[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06967467":3,"trial-entities:NCT06967467":92,"trial-summary:NCT06967467":97},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":27,"interventions":30,"primary_outcomes":54,"secondary_outcomes":62,"sex":63,"minimum_age":64,"maximum_age":25,"healthy_volunteers":65,"eligibility_criteria":66,"std_ages":75,"locations":78,"central_contacts":88,"overall_officials":89,"references":90,"see_also_links":91},"NCT06967467","02725","Allergy Delabeling in Antibiotic Stewardship - Evaluations","Optimizing Antibiotic Selection in Hematologic Malignancy Patients With Reported Beta-lactam Allergy","ENROLLING_BY_INVITATION","2029-10","2026-06","2026-06-05","2025-12-01","Abramson Cancer Center at Penn Medicine","OTHER",true,"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.","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.\n\nThe implementation of clinical interventions are often affected by non-clinical factors including workflow challenges and the beliefs of patients, their families, and clinical staff.\n\nThe 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.\n\nThree 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.",[19],"Beta Lactam Allergy in Patients With a Hematologic Malignancy",[21,22,23],"penicillin allergy","hematologic cancer","allergy delabeling","OBSERVATIONAL",null,[],{"count":28,"type":29},80,"ESTIMATED",[31,38,42,47,51],{"type":32,"name":33,"description":34,"armGroupLabels":35},"BEHAVIORAL","Semi-structured interview","Interviews designed to obtain information about patient reasons for enrolling or declining participation in the RENEW Intervention",[36,37],"Patients who decline enrollment in the RENEW intervention","Patients who enroll in the RENEW intervention",{"type":32,"name":39,"description":40,"armGroupLabels":41},"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",[37],{"type":32,"name":43,"description":44,"armGroupLabels":45},"Ethnographic observation","Observations designed to identify communication and contextual barriers to the implementation of RENEW",[46],"RENEW Clinical Pharmacist",{"type":32,"name":39,"description":48,"armGroupLabels":49},"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",[50],"Clinicians",{"type":32,"name":33,"description":52,"armGroupLabels":53},"Interviews designed to obtain information from clinicians about their perception of the implementation of the RENEW intervention",[50],[55,59],{"measure":56,"description":57,"timeFrame":58},"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",{"measure":60,"description":61,"timeFrame":58},"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.",[],"ALL","18 Years",false,{"inclusion":67,"exclusion":72,"raw_text":74},[68,69,70,71],"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","member of the primary inpatient care team",[73],"no exclusions","Inclusion Criteria:\n\nPatient participants:\n\n* a diagnosis of a hematologic malignancy (lymphoma, leukemia, myeloma)\n* a prior label applied to their medical record to indicate a beta lactam allergy\n* hospitalized as an inpatient to an oncology service at the time the study is conducted\n\nClinician participants:\n\n* member of the primary inpatient care team\n\nExclusion Criteria:\n\nPatient participants:\n\n* meet one of the exclusionary criteria for the RENEW clinical intervention\n\nClinician participants:\n\n* no exclusions",[76,77],"ADULT","OLDER_ADULT",[79],{"facility":80,"city":81,"state":82,"zip":83,"country":84,"geoPoint":85},"Hospital of the University of Pennsylvania","Philadelphia","Pennsylvania","19104","United States",{"lat":86,"lon":87},39.95238,-75.16362,[],[],[],[],{"nct_id":4,"conditions":93,"biomarkers":96},[94,95],"Beta Lactam Allergy","Malignant neoplasm of lymphoid, hematopoietic and\u002For related tissue",[],{"nct_id":4,"found":65,"summary":25,"prompt_version":25}]