Status:
COMPLETED
A Clinician-Focused Nudging Intervention to Optimize Post-Surgical Prescribing
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Opioid Prescribing
Surgical Procedure, Unspecified
Eligibility:
All Genders
18+ years
Phase:
NA
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' po...
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, ...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Patients:
- 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
- Exclusion Criteria for Patients:
- 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)
- Inclusion Criteria for Surgeon Participants
- 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)
- Exclusion Criteria for Surgeon Participants - None
Exclusion
Key Trial Info
Start Date :
December 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2023
Estimated Enrollment :
465 Patients enrolled
Trial Details
Trial ID
NCT05299528
Start Date
December 1 2022
End Date
November 2 2023
Last Update
October 8 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212