Trial Outcomes & Findings for Application of Economics & Social Psychology to Improve Opioid Prescribing Safety Trial 1: EHR Nudges (NCT NCT04477304)

NCT ID: NCT04477304

Last Updated: 2025-08-07

Results Overview

Change = (18-month intervention average of natural log MME summed per-clinician, per-week - 6-month baseline average of natural log MME summed per-clinician, per-week). Log(total MME) = log(Rx strength x number of pills x opioid conversion factor)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

555 participants

Primary outcome timeframe

6-month baseline and 18-month intervention

Results posted on

2025-08-07

Participant Flow

Unit of analysis: Clinics

Participant milestones

Participant milestones
Measure
Behavioral Intervention Arm
Clinicians in clinics randomized to the intervention group will receive guideline education and be prompted with an EHR nudge when the prescribing history for the patient falls into one of the following three categories: Opioid naïve, At-risk for long-term use, or Long-term opioid recipient.
Control
Clinicians in clinics randomized to the control group will receive web-based guideline education, consisting of an online educational module at the start of the study period. This will include educational clinical content related to the CDC guidelines, the Oregon Pain Guidance document, tapering training and other resources such as Substance Abuse and Mental Health Services Administration (SAMHSA) Medication-Assisted Treatment Physician Locator and the Naloxone Provider Guide.
Overall Study
STARTED
322 43
233 43
Overall Study
COMPLETED
275 43
207 42
Overall Study
NOT COMPLETED
47 0
26 1

Reasons for withdrawal

Reasons for withdrawal
Measure
Behavioral Intervention Arm
Clinicians in clinics randomized to the intervention group will receive guideline education and be prompted with an EHR nudge when the prescribing history for the patient falls into one of the following three categories: Opioid naïve, At-risk for long-term use, or Long-term opioid recipient.
Control
Clinicians in clinics randomized to the control group will receive web-based guideline education, consisting of an online educational module at the start of the study period. This will include educational clinical content related to the CDC guidelines, the Oregon Pain Guidance document, tapering training and other resources such as Substance Abuse and Mental Health Services Administration (SAMHSA) Medication-Assisted Treatment Physician Locator and the Naloxone Provider Guide.
Overall Study
No valid opioid prescriptions during study timeframe
47
26

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Behavioral Intervention Arm
n=322 Participants
Clinicians in clinics randomized to the intervention group receive guideline education and will be prompted with an EHR nudge when the prescribing history for the patient falls into one of the following three categories: Opioid naïve, At-risk for long-term use, or Long-term opioid recipient.
Control
n=233 Participants
Clinicians in clinics randomized to the control group will receive web-based guideline education, consisting of an online educational module at the start of the study period. This will include educational clinical content related to the CDC guidelines, the Oregon Pain Guidance document, tapering training and other resources such as Substance Abuse and Mental Health Services Administration (SAMHSA) Medication-Assisted Treatment Physician Locator and the Naloxone Provider Guide.
Total
n=555 Participants
Total of all reporting groups
Age, Customized
Unknown/Not reported
322 years
n=322 Participants
233 years
n=233 Participants
555 years
n=555 Participants
Sex/Gender, Customized
Female
199 Participants
n=322 Participants
135 Participants
n=233 Participants
334 Participants
n=555 Participants
Sex/Gender, Customized
Male
121 Participants
n=322 Participants
92 Participants
n=233 Participants
213 Participants
n=555 Participants
Sex/Gender, Customized
Unknown/Not reported
2 Participants
n=322 Participants
6 Participants
n=233 Participants
8 Participants
n=555 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
United States
322 Participants
n=322 Participants
233 Participants
n=233 Participants
555 Participants
n=555 Participants

PRIMARY outcome

Timeframe: 6-month baseline and 18-month intervention

Population: Clinicians enrolled at AltaMed and Northwestern University who prescribed an opioid Rx \< 50 MME during study period. Historical Rxs, suppositories/injectionables, control clinicians who erroneously received alerts, and Rxs prescribed to patients diagnosed with cancer, or who were under 18 years, were excluded.

