Opioid PrescribingNCT05299528

A Clinician-Focused Nudging Intervention to Optimize Post-Surgical Prescribing

A study testing Direct Feedback in people with Opioid Prescribing and Surgical Procedure, Unspecified, run by Vanderbilt University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a pilot single site randomized controlled trial to assess the feasibility and acceptability of a nudging intervention providing surgeons with procedure-specific feedback regarding patients' postoperative opioid prescription-to-consumption ratio in individuals 18 years of age and older. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Opioid Prescribing, Surgical Procedure, Unspecified
What is being tested?: Direct Feedback
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 465 participants
Where: 1 siteUnited States
Study dates: 1 Dec 2022to 2 Nov 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Aged greater or equal to 18 years
Undergoing specified elective general, gynecologic, orthopedic, and neurological surgeries at VUMC during the specified study periods (days 1-60 for the initial patient group; days 105-164 for the follow-up patient group)
General: laparoscopic or open cholecystectomy, laparoscopic or open appendectomy
Gynecologic: abdominal hysterectomy, laparoscopic/robotic hysterectomy, vaginal hysterectomy, anterior repair/colporrhaphy, posterior repair/colporrhaphy, tension-free vaginal tape procedure, sacrospinous ligament suspension sacrocolpopexy
Orthopedic: total knee arthroplasty, total hip arthroplasty, total shoulder arthroplasty, 1- or 2-level spinal laminectomy (without fusion)
Neurological: 1- or 2-level spinal laminectomy (without fusion)

Show all 14Show fewer

Provided postoperative opioid prescription (verified in VUMC electronic medical record (EMR)
Able to understand study procedures and participate in the pill count and telephone/electronic interview process in English or Spanish
Able to provide informed consent
-General, gynecologic, orthopedic, or neurological surgeon at VUMC during the study period performing any of the surgeries listed below
General: laparoscopic or open cholecystectomy, laparoscopic or open appendectomy
Gynecologic: abdominal hysterectomy, laparoscopic/robotic hysterectomy, vaginal hysterectomy, anterior repair/colporrhaphy, posterior repair/colporrhaphy, tension- free vaginal tape procedure, sacrospinous ligament suspension sacrocolpopexy
Orthopedic: total knee arthroplasty, total hip arthroplasty, total shoulder arthroplasty, 1- or 2-level spinal laminectomy (without fusion)
Neurological: 1- or 2-level spinal laminectomy (without fusion)

Who cannot join

Opioid prescription filled (per VUMC EMR and patient self report) between 3 months and 7 days prior to surgery
Primary reason for surgery as assessed by chart review is cancer-related
Surgery is a repeat/revision surgery (e.g., revision total knee arthroplasty)
Patient has been inpatient for >3 days postoperatively prior to receiving post-discharge prescription
Vulnerable populations: current pregnancy, prisoners
Prior participation in the study (e.g., a patient included in the initial patient group will not be recontacted for the follow-up patient group)

Trial locations and contacts

1 site in 1 country.

United States1 site

Vanderbilt University Medical Center
Nashville, Tennessee, 37212

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About this study

Read the detailed description

The trial will randomize surgeons to either intervention (direct feedback) or control (no direct feedback) arms. Surgeons who frequently performing specific elective general, gynecologic, orthopedic, and neurologic surgeries at Vanderbilt University Medical Center will be identified during a 30-day study lead-in period. Then, patients aged at least 18 years undergoing these surgeries at VUMC during study days 1-60 will be contacted by telephone 14 days postoperatively (study days 15-74) and asked to perform an opioid pill count; they will also be asked about opioid refills, satisfaction with analgesia, emergency room visits or hospitalizations for pain, and opioid misuse. The electronic medical record will be also queried for the size of the initial postoperative opioid prescription as well as evidence of any refills for each enrolled subject. Following the first block of surgeries and associated patient follow-up (study days 1-74), data will be analyzed and then surgeons will be randomized in a 1:1 ratio to the intervention or control arms. Randomization will be stratified by both surgical specialty and by mean opioid prescription size during the initial block of surgeries. After study day 97, surgeons in the intervention arm will be provided procedure-specific direct feedback on opioid prescribing and consumption for their patients who had surgery during days 1-60.

