Trial Outcomes & Findings for The Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal (NCT NCT03702270)
NCT ID: NCT03702270
Last Updated: 2024-12-18
Results Overview
The percentage of patients with low risk penicillin allergy whose labels are removed from the medical chart's allergy section.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2052 participants
Primary outcome timeframe
Hospital discharge at approximately 4 days after admission
Results posted on
2024-12-18
Participant Flow
Control Group: Patients who did not have 24-hour exposure to a study unit where the intervention was active but did have at least 24-hour exposure to a control unit. Intervention Group: Patients who had a 24-hour exposure to a study unit at any time where the intervention was active. Patients could move through different hospital units throughout the course of clinical care. The number of participants per sequence reflects the first unit where a participant had a 24-hour exposure.
Unit of analysis: Medical Units
Participant milestones
| Measure |
Sequence A
1 month control, then 12 months of intervention. The intervention will provide access to a best-practice alert containing a penicillin allergy risk stratification tool and recommendations on whether to use an oral amoxicillin test dose challenge order set for patients who stratify as low risk.
The penicillin allergic risk stratification Best Practice Alert provides best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.
In this stepped wedge design, all units have a period of being in control, and then providing the intervention. Medical units transitioned from the control condition to the intervention condition at monthly intervals. Units remained in the intervention condition once transitioned.
|
Sequence B
2 months control, then 11 months of intervention. The intervention will provide access to a best-practice alert containing a penicillin allergy risk stratification tool and recommendations on whether to use an oral amoxicillin test dose challenge order set for patients who stratify as low risk.
The penicillin allergic risk stratification Best Practice Alert provides best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.
In this stepped wedge design, all units have a period of being in control, and then providing the intervention. Medical units transitioned from the control condition to the intervention condition at monthly intervals. Units remained in the intervention condition once transitioned.
|
Sequence C
3 month control, then 10 months of intervention. The intervention will provide access to a best-practice alert containing a penicillin allergy risk stratification tool and recommendations on whether to use an oral amoxicillin test dose challenge order set for patients who stratify as low risk.
The penicillin allergic risk stratification Best Practice Alert provides best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.
In this stepped wedge design, all units have a period of being in control, and then providing the intervention. Medical units transitioned from the control condition to the intervention condition at monthly intervals. Units remained in the intervention condition once transitioned.
|
Sequence D
4 months control, then 9 months of intervention. The intervention will provide access to a best-practice alert containing a penicillin allergy risk stratification tool and recommendations on whether to use an oral amoxicillin test dose challenge order set for patients who stratify as low risk.
The penicillin allergic risk stratification Best Practice Alert provides best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.
In this stepped wedge design, all units have a period of being in control, and then providing the intervention. Medical units transitioned from the control condition to the intervention condition at monthly intervals. Units remained in the intervention condition once transitioned.
|
Sequence E
5 months control, then 8 months of intervention. The intervention will provide access to a best-practice alert containing a penicillin allergy risk stratification tool and recommendations on whether to use an oral amoxicillin test dose challenge order set for patients who stratify as low risk.
The penicillin allergic risk stratification Best Practice Alert provides best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.
In this stepped wedge design, all units have a period of being in control, and then providing the intervention. Medical units transitioned from the control condition to the intervention condition at monthly intervals. Units remained in the intervention condition once transitioned.
|
Sequence F
6 months control, then 7 months of intervention. The intervention will provide access to a best-practice alert containing a penicillin allergy risk stratification tool and recommendations on whether to use an oral amoxicillin test dose challenge order set for patients who stratify as low risk.
The penicillin allergic risk stratification Best Practice Alert provides best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.
In this stepped wedge design, all units have a period of being in control, and then providing the intervention. Medical units transitioned from the control condition to the intervention condition at monthly intervals. Units remained in the intervention condition once transitioned.
|
Sequence G
7 months control, then 6 months of intervention. The intervention will provide access to a best-practice alert containing a penicillin allergy risk stratification tool and recommendations on whether to use an oral amoxicillin test dose challenge order set for patients who stratify as low risk.
