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Completed

NCT Number: NCT05436392

De-adopting Routine Preoperative Benzodiazepines for 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.

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Key information

Conditions

Surgery Aging

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

US Anesthesia Partners

Dallas, Texas, 75240, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Peer comparison feedback

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Benzodiazepine administration rate

    Time frame: Intraoperative period

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

Secondary outcomes

  1. Patient satisfaction

    Time frame: Up to 30 days after surgery

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

Other outcomes

  1. Hospital length of stay

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

    Time from surgery to hospital discharge in days

  2. Postoperative pulmonary complications

    Time frame: Up to 30 days after surgery

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

  3. Postoperative Delirium

    Time frame: Up to 30 days after surgery

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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Donaghue Medical Research Foundation
  • US Anesthesia Partners

Registry information

Official study 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

Acronym: DROP-Benzo

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 29, 2022
Registry last updated
Jan 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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