Trial Outcomes & Findings for A Clinician-Focused Nudging Intervention to Optimize Post-Surgical Prescribing (NCT NCT05299528)
NCT ID: NCT05299528
Last Updated: 2024-10-08
Results Overview
Feasibility outcome: Percentage of surgeons approached who agree to participate in study
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
465 participants
Primary outcome timeframe
At consent (study days -30 to 0)
Results posted on
2024-10-08
Participant Flow
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.
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.
Participant milestones
| Measure |
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
|
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.
|
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.
|
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.
|
Phase 2 Patient Participants in the Direct Feedback Group
Patients who underwent surgery with a surgeon who was randomized to the direct feedback intervention
|
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
|
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
|
|---|---|---|---|---|---|---|---|
|
Surgeon Recruitment
STARTED
|
35
|
0
|
6
|
6
|
0
|
0
|
0
|
|
Surgeon Recruitment
Surgeon Recruitment
|
35
|
0
|
6
|
6
|
0
|
0
|
0
|
|
Surgeon Recruitment
COMPLETED
|
35
|
0
|
6
|
6
|
0
|
0
|
0
|
|
Surgeon Recruitment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 Patient Recruitment
STARTED
|
0
|
135
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 Patient Recruitment
COMPLETED
|
0
|
131
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 Patient Recruitment
NOT COMPLETED
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Surgeon Randomization
STARTED
|
0
|
0
|
6
|
6
|
0
|
0
|
0
|
|
Surgeon Randomization
COMPLETED
|
0
|
0
|
6
|
6
|
0
|
0
|
0
|
|
Surgeon Randomization
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2 Patient Recruitment
STARTED
|
0
|
0
|
0
|
0
|
27
|
31
|
225
|
|
Phase 2 Patient Recruitment
COMPLETED
|
0
|
0
|
0
|
0
|
27
|
30
|
225
|
|
Phase 2 Patient Recruitment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Surgeon Follow-up
STARTED
|
0
|
0
|
6
|
6
|
0
|
0
|
0
|
|
Surgeon Follow-up
COMPLETED
|
0
|
0
|
5
|
6
|
0
|
0
|
0
|
|
Surgeon Follow-up
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
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
|
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.
|
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.
|
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.
|
Phase 2 Patient Participants in the Direct Feedback Group
Patients who underwent surgery with a surgeon who was randomized to the direct feedback intervention
|
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
|
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
|
|---|---|---|---|---|---|---|---|
|
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
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.
Baseline characteristics by cohort
| Measure |
Non-randomized Surgeons Recruited
n=35 Participants
Non-randomized surgeons recruited to participate in the study
|
Phase 1 Patient Participants
n=135 Participants
Patients who were enrolled into Phase 1 of the study prior to randomization of the surgeons to receive the nudge intervention.
|
Direct Feedback
n=6 Participants
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.
|
No Direct Feedback
n=6 Participants
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.
|
Phase 2 Patient Participants in the Direct Feedback Group
n=27 Participants
Patients who underwent surgery with a surgeon who was randomized to the direct feedback intervention
|
Phase 2 Patient Participants in the No Direct Feedback Group
n=31 Participants
Patients who underwent surgery with a surgeon who was randomized to the no direct feedback intervention
|
Patients Who Underwent Surgery Performed by a Surgeon Who Received the Nudge Intervention
n=225 Participants
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.
|
Total
n=465 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=35 Participants • 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.
|
0 Participants
n=135 Participants • 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.
|
0 Participants
n=6 Participants • 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.
|
0 Participants
n=6 Participants • 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.
|
0 Participants
n=27 Participants • 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.
|
0 Participants
n=31 Participants • 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.
|
0 Participants
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.
|
0 Participants
n=240 Participants • 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.
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=35 Participants • 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.
|
76 Participants
n=135 Participants • 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.
|
5 Participants
n=6 Participants • 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.
|
4 Participants
n=6 Participants • 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.
|
20 Participants
n=27 Participants • 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.
|
21 Participants
n=31 Participants • 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.
|
0 Participants
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.
|
161 Participants
n=240 Participants • 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.
|
|
Age, Categorical
>=65 years
|
0 Participants
n=35 Participants • 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.
|
59 Participants
n=135 Participants • 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.
|
1 Participants
n=6 Participants • 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.
|
2 Participants
n=6 Participants • 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.
|
7 Participants
n=27 Participants • 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.
|
10 Participants
n=31 Participants • 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.
|
0 Participants
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.
|
79 Participants
n=240 Participants • 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.
|
|
Sex: Female, Male
Female
|
12 Participants
n=35 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.
|
87 Participants
n=135 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.
|
1 Participants
n=6 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.
|
1 Participants
n=6 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.
|
20 Participants
n=27 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.
|
21 Participants
n=31 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.
|
0 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.
|
142 Participants
n=240 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.
|
|
Sex: Female, Male
Male
|
23 Participants
n=35 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.