After this intervention, the trial will assess pre-post change in opioid prescription size (measured in oral morphine equivalents) from baseline between the two groups for surgeries performed during days 108-167.

Conditions: Opioid Prescribing, Surgical Procedure, Unspecified
Being tested: Direct Feedback

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Direct FeedbackBehavioural
Procedure-specific direct feedback will be provided to surgeon participants through electronic and written communication, on patients' opioid consumption-to-prescription ratio. Surgeon participants who perform more than 1 of the specified procedures will receive nudging communications for each individual procedure.

Study groups in NCT05299528
Study group	Role	What they receive
Direct Feedback	Experimental	On approximately study day 97, surgeon participants will receive procedure-specific direct feedback through electronic and written communication, on patients' opioid consumption-to-prescription ratio. Surgeon participants who perform more than 1 of the specified procedures will receive nudging communications for each individual procedure. Receives: Behavioral: Direct Feedback
No Direct Feedback	No intervention	Surgeon participants randomized to No Direct Feedback will not be contacted directly at any time in the study and will not receive feedback about patients' opioid consumption-to-prescription ratio.

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Surgeons Approached Who Agree to Participate
Feasibility outcome: Percentage of surgeons approached who agree to participate in study
Measured: At consent (study days -30 to 0)
Percentage of Patients Contacted Who Agree to Participate in Study
Feasibility outcome: Percentage of patients contacted who agree to participate in study
Measured: At consent (single time during study days 15-74 (group 1) or 122-181 (group 2))
Surgeon-reported Acceptability of Intervention
Acceptability outcome: Surgeon-reported acceptability of intervention as measured by a "yes" response to the question "Would you find receiving such feedback on your patients' opioid consumption acceptable?"
Measured: Post intervention (once on study day 181)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 20222 Nov 2023

First posted29 Mar 2022
Study start1 Dec 2022
Primary completion11 Aug 2023
Study completion2 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Opioid PrescribingStudies of the same condition, open and under way.
More trials run by Vanderbilt University Medical CenterThe 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: Parallel groups
Masking: None (open label)
Enrolment: 465 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05299528
Sponsor's protocol ID: 220508
Other IDs: 5P30AG024968-18
Status last verified: Sep 2024
First submitted: 17 Mar 2022
Last updated: 8 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinician-Focused Nudging Intervention to Optimize Post-Surgical Prescribing
ClinicalTrials.gov ID: NCT05299528
Acronym / sponsor ID: 220508
Conditions: Opioid Prescribing, Surgical Procedure, Unspecified
Study type: Interventional
Recruitment status: Completed
Enrolment: 465 participants (actual)
Lead sponsor: Vanderbilt University Medical CenterUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: 1 Dec 2022 (actual)
Primary completion: 11 Aug 2023 (actual)
Study completion: 2 Nov 2023 (actual)
First posted: 29 Mar 2022 (actual)
Results: Posted 19 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Direct Feedback	Experimental	Behavioral: Direct FeedbackOn approximately study day 97, surgeon participants will receive procedure-specific direct feedback through electronic and written communication, on patients' opioid consumption-to-prescription ratio. Surgeon participants who perform more than 1 of the specified procedures will receive nudging communications for each individual procedure.
No Direct Feedback	No intervention	–Surgeon participants randomized to No Direct Feedback will not be contacted directly at any time in the study and will not receive feedback about patients' opioid consumption-to-prescription ratio.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Aged greater or equal to 18 years
Undergoing specified elective general, gynecologic, orthopedic, and neurological surgeries at VUMC during the specified study periods (days 1-60 for the initial patient group; days 105-164 for the follow-up patient group)
Provided postoperative opioid prescription (verified in VUMC electronic medical record (EMR)
Able to understand study procedures and participate in the pill count and telephone/electronic interview process in English or Spanish
Able to provide informed consent

Key exclusion criteria (6 listed)

