Opioid Prescribing, Surgical Procedure, Unspecified
Conditions
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.
Interventions
BEHAVIORALDirect 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.
Sponsors
National Institute on Aging (NIA)
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Surgeons Approached Who Agree to Participate | 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 | 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 | 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? |
Countries
United States
Participant flow
Recruitment details
Surgeon recruitment began on 12/01/2022 and ended on 12/31/2022. Patient recruitment for Phase 1 began on 1/15/2023 and continued through 3/15/2023. Phase 2 recruitment began on 5/22/2023 and ended on 6/30/2023.
Pre-assignment details
94 surgeons were identified as potential participants in the study. 27 did not meet eligibility criteria. 20 did not agree to participate. 47 were consented and enrolled into the study. 12 surgeons met criteria to be randomized following Phase 1 Patient Recruitment period. Patients who underwent surgery performed by a surgeon who received the nudge intervention were patients who were analyzed only for safety and were not included in other groups. There was a waiver of consent for this group.
Participants by arm
| Arm | Count |
|---|---|
| Non-randomized Surgeons Recruited Non-randomized surgeons recruited to participate in the study | 35 |
| Phase 1 Patient Participants Patients who were enrolled into Phase 1 of the study prior to randomization of the surgeons to receive the nudge intervention. | 135 |
| Direct Feedback On approximately study day 97, surgeon participants will receive procedure-specific direct feedback 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.
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. | 6 |
| No Direct Feedback Surgeon participants randomized to No Direct Feedback will not be contacted directly at any time in the study and will not receive feedback about patients' opioid consumption-to-prescription ratio. | 6 |
| Phase 2 Patient Participants in the Direct Feedback Group Patients who underwent surgery with a surgeon who was randomized to the direct feedback intervention | 27 |
| Phase 2 Patient Participants in the No Direct Feedback Group Patients who underwent surgery with a surgeon who was randomized to the no direct feedback intervention | 31 |
| Patients Who Underwent Surgery Performed by a Surgeon Who Received the Nudge Intervention Patients who underwent surgery performed by a surgeon who received the nudge intervention for 30 days after the intervention. Does not include Phase 2 patient participants. Adverse events were assessed at post op days 10 and 30. | 225 |
| Total | 465 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Phase 1 Patient Recruitment | 4 patient participants were not eligible after consent. | 0 | 4 | 0 | 0 | 0 | 0 | 0 |
| Phase 2 Patient Recruitment | Participant was determined to be ineligible after consent | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Surgeon Follow-up | Lost to Follow-up | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Phase 1 Patient Participants | Direct Feedback | Non-randomized Surgeons Recruited | No Direct Feedback | Phase 2 Patient Participants in the Direct Feedback Group | Phase 2 Patient Participants in the No Direct Feedback Group | Patients Who Underwent Surgery Performed by a Surgeon Who Received the Nudge Intervention |
|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 79 Participants | 59 Participants | 1 Participants | 0 Participants | 2 Participants | 7 Participants | 10 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 161 Participants | 76 Participants | 5 Participants | 35 Participants | 4 Participants | 20 Participants | 21 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 4 Participants | — | — | — | 1 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 154 Participants | 100 Participants | — | — | — | 24 Participants | 30 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 34 Participants | 31 Participants | — | — | — | 2 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | — | — | — | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | — | — | — | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants | 12 Participants | — | — | — | 6 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 2 Participants | — | — | — | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | — | — | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 6 Participants | — | — | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 159 Participants | 114 Participants | — | — | — | 19 Participants | 26 Participants | 0 Participants |
| Region of Enrollment United States | 240 participants | 135 participants | 6 participants | 35 participants | 6 participants | 27 participants | 31 participants | 225 participants |
| Sex: Female, Male Female | 142 Participants | 87 Participants | 1 Participants | 12 Participants | 1 Participants | 20 Participants | 21 Participants | 0 Participants |
| Sex: Female, Male Male | 98 Participants | 48 Participants | 5 Participants | 23 Participants | 5 Participants | 7 Participants | 10 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 31 | 0 / 225 |
| other Total, other adverse events | 2 / 27 | 1 / 31 | 5 / 225 |
| serious Total, serious adverse events | 1 / 27 | 0 / 31 | 5 / 225 |
Outcome results
Primary
Percentage of Patients Contacted Who Agree to Participate in Study
Feasibility outcome: 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))
Population: Total number of potentially eligible patients who were contacted about participation.~Patients who underwent surgery performed by a surgeon who received the nudge intervention were patients who were analyzed only for safety. They were not contacted about the study, and were not included in the primary outcome analysis. This group was enrolled with a waiver of consent.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Surgeon Recruitment | Percentage of Patients Contacted Who Agree to Participate in Study | 135 Participants |
| Phase 2 Patient Participants in the Direct Feedback Group | Percentage of Patients Contacted Who Agree to Participate in Study | 27 Participants |
| Phase 2 Patient Participants in the No Direct Feedback Group | Percentage of Patients Contacted Who Agree to Participate in Study | 31 Participants |
Primary
Percentage of Surgeons Approached Who Agree to Participate
Feasibility outcome: Percentage of surgeons approached who agree to participate in study
Time frame: At consent (study days -30 to 0)
Population: Total number of potentially eligible surgeons who were eligible
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Surgeon Recruitment | Percentage of Surgeons Approached Who Agree to Participate | 47 Participants |
Primary
Surgeon-reported Acceptability of Intervention
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?
Time frame: Post intervention (once on study day 181)
Population: One surgeon randomized to the direct feedback group did not complete the post-study survey
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Surgeon Recruitment | Surgeon-reported Acceptability of Intervention | 5 Participants |
| Phase 2 Patient Participants in the Direct Feedback Group | Surgeon-reported Acceptability of Intervention | 4 Participants |