De-adopting Routine Preoperative Benzodiazepines for Older Surgical Patients

Surgery Clinical Trial

— DROP-Benzo  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05436392
• Other study ID #: 850809
• Status: Completed
• Phase: N/A
• Start date: August 8, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 517611
• Est. completion date: December 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Aging
• Surgery

Intervention

Behavioral:
• Peer Comparison Feedback
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.
• Patient Informational Letter
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.

Locations

Country	Name	City	State
United States	US Anesthesia Partners	Dallas	Texas

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	Donaghue Medical Research Foundation, US Anesthesia Partners

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hospital length of stay	Time from surgery to hospital discharge in days	Length of stay will be evaluated at approximately 30 days after surgery
Other	Postoperative pulmonary complications	Postoperative pulmonary complications as identified by ICD-10 codes for patients undergoing hospitalization after surgery	Up to 30 days after surgery
Other	Postoperative Delirium	Postoperative delirium as identified by ICD-10 codes for patients undergoing hospitalization after surgery	Up to 30 days after surgery
Primary	Benzodiazepine administration rate	The primary outcome measure is the change in the rate of benzodiazepine administration among eligible surgical cases.	Intraoperative period
Secondary	Patient satisfaction	Change in patient satisfaction with care, as measured by Anesthesiologist Patient Satisfaction Questionnaire Composite Satisfaction Score, Version 2 (APSQ2).	Up to 30 days after surgery