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

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.

Study Overview

• Status: Completed
• Conditions: Aging; Surgery
• Intervention / Treatment: Behavioral: Peer Comparison Feedback; Behavioral: Patient Informational Letter

• Study Type: Interventional
• Enrollment (Actual): 517611
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mark D. Neuman, MD, MSc; Phone Number: 215-746-7468; Email: neumanm@pennmedicine.upenn.edu
• Study Contact Backup: Name: Annamarie M Horan, PhD; Phone Number: 215-294-9132; Email: horana@pennmedicine.upenn.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75240
      • US Anesthesia Partners

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Peer Comparison Feedback	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.
Experimental: Patient Informational Letter	Behavioral: 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.
Experimental: Peer Comparison Feedback plus Patient Informational Letter	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.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Benzodiazepine administration rate	The primary outcome measure is the change in the rate of benzodiazepine administration among eligible surgical cases.	Intraoperative period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital length of stay	Time from surgery to hospital discharge in days	Length of stay will be evaluated at approximately 30 days after surgery
Postoperative pulmonary complications	Postoperative pulmonary complications as identified by ICD-10 codes for patients undergoing hospitalization after surgery	Up to 30 days after surgery
Postoperative Delirium	Postoperative delirium as identified by ICD-10 codes for patients undergoing hospitalization after surgery	Up to 30 days after surgery

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Donaghue Medical Research Foundation; US Anesthesia Partners
• Investigators: Principal Investigator: Mark D Neuman, MD, MSc, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: June 2, 2022
• First Submitted That Met QC Criteria: June 24, 2022
• First Posted (Actual): June 29, 2022

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 850809

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No