Surgical Procedure, Unspecified Clinical Trial
Official title:
A Clinician-Focused Nudging Intervention to Optimize Post-Surgical Prescribing
Verified date | February 2024 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center | National Institute on Aging (NIA) |
United States,
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) |
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