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CompletedNCT05436392DROP-BenzoUpdated Jan 18, 2024

De-adopting Routine Preoperative Benzodiazepines for Older Surgical Patients

An interventional study of Peer Comparison Feedback and Patient Informational Letter in Surgery and Aging, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-01-18.

Sponsored by University of Pennsylvania · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
517,611
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Surgery
  • Aging
03

In context

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
517,611 participants (actual)

Study arms

  • No intervention
    Control
  • Experimental
    Peer Comparison Feedback

    Behavioral: Peer Comparison Feedback

  • Experimental
    Patient Informational Letter

    Behavioral: Patient Informational Letter

  • Experimental
    Peer Comparison Feedback plus Patient Informational Letter

    Behavioral: Peer Comparison Feedback · Behavioral: Patient Informational Letter

Interventions

  • BehavioralPeer 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.

  • BehavioralPatient 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.

06

What researchers measure

Primary outcomes

  1. Benzodiazepine administration rate

    The primary outcome measure is the change in the rate of benzodiazepine administration among eligible surgical cases.

    Time frame: Intraoperative period

Secondary outcomes

  1. Patient satisfaction

    Change in patient satisfaction with care, as measured by Anesthesiologist Patient Satisfaction Questionnaire Composite Satisfaction Score, Version 2 (APSQ2).

    Time frame: Up to 30 days after surgery

Other outcomes

  1. Hospital length of stay

    Time from surgery to hospital discharge in days

    Time frame: Length of stay will be evaluated at approximately 30 days after surgery

  2. Postoperative pulmonary complications

    Postoperative pulmonary complications as identified by ICD-10 codes for patients undergoing hospitalization after surgery

    Time frame: Up to 30 days after surgery

  3. Postoperative Delirium

    Postoperative delirium as identified by ICD-10 codes for patients undergoing hospitalization after surgery

    Time frame: Up to 30 days after surgery

07

Study locations

1 site
  • US Anesthesia Partners
    Dallas, Texas 75240, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05436392
Lead sponsor
University of Pennsylvania
Collaborators
US Anesthesia Partners, Donaghue Medical Research Foundation
Responsible party
Mark Neuman (Associate Professor, University of Pennsylvania) — Principal investigator
First posted
Jun 29, 2022
Start date
Aug 8, 2022
Primary completion
Jun 30, 2023
Completion
Dec 31, 2023
Last update
Jan 18, 2024

Study contacts

Mark D Neuman, MD, MSc
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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