|
48 Participants
n=135 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.
|
5 Participants
n=6 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.
|
5 Participants
n=6 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.
|
7 Participants
n=27 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.
|
10 Participants
n=31 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.
|
0 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.
|
98 Participants
n=240 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.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
4 Participants
n=135 Participants • 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.
|
—
|
—
|
1 Participants
n=27 Participants • 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.
|
0 Participants
n=31 Participants • 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.
|
0 Participants
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.
|
5 Participants
n=193 Participants • 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.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
100 Participants
n=135 Participants • 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.
|
—
|
—
|
24 Participants
n=27 Participants • 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.
|
30 Participants
n=31 Participants • 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.
|
0 Participants
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.
|
154 Participants
n=193 Participants • 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.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
31 Participants
n=135 Participants • 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.
|
—
|
—
|
2 Participants
n=27 Participants • 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.
|
1 Participants
n=31 Participants • 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.
|
0 Participants
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.
|
34 Participants
n=193 Participants • 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.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
1 Participants
n=135 Participants • Race/Ethnicity data was not collected for the surgeon participants
|
—
|
—
|
1 Participants
n=27 Participants • Race/Ethnicity data was not collected for the surgeon participants
|
0 Participants
n=31 Participants • Race/Ethnicity data was not collected for the surgeon participants
|
0 Participants
Race/Ethnicity data was not collected for the surgeon participants
|
2 Participants
n=193 Participants • Race/Ethnicity data was not collected for the surgeon participants
|
|
Race (NIH/OMB)
Asian
|
—
|
0 Participants
n=135 Participants • Race/Ethnicity data was not collected for the surgeon participants
|
—
|
—
|
0 Participants
n=27 Participants • Race/Ethnicity data was not collected for the surgeon participants
|
1 Participants
n=31 Participants • Race/Ethnicity data was not collected for the surgeon participants
|
0 Participants
Race/Ethnicity data was not collected for the surgeon participants
|
1 Participants
n=193 Participants • Race/Ethnicity data was not collected for the surgeon participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=135 Participants • Race/Ethnicity data was not collected for the surgeon participants
|
—
|
—
|
0 Participants
n=27 Participants • Race/Ethnicity data was not collected for the surgeon participants
|
0 Participants
n=31 Participants • Race/Ethnicity data was not collected for the surgeon participants
|
0 Participants
Race/Ethnicity data was not collected for the surgeon participants
|
0 Participants
n=193 Participants • Race/Ethnicity data was not collected for the surgeon participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
12 Participants
n=135 Participants • Race/Ethnicity data was not collected for the surgeon participants
|
—
|
—
|
6 Participants
n=27 Participants • Race/Ethnicity data was not collected for the surgeon participants
|
4 Participants
n=31 Participants • Race/Ethnicity data was not collected for the surgeon participants
|
0 Participants
Race/Ethnicity data was not collected for the surgeon participants
|
22 Participants
n=193 Participants • Race/Ethnicity data was not collected for the surgeon participants
|
|
Race (NIH/OMB)
White
|
—
|
114 Participants
n=135 Participants • Race/Ethnicity data was not collected for the surgeon participants
|
—
|
—
|
19 Participants
n=27 Participants • Race/Ethnicity data was not collected for the surgeon participants
|
26 Participants
n=31 Participants • Race/Ethnicity data was not collected for the surgeon participants
|
0 Participants
Race/Ethnicity data was not collected for the surgeon participants
|
159 Participants
n=193 Participants • Race/Ethnicity data was not collected for the surgeon participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
2 Participants
n=135 Participants • Race/Ethnicity data was not collected for the surgeon participants
|
—
|
—
|
1 Participants
n=27 Participants • Race/Ethnicity data was not collected for the surgeon participants
|
0 Participants
n=31 Participants • Race/Ethnicity data was not collected for the surgeon participants
|
0 Participants
Race/Ethnicity data was not collected for the surgeon participants
|
3 Participants
n=193 Participants • Race/Ethnicity data was not collected for the surgeon participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
6 Participants
n=135 Participants • Race/Ethnicity data was not collected for the surgeon participants
|
—
|
—
|
0 Participants
n=27 Participants • Race/Ethnicity data was not collected for the surgeon participants
|
0 Participants
n=31 Participants • Race/Ethnicity data was not collected for the surgeon participants
|
0 Participants
Race/Ethnicity data was not collected for the surgeon participants
|
6 Participants
n=193 Participants • Race/Ethnicity data was not collected for the surgeon participants
|
|
Region of Enrollment
United States
|
35 participants
n=35 Participants
|
135 participants
n=135 Participants
|
6 participants
n=6 Participants
|
6 participants
n=6 Participants
|
27 participants
n=27 Participants
|
31 participants
n=31 Participants
|
225 participants
n=225 Participants
|
240 participants
n=465 Participants
|
PRIMARY outcome
