Allergy Delabeling in Antibiotic Stewardship - Evaluations

NCT06967467 | Enrolling By Invitation DMC

• 2 other identifiers: 855769R01HS029879
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Beta Lactam Allergy in Patients With a Hematologic Malignancy

Keywords

penicillin allergy; hematologic cancer; allergy delabeling

Outcome Measures

Primary Outcomes (2)

• Feasibility of Implementation

  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.

  From baseline Month 1 to Month 36

• Acceptability of Implementation

  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.

  From baseline Month 1 to Month 36

Study Arms (4)

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.

Behavioral: Semi-structured interview; Behavioral: Survey

Patients who decline enrollment in the RENEW intervention

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

Behavioral: Semi-structured interview

Clinicians

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

Behavioral: Survey; Behavioral: Semi-structured interview

RENEW Clinical Pharmacist

The RENEW Clinical Pharmacist will screen, recruit, and consent potential participants and perform the RENEW intervention.

Behavioral: Ethnographic observation

Interventions

Ethnographic observation BEHAVIORAL

Observations designed to identify communication and contextual barriers to the implementation of RENEW

RENEW Clinical Pharmacist

Survey BEHAVIORAL

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

Patients who enroll in the RENEW intervention

Semi-structured interview BEHAVIORAL

Interviews designed to obtain information about patient reasons for enrolling or declining participation in the RENEW Intervention

Patients who decline enrollment in the RENEW intervention; Patients who enroll in the RENEW intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes patient participants who are admitted to an inpatient oncology service at the Hospital of the University of Pennsylvania, and clinician participants who provide clinical care during the admission. By definition, the Clinical Pharmacist who enrolls patient participants will also be part of the study population.

You may qualify if:

• 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

You may not qualify if:

• Patient participants:
• Clinician participants:

Sponsors & Collaborators

• University of Pennsylvania: lead
• University of Utah: collaborator

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Epidemiology

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: May 13, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

US (1)