Trial Outcomes & Findings for Use of Behavioral Economics to Improve Treatment of Acute Respiratory Infections (Main Study) (NCT NCT01454947)
NCT ID: NCT01454947
Last Updated: 2024-05-23
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
248 participants
Primary outcome timeframe
18 months
Results posted on
2024-05-23
Participant Flow
Participant milestones
| Measure |
Education Control
Participants do not receive any of the 3 interventions.
|
Suggested Alternatives (SA)
Participants receive the Suggested Alternatives intervention, but not the Accountable Justification or Peer Comparison interventions.
|
Accountable Justification (AJ)
Participants receive the Accountable Justification intervention, but do not receive the Suggested Alternatives or Peer Comparison interventions.
|
Peer Comparison (PC)
Participants receive the Peer Comparison intervention, but do not receive the Suggested Alternatives or Accountable Justification interventions.
|
SA, AJ
Participants receive the Suggested Alternatives and Accountable Justification interventions, but not the Peer Comparison intervention.
|
SA, PC
Participants receive the Suggested Alternative and Peer Comparison interventions, but not the Accountable Justification intervention.
|
AJ, PC
Participants receive the Accountable Justification and Peer Comparison interventions, but not the Suggested Alternative intervention.
|
SA, AJ, PC
Participants are given all 3 interventions.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
27
|
42
|
35
|
20
|
34
|
35
|
27
|
28
|
|
Overall Study
COMPLETED
|
24
|
38
|
32
|
19
|
33
|
32
|
26
|
23
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
3
|
1
|
1
|
3
|
1
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Behavioral Economics to Improve Treatment of Acute Respiratory Infections (Main Study)
Baseline characteristics by cohort
| Measure |
Education Control
n=27 Participants
Participants do not receive any of the 3 interventions.
|
Suggested Alternatives (SA)
n=42 Participants
Participants receive the Suggested Alternatives intervention, but not the Accountable Justification or Peer Comparison interventions.
|
Accountable Justification (AJ)
n=35 Participants
Participants receive the Accountable Justification intervention, but do not receive the Suggested Alternatives or Peer Comparison interventions.
|
Peer Comparison (PC)
n=20 Participants
Participants receive the Peer Comparison intervention, but do not receive the Suggested Alternatives or Accountable Justification interventions.
|
SA, AJ
n=34 Participants
Participants receive the Suggested Alternatives and Accountable Justification interventions, but not the Peer Comparison intervention.
|
SA, PC
n=35 Participants
Participants receive the Suggested Alternative and Peer Comparison interventions, but not the Accountable Justification intervention.
|
AJ, PC
n=27 Participants
Participants receive the Accountable Justification and Peer Comparison interventions, but not the Suggested Alternative intervention.
|
SA, AJ, PC
n=28 Participants
Participants are given all 3 interventions.
|
Total
n=248 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 12 • n=5 Participants
|
49 years
STANDARD_DEVIATION 10 • n=7 Participants
|
49 years
STANDARD_DEVIATION 9 • n=5 Participants
|
46 years
STANDARD_DEVIATION 9 • n=4 Participants
|
48 years
STANDARD_DEVIATION 9 • n=21 Participants
|
51 years
STANDARD_DEVIATION 11 • n=8 Participants
|
48 years
STANDARD_DEVIATION 10 • n=8 Participants
|
46 years
STANDARD_DEVIATION 9 • n=24 Participants
|
48 years
STANDARD_DEVIATION 10 • n=42 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
16 Participants
n=24 Participants
|
157 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
91 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: 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.
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
Outcome measures
| Measure |
Control
n=2095 Qualifying ARI visits
Participants received no study interventions
|
Suggested Alternatives (SA)
n=2388 Qualifying ARI visits
Participants receive the Suggested Alternatives intervention, but not the Accountable Justification or Peer Comparison interventions.
|
Accountable Justification (AJ)
n=1979 Qualifying ARI visits
Participants receive the Accountable Justification intervention, but do not receive the Suggested Alternatives or Peer Comparison interventions.
|
Peer Comparison (PC)
n=1620 Qualifying ARI visits
Participants receive the Peer Comparison intervention, but do not receive the Suggested Alternatives or Accountable Justification interventions.
