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.

Study Overview

• Status: Completed
• Conditions: Surgical Procedure, Unspecified; Opioid Prescribing
• Intervention / Treatment: Behavioral: Direct Feedback

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.

• Study Type: Interventional
• Enrollment (Actual): 465
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No Direct Feedback; 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.
Experimental: Direct Feedback; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean percentage change of oral morphine equivalent (OME) pre versus post procedure-specific opioid prescription	Mean size of post-intervention prescriptions, as measured by OME, will be compared with mean pre-intervention prescription size by the same surgeon for the same procedure in order to calculate change from baseline.	Before and after intervention (between study days 1-60 and 108-167)
Patient opioid consumption pre and post procedure	Pre-post change in patient opioid consumption, as measured by OMEs	Before and after intervention (Study days 15-74 and days 122-181)
Patient satisfaction with overall postoperative analgesia	Change in satisfaction of pre and post intervention patients with overall postoperative analgesia, as measured by patient-reported numeric rating scale (11 point rating scale when 0 =dissatisfied and 10=completely satisfied)	Before and after intervention (Study days 15-74 and days 122-181)
Change in incidence of medical visits for pain	Change in incidence of medical visits for pain (office visits, emergency department visits, and/or hospital admissions) in pre and post intervention patients	Before and after intervention (Study days 15-74 and days 122-181)
Change in number of subsequent opioid refills after initial postoperative prescription	Change in number of subsequent opioid refills after the initial postoperative prescription in pre and post intervention patients.	Before and after intervention (Study days 15-74 and days 122-181)
Surgeon-reported perceived usefulness of intervention	Surgeon-reported perceived usefulness of intervention as measured by response to question "Do you think the nudge intervention would be useful?" on 0-5 scale, where 0 is "not at all" and 5 "extremely."	Post intervention (once on study day 181)

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Daniel Larach, MD, MSTR, MA, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): August 11, 2023
• Study Completion (Actual): November 2, 2023

Study Registration Dates

• First Submitted: March 17, 2022
• First Submitted That Met QC Criteria: March 25, 2022
• First Posted (Actual): March 29, 2022

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: September 13, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 220508; 5P30AG024968-18 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No