Allergy Delabeling in Antibiotic Stewardship - Evaluations

Not yet recruiting

• Conditions: Beta Lactam Allergy in Patients With a Hematologic Malignancy

• Registration Number: NCT06967467
• Lead Sponsor: University of Pennsylvania

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.

Study Timeline

• Study First Submitted: 2025-04-08
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-02
• Last Update Submitted: 2025-05-02
• Study First Posted: 2025-05-13
• Last Update Posted: 2025-05-13
• Study Start: 2025-09
• Primary Completion: 2028-09
• Study Completion: 2029-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of Implementation	From baseline Month 1 to Month 36	Feasibility of implementation among clinicians and patients measured by questionnaire. Items are adapted from the validated Feasibility of Implementation Measure (FIM) and are rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better feasibility. The items are analyzed individually and not summed to a total score.
Acceptability of Implementation	From baseline Month 1 to Month 36	Acceptability of implementation among clinicians and patients measured by questionnaire. Items are adapted from the validated Acceptability of Implementation Measure (AIM) and are rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better acceptability. The items are analyzed individually and not summed to a total score.