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)
COMPLETED
NA
555 participants
6-month baseline and 18-month intervention
2025-08-07
Participant Flow
Unit of analysis: Clinics
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
| 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
| 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 interventionPopulation: 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
| 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 interventionPopulation: 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
| 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 interventionPopulation: 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
| 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-interventionPopulation: 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
| 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-interventionPopulation: 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
| 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-interventionPopulation: 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
| 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
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place