The Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03702270|
Recruitment Status : Not yet recruiting
First Posted : October 11, 2018
Last Update Posted : August 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Penicillin Allergy||Other: Penicillin Allergic Risk Stratification Best Practice Alert||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2040 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||During the trial, randomization will occur using a stepped wedge cluster randomized controlled trial design. Medical units at VUMC will 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 2 months.|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal|
|Estimated Study Start Date :||November 2019|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2021|
Experimental: 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.
Other: 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.
No Intervention: 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.
- Penicillin allergy label removal [ Time Frame: Hospital discharge at approximately 4 days after admission ]The proportion of patients with low risk penicillin allergy whose labels are removed from the medical chart's allergy section.
- Patients with low risk penicillin allergy label who underwent amoxicillin challenge [ Time Frame: Hospital discharge at approximately 4 days after admission ]The proportion of patients with low risk penicillin allergy who underwent amoxicillin challenge
- Adverse events (in particular, reported allergic events) [ Time Frame: Hospital discharge at approximately 4 days after admission ]The proportion of penicillin allergic patients challenged with amoxicillin who reported adverse events
- Communication about penicillin allergy in discharge summary [ Time Frame: Hospital discharge at approximately 4 days after admission ]The proportion of penicillin allergic patients whose discharge summary contains information about penicillin allergy at discharge.
- Antibiotic utilization by patients [ Time Frame: Hospital discharge at approximately 4 days after admission and at 9 Months, 12 Months and 18 Months after discharge ]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
- Durability of penicillin allergy label removal [ Time Frame: Hospital discharge at approximately 4 days after admission and at 9 Months, 12 Months and 18 Months after discharge ]The proportion of penicillin allergic patients whose penicillin allergy labels were removed at discharge whose labels are not reentered into the chart.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03702270
|Contact: Cosby Stone, MD, MPHfirstname.lastname@example.org|
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Elizabeth J Phillips, MD||Vanderbilt University Medical Center|
|Study Chair:||Chris Lindsell, PhD||Vanderbilt University Medical Center|