The penicillin allergic risk stratification Best Practice Alert provides best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.
In this stepped wedge design, all units have a period of being in control, and then providing the intervention. Medical units transitioned from the control condition to the intervention condition at monthly intervals. Units remained in the intervention condition once transitioned.
|
Sequence H
8 months control, then 5 months of intervention. The intervention will provide access to a best-practice alert containing a penicillin allergy risk stratification tool and recommendations on whether to use an oral amoxicillin test dose challenge order set for patients who stratify as low risk.
The penicillin allergic risk stratification Best Practice Alert provides best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.
In this stepped wedge design, all units have a period of being in control, and then providing the intervention. Medical units transitioned from the control condition to the intervention condition at monthly intervals. Units remained in the intervention condition once transitioned.
|
Sequence I
9 months control, then 4 months of intervention. The intervention will provide access to a best-practice alert containing a penicillin allergy risk stratification tool and recommendations on whether to use an oral amoxicillin test dose challenge order set for patients who stratify as low risk.
The penicillin allergic risk stratification Best Practice Alert provides best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.
In this stepped wedge design, all units have a period of being in control, and then providing the intervention. Medical units transitioned from the control condition to the intervention condition at monthly intervals. Units remained in the intervention condition once transitioned.
|
Sequence J
10 months control, then 3 months of intervention. The intervention will provide access to a best-practice alert containing a penicillin allergy risk stratification tool and recommendations on whether to use an oral amoxicillin test dose challenge order set for patients who stratify as low risk.
The penicillin allergic risk stratification Best Practice Alert provides best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.
In this stepped wedge design, all units have a period of being in control, and then providing the intervention. Medical units transitioned from the control condition to the intervention condition at monthly intervals. Units remained in the intervention condition once transitioned.
|
Sequence K
11 months control, then 2 months of intervention. The intervention will provide access to a best-practice alert containing a penicillin allergy risk stratification tool and recommendations on whether to use an oral amoxicillin test dose challenge order set for patients who stratify as low risk.
The penicillin allergic risk stratification Best Practice Alert provides best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.
In this stepped wedge design, all units have a period of being in control, and then providing the intervention. Medical units transitioned from the control condition to the intervention condition at monthly intervals. Units remained in the intervention condition once transitioned.
|
Sequence L
12 months control, then 1 month of intervention. The intervention will provide access to a best-practice alert containing a penicillin allergy risk stratification tool and recommendations on whether to use an oral amoxicillin test dose challenge order set for patients who stratify as low risk.
The penicillin allergic risk stratification Best Practice Alert provides best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.
In this stepped wedge design, all units have a period of being in control, and then providing the intervention. Medical units transitioned from the control condition to the intervention condition at monthly intervals. Units remained in the intervention condition once transitioned.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Control
STARTED
|
17 1
|
31 1
|
51 1
|
27 1
|
53 1
|
65 1
|
97 1
|
87 1
|
125 1
|
179 1
|
191 1
|
111 1
|
|
Control
COMPLETED
|
17 1
|
31 1
|
51 1
|
27 1
|
53 1
|
65 1
|
97 1
|
87 1
|
125 1
|
179 1
|
191 1
|
111 1
|
|
Control
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Intervention
STARTED
|
237 1
|
138 1
|
113 1
|
65 1
|
76 1
|
70 1
|
77 1
|
62 1
|
61 1
|
59 1
|
41 1
|
19 1
|
|
Intervention
COMPLETED
|
237 1
|
138 1
|
113 1
|
65 1
|
76 1
|
70 1
|
77 1
|
62 1
|
61 1
|
59 1
|
41 1
|
19 1
|
|
Intervention
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Penicillin Allergic Floor Patients- Experimental
n=1018 Participants
The intervention will provide access to a best-practices alert containing a penicillin allergy risk stratification tool and recommendations on whether to use an oral amoxicillin test dose challenge order set for patients who stratify as low risk.
