SurgeryDROP-BenzoNCT05436392
De-adopting Routine Preoperative Benzodiazepines for Older Surgical Patients
A study testing Peer Comparison Feedback and Patient Informational Letter in people with Surgery and Aging, run by University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- What is being tested?
- Peer Comparison Feedback and Patient Informational Letter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 517,611 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Peer Comparison Feedback, Patient Informational Letter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer Comparison FeedbackBehavioural
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 LetterBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Peer Comparison Feedback | Experimental | Not described Receives: Behavioral: Peer Comparison Feedback |
| Patient Informational Letter | Experimental | Not described Receives: Behavioral: Patient Informational Letter |
| Peer Comparison Feedback plus Patient Informational Letter | Experimental | Not described Receives: Behavioral: Peer Comparison Feedback; Behavioral: Patient Informational Letter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Benzodiazepine administration rate
The primary outcome measure is the change in the rate of benzodiazepine administration among eligible surgical cases.
Measured: 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).
Measured: Up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start8 Aug 2022
- Primary completion30 Jun 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 517,611 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- US Anesthesia Partners, Donaghue Medical Research Foundation
- Responsible party
- Principal investigator, Mark Neuman, University of Pennsylvania
- Investigators
- Mark D Neuman, MD, MSc, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436392
- Sponsor's protocol ID
- 850809
- Acronym
- DROP-Benzo
- Status last verified
- Jan 2024
- First submitted
- 2 Jun 2022
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39480422
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05436392
- Acronym / sponsor ID
- DROP-Benzo / 850809
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 517,611 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- US Anesthesia Partners, Donaghue Medical Research Foundation
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Peer Comparison Feedback | Experimental | Behavioral: Peer Comparison Feedback |
| Patient Informational Letter | Experimental | Behavioral: Patient Informational Letter |
| Peer Comparison Feedback plus Patient Informational Letter | Experimental | Behavioral: Peer Comparison Feedback, Behavioral: Patient Informational Letter |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer Comparison FeedbackUSAP 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. | Behavioural | Peer Comparison Feedback, Peer Comparison Feedback plus Patient Informational Letter |
| Patient Informational LetterBreif 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. | Behavioural | Patient Informational Letter, Peer Comparison Feedback plus Patient Informational Letter |
Primary outcome
Benzodiazepine administration rate
Time frame: Intraoperative period
The primary outcome measure is the change in the rate of benzodiazepine administration among eligible surgical cases.
1 secondary outcome
Patient satisfaction
Time frame: Up to 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Derived from this study: PubMed 39480422Neuman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark D Neuman, MD, MSc principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Comparison Feedback and Patient Informational Letter in people with Surgery and Aging, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Benzodiazepine administration rate (time frame: Intraoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05436392, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.