Change = (18-month intervention average of natural log MME summed per-clinician, per-week - 6-month baseline average of natural log MME summed per-clinician, per-week). Log(total MME) = log(Rx strength x number of pills x opioid conversion factor)

Outcome measures

Outcome measures
Measure
Behavioral Intervention Arm
n=275 Participants
Clinicians in clinics randomized to the intervention group receive guideline education and will be prompted with an EHR nudge when the prescribing history for the patient falls into one of the following three categories: Opioid naïve, At-risk for long-term use, or Long-term opioid recipient.
Control
n=207 Participants
Clinicians in clinics randomized to the control group will receive web-based guideline education, consisting of an online educational module at the start of the study period. This will include educational clinical content related to the CDC guidelines, the Oregon Pain Guidance document, tapering training and other resources such as Substance Abuse and Mental Health Services Administration (SAMHSA) Medication-Assisted Treatment Physician Locator and the Naloxone Provider Guide.
Change in Average Per-clinician Log Total Weekly MME Between Baseline and Intervention for Opioid Naïve and At-Risk Patients (Below 50 MME Daily Dose Rxs)
-0.14 chg in avg per-clin log total weekly MME
Standard Deviation 0.01
-0.05 chg in avg per-clin log total weekly MME
Standard Deviation 0.01

PRIMARY outcome

Timeframe: 6-month baseline and 18-month intervention

Population: Clinicians enrolled at AltaMed and Northwestern University who prescribed an opioid Rx =\> 50 MME during study period. Historical Rxs, suppositories/injectionables, control clinicians who erroneously received alerts, and Rxs prescribed to patients diagnosed with cancer, or who were under 18 years, were excluded.

Change = (18-month intervention average of natural log MME summed per-clinician, per-week - 6-month baseline average of natural log MME summed per-clinician, per-week). Log(total MME) = log(Rx strength x number of pills x opioid conversion factor)

Outcome measures

Outcome measures
Measure
Behavioral Intervention Arm
n=185 Participants
Clinicians in clinics randomized to the intervention group receive guideline education and will be prompted with an EHR nudge when the prescribing history for the patient falls into one of the following three categories: Opioid naïve, At-risk for long-term use, or Long-term opioid recipient.
Control
n=129 Participants
Clinicians in clinics randomized to the control group will receive web-based guideline education, consisting of an online educational module at the start of the study period. This will include educational clinical content related to the CDC guidelines, the Oregon Pain Guidance document, tapering training and other resources such as Substance Abuse and Mental Health Services Administration (SAMHSA) Medication-Assisted Treatment Physician Locator and the Naloxone Provider Guide.
Change in Average Per-clinician Log Total Weekly MME Between Baseline and Intervention for Chronic Opioid Patients (=> 50 MME Daily Dose Rxs)
-0.21 chg in avg per-clin log total weekly MME
Standard Deviation 0.02
-0.02 chg in avg per-clin log total weekly MME
Standard Deviation 0.01

SECONDARY outcome

Timeframe: 6-month baseline and 18-month intervention

Population: Clinicians enrolled at AltaMed and Northwestern University who prescribed an opioid Rx during study period. Historical Rxs, suppositories/injectionables, control clinicians who erroneously received alerts, and Rxs prescribed to patients diagnosed with cancer, or who were under 18 years, were excluded.

Change = (18-month intervention average per-clinician weekly proportion - 6-month baseline average per-clinician weekly proportion). Proportion = number of chronic patients who received Rx =\> 50 MME per-clinician, per-week/total patients who received opioid Rx per-clinician, per-week

Outcome measures

Outcome measures
Measure
Behavioral Intervention Arm
n=275 Participants
Clinicians in clinics randomized to the intervention group receive guideline education and will be prompted with an EHR nudge when the prescribing history for the patient falls into one of the following three categories: Opioid naïve, At-risk for long-term use, or Long-term opioid recipient.
Control
n=207 Participants
Clinicians in clinics randomized to the control group will receive web-based guideline education, consisting of an online educational module at the start of the study period. This will include educational clinical content related to the CDC guidelines, the Oregon Pain Guidance document, tapering training and other resources such as Substance Abuse and Mental Health Services Administration (SAMHSA) Medication-Assisted Treatment Physician Locator and the Naloxone Provider Guide.
Change in Average Per-clinician Weekly Proportion of Chronic Patients Prescribed a High Dose Opioid (=> 50 MME Daily Dose Rxs) Between Baseline and Intervention
-0.08 Mean weekly proportion of chronic pts
Standard Deviation 0.01
0 Mean weekly proportion of chronic pts
Standard Deviation 0.01

OTHER_PRE_SPECIFIED outcome

Timeframe: 6-month baseline and 6-month post-intervention

Population: Clinicians enrolled at AltaMed and Northwestern University who prescribed an opioid Rx during study period. Historical Rxs, suppositories/injectionables, control clinicians who erroneously received alerts, and Rxs prescribed to patients diagnosed with cancer, or who were under 18 years, were excluded.