Opioid prescription filled (per VUMC EMR and patient self report) between 3 months and 7 days prior to surgery
Primary reason for surgery as assessed by chart review is cancer-related
Surgery is a repeat/revision surgery (e.g., revision total knee arthroplasty)
Patient has been inpatient for >3 days postoperatively prior to receiving post-discharge prescription
Vulnerable populations: current pregnancy, prisoners

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
Direct FeedbackProcedure-specific direct feedback will be provided to surgeon participants through electronic and written communication, on patients' opioid consumption-to-prescription ratio. Surgeon participants who perform more than 1 of the specified procedures will receive nudging communications for each individual procedure.	Behavioural	Direct Feedback

Primary outcome

Percentage of Surgeons Approached Who Agree to Participate
Time frame: At consent (study days -30 to 0)
Feasibility outcome: Percentage of surgeons approached who agree to participate in study
Percentage of Patients Contacted Who Agree to Participate in Study
Time frame: At consent (single time during study days 15-74 (group 1) or 122-181 (group 2))
Feasibility outcome: Percentage of patients contacted who agree to participate in study
Surgeon-reported Acceptability of Intervention
Time frame: Post intervention (once on study day 181)
Acceptability outcome: Surgeon-reported acceptability of intervention as measured by a "yes" response to the question "Would you find receiving such feedback on your patients' opioid consumption acceptable?"

Results and safety

Results posted to the registry on 19 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Non-Randomized Surgeons Recruited	35	35
Phase 1 Patient Participants	0	0
Direct Feedback	6	6
No Direct Feedback	6	6
Phase 2 Patient Participants in the Direct Feedback Group	0	0
Phase 2 Patient Participants in the No Direct Feedback Group	0	0
Patients Who Underwent Surgery Performed by a Surgeon Who Received the Nudge Intervention	0	0

Primary outcome: Percentage of Surgeons Approached Who Agree to Participate

Time frame: At consent (study days -30 to 0). Count of participants. Unit: Participants

Measure	Surgeon Recruitment n = 94
Value	47

Population analysed: Total number of potentially eligible surgeons who were eligible

Primary outcome: Percentage of Patients Contacted Who Agree to Participate in Study

Time frame: At consent (single time during study days 15-74 (group 1) or 122-181 (group 2)). Count of participants. Unit: Participants

Measure	Phase 1 Patient Participants n = 228	Phase 2 Patient Participants in the Direct Feedback Group n = 42	Phase 2 Patient Participants in the No Direct Feedback Group n = 66
Value	135	27	31

Population analysed: Total number of potentially eligible patients who were contacted about participation. Patients who underwent surgery performed by a surgeon who received the nudge intervention were patients who were analyzed only for safety. They were not contacted about the study, and were not included in the primary outcome analysis. This group was enrolled with a waiver of consent.

Primary outcome: Surgeon-reported Acceptability of Intervention

Time frame: Post intervention (once on study day 181). Count of participants. Unit: Participants

Measure	Direct Feedback n = 5	No Direct Feedback n = 6
Value	5	4

Population analysed: One surgeon randomized to the direct feedback group did not complete the post-study survey

Adverse events

Time frame: Adverse events were collected on patients who had surgery following the surgeon nudge intervention on Day 97. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 2 Patient Participants in the Direct Feedback Group	1 of 27 (3.7%)	2 of 27 (7.4%)	0 of 27
Phase 2 Patient Participants in the No Direct Feedback Group	0 of 31 (0%)	1 of 31 (3.2%)	0 of 31
Patients Who Underwent Surgery Performed by a Surgeon Who Received the Nudge Intervention	5 of 225 (2.2%)	5 of 225 (2.2%)	0 of 225

Limitations and caveats (from the sponsor): * Not powered for efficacy * Cohort was mostly non-Hispanic white * Participants self-reported pill count * Surgeons did not remember the nudge

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Daniel Larach, MD, MSTR, MA principal investigator

Vanderbilt University Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Direct Feedback in people with Opioid Prescribing and Surgical Procedure, Unspecified, run by Vanderbilt University Medical Center 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 14 inclusion and 6 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 8 Oct 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?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Surgeons Approached Who Agree to Participate (time frame: At consent (study days -30 to 0)). The study lists 3 primary outcomes in all. 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 NCT05299528.

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 8 Oct 2024.