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Enrolling by Invitation

NCT Number: NCT06967467

Allergy Delabeling in Antibiotic Stewardship - Evaluations

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.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Semi-structured interview

Behavioral

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

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

Ethnographic observation

Behavioral

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

Primary outcomes

  1. Feasibility of Implementation

    Time frame: 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.

  2. Acceptability of Implementation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Collaborators

  • University of Utah

Registry information

Official study title

Optimizing Antibiotic Selection in Hematologic Malignancy Patients With Reported Beta-lactam Allergy

Acronym: RENEW-EVAL

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
May 13, 2025
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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