Clinical trial NCT06967467: Allergy Delabeling in Antibiotic Stewardship - Evaluations
Official title: Optimizing Antibiotic Selection in Hematologic Malignancy Patients With Reported Beta-lactam Allergy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Beta Lactam Allergy in Patients With a Hematologic Malignancy
Keywords: penicillin allergy
hematologic cancer
allergy delabeling
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: University of Utah
First posted: 2025-05-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes patient participants who are admitted to an inpatient oncology service at the Hospital of the University of Pennsylvania, and clinician participants who provide clinical care during the admission. By definition, the Clinical Pharmacist who enrolls patient participants will also be part of the study population.

Brief summary: The goal of this RENEW-EVAL project is to understand the potential barriers to implementation of the RENEW intervention into the routine clinical care of patients with a hematological malignancy.

Detailed description: The RENEW clinical intervention is designed to evaluate the impact of a comprehensive beta lactam (BL) 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. The RENEW intervention will test the impact of a pharmacist-led BL allergy delabeling intervention on clinical outcomes and antibiotic use in hospitalized patients with HM.

The implementation of clinical interventions are often affected by non-clinical factors including workflow challenges and the beliefs of patients, their families, and clinical staff.

The RENEW-EVAL study is a concurrent mixed methods process evaluation of the RENEW intervention that aims to identify the social and behavioral factors that shape implementation of the intervention and to measure implementation outcomes including feasibility, acceptability, and fidelity.

Three types of data will be gathered by the research team as part of the RENEW-EVAL project: 1) semistructured interviews with patients and clinicians, (2) ethnographic observations of the delivery of the RENEW intervention, and 3) surveys assessing patient and clinician attitudes towards BL allergy delabeling, and implementation outcomes.

Eligibility criteria: Inclusion Criteria:

Patient participants:

* a diagnosis of a hematologic malignancy (lymphoma, leukemia, myeloma)
* a prior label applied to their medical record to indicate a beta lactam allergy
* hospitalized as an inpatient to an oncology service at the time the study is conducted

Clinician participants:

* member of the primary inpatient care team

Exclusion Criteria:

Patient participants:

* meet one of the exclusionary criteria for the RENEW clinical intervention

Clinician participants:

* no exclusions

Primary outcomes:
measure: Feasibility of Implementation
timeFrame: From baseline Month 1 to Month 36
measure: Acceptability of Implementation
timeFrame: From baseline Month 1 to Month 36
Secondary outcomes:
Other outcomes:
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Study officials:
References: