Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal in ICU Setting
|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: NCT03702283|
Recruitment Status : Recruiting
First Posted : October 11, 2018
Last Update Posted : April 13, 2020
|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 :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal in ICU Setting|
|Actual Study Start Date :||March 26, 2019|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||April 30, 2021|
Experimental: Penicillin Allergic ICU Patients
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.
- Penicillin allergy label removal [ Time Frame: Hospital discharge at approximately 7 days after ICU transfer ]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 7 days after ICU transfer ]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 7 days after ICU transfer ]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 7 days after ICU transfer ]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 7 days after ICU transfer ]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
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): NCT03702283
|Contact: Cosby A Stone, MD, MPHfirstname.lastname@example.org|
|United States, Tennessee|
|Vanderbilt University Medical Center||Recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: Cosby A Stone, MD, MPH|
|Principal Investigator:||Elizabeth J Phillips, MD||Vanderbilt University Medical Center|
|Study Chair:||Chris Lindsell, PhD||Vanderbilt University Medical Center|