Change = (6-month post-intervention average of natural log MME summed per-clinician, per-week - the 18-month baseline average of natural log MME summed per-clinician, per-week). Log(total MME) = log(Rx strength x number of pills x opioid conversion factor)

Outcome measures

Outcome measures
Measure
Behavioral Intervention Arm
n=275 Participants
Clinicians in clinics randomized to the intervention group receive guideline education and will be prompted with an EHR nudge when the prescribing history for the patient falls into one of the following three categories: Opioid naïve, At-risk for long-term use, or Long-term opioid recipient.
Control
n=207 Participants
Clinicians in clinics randomized to the control group will receive web-based guideline education, consisting of an online educational module at the start of the study period. This will include educational clinical content related to the CDC guidelines, the Oregon Pain Guidance document, tapering training and other resources such as Substance Abuse and Mental Health Services Administration (SAMHSA) Medication-Assisted Treatment Physician Locator and the Naloxone Provider Guide.
Change in Average Per-clinician Log Total Weekly MME Between Baseline and Post-intervention for Opioid Naïve and At-Risk Patients (Below 50 MME Daily Dose Rxs)
-0.09 chg in avg per-clin log total weekly MME
Standard Deviation 0.01
-0.04 chg in avg per-clin log total weekly MME
Standard Deviation 0.01

OTHER_PRE_SPECIFIED outcome

Timeframe: 6-month baseline and 6-month post-intervention

Population: Clinicians enrolled at AltaMed and Northwestern University who prescribed an opioid Rx during study period. Historical Rxs, suppositories/injectionables, control clinicians who erroneously received alerts, and Rxs prescribed to patients diagnosed with cancer, or who were under 18 years, were excluded.

Change = (6-month post-intervention average per-clinician weekly proportion - 6-month baseline average per-clinician weekly proportion). Proportion = number of chronic patients who received Rx =\> 50 MME per-clinician, per-week/total patients who received opioid Rx per-clinician, per-week

Outcome measures

Outcome measures
Measure
Behavioral Intervention Arm
n=275 Participants
Clinicians in clinics randomized to the intervention group receive guideline education and will be prompted with an EHR nudge when the prescribing history for the patient falls into one of the following three categories: Opioid naïve, At-risk for long-term use, or Long-term opioid recipient.
Control
n=207 Participants
Clinicians in clinics randomized to the control group will receive web-based guideline education, consisting of an online educational module at the start of the study period. This will include educational clinical content related to the CDC guidelines, the Oregon Pain Guidance document, tapering training and other resources such as Substance Abuse and Mental Health Services Administration (SAMHSA) Medication-Assisted Treatment Physician Locator and the Naloxone Provider Guide.
Change in Average Per-clinician Weekly Proportion of Chronic Patients Prescribed a High Dose Opioid (=> 50 MME Daily Dose Rxs) Between Baseline and Post-intervention
-0.02 Mean weekly proportion of chronic pts
Standard Deviation 0.01
-0.01 Mean weekly proportion of chronic pts
Standard Deviation 0.01

OTHER_PRE_SPECIFIED outcome

Timeframe: 6-month baseline and 6-month post-intervention

Population: Clinicians enrolled at AltaMed and Northwestern University who prescribed an opioid Rx =\> 50 MME during study period. Historical Rxs, suppositories/injectionables, control clinicians who erroneously received alerts, and Rxs prescribed to patients diagnosed with cancer, or who were under 18 years, were excluded.

Change = (6-month post-intervention average of natural log MME summed per-clinician, per-week - the 6-month baseline average of natural log MME summed per-clinician, per-week). Log(total MME) = log(Rx strength x number of pills x opioid conversion factor)

Outcome measures

Outcome measures
Measure
Behavioral Intervention Arm
n=185 Participants
Clinicians in clinics randomized to the intervention group receive guideline education and will be prompted with an EHR nudge when the prescribing history for the patient falls into one of the following three categories: Opioid naïve, At-risk for long-term use, or Long-term opioid recipient.
Control
n=129 Participants
Clinicians in clinics randomized to the control group will receive web-based guideline education, consisting of an online educational module at the start of the study period. This will include educational clinical content related to the CDC guidelines, the Oregon Pain Guidance document, tapering training and other resources such as Substance Abuse and Mental Health Services Administration (SAMHSA) Medication-Assisted Treatment Physician Locator and the Naloxone Provider Guide.
Change in Average Per-clinician Log Total Weekly MME Between Baseline and Post-intervention for Chronic Opioid Patients (=> 50 MME Daily Dose Rxs)
-0.13 chg in avg per-clin log total weekly MME
Standard Deviation 0.01
-0.04 chg in avg per-clin log total weekly MME
Standard Deviation 0.02

Adverse Events

Behavioral Intervention Arm

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control

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

Jason Doctor

University of Southern California

Phone: (213) 821-8142

Results disclosure agreements

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