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| ID | Type | Description | Link |
|---|---|---|---|
| 5P30AG024968-18 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Direct Feedback | Experimental | 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. |
|
| No Direct Feedback | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Direct Feedback | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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)) |
| 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?" | Post intervention (once on study day 181) |
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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)
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:
Inclusion Criteria for Surgeon Participants
-General, gynecologic, orthopedic, or neurological surgeon at VUMC during the study period performing any of the surgeries listed below
Exclusion Criteria for Surgeon Participants - None
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Larach, MD, MSTR, MA | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-Randomized Surgeons Recruited | Surgeons were recruitment on Days -30 through 0. Surgeons who agreed to participate were consented and their patients were screened for Phase 1 |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | Phase 2 Patient Participants in the Direct Feedback Group | Patients who underwent surgery with a surgeon who was randomized to the direct feedback intervention |
| FG005 | 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 Group |
| FG006 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Surgeon Recruitment |
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| Phase 1 Patient Recruitment |
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| Surgeon Randomization |
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| Phase 2 Patient Recruitment |
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| Surgeon Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-randomized Surgeons Recruited | Non-randomized surgeons recruited to participate in the study |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | The group "Patients Who Underwent Surgery Performed by a Surgeon Who Received the Nudge Intervention" did not have age, sex, race or ethnicity data collected. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Surgeons Approached Who Agree to Participate | Feasibility outcome: Percentage of surgeons approached who agree to participate in study | Total number of potentially eligible surgeons who were eligible | Posted | Count of Participants | Participants | At consent (study days -30 to 0) |
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Adverse events were collected on patients who had surgery following the surgeon nudge intervention on Day 97
Adverse events were not monitored in surgeon participants or Phase 1 patient participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 2 Patient Participants in the Direct Feedback Group | Patients who underwent surgery with a surgeon who was randomized to the direct feedback intervention |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | Systematic Assessment | Intractable vomiting that required inpatient hospitalization for IV fluids and medication |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | Systematic Assessment | Post-operative pain following surgery |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Larach, MD | Vanderbilt University Medical Center | (615) 322-6033 | daniel.larach@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 27, 2023 | Jul 8, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 19, 2023 | Aug 28, 2023 | ICF_000.pdf |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| BG002 | 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. |
| BG003 | 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. |
| BG004 | Phase 2 Patient Participants in the Direct Feedback Group | Patients who underwent surgery with a surgeon who was randomized to the direct feedback intervention |
| BG005 | 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 |
| BG006 | 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. |
| BG007 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
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| Sex: Female, Male | Patients in the arm "Patients Who Underwent Surgery Performed by a Surgeon Who Received the Nudge Intervention" did not have age, sex, race or ethnicity data collected. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Race/Ethnicity data was not collected for the surgeon participants. Patients in the arm "Patients Who Underwent Surgery Performed by a Surgeon Who Received the Nudge Intervention" did not have age, sex, race or ethnicity data collected. | Count of Participants | Participants |
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| Race (NIH/OMB) | Race/Ethnicity data was not collected for the surgeon participants | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Percentage of Patients Contacted Who Agree to Participate in Study | Feasibility outcome: Percentage of patients contacted who agree to participate in study | 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. | Posted | Count of Participants | Participants | At consent (single time during study days 15-74 (group 1) or 122-181 (group 2)) |
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| 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?" | One surgeon randomized to the direct feedback group did not complete the post-study survey | Posted | Count of Participants | Participants | Post intervention (once on study day 181) |
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| 0 |
| 27 |
| 1 |
| 27 |
| 2 |
| 27 |
| EG001 | 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 Group | 0 | 31 | 0 | 31 | 1 | 31 |
| EG002 | 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. | 0 | 225 | 5 | 225 | 5 | 225 |
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| Abdominal pain | Surgical and medical procedures | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | Systematic Assessment |
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| Clostridioides difficile infection | Infections and infestations | Systematic Assessment |
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| Chest pain | Cardiac disorders | Systematic Assessment |
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| diverticulosis | Gastrointestinal disorders | Systematic Assessment | GI bleeding secondary to diverticulosis |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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