Clinical trial NCT05299528: A Clinician-Focused Nudging Intervention to Optimize Post-Surgical Prescribing
Official title: A Clinician-Focused Nudging Intervention to Optimize Post-Surgical Prescribing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Prescribing
Surgical Procedure, Unspecified
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-03-29
Enrollment: 465
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Surgeons Approached Who Agree to Participate
timeFrame: At consent (study days -30 to 0)
measure: Percentage of Patients Contacted Who Agree to Participate in Study
timeFrame: At consent (single time during study days 15-74 (group 1) or 122-181 (group 2))
measure: Surgeon-reported Acceptability of Intervention
timeFrame: Post intervention (once on study day 181)
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Daniel Larach, MD, MSTR, MA
role: PRINCIPAL_INVESTIGATOR
References: