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

NCT05299528 | Completed Results

• 2 other identifiers: 2205085P30AG024968-18
• Study Type: interventional
• Target: 465
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid Prescribing; Surgical Procedure, Unspecified

Outcome Measures

Primary Outcomes (3)

• Percentage of Surgeons Approached Who Agree to Participate

  Feasibility outcome: Percentage of surgeons approached who agree to participate in study

  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

  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?"

  Post intervention (once on study day 181)

Study Arms (2)

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.

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.

Interventions

Direct Feedback BEHAVIORAL

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.

Direct Feedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Limitations and Caveats

* Not powered for efficacy * Cohort was mostly non-Hispanic white * Participants self-reported pill count * Surgeons did not remember the nudge

Results Point of Contact

• Title: Daniel Larach, MD
• Organization: Vanderbilt University Medical Center

daniel.larach@vumc.org

(615) 322-6033

Study Officials

• Daniel Larach, MD, MSTR, MA

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst Professor of Anesthesiology

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: March 29, 2022
• Study Start: December 1, 2022
• Primary Completion: August 11, 2023
• Study Completion: November 2, 2023
• Last Updated: October 8, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)