Timeframe: At consent (study days -30 to 0)Population: Total number of potentially eligible surgeons who were eligible
Feasibility outcome: Percentage of surgeons approached who agree to participate in study
Outcome measures
| Measure |
Surgeon Recruitment
n=94 Participants
Surgeons were recruitment on Days -30 through 0. Surgeons who agreed to participate were consented and their patients were screened for Phase 1
|
Phase 2 Patient Participants in the Direct Feedback Group
Patients who underwent surgery with a surgeon who was randomized to the direct feedback intervention
|
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
|
|---|---|---|---|
|
Percentage of Surgeons Approached Who Agree to Participate
|
47 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
Feasibility outcome: Percentage of patients contacted who agree to participate in study
Outcome measures
| Measure |
Surgeon Recruitment
n=228 Participants
Surgeons were recruitment on Days -30 through 0. Surgeons who agreed to participate were consented and their patients were screened for Phase 1
|
Phase 2 Patient Participants in the Direct Feedback Group
n=42 Participants
Patients who underwent surgery with a surgeon who was randomized to the direct feedback intervention
|
Phase 2 Patient Participants in the No Direct Feedback Group
n=66 Participants
Patients who underwent surgery with a surgeon who was randomized to the No Direct Feedback Group
|
|---|---|---|---|
|
Percentage of Patients Contacted Who Agree to Participate in Study
|
135 Participants
|
27 Participants
|
31 Participants
|
PRIMARY outcome
Timeframe: Post intervention (once on study day 181)Population: One surgeon randomized to the direct feedback group did not complete the post-study survey
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?"
Outcome measures
| Measure |
Surgeon Recruitment
n=5 Participants
Surgeons were recruitment on Days -30 through 0. Surgeons who agreed to participate were consented and their patients were screened for Phase 1
|
Phase 2 Patient Participants in the Direct Feedback Group
n=6 Participants
Patients who underwent surgery with a surgeon who was randomized to the direct feedback intervention
|
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
|
|---|---|---|---|
|
Surgeon-reported Acceptability of Intervention
|
5 Participants
|
4 Participants
|
—
|
Adverse Events
Phase 2 Patient Participants in the Direct Feedback Group
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase 2 Patient Participants in the No Direct Feedback Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Patients Who Underwent Surgery Performed by a Surgeon Who Received the Nudge Intervention
Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 2 Patient Participants in the Direct Feedback Group
n=27 participants at risk
Patients who underwent surgery with a surgeon who was randomized to the direct feedback intervention
|
Phase 2 Patient Participants in the No Direct Feedback Group
n=31 participants at risk
Patients who underwent surgery with a surgeon who was randomized to the No Direct Feedback Group
|
Patients Who Underwent Surgery Performed by a Surgeon Who Received the Nudge Intervention
n=225 participants at risk
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.
|
|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
3.7%
1/27 • Number of events 1 • 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.
|
0.00%
0/31 • 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.
|
0.44%
1/225 • Number of events 1 • 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.
|
|
Surgical and medical procedures
Abdominal pain
|
0.00%
0/27 • 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.
|
0.00%
0/31 • 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.
|
1.3%
3/225 • Number of events 3 • 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.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/27 • 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.
|
0.00%
0/31 • 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.
|
0.44%
1/225 • Number of events 1 • 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.
|
|
Infections and infestations
Clostridioides difficile infection
|
0.00%
0/27 • 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.
|
0.00%
0/31 • 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.
|
0.44%
1/225 • Number of events 1 • 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.
|
|
Cardiac disorders
Chest pain
|
0.00%
0/27 • 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.
|
0.00%
0/31 • 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.
|
0.44%
1/225 • Number of events 1 • 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.
|
Other adverse events
| Measure |
Phase 2 Patient Participants in the Direct Feedback Group
n=27 participants at risk
Patients who underwent surgery with a surgeon who was randomized to the direct feedback intervention
|
Phase 2 Patient Participants in the No Direct Feedback Group
n=31 participants at risk
Patients who underwent surgery with a surgeon who was randomized to the No Direct Feedback Group
|
Patients Who Underwent Surgery Performed by a Surgeon Who Received the Nudge Intervention
n=225 participants at risk
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.
|
|---|---|---|---|
|
General disorders
Pain
|
3.7%
1/27 • Number of events 1 • 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.
|
3.2%
1/31 • Number of events 1 • 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.
|
0.89%
2/225 • Number of events 2 • 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.
|
|
Gastrointestinal disorders
diverticulosis
|
3.7%
1/27 • Number of events 1 • 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.
|
0.00%
0/31 • 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.
|
0.44%
1/225 • Number of events 1 • 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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/27 • 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.
|
0.00%
0/31 • 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.
|
0.89%
2/225 • Number of events 2 • 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.
|
Additional Information
Daniel Larach, MD
Vanderbilt University Medical Center
Phone: (615) 322-6033
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place