Skip to main content
OpenTrials
Completed

NCT Number: NCT05299528

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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

  3. 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?"

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 29, 2022
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.