Penicillin Allergy
Conditions
Brief summary
Currently it is estimated that at least 25 million people in the United States are labeled as penicillin allergic although less than 1.5 million of these are truly allergic. Although combined skin testing and oral challenge is an evidence-based de-labeling strategy the high burden of penicillin allergy labels means these services are available only through specialty allergy practices. There is therefore a need to provide evidence for alternative penicillin de-labeling strategies such as direct oral challenge. Previous studies have utilized quasi-experimental designs. Test dose challenges are currently recommended as a strategy for removal of low risk drug allergies, but the current experience is limited to single arm observational studies and evidence-based strategies for identifying low risk patients are lacking. Our objective is to demonstrate the benefit of providing risk stratification in removing penicillin allergy labels for low risk penicillin allergy patients in a randomized controlled trial.
Interventions
Providing best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
During the trial, randomization will occur using a stepped wedge cluster randomized controlled trial design. Medical units at VUMC will be assigned to clusters. A single cluster will be selected for intervention at the outset of the trial. Subsequent additional clusters will first contribute to the control group, and be selected to randomly cross over to the intervention group at regular intervals of 1 months.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* VUMC patients age 18 or older with a penicillin allergy reported in their chart, and are medically stable, currently admitted to stepdown unit or regular floor bed.
Exclusion criteria
* Patients with a penicillin allergy reported in their chart, but who are currently medically unstable. * Pregnant patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Penicillin Allergy Label Removal | Hospital discharge at approximately 4 days after admission | The percentage of patients with low risk penicillin allergy whose labels are removed from the medical chart's allergy section. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Communication About Penicillin Allergy in Discharge Summary | Hospital discharge at approximately 4 days after admission | The percentage of penicillin allergic patients whose discharge summary contains information about penicillin allergy at discharge. |
| Antibiotic Utilization by Patients | Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up | The 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 |
| Durability of Penicillin Allergy Label Removal | Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up | The percentage of penicillin allergic patients whose penicillin allergy labels were removed at discharge whose labels are not reentered into the chart. |
| Adverse Events (in Particular, Reported Allergic Events) | Hospital discharge at approximately 4 days after admission | The percentage of penicillin allergic patients challenged with amoxicillin who reported adverse events |
| Time to Penicillin Allergy Label Return | From 3-18 months of follow up | 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 |
| Penicillin Utilization by Patients | Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up | The 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 |
| Cephalosporin Utilization by Patients | Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up | The 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 |
| Receipt of Risk Stratification Tool Assessment | Hospital discharge at approximately 4 days after admission | Number of patients with a penicillin allergy label who received a risk assessment. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Penicillin Allergic Floor Patients- Experimental 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. | 1,018 |
| Penicillin Allergic Floor Patients- Control Patients will receive current standard of care for penicillin allergy, which typically involves physician judgement on challenges versus consultation of allergy service. | 1,034 |
| Total | 2,052 |
Baseline characteristics
| Characteristic | Penicillin Allergic Floor Patients- Control | Penicillin Allergic Floor Patients- Experimental | Total |
|---|---|---|---|
| Age, Continuous | 61.7 years | 64.6 years | 63.1 years |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic, Latino | 19 Participants | 14 Participants | 33 Participants |
| Race/Ethnicity, Customized Ethnicity Non-Hispanic, Latino | 445 Participants | 448 Participants | 893 Participants |
| Race/Ethnicity, Customized Ethnicity Unknown/Not Reported | 570 Participants | 556 Participants | 1126 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 2 Participants | 8 Participants | 10 Participants |
| Race/Ethnicity, Customized Race Asian | 4 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Race Black or African American | 156 Participants | 165 Participants | 321 Participants |
| Race/Ethnicity, Customized Race More Than One Race | 10 Participants | 8 Participants | 18 Participants |
| Race/Ethnicity, Customized Race Unknown/Not Reported | 15 Participants | 9 Participants | 24 Participants |
| Race/Ethnicity, Customized Race White | 847 Participants | 827 Participants | 1674 Participants |
| Region of Enrollment United States | 1034 Participants | 1018 Participants | 2052 Participants |
| Sex: Female, Male Female | 593 Participants | 596 Participants | 1189 Participants |
| Sex: Female, Male Male | 441 Participants | 422 Participants | 863 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,018 | 0 / 1,034 |
| other Total, other adverse events | 0 / 1,018 | 0 / 1,034 |
| serious Total, serious adverse events | 0 / 1,018 | 0 / 1,034 |
Outcome results
Primary
Penicillin Allergy Label Removal
The percentage of patients with low risk penicillin allergy whose labels are removed from the medical chart's allergy section.
Time frame: Hospital discharge at approximately 4 days after admission
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Penicillin Allergic Floor Patients- Experimental | Penicillin Allergy Label Removal | 45 Participants |
| Penicillin Allergic Floor Patients- Control | Penicillin Allergy Label Removal | 31 Participants |
Secondary
Adverse Events (in Particular, Reported Allergic Events)
The percentage of penicillin allergic patients challenged with amoxicillin who reported adverse events
Time frame: Hospital discharge at approximately 4 days after admission
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Penicillin Allergic Floor Patients- Experimental | Adverse Events (in Particular, Reported Allergic Events) | 0 Participants |
| Penicillin Allergic Floor Patients- Control | Adverse Events (in Particular, Reported Allergic Events) | 0 Participants |
Secondary
Antibiotic Utilization by Patients
The 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
Time frame: Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Penicillin Allergic Floor Patients- Experimental | Antibiotic Utilization by Patients | Same Hospitalization | Never | 680 Participants |
| Penicillin Allergic Floor Patients- Experimental | Antibiotic Utilization by Patients | Same Hospitalization | Ever | 338 Participants |
| Penicillin Allergic Floor Patients- Experimental | Antibiotic Utilization by Patients | 3 Months Post-Randomization | Never | 826 Participants |
| Penicillin Allergic Floor Patients- Experimental | Antibiotic Utilization by Patients | 3 Months Post-Randomization | Ever | 192 Participants |
| Penicillin Allergic Floor Patients- Experimental | Antibiotic Utilization by Patients | 18 Months Post-Randomization | Never | 602 Participants |
| Penicillin Allergic Floor Patients- Experimental | Antibiotic Utilization by Patients | 18 Months Post-Randomization | Ever | 416 Participants |
| Penicillin Allergic Floor Patients- Control | Antibiotic Utilization by Patients | 18 Months Post-Randomization | Never | 627 Participants |
| Penicillin Allergic Floor Patients- Control | Antibiotic Utilization by Patients | Same Hospitalization | Never | 715 Participants |
| Penicillin Allergic Floor Patients- Control | Antibiotic Utilization by Patients | 3 Months Post-Randomization | Ever | 187 Participants |
| Penicillin Allergic Floor Patients- Control | Antibiotic Utilization by Patients | Same Hospitalization | Ever | 319 Participants |
| Penicillin Allergic Floor Patients- Control | Antibiotic Utilization by Patients | 18 Months Post-Randomization | Ever | 407 Participants |
| Penicillin Allergic Floor Patients- Control | Antibiotic Utilization by Patients | 3 Months Post-Randomization | Never | 847 Participants |
Secondary
Cephalosporin Utilization by Patients
The 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
Time frame: Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Penicillin Allergic Floor Patients- Experimental | Cephalosporin Utilization by Patients | 3 Months Post-Randomization | 156 Participants |
| Penicillin Allergic Floor Patients- Experimental | Cephalosporin Utilization by Patients | 18 Months Post-Randomization | 363 Participants |
| Penicillin Allergic Floor Patients- Experimental | Cephalosporin Utilization by Patients | Same Hospitalization | 293 Participants |
| Penicillin Allergic Floor Patients- Control | Cephalosporin Utilization by Patients | Same Hospitalization | 297 Participants |
| Penicillin Allergic Floor Patients- Control | Cephalosporin Utilization by Patients | 18 Months Post-Randomization | 379 Participants |
| Penicillin Allergic Floor Patients- Control | Cephalosporin Utilization by Patients | 3 Months Post-Randomization | 173 Participants |
Secondary
Communication About Penicillin Allergy in Discharge Summary
The percentage of penicillin allergic patients whose discharge summary contains information about penicillin allergy at discharge.
Time frame: Hospital discharge at approximately 4 days after admission
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Penicillin Allergic Floor Patients- Experimental | Communication About Penicillin Allergy in Discharge Summary | Missing | 0 Participants |
| Penicillin Allergic Floor Patients- Experimental | Communication About Penicillin Allergy in Discharge Summary | No | 5 Participants |
| Penicillin Allergic Floor Patients- Experimental | Communication About Penicillin Allergy in Discharge Summary | Yes | 21 Participants |
| Penicillin Allergic Floor Patients- Control | Communication About Penicillin Allergy in Discharge Summary | Missing | 4 Participants |
| Penicillin Allergic Floor Patients- Control | Communication About Penicillin Allergy in Discharge Summary | No | 2 Participants |
| Penicillin Allergic Floor Patients- Control | Communication About Penicillin Allergy in Discharge Summary | Yes | 14 Participants |
Secondary
Durability of Penicillin Allergy Label Removal
The percentage of penicillin allergic patients whose penicillin allergy labels were removed at discharge whose labels are not reentered into the chart.
Time frame: Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Penicillin Allergic Floor Patients- Experimental | Durability of Penicillin Allergy Label Removal | 3 Months Post-Randomization | 44 Participants |
| Penicillin Allergic Floor Patients- Experimental | Durability of Penicillin Allergy Label Removal | 18 Months Post-Randomization | 43 Participants |
| Penicillin Allergic Floor Patients- Control | Durability of Penicillin Allergy Label Removal | 3 Months Post-Randomization | 28 Participants |
| Penicillin Allergic Floor Patients- Control | Durability of Penicillin Allergy Label Removal | 18 Months Post-Randomization | 29 Participants |
Secondary
Penicillin Utilization by Patients
The 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
Time frame: Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Penicillin Allergic Floor Patients- Experimental | Penicillin Utilization by Patients | Same Hospitalization | 84 Participants |
| Penicillin Allergic Floor Patients- Experimental | Penicillin Utilization by Patients | 3 Months Post-Randomization | 68 Participants |
| Penicillin Allergic Floor Patients- Experimental | Penicillin Utilization by Patients | 18 Months Post-Randomization | 173 Participants |
| Penicillin Allergic Floor Patients- Control | Penicillin Utilization by Patients | Same Hospitalization | 57 Participants |
| Penicillin Allergic Floor Patients- Control | Penicillin Utilization by Patients | 3 Months Post-Randomization | 46 Participants |
| Penicillin Allergic Floor Patients- Control | Penicillin Utilization by Patients | 18 Months Post-Randomization | 140 Participants |
Secondary
Receipt of Risk Stratification Tool Assessment
Number of patients with a penicillin allergy label who received a risk assessment.
Time frame: Hospital discharge at approximately 4 days after admission
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Penicillin Allergic Floor Patients- Experimental | Receipt of Risk Stratification Tool Assessment | 86 Participants |
| Penicillin Allergic Floor Patients- Control | Receipt of Risk Stratification Tool Assessment | 27 Participants |
Secondary
Time to Penicillin Allergy Label 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
Time frame: From 3-18 months of follow up
Population: Intervention arm had 40 patients whose labels did not return. The control had 27 patients whose labels did not return.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Penicillin Allergic Floor Patients- Experimental | Time to Penicillin Allergy Label Return | 35.62 days |
| Penicillin Allergic Floor Patients- Control | Time to Penicillin Allergy Label Return | 52.89 days |