions. Participants receive the Accountable Justification intervention, but do not receive the Suggested Alternatives or Peer Comparison interventions. Participants receive the Peer Comparison intervention, but do not receive the Suggested Alternatives or Accountable Justification interventions. Participants receive the Suggested Alternatives and Accountable Justification interventions, but not the Peer Comparison intervention. Participants receive the Suggested Alternative and Peer Comparison interventions, but not the Accountable Justification intervention. Participants receive the Accountable Justification and Peer Comparison interventions, but not the Suggested Alternative intervention. Participants are given all 3 interventions.
All-Cause Mortality
Education Control Suggested Alternatives (SA) Accountable Justification (AJ) Peer Comparison (PC) SA, AJ SA, PC AJ, PC SA, AJ, PC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Education Control Suggested Alternatives (SA) Accountable Justification (AJ) Peer Comparison (PC) SA, AJ SA, PC AJ, PC SA, AJ, PC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3245 (0.00%)   0/4579 (0.00%)   0/4622 (0.00%)   0/3781 (0.00%)   0/5717 (0.00%)   0/5993 (0.00%)   0/3398 (0.00%)   0/4164 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Education Control Suggested Alternatives (SA) Accountable Justification (AJ) Peer Comparison (PC) SA, AJ SA, PC AJ, PC SA, AJ, PC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/3245 (0.43%)   16/4579 (0.35%)   16/4622 (0.35%)   13/3781 (0.34%)   22/5717 (0.38%)   23/5993 (0.38%)   48/3398 (1.41%)   15/4164 (0.36%) 
Infections and infestations                 
return visits for bacterial infections occurring within 30 days of study qualifying ARI visit where  1 [1]  14/3245 (0.43%)  16/4579 (0.35%)  16/4622 (0.35%)  13/3781 (0.34%)  22/5717 (0.38%)  23/5993 (0.38%)  48/3398 (1.41%)  15/4164 (0.36%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, ICD9
[1]
For antibiotic-inappropriate visits in which no antibiotic was prescribed, we assessed return visits within 30 days for the presence of complications potentially attributable to untreated bacterial infections
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 N. Doctor
Organization: University of Southern California
Phone: 213.821.8142
EMail: jdoctor@usc.edu
Layout table for additonal information
Responsible Party: Jason Doctor, University of Southern California
ClinicalTrials.gov Identifier: NCT01454947     History of Changes
Other Study ID Numbers: 1RC4AG039115-01 ( U.S. NIH Grant/Contract )
1RC4AG039115-01 ( U.S. NIH Grant/Contract )
First Submitted: August 4, 2011
First Posted: October 19, 2011
Results First Submitted: July 20, 2015
Results First Posted: June 20, 2017
Last Update Posted: June 20, 2017