Beta Lactam Allergy in Patients With a Hematologic Malignancy
Conditions
Keywords
penicillin allergy, hematologic cancer, allergy delabeling
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.
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
BEHAVIORALSemi-structured interview
Interviews designed to obtain information about patient reasons for enrolling or declining participation in the RENEW Intervention
BEHAVIORALSurvey
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
BEHAVIORALEthnographic observation
Observations designed to identify communication and contextual barriers to the implementation of RENEW
Sponsors
Abramson Cancer Center at Penn Medicine
University of Utah
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Implementation | 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. |
| Acceptability of Implementation | 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. |
Countries
United States
Outcome results
None listed