An interventional study of Choice Architecture Nudge and PMP Integration & Nudge in Opioid-use Disorder, Opioid Use and Opioid Abuse, sponsored by University of Minnesota. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2024-08-26.
Sponsored by University of Minnesota · Not applicable, Interventional, and Prevention
The objective of this research is to assess the effects of electronic health record (EHR)-based decision support tools on primary care provider (PCP) decision-making around pain treatment and opioid prescribing. The decision support tools are informed by principles of "behavioral economics," whereby clinicians are "nudged," though never forced, towards guideline-concordant care.
To test the effects of these decision support tools for improving the quality of care for pain treatment, the investigators will implement a pragmatic clinic-randomized trial across the primary care clinics of Fairview Medical Group and University of Minnesota Physicians.
The study has two parallel components. The decision support tools to be tested will differ somewhat depending on whether a given patient is opioid-naïve, or whether a given patient is a current opioid-user. Four sets of analyses will be conducted separately: one for the opioid-naïve group using EHR data, one for the current opioid-user group using EHR data, one at the PCP-level using web survey data, and one at the PCP-level using MN Prescription Drug Monitoring Program (PDMP) data.
1,439 studies on the registry are indexed under Opioid-Related Disorders; 291 are open to participants now.
This study's enrollment of 631 is above the median of 62 across 1,145 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →University of Minnesota is the lead sponsor of 1,210 studies on the registry; 195 are open to participants now.
Of its 133 completed or terminated interventional studies of FDA-regulated products, 92 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- All primary care providers from all of the Fairview and University of Minnesota Physicians study clinics
Exclusion Criteria:
- Primary care providers who work less than 20% full time equivalent (FTE)
Clinics assigned to this arm will continue to care for the patients as usual in regards to opioid prescribing.
Clinics in this arm will receive the choice architecture nudge intervention.
Behavioral: Choice Architecture Nudge
Clinics in this arm will receive the Prescription Drug Monitoring (PMP) Integration \& Nudge intervention.
Behavioral: PMP Integration & Nudge
Clinics in this arm will receive both the choice architecture nudge and prescription drug monitoring (PMP) integration \& nudge interventions.
Behavioral: Choice Architecture Nudge · Behavioral: PMP Integration & Nudge
During the choice architecture nudge intervention, Primary Care Providers (PCPs) will be sent alerts in the Electronic Health Record (EHR) system when they initiate an opioid order for a patient who has not had an opioid prescription within the past six months. The alert provides guidance language about opioid prescribing and prompts the PCP to open the "SmartSet" to order non-opioid treatment alternatives. PCPs can choose to ignore this, but opening the SmartSet is the default option. When the SmartSet is opened, PCPs can choose to click on a variety of treatment order options, including both non-opioid pharmacological options and non-pharmacological options (e.g., referral to physical therapy or pain clinic).
During the Prescription Drug Monitoring Program (PMP) integration \& nudge intervention, Primary Care Providers (PCPs) will have integrated access to the PMP embedded within the EHR. All clinicians can already access the PMP to look up a patient's prior opioid prescriptions and prescription fills. However, this process involves signing in to the separate PMP website and can be complicated and time-consuming within typical clinical workflow. The integrated PMP tool makes it much easier and faster for a PCP to access the PMP information for a given patient.
Opioid Prescription Rate
Outcome reported as the percent of Primary Care Appointments (PCAs) at each clinic during which an opioid is prescribed, without currently receiving a non-opioid alternative pain treatment (including a new order for a non-opioid pain treatment).
Time frame: 12 months
Rate of Non-Opioid Treatment Prescription
Outcome reported as the percent of Primary Care Appointments (PCAs) at each clinic during which a CDC-recommended non-opioid treatment in ordered
Time frame: 12 months
Opioid Prescription Length
Outcome reported as the mean length of opioid prescription (in days) given during Primary Care Appointments
Time frame: 12 months
Opioid Prescription MME
Outcome reported as the mean Milligram Morphine Equivalents (MME) of opioid prescriptions given during Primary Care Appointments
Time frame: 12 months
| Milestone | Care as Usual | Choice Architecture Nudge | PMP Integration & Nudge | Choice Architecture Nudge + PMP Integration & Nudge |
|---|---|---|---|---|
| Started | 126 | 112 | 104 | 131 |
| Completed | 126 | 112 | 104 | 131 |
| Not completed | 0 | 0 | 0 | 0 |
Outcome reported as the percent of Primary Care Appