Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT06967467
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-18
First Post:
2025-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Allergy Delabeling in Antibiotic Stewardship - Evaluations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-04-08', 'studyFirstSubmitQcDate': '2025-05-02', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Implementation', 'timeFrame': 'From baseline Month 1 to Month 36', 'description': '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.'}, {'measure': 'Acceptability of Implementation', 'timeFrame': 'From baseline Month 1 to Month 36', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['penicillin allergy', 'hematologic cancer', 'allergy delabeling'], 'conditions': ['Beta Lactam Allergy in Patients With a Hematologic Malignancy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': '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'}, 'identificationModule': {'nctId': 'NCT06967467', 'acronym': 'RENEW-EVAL', 'briefTitle': 'Allergy Delabeling in Antibiotic Stewardship - Evaluations', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Optimizing Antibiotic Selection in Hematologic Malignancy Patients With Reported Beta-lactam Allergy', 'orgStudyIdInfo': {'id': '855769'}, 'secondaryIdInfos': [{'id': 'R01HS029879', 'link': 'https://reporter.nih.gov/quickSearch/R01HS029879', 'type': 'AHRQ'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients who enroll in the RENEW intervention', 'description': '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.', 'interventionNames': ['Behavioral: Semi-structured interview', 'Behavioral: Survey']}, {'label': 'Patients who decline enrollment in the RENEW intervention', 'description': 'Patients who were approached for enrollment in the RENEW intervention but declined consent.', 'interventionNames': ['Behavioral: Semi-structured interview']}, {'label': 'Clinicians', 'description': 'Clinicians who provide clinical care to patients enrolled in the intervention.', 'interventionNames': ['Behavioral: Survey', 'Behavioral: Semi-structured interview']}, {'label': 'RENEW Clinical Pharmacist', 'description': 'The RENEW Clinical Pharmacist will screen, recruit, and consent potential participants and perform the RENEW intervention.', 'interventionNames': ['Behavioral: Ethnographic observation']}], 'interventions': [{'name': 'Semi-structured interview', 'type': 'BEHAVIORAL', 'description': 'Interviews designed to obtain information about patient reasons for enrolling or declining participation in the RENEW Intervention', 'armGroupLabels': ['Patients who decline enrollment in the RENEW intervention', 'Patients who enroll in the RENEW intervention']}, {'name': 'Survey', 'type': 'BEHAVIORAL', 'description': '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', 'armGroupLabels': ['Patients who enroll in the RENEW intervention']}, {'name': 'Ethnographic observation', 'type': 'BEHAVIORAL', 'description': 'Observations designed to identify communication and contextual barriers to the implementation of RENEW', 'armGroupLabels': ['RENEW Clinical Pharmacist']}, {'name': 'Survey', 'type': 'BEHAVIORAL', 'description': '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', 'armGroupLabels': ['Clinicians']}, {'name': 'Semi-structured interview', 'type': 'BEHAVIORAL', 'description': 'Interviews designed to obtain information from clinicians about their perception of the implementation of the RENEW intervention', 'armGroupLabels': ['Clinicians']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Utah', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine and Epidemiology', 'investigatorFullName': 'Ebbing Lautenbach', 'investigatorAffiliation': 'University of Pennsylvania'}}}}