Penicillin Allergic Risk Stratification Best Practice Alert: Providing best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.
|
Penicillin Allergic Floor Patients- Control
n=1034 Participants
Patients will receive current standard of care for penicillin allergy, which typically involves physician judgement on challenges versus consultation of allergy service.
|
Total
n=2052 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.6 years
n=1018 Participants
|
61.7 years
n=1034 Participants
|
63.1 years
n=2052 Participants
|
|
Sex: Female, Male
Female
|
596 Participants
n=1018 Participants
|
593 Participants
n=1034 Participants
|
1189 Participants
n=2052 Participants
|
|
Sex: Female, Male
Male
|
422 Participants
n=1018 Participants
|
441 Participants
n=1034 Participants
|
863 Participants
n=2052 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
8 Participants
n=1018 Participants
|
2 Participants
n=1034 Participants
|
10 Participants
n=2052 Participants
|
|
Race/Ethnicity, Customized
Race · More Than One Race
|
8 Participants
n=1018 Participants
|
10 Participants
n=1034 Participants
|
18 Participants
n=2052 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=1018 Participants
|
4 Participants
n=1034 Participants
|
5 Participants
n=2052 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
165 Participants
n=1018 Participants
|
156 Participants
n=1034 Participants
|
321 Participants
n=2052 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown/Not Reported
|
9 Participants
n=1018 Participants
|
15 Participants
n=1034 Participants
|
24 Participants
n=2052 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
827 Participants
n=1018 Participants
|
847 Participants
n=1034 Participants
|
1674 Participants
n=2052 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Non-Hispanic, Latino
|
448 Participants
n=1018 Participants
|
445 Participants
n=1034 Participants
|
893 Participants
n=2052 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic, Latino
|
14 Participants
n=1018 Participants
|
19 Participants
n=1034 Participants
|
33 Participants
n=2052 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Unknown/Not Reported
|
556 Participants
n=1018 Participants
|
570 Participants
n=1034 Participants
|
1126 Participants
n=2052 Participants
|
|
Region of Enrollment
United States
|
1018 Participants
n=1018 Participants
|
1034 Participants
n=1034 Participants
|
2052 Participants
n=2052 Participants
|
PRIMARY outcome
Timeframe: Hospital discharge at approximately 4 days after admissionThe percentage of patients with low risk penicillin allergy whose labels are removed from the medical chart's allergy section.
Outcome measures
| Measure |
Penicillin Allergic Floor Patients- Experimental
n=1018 Participants
The intervention will provide access to a best-practices alert containing a penicillin allergy risk stratification tool and recommendations on whether to use an oral amoxicillin test dose challenge order set for patients who stratify as low risk.
Penicillin Allergic Risk Stratification Best Practice Alert: Providing best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.
|
Penicillin Allergic Floor Patients- Control
n=1034 Participants
Patients will receive current standard of care for penicillin allergy, which typically involves physician judgement on challenges versus consultation of allergy service.
|
|---|---|---|
|
Penicillin Allergy Label Removal
|
45 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: Hospital discharge at approximately 4 days after admissionThe percentage of penicillin allergic patients challenged with amoxicillin who reported adverse events
Outcome measures
| Measure |
Penicillin Allergic Floor Patients- Experimental
n=27 Participants
The intervention will provide access to a best-practices alert containing a penicillin allergy risk stratification tool and recommendations on whether to use an oral amoxicillin test dose challenge order set for patients who stratify as low risk.
Penicillin Allergic Risk Stratification Best Practice Alert: Providing best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.
|
Penicillin Allergic Floor Patients- Control
n=21 Participants
Patients will receive current standard of care for penicillin allergy, which typically involves physician judgement on challenges versus consultation of allergy service.
|
|---|---|---|
|
Adverse Events (in Particular, Reported Allergic Events)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Hospital discharge at approximately 4 days after admissionThe percentage of penicillin allergic patients whose discharge summary contains information about penicillin allergy at discharge.
