Clinical trial NCT04477304: Application of Economics & Social Psychology to Improve Opioid Prescribing Safety Trial 1: EHR Nudges
Official title: Application of Economics & Social Psychology to Improve Opioid Prescribing Safety Trial 1: Electronic Health Record Nudges
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Abuse, Unspecified
Keywords: opioid use disorder
randomized control trial
behavioral economics
nudges
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: AltaMed Health Services Corporation
name: National Institute on Aging (NIA)
First posted: 2020-07-20
Enrollment: 555
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The opioid epidemic has had a tremendous negative impact on the health of persons in the U.S. The objective of the trial 1 of Application of Economics \& Social psychology to improve Opioid Prescribing Safety (AESOPS-T1), is to discourage unnecessary opioid prescribing through the application of "behavioral insights"-empirically-tested social and psychological interventions that affect choice.

Detailed description: A multisite study, AESOPS-T1 randomizes clinics to behavioral intervention or control. Clinics randomized to the behavioral intervention arm receive electronic health record (EHR)-based nudges. Eligible participants are clinicians who practice ambulatory primary care at the participating clinical sites in Illinois and California. At the time of opioid prescribing, clinicians in clinics randomized to the intervention group will be prompted with an EHR nudge when the prescribing history for the patient falls into one of the following three mutually exclusive categories: Opioid naïve, At-risk for long-term use, or Long-term opioid recipient. These EHR-based nudges include accountable justification, defaults and precommitments. The control arm receives no EHR-based intervention. Both arms receive guideline education. The primary outcome is the change in clinician aggregate weekly milligram morphine equivalent (MME) dose and the secondary outcome is the proportion of dosages that equal or exceed 50 MME per day. These outcomes will be estimated by treatment arm with an intent-to-treat difference-in-differences framework using a mixed-effects regression model on clinician MME daily dose. The intervention period will be 18-months, with a 6-month follow-up period to measure the persistence of effects after the interventions conclude.

Eligibility criteria: Inclusion Criteria:

* Providers of clinics that see patients ≥ 18 years old and for whom clinic leadership agrees to participate.

Exclusion Criteria:

* Visits will be excluded from intervention when the patient has active cancer.

Primary outcomes:
measure: 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)
timeFrame: 18-month baseline and 18-month intervention
measure: Change in Average Per-clinician Log Total Weekly MME Between Baseline and Intervention for Chronic Opioid Patients (=> 50 MME Daily Dose Rxs)
timeFrame: 18-month baseline and 18-month intervention
Secondary outcomes:
measure: Change in Average Per-clinician Weekly Proportion of Chronic Patients Prescribed a High Dose Opioid (=> 50 MME Daily Dose Rxs) Between Baseline and Intervention
timeFrame: 18-month baseline and 18-month intervention
Other outcomes:
measure: 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)
timeFrame: 18-month baseline and 6-month post-intervention
measure: 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
timeFrame: 18-month baseline and 6-month post-intervention
measure: Change in Average Per-clinician Log Total Weekly MME Between Baseline and Post-intervention for Chronic Opioid Patients (=> 50 MME Daily Dose Rxs)
timeFrame: 18-month baseline and 6-month post-intervention
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: University of Southern California
name: Jason N Doctor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kelley MA, Persell SD, Linder JA, Friedberg MW, Meeker D, Fox CR, Goldstein NJ, Knight TK, Zein D, Rowe TA, Sullivan MD, Doctor JN. The protocol of the Application of Economics & Social psychology to improve Opioid Prescribing Safety Trial 1 (AESOPS-1): Electronic health record nudges. Contemp Clin Trials. 2021 Apr;103:106329. doi: 10.1016/j.cct.2021.106329. Epub 2021 Feb 24.