Allergy Delabeling in Antibiotic Stewardship - Evaluations

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Semi-structured interview
  Interviews designed to obtain information about patient reasons for enrolling or declining participation in the RENEW Intervention
• Поведенческое 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
• Поведенческое Ethnographic observation
  Observations designed to identify communication and contextual barriers to the implementation of RENEW
• Поведенческое 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
• Поведенческое Semi-structured interview
  Interviews designed to obtain information from clinicians about their perception of the implementation of the RENEW intervention

Первичные конечные точки

• Feasibility of Implementation [Срок оценки: From baseline Month 1 to Month 36]
• Acceptability of Implementation [Срок оценки: From baseline Month 1 to Month 36]

Критерии участия

Критерии включения

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

Критерии исключения

Patient participants:

• meet one of the exclusionary criteria for the RENEW clinical intervention

Clinician participants:

• no exclusions

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

США · 1 центр

• Hospital of the University of Pennsylvania — Philadelphia

Идентификаторы

NCT: NCT06967467 · 02725 · R01HS029879

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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