Outcome measures
| Measure |
Penicillin Allergic Floor Patients- Experimental
n=26 Participants
The intervention will provide access to a best-practices alert containing a penicillin allergy risk stratification tool and recommendations on whether to use an oral amoxicillin test dose challenge order set for patients who stratify as low risk.
Penicillin Allergic Risk Stratification Best Practice Alert: Providing best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.
|
Penicillin Allergic Floor Patients- Control
n=20 Participants
Patients will receive current standard of care for penicillin allergy, which typically involves physician judgement on challenges versus consultation of allergy service.
|
|---|---|---|
|
Communication About Penicillin Allergy in Discharge Summary
Yes
|
21 Participants
|
14 Participants
|
|
Communication About Penicillin Allergy in Discharge Summary
No
|
5 Participants
|
2 Participants
|
|
Communication About Penicillin Allergy in Discharge Summary
Missing
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Hospital discharge at approximately 4 days after admission and from 3-18 months of follow upThe number of changes or new starts of penicillin or cephalosporin treatments as a result of penicillin allergy label removal and the proportion of patients experiencing this event, this will be looked at as "Same hospitalization" as the challenge or "Subsequent Utilization"
Outcome measures
| Measure |
Penicillin Allergic Floor Patients- Experimental
n=1018 Participants
The intervention will provide access to a best-practices alert containing a penicillin allergy risk stratification tool and recommendations on whether to use an oral amoxicillin test dose challenge order set for patients who stratify as low risk.
Penicillin Allergic Risk Stratification Best Practice Alert: Providing best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.
|
Penicillin Allergic Floor Patients- Control
n=1034 Participants
Patients will receive current standard of care for penicillin allergy, which typically involves physician judgement on challenges versus consultation of allergy service.
|
|---|---|---|
|
Antibiotic Utilization by Patients
Same Hospitalization · Never
|
680 Participants
|
715 Participants
|
|
Antibiotic Utilization by Patients
Same Hospitalization · Ever
|
338 Participants
|
319 Participants
|
|
Antibiotic Utilization by Patients
3 Months Post-Randomization · Never
|
826 Participants
|
847 Participants
|
|
Antibiotic Utilization by Patients
3 Months Post-Randomization · Ever
|
192 Participants
|
187 Participants
|
|
Antibiotic Utilization by Patients
18 Months Post-Randomization · Never
|
602 Participants
|
627 Participants
|
|
Antibiotic Utilization by Patients
18 Months Post-Randomization · Ever
|
416 Participants
|
407 Participants
|
SECONDARY outcome
Timeframe: Hospital discharge at approximately 4 days after admission and from 3-18 months of follow upThe percentage of penicillin allergic patients whose penicillin allergy labels were removed at discharge whose labels are not reentered into the chart.
Outcome measures
| Measure |
Penicillin Allergic Floor Patients- Experimental
n=45 Participants
The intervention will provide access to a best-practices alert containing a penicillin allergy risk stratification tool and recommendations on whether to use an oral amoxicillin test dose challenge order set for patients who stratify as low risk.
Penicillin Allergic Risk Stratification Best Practice Alert: Providing best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.
|
Penicillin Allergic Floor Patients- Control
n=31 Participants
Patients will receive current standard of care for penicillin allergy, which typically involves physician judgement on challenges versus consultation of allergy service.
|
|---|---|---|
|
Durability of Penicillin Allergy Label Removal
3 Months Post-Randomization
|
44 Participants
|
28 Participants
|
|
Durability of Penicillin Allergy Label Removal
18 Months Post-Randomization
|
43 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Hospital discharge at approximately 4 days after admissionNumber of patients with a penicillin allergy label who received a risk assessment.
Outcome measures
| Measure |
Penicillin Allergic Floor Patients- Experimental
n=1018 Participants
The intervention will provide access to a best-practices alert containing a penicillin allergy risk stratification tool and recommendations on whether to use an oral amoxicillin test dose challenge order set for patients who stratify as low risk.
