Trial Outcomes & Findings for Application of Economics & Social Psychology to Improve Opioid Prescribing Safety (AESOPS): R21 Pilot Phase (NCT NCT03773484)

NCT ID: NCT03773484

Last Updated: 2023-02-14

Results Overview

Average per-clinician weekly milligram morphine equivalent (MME) in the 34-week period post-intervention

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 41 participants
• Primary outcome timeframe: 34 weeks
• Results posted on: 2023-02-14

Participant Flow

41 primary care clinicians from 3 clinics at Northwestern Medicine in Chicago, Illinois were enrolled.

Only clinicians listed as a treating member of the clinic receive the intervention.

Participant milestones

Measure	Clinical Decision Support Nudges 1. Opioid naïve: Visit where the order is for an included opioid and there is no prior opioid prescription with a start date of greater than 1 day and less than 91 days 2. At-risk for long term use: Visit where the order is for an included opioid, there is a prior opioid prescription with a start date greater than 1 day and less than 91 days, and there is no prior opioid prescription with a start date greater than 90 days 3. Long-term opioid recipient: Total opioid doses are at least 50 MME per day, there are two or more prior opioid prescriptions with two different start dates both greater than 1 day and less than 91 days, and there is a prior opioid prescription with a start date greater than 90 days and less than 181 days
Pre-intervention STARTED	41
Pre-intervention COMPLETED	41
Pre-intervention NOT COMPLETED	0
Post-intervention STARTED	41
Post-intervention COMPLETED	36
Post-intervention NOT COMPLETED	5

Reasons for withdrawal

Measure

Clinical Decision Support Nudges 1. Opioid naïve: Visit where the order is for an included opioid and there is no prior opioid prescription with a start date of greater than 1 day and less than 91 days 2. At-risk for long term use: Visit where the order is for an included opioid, there is a prior opioid prescription with a start date greater than 1 day and less than 91 days, and there is no prior opioid prescription with a start date greater than 90 days 3. Long-term opioid recipient: Total opioid doses are at least 50 MME per day, there are two or more prior opioid prescriptions with two different start dates both greater than 1 day and less than 91 days, and there is a prior opioid prescription with a start date greater than 90 days and less than 181 days

Post-intervention 5 clinicians were excluded from analysis due to lack of prescribing data

5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Clinical Decision Support n=41 Participants Participating clinicians will receive any of three clinical decision support nudges within the electronic health record when eligibility criteria are met within a patient's chart: Opioid naïve: Visit where the order is for an included opioid and there is no prior opioid prescription with a start date of greater than 1 day and less than 91 days At risk for long term use: Visit where the order is for an included opioid, there is a prior opioid prescription with a start date greater than 1 day and less than 91 days, and there is no prior opioid prescription with a start date greater than 90 days Long term opioid recipient: Total opioid doses are at least 50 MME per day, there are two or more prior opioid prescriptions with two different start dates both greater than 1 day and less than 91 days, and there is a prior opioid prescription with a start date greater than 90 days and less than 181 days
Age, Categorical <=18 years	0 Participants n=41 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=41 Participants
Age, Categorical >=65 years	8 Participants n=41 Participants
Sex: Female, Male Female	26 Participants n=41 Participants
Sex: Female, Male Male	15 Participants n=41 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=41 Participants
Race (NIH/OMB) Asian	0 Participants n=41 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=41 Participants
Race (NIH/OMB) Black or African American	0 Participants n=41 Participants
Race (NIH/OMB) White	0 Participants n=41 Participants
Race (NIH/OMB) More than one race	0 Participants n=41 Participants
Race (NIH/OMB) Unknown or Not Reported	41 Participants n=41 Participants
Region of Enrollment United States	41 participants n=41 Participants
Average weekly milligram morphine equivalent (MME) Opioid naive	34.88 Weekly MME STANDARD_DEVIATION 86.07 • n=41 Participants
Average weekly milligram morphine equivalent (MME) At risk for long term use	34.44 Weekly MME STANDARD_DEVIATION 168.03 • n=41 Participants

PRIMARY outcome

Timeframe: 34 weeks

Population: Of the 41 clinicians enrolled in the study, 5 were excluded due to lack of prescribing information.

Average per-clinician weekly milligram morphine equivalent (MME) in the 34-week period post-intervention

Outcome measures

Measure	Clinical Decision Support Nudges n=36 Participants 1. Opioid naïve 2. At-risk for long term use 3. Long-term opioid recipient Details can be found in the Arms and Interventions section.
Average Weekly Milligram Morphine Equivalent (MME) Opioid naïve	34.62 Weekly MME per clinician Standard Deviation 97.13
Average Weekly Milligram Morphine Equivalent (MME) At-risk for long term use	22.37 Weekly MME per clinician Standard Deviation 102.67
Average Weekly Milligram Morphine Equivalent (MME) Long-term opioid recipient	NA Weekly MME per clinician Standard Deviation NA MME cannot be calculated because the algorithm for long term opioids was not fully built at the conclusion of the study pilot. It was built and deployed for our full RCT (NCT04477304)

Adverse Events

Clinical Decision Support Nudges

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jason Doctor

University of Southern California

Phone: 213-821-8142

Email: jdoctor@usc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place