Allergy Delabeling in Antibiotic Stewardship - Evaluations
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Semi-structured interview, Survey, Ethnographic observation, Survey.
- Who it may be relevant to
- Registry conditions: Beta Lactam Allergy in Patients With a Hematologic Malignancy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Optimizing Antibiotic Selection in Hematologic Malignancy Patients With Reported Beta-lactam Allergy
Overview
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.
Interventions
- 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
Primary outcome measures
- Feasibility of Implementation [Time frame: From baseline Month 1 to Month 36]
- Acceptability of Implementation [Time frame: From baseline Month 1 to Month 36]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- Hospital of the University of Pennsylvania — Philadelphia
Identifiers
NCT: NCT06967467 · 02725 · R01HS029879