De-adopting Routine Preoperative Benzodiazepines for Older Surgical Patients

NCT ID: NCT05436392

Last Updated: 2024-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

517611 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-08

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Surgery Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Peer Comparison Feedback

Group Type EXPERIMENTAL

Peer Comparison Feedback

Intervention Type 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

Group Type EXPERIMENTAL

Patient Informational Letter

Intervention Type 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.

Peer Comparison Feedback plus Patient Informational Letter

Group Type EXPERIMENTAL

Peer Comparison Feedback

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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US Anesthesia Partners

UNKNOWN

Sponsor Role collaborator

Donaghue Medical Research Foundation

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Mark Neuman

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark D Neuman, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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US Anesthesia Partners

Dallas, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39480422 (View on PubMed)

Other Identifiers

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850809

Identifier Type: -

Identifier Source: org_study_id

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