Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05299528
Other study ID # 220508
Secondary ID 5P30AG024968-18
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
See also
  Status Clinical Trial Phase
Completed NCT04061629 - Minimal Occlusive Pressure With Cuffed ETTs: The Effect of 3 Different Sizes of cETT on Intracuff Pressure in Children
Completed NCT03299920 - Opioid Consumption After Knee Arthroscopy N/A
Not yet recruiting NCT03213548 - Aesthetic and Functional Results of Alar Base Modifications in Rhinoplasty N/A
Completed NCT06164158 - Role of Procedural Videos in Teaching the Surgery Residents N/A
Recruiting NCT03854669 - Experimental Pain Reporting Accuracy and Clinical Post-operative Pain N/A
Active, not recruiting NCT03776591 - Open D3 Right Hemicolectomy Compared to Laparoscopic CME for Right Sided Colon Cancer N/A
Completed NCT04332679 - Non-resorbable Membranes Versus Titanium Meshes and Resorbable Membranes N/A
Completed NCT03305666 - Trial of Injected Liposomal Bupivacaine vs Bupivacaine Infusion After Surgical Stabilization of Rib Fractures Phase 4
Completed NCT05008107 - Virtual Reality as a Perioperative Teaching Tool for Families N/A
Terminated NCT02399111 - A Trial to Evaluate Negative Pressure Incision Management System for Groin Wounds in Vascular Surgery Patients N/A
Terminated NCT00753766 - Multifactorial Pre-operative Intervention in Diabetes Mellitus N/A
Active, not recruiting NCT03684720 - Using 'Guided-Discovery-Learning' to Optimize and Maximize Transfer of Surgical Simulation N/A
Recruiting NCT04134975 - Evaluation of the Contribution of Intraoperative Scans Coupled With the Navigation for the Precision of the Positioning of the Pedicle Screws During a Lumbar Spine Surgery: a Prospective Randomised Study N/A
Completed NCT06148701 - Preoperative Anesthesia Automatic System:a Retrospective Cohort Study
Active, not recruiting NCT04202874 - A Trial Comparing Surgeon-administered TAP Block With Placebo After Midline Laparotomy in Gynecologic Oncology Phase 3
Completed NCT05428579 - Status of Surgical Resection and Histologic Subtype as Predictors of Local Recurrence in Retroperitoneal Liposarcoma
Completed NCT02626546 - Predictors, Risk Factors and Outcome Following Major Surgery
Recruiting NCT06278610 - Pelvic Exenteration and Laterally Extended Pelvic Resection
Recruiting NCT05044832 - Decreasing Emergence Agitation With Personalized Music N/A
Completed NCT04327895 - Surgery in Context of Terrorist Attack : a Survey of French Surgeons