The overall goal of the RENEW-IN intervention is to assess the impact of a BL allergy delabeling intervention on antibiotic use and clinical outcomes in patients with a hematologic malignancy.
The RENEW clinical intervention is designed to evaluate the impact of a comprehensive beta lactam allergy delabeling intervention on clinical outcomes among patients hospitalized with a hematologic malignancy (HM). HM patients are at a high risk of infection-related complications but are limited to antibiotic therapy based on self-reported allergies. Beta-lactam (BL) antibiotics are a preferred treatment option for many bacterial infections, however, these antibiotics remain inaccessible as a treatment option for patients with a self-reported BL allergy. In the hospital setting, BL allergies are documented in the electronic medical record in up to 20% of hospitalized patients. Prior studies have shown that 90% of the patients for whom these allergies are reported are able to tolerate penicillin (PCN) or other BLs. Delabeling strategies to correctly identify true BL allergies in the general hospital population have proven successful. However, these studies have not been conducted among patients diagnosed with a hematological malignancy. The investigators propose to test the impact of a pharmacist-led BL allergy delabeling intervention on clinical outcomes and antibiotic use in hospitalized patients with HM. The intervention is a multi-step PCN delabeling strategy that includes 1) an assessment of the participant's BL allergy by a clinical pharmacist based on a detailed medical history; 2) assignment of additional allergy testing based on the RENEW-IN algorithm; and 3) delabeling of the allergy within the participants electronic medical record if appropriate.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
3,800
The RENEW-IN intervention includes a detailed assessment of the participant's beta-lactam allergy history and determination of a risk-level for allergy-delabeling.
Electronic medical record review for comparative analysis
Antibiotic Days of therapy
Proportion of participants prescribed an antibiotic during index hospitalization, from enrollment in the study to hospital discharge or death, whichever occurs first
Time frame: From baseline enrollment to end of index hospitalization or death, up to 36 months
Hospital length of stay
Number of days participants are admitted to the hospital during the index visit, from enrollment in the study to hospital discharge or death, whichever occurs first
Time frame: From baseline enrollment to end of index index hospitalization or death, up to 36 months
Clinical Cultures positive for multi-drug resistant organisms
Proportion of participants diagnosed with multi-drug resistant organism during index hospitalization, from enrollment in the study to hospital discharge or death, whichever occurs first
Time frame: From baseline enrollment to end of index index hospitalization or death, up to 36 months
Clinical Cultures positive for Clostridioides difficile infection
Proportion of participants diagnosed with Clostridioides difficile infection during index hospitalization, from enrollment in the study to hospital discharge or death, whichever occurs first
Time frame: From baseline enrollment to end of index index hospitalization or death, up to 36 months
Clinical Cultures positive for Health-care Associated Infections (HAIs)
Proportion of participants diagnosed during index visit with an infection identified as related to their hospitalization, from enrollment in the study to hospital discharge or death, whichever occurs first
Time frame: From baseline enrollment to end of index index hospitalization or death, up to 36 months
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Need for ICU transfer
Proportion of participants admitted to the ICU during their index hospitalization, from enrollment in the study to hospital discharge or death, whichever occurs first
Time frame: From baseline enrollment to end of index index hospitalization or death, up to 36 months
ICU length of stay
Number of days participants are admitted to the ICU during their index hospitalization, from enrollment in the study to hospital discharge or death, whichever occurs first
Time frame: From baseline enrollment to end of index index hospitalization or death, up to 36 months
Patient Disposition
Proportion of participants who are discharged from the hospital at the end of their index visit compared to the number of participants who expire during their index visit
Time frame: From baseline enrollment to end of index index hospitalization or death, up to 36 months