De-adopting Routine Preoperative Benzodiazepines for Older Surgical Patients
DROP-Benzo
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
1 other identifier
interventional
517,611
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable surgery
Started Aug 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2022
CompletedFirst Posted
Study publicly available on registry
June 29, 2022
CompletedStudy Start
First participant enrolled
August 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedJanuary 18, 2024
January 1, 2024
11 months
June 2, 2022
January 17, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Benzodiazepine administration rate
The primary outcome measure is the change in the rate of benzodiazepine administration among eligible surgical cases.
Intraoperative period
Secondary Outcomes (1)
Patient satisfaction
Up to 30 days after surgery
Other Outcomes (3)
Hospital length of stay
Length of stay will be evaluated at approximately 30 days after surgery
Postoperative pulmonary complications
Up to 30 days after surgery
Postoperative Delirium
Up to 30 days after surgery
Study Arms (4)
Control
NO INTERVENTIONPeer Comparison Feedback
EXPERIMENTALPatient Informational Letter
EXPERIMENTALPeer Comparison Feedback plus Patient Informational Letter
EXPERIMENTALInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pennsylvanialead
- US Anesthesia Partnerscollaborator
- Donaghue Medical Research Foundationcollaborator
Study Sites (1)
US Anesthesia Partners
Dallas, Texas, 75240, United States
Related Publications (1)
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.
PMID: 39480422DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Mark D Neuman, MD, MSc
University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 2, 2022
First Posted
June 29, 2022
Study Start
August 8, 2022
Primary Completion
June 30, 2023
Study Completion
December 31, 2023
Last Updated
January 18, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share