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

Surgical Procedure, Unspecified Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05299528
• Other study ID #: 220508
• Secondary ID: 5P30AG024968-18
• Status: Completed
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: November 2, 2023

Study information

• Verified date: February 2024
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: November 2, 2023
• Est. primary completion date: August 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Prescribing
• Surgical Procedure, Unspecified

Intervention

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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Primary	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)
Primary	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))
Primary	Surgeon-reported acceptability of intervention	Acceptability outcome: Surgeon-reported acceptability of intervention as measured by response to question "Would you find receiving such feedback on your patients' opioid consumption acceptable?"	Post intervention (once on study day 181)