Allergy Delabeling in Antibiotic Stewardship - Evaluations (RENEW-EVAL)

University of Pennsylvania

Status

Invitation-only

Conditions

Beta Lactam Allergy in Patients With a Hematologic Malignancy

Treatments

Behavioral: Ethnographic observation

Behavioral: Semi-structured interview

Behavioral: Survey

Study type

Observational

Funder types

Other

Identifiers

NCT06967467

855769

R01HS029879 (U.S. AHRQ Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

80 participants in 4 patient groups

Patients who enroll in the RENEW intervention

Description:

Patients who agree to actively participate in the RENEW intervention designed to identify opportunities to have the beta lactam allergy label removed from their electronic medical record.

Treatment:

Behavioral: Survey

Behavioral: Semi-structured interview

Patients who decline enrollment in the RENEW intervention

Description:

Patients who were approached for enrollment in the RENEW intervention but declined consent.

Treatment:

Behavioral: Semi-structured interview

Clinicians

Description:

Clinicians who provide clinical care to patients enrolled in the intervention.

Treatment: