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Clinical Trials/NCT05299528
NCT05299528
Completed
Not Applicable

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

Vanderbilt University Medical Center1 site in 1 country240 target enrollmentDecember 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Opioid Prescribing
Sponsor
Vanderbilt University Medical Center
Enrollment
240
Locations
1
Primary Endpoint
Percentage of Surgeons Approached Who Agree to Participate
Status
Completed
Last Updated
last year

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2022
End Date
November 2, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Daniel Larach

Asst Professor of Anesthesiology

Vanderbilt University Medical Center

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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?"

Study Sites (1)

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