|
Suggested Alternatives + Accountable Justification
n=2131 Qualifying ARI visits
Participants receive the Suggested Alternatives and Accountable Justification interventions, but do not receive the Peer Comparison intervention
|
Suggested Alternatives + Peer Comparison
n=2014 Qualifying ARI visits
Participants receive the Suggested Alternatives and Peer Comparison interventions, but do not receive the Accountable Justification intervention
|
Accountable Justification + Peer Comparison
n=2240 Qualifying ARI visits
Participants receive the Accountable Justification and Peer Comparison interventions, but do not receive the Suggested Alternatives intervention
|
SA+AJ+PC
n=2492 Qualifying ARI visits
Participants receive all three interventions: Suggested Alternatives, Accountable Justification, and Peer Comparison interventions
|
|---|---|---|---|---|---|---|---|---|
|
Inappropriate Antibiotic Prescribing Rate for Qualifying Acute Respiratory Infection Diagnoses
|
0.20 proportion of visits
Interval 0.1 to 0.31
|
0.19 proportion of visits
Interval 0.06 to 0.66
|
0.08 proportion of visits
Interval 0.03 to 0.23
|
0.09 proportion of visits
Interval 0.03 to 0.31
|
0.07 proportion of visits
Interval 0.02 to 0.24
|
0.01 proportion of visits
Interval 0.0 to 0.08
|
0.03 proportion of visits
Interval 0.0 to 0.18
|
0.03 proportion of visits
Interval 0.0 to 0.22
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Overall number of units analyzed is the number of intervention-qualifying acute respiratory infections (ARI) encounters where no antibiotic was prescribed. Intervention-qualifying 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).
Within intervention-qualifying acute respiratory infections (ARI) encounters where no antibiotic was prescribed, we will monitor return visit rates for the specified diagnoses and other acute respiratory infection diagnoses (ICD-9), including whooping cough (033.9), rheumatic fever (390-392) and pneumonia (481-487).
Outcome measures
| Measure |
Control
n=3245 Qualifying encounters
Participants received no study interventions
|
Suggested Alternatives (SA)
n=4579 Qualifying encounters
Participants receive the Suggested Alternatives intervention, but not the Accountable Justification or Peer Comparison interventions.
|
Accountable Justification (AJ)
n=4622 Qualifying encounters
Participants receive the Accountable Justification intervention, but do not receive the Suggested Alternatives or Peer Comparison interventions.
|
Peer Comparison (PC)
n=3781 Qualifying encounters
Participants receive the Peer Comparison intervention, but do not receive the Suggested Alternatives or Accountable Justification interventions.
|
Suggested Alternatives + Accountable Justification
n=5717 Qualifying encounters
Participants receive the Suggested Alternatives and Accountable Justification interventions, but do not receive the Peer Comparison intervention
|
Suggested Alternatives + Peer Comparison
n=5993 Qualifying encounters
Participants receive the Suggested Alternatives and Peer Comparison interventions, but do not receive the Accountable Justification intervention
|
Accountable Justification + Peer Comparison
n=3398 Qualifying encounters
Participants receive the Accountable Justification and Peer Comparison interventions, but do not receive the Suggested Alternatives intervention
|
SA+AJ+PC
n=4164 Qualifying encounters
Participants receive all three interventions: Suggested Alternatives, Accountable Justification, and Peer Comparison interventions
|
|---|---|---|---|---|---|---|---|---|
|
Encounters Closely Following the Index Encounter for Serious Diagnoses
|
14 Qualifying encounters
|
16 Qualifying encounters
|
16 Qualifying encounters
|
13 Qualifying encounters
|
22 Qualifying encounters
|
23 Qualifying encounters
|
48 Qualifying encounters
|
15 Qualifying encounters
|
Adverse Events
Education Control
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Suggested Alternatives (SA)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Accountable Justification (AJ)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Peer Comparison (PC)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
SA, AJ
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
SA, PC
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
AJ, PC
Serious events: 0 serious events
Other events: 48 other events
Deaths: 0 deaths
SA, AJ, PC
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Education Control
n=3245 participants at risk
Participants do not receive any of the 3 interventions.
|
Suggested Alternatives (SA)
n=4579 participants at risk
Participants receive the Suggested Alternatives intervention, but not the Accountable Justification or Peer Comparison interventions.
|
Accountable Justification (AJ)
n=4622 participants at risk
Participants receive the Accountable Justification intervention, but do not receive the Suggested Alternatives or Peer Comparison interventions.
|
Peer Comparison (PC)
n=3781 participants at risk
Participants receive the Peer Comparison intervention, but do not receive the Suggested Alternatives or Accountable Justification interventions.
|
SA, AJ
n=5717 participants at risk
Participants receive the Suggested Alternatives and Accountable Justification interventions, but not the Peer Comparison intervention.
|
SA, PC
n=5993 participants at risk
Participants receive the Suggested Alternative and Peer Comparison interventions, but not the Accountable Justification intervention.
|
AJ, PC
n=3398 participants at risk
Participants receive the Accountable Justification and Peer Comparison interventions, but not the Suggested Alternative intervention.
|
SA, AJ, PC
n=4164 participants at risk
Participants are given all 3 interventions.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
return visits for bacterial infections occurring within 30 days of study qualifying ARI visit where
|
0.43%
14/3245 • 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
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.
|
0.35%
16/4579 • 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
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.
|
0.35%
16/4622 • 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
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.
|
0.34%
13/3781 • 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
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.
|
0.38%
22/5717 • 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
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.
|
0.38%
23/5993 • 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
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.
|
1.4%
48/3398 • 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
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.
|
0.36%
15/4164 • 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
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place