Allergy Delabeling in Antibiotic Stewardship - Evaluations
NCT ID: NCT06967467
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
80 participants
OBSERVATIONAL
2025-12-01
2029-10-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients who decline enrollment in the RENEW intervention
Patients who were approached for enrollment in the RENEW intervention but declined consent.
Semi-structured interview
Interviews designed to obtain information about patient reasons for enrolling or declining participation in the RENEW Intervention
Clinicians
Clinicians who provide clinical care to patients enrolled in the intervention.
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
Semi-structured interview
Interviews designed to obtain information from clinicians about their perception of the implementation of the RENEW intervention
RENEW Clinical Pharmacist
The RENEW Clinical Pharmacist will screen, recruit, and consent potential participants and perform the RENEW intervention.
Ethnographic observation
Observations designed to identify communication and contextual barriers to the implementation of RENEW
Patients who enroll in the RENEW intervention
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.
Semi-structured interview
Interviews designed to obtain information about patient reasons for enrolling or declining participation in the RENEW Intervention
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
Interventions
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Semi-structured interview
Interviews designed to obtain information about patient reasons for enrolling or declining participation in the RENEW Intervention
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
Ethnographic observation
Observations designed to identify communication and contextual barriers to the implementation of RENEW
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
Semi-structured interview
Interviews designed to obtain information from clinicians about their perception of the implementation of the RENEW intervention
Eligibility Criteria
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Inclusion Criteria
* 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
* meet one of the exclusionary criteria for the RENEW clinical intervention
Clinician participants:
* no exclusions
18 Years
ALL
No
Sponsors
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University of Utah
OTHER
University of Pennsylvania
OTHER
Responsible Party
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Ebbing Lautenbach
Professor of Medicine and Epidemiology
Locations
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Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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855769
Identifier Type: -
Identifier Source: org_study_id