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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Penicillin Allergic Floor Patients- Experimental | 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 Floor Patients- Control | No Intervention | Patients will receive current standard of care for penicillin allergy, which typically involves physician judgement on challenges versus consultation of allergy service. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Penicillin Allergic Risk Stratification Best Practice Alert | Other | Providing best practice information on a patient's penicillin allergy risk and how to manage different levels of risk. |
| Measure | Description | Time Frame |
|---|---|---|
| Penicillin Allergy Label Removal | The percentage of patients with low risk penicillin allergy whose labels are removed from the medical chart's allergy section. | Hospital discharge at approximately 4 days after admission |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (in Particular, Reported Allergic Events) | The percentage of penicillin allergic patients challenged with amoxicillin who reported adverse events | Hospital discharge at approximately 4 days after admission |
| Communication About Penicillin Allergy in Discharge Summary |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cosby Stone, MD, MPH | Vanderbilt University Medical Center | Principal Investigator |
| Chris Lindsell, PhD | Vanderbilt University Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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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.
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| FG006 | 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. |
| FG007 | 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. |
| FG008 | 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. |
| FG009 | 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. |
| FG010 | 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. |
| FG011 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Control |
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| Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Hospital discharge at approximately 4 days after admission |
|
Adverse event data was collected during the index hospitalization, from randomization to discharge (~4 days post-randomization).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cosby A Stone, Jr. | VANDERBILT UNIVERSITY MEDICAL CENTER | 6153223412 | Cosby.a.stone@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 26, 2022 | Apr 29, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 5, 2024 | Dec 3, 2024 | SAP_002.pdf |
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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.
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The percentage of penicillin allergic patients whose discharge summary contains information about penicillin allergy at discharge. |
| Hospital discharge at approximately 4 days after admission |
| 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" | Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up |
| 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. | Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up |
| Receipt of Risk Stratification Tool Assessment | Number of patients with a penicillin allergy label who received a risk assessment. | Hospital discharge at approximately 4 days after admission |
| 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 | From 3-18 months of follow up |
| 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" | Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up |
| 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" | Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up |
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| NOT COMPLETED |
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| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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Patients will receive current standard of care for penicillin allergy, which typically involves physician judgement on challenges versus consultation of allergy service. |
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| Secondary | Adverse Events (in Particular, Reported Allergic Events) | The percentage of penicillin allergic patients challenged with amoxicillin who reported adverse events | Posted | Count of Participants | Participants | Hospital discharge at approximately 4 days after admission |
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| Secondary | Communication About Penicillin Allergy in Discharge Summary | The percentage of penicillin allergic patients whose discharge summary contains information about penicillin allergy at discharge. | Posted | Count of Participants | Participants | Hospital discharge at approximately 4 days after admission |
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| 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" | Posted | Count of Participants | Participants | Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up |
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| 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. | Posted | Count of Participants | Participants | Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up |
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| Secondary | Receipt of Risk Stratification Tool Assessment | Number of patients with a penicillin allergy label who received a risk assessment. | Posted | Count of Participants | Participants | Hospital discharge at approximately 4 days after admission |
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| 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 | Intervention arm had 40 patients whose labels did not return. The control had 27 patients whose labels did not return. | Posted | Median | Inter-Quartile Range | days | From 3-18 months of follow up |
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| 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" | Posted | Count of Participants | Participants | Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up |
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| 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" | Posted | Count of Participants | Participants | Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up |
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| 0 |
| 1,018 |
| 0 |
| 1,018 |
| 0 |
| 1,018 |
| EG001 | 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. | 0 | 1,034 | 0 | 1,034 | 0 | 1,034 |
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| Asian |
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| Black or African American |
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| Unknown/Not Reported |
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| White |
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| Unknown/Not Reported |
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| Missing |
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| 3 Months Post-Randomization |
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| 18 Months Post-Randomization |
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| 18 Months Post-Randomization |
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| 18 Months Post-Randomization |
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