Penicillin Allergic Risk Stratification Best Practice Alert: Providing best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.
|
Penicillin Allergic Floor Patients- Control
n=1034 Participants
Patients will receive current standard of care for penicillin allergy, which typically involves physician judgement on challenges versus consultation of allergy service.
|
|---|---|---|
|
Receipt of Risk Stratification Tool Assessment
|
86 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: From 3-18 months of follow upPopulation: Intervention arm had 40 patients whose labels did not return. The control had 27 patients whose labels did not return.
For those patients who underwent a penicillin allergy label removal and it returns, we will compare the date the allergy label returned with the date it was removed
Outcome measures
| Measure |
Penicillin Allergic Floor Patients- Experimental
n=5 Participants
The intervention will provide access to a best-practices alert containing a penicillin allergy risk stratification tool and recommendations on whether to use an oral amoxicillin test dose challenge order set for patients who stratify as low risk.
Penicillin Allergic Risk Stratification Best Practice Alert: Providing best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.
|
Penicillin Allergic Floor Patients- Control
n=4 Participants
Patients will receive current standard of care for penicillin allergy, which typically involves physician judgement on challenges versus consultation of allergy service.
|
|---|---|---|
|
Time to Penicillin Allergy Label Return
|
35.62 days
Interval 22.01 to 115.91
|
52.89 days
Interval 36.49 to 109.98
|
SECONDARY outcome
Timeframe: Hospital discharge at approximately 4 days after admission and from 3-18 months of follow upThe number of changes or new starts of penicillin treatments as a result of penicillin allergy label removal and the proportion of patients experiencing this event, this will be looked at as "Same hospitalization" as the challenge or "Subsequent Utilization"
Outcome measures
| Measure |
Penicillin Allergic Floor Patients- Experimental
n=1018 Participants
The intervention will provide access to a best-practices alert containing a penicillin allergy risk stratification tool and recommendations on whether to use an oral amoxicillin test dose challenge order set for patients who stratify as low risk.
Penicillin Allergic Risk Stratification Best Practice Alert: Providing best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.
|
Penicillin Allergic Floor Patients- Control
n=1034 Participants
Patients will receive current standard of care for penicillin allergy, which typically involves physician judgement on challenges versus consultation of allergy service.
|
|---|---|---|
|
Penicillin Utilization by Patients
Same Hospitalization
|
84 Participants
|
57 Participants
|
|
Penicillin Utilization by Patients
3 Months Post-Randomization
|
68 Participants
|
46 Participants
|
|
Penicillin Utilization by Patients
18 Months Post-Randomization
|
173 Participants
|
140 Participants
|
SECONDARY outcome
Timeframe: Hospital discharge at approximately 4 days after admission and from 3-18 months of follow upThe number of changes or new starts of cephalosporin treatments as a result of penicillin allergy label removal and the proportion of patients experiencing this event, this will be looked at as "Same hospitalization" as the challenge or "Subsequent Utilization"
Outcome measures
| Measure |
Penicillin Allergic Floor Patients- Experimental
n=1018 Participants
The intervention will provide access to a best-practices alert containing a penicillin allergy risk stratification tool and recommendations on whether to use an oral amoxicillin test dose challenge order set for patients who stratify as low risk.
Penicillin Allergic Risk Stratification Best Practice Alert: Providing best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.
|
Penicillin Allergic Floor Patients- Control
n=1034 Participants
Patients will receive current standard of care for penicillin allergy, which typically involves physician judgement on challenges versus consultation of allergy service.
|
|---|---|---|
|
Cephalosporin Utilization by Patients
Same Hospitalization
|
293 Participants
|
297 Participants
|
|
Cephalosporin Utilization by Patients
3 Months Post-Randomization
|
156 Participants
|
173 Participants
|
|
Cephalosporin Utilization by Patients
18 Months Post-Randomization
|
363 Participants
|
379 Participants
|
Adverse Events
Penicillin Allergic Floor Patients- Experimental
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Penicillin Allergic Floor Patients- Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Cosby A Stone, Jr.
VANDERBILT UNIVERSITY MEDICAL CENTER
Phone: 6153223412
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place