Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-29 @ 12:31 PM
Study NCT ID:
NCT05436392
Status:
COMPLETED
Last Update Posted:
2024-01-18
First Post:
2022-06-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
De-adopting Routine Preoperative Benzodiazepines for Older Surgical Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 517611}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-17', 'studyFirstSubmitDate': '2022-06-02', 'studyFirstSubmitQcDate': '2022-06-24', 'lastUpdatePostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hospital length of stay', 'timeFrame': 'Length of stay will be evaluated at approximately 30 days after surgery', 'description': 'Time from surgery to hospital discharge in days'}, {'measure': 'Postoperative pulmonary complications', 'timeFrame': 'Up to 30 days after surgery', 'description': 'Postoperative pulmonary complications as identified by ICD-10 codes for patients undergoing hospitalization after surgery'}, {'measure': 'Postoperative Delirium', 'timeFrame': 'Up to 30 days after surgery', 'description': 'Postoperative delirium as identified by ICD-10 codes for patients undergoing hospitalization after surgery'}], 'primaryOutcomes': [{'measure': 'Benzodiazepine administration rate', 'timeFrame': 'Intraoperative period', 'description': 'The primary outcome measure is the change in the rate of benzodiazepine administration among eligible surgical cases.'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': 'Up to 30 days after surgery', 'description': 'Change in patient satisfaction with care, as measured by Anesthesiologist Patient Satisfaction Questionnaire Composite Satisfaction Score, Version 2 (APSQ2).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgery', 'Aging']}, 'referencesModule': {'references': [{'pmid': '39480422', 'type': 'DERIVED', 'citation': 'Neuman MD, Feng R, Shukla AS, Han X, Horan AD, Whatley K, Schapira MM, Marcantonio ER, Dutton RP. Strategies to Limit Benzodiazepine Use in Anesthesia for Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2024 Oct 1;7(10):e2442207. doi: 10.1001/jamanetworkopen.2024.42207.'}]}, 'descriptionModule': {'briefSummary': 'Over 21 million surgical procedures take place among adults aged 65 and older in the US each year, and most older surgical patients in the US now receive benzodiazepines (e.g., midazolam, lorazepam) during anesthesia care. This occurs despite recommendations to avoid these medications in older patients due to associated medical risks and lack of demonstrated benefit. In other words, routine benzodiazepine administration to older surgical patients is likely to represent low-value care that is a suitable target for de-adoption. In this study, we will evaluate a United States Anesthesia Partners (USAP, Dallas, TX) quality improvement initiative using peer comparison feedback to clinicians and/or mailed informational letters to patients as strategies to encourage physician de-adoption of routine preoperative benzodiazepine administration to older surgical patients. In partnership with USAP, this study will be conducted using randomization to evaluate its effect.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All anesthesia clinicians employed by USAP will be included in the evaluation. Patients will be included if they are at least aged 65 and undergo an elective (scheduled) surgical or endoscopic procedure under general anesthesia.\n\nExclusion Criteria:\n\n* Patients will be excluded if they are unscheduled (urgent/emergent) cases due to inability to reliably deliver study interventions to this group; if they did not receive general anesthesia; or if they received a nerve block procedure.'}, 'identificationModule': {'nctId': 'NCT05436392', 'acronym': 'DROP-Benzo', 'briefTitle': 'De-adopting Routine Preoperative Benzodiazepines for Older Surgical Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'DROP-Benzo (De-adopting Routine Preoperative Benzodiazepines for Older Surgical Patients): a Randomized Trial of Behavioral Strategies to Reduce Unnecessary Midazolam Administration to Older Surgical Patients', 'orgStudyIdInfo': {'id': '850809'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control'}, {'type': 'EXPERIMENTAL', 'label': 'Peer Comparison Feedback', 'interventionNames': ['Behavioral: Peer Comparison Feedback']}, {'type': 'EXPERIMENTAL', 'label': 'Patient Informational Letter', 'interventionNames': ['Behavioral: Patient Informational Letter']}, {'type': 'EXPERIMENTAL', 'label': 'Peer Comparison Feedback plus Patient Informational Letter', 'interventionNames': ['Behavioral: Peer Comparison Feedback', 'Behavioral: Patient Informational Letter']}], 'interventions': [{'name': 'Peer Comparison Feedback', 'type': 'BEHAVIORAL', 'description': "USAP anesthesia providers will receive monthly alerts via USAP's smartphone-based practice management application, text message, or email presenting individual-level data on their benzodiazepine administration patterns versus other USAP providers, using data from the USAP clinical and quality data warehouse.", 'armGroupLabels': ['Peer Comparison Feedback', 'Peer Comparison Feedback plus Patient Informational Letter']}, {'name': 'Patient Informational Letter', 'type': 'BEHAVIORAL', 'description': "Breif informational letters will be distributed to eligible patients within the 2 weeks prior to surgery. Letters will be produced on USAP letterhead and signed by the USAP Chief Quality Officer. Letter text will state USAP's commitment to brain health and avoiding potentially unnecessary medications for patients undergoing surgery. It will also include a statement encouraging patients to discuss anesthesia plans with their clinicians at the time of surgery to aid tailoring of care to individual needs. Letters will be distributed directly to patients via text link, email, or hard copy as a component of standard pre-operative instructional communications and other educational and patient outreach materials related to clinical care.", 'armGroupLabels': ['Patient Informational Letter', 'Peer Comparison Feedback plus Patient Informational Letter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75240', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'US Anesthesia Partners', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Mark D Neuman, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'US Anesthesia Partners', 'class': 'UNKNOWN'}, {'name': 'Donaghue Medical Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Mark Neuman', 'investigatorAffiliation': 'University of Pennsylvania'}}}}