NCT06967467

Allergy Delabeling in Antibiotic Stewardship - Evaluations

Optimizing Antibiotic Selection in Hematologic Malignancy Patients With Reported Beta-lactam Allergy

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Beta Lactam Allergy in Patients With a Hematologic Malignancy

Interventions

Type	Name	Description
BEHAVIORAL	Semi-structured interview	Interviews designed to obtain information about patient reasons for enrolling or declining participation in the RENEW Intervention
BEHAVIORAL	Survey	Survey which will incorporate a series of closed-ended questions eliciting attitudes about the feasibility and acceptability of the intervention, allergy delabeling and future BL antibiotic use
BEHAVIORAL	Ethnographic observation	Observations designed to identify communication and contextual barriers to the implementation of RENEW
BEHAVIORAL	Survey	Survey instruments will measure knowledge,attitudes, and practices surrounding allergy delabeling and antibiotic stewardship in patients with HM and perceptions of the feasibility and acceptability of the RENEW intervention
BEHAVIORAL	Semi-structured interview	Interviews designed to obtain information from clinicians about their perception of the implementation of the RENEW intervention

Timeline

• Start date: 2025-12-01
• Primary completion: 2028-09-01
• Completion: 2029-10-01
• First posted: 2025-05-13
• Last updated: 2025-12-18

Locations

1 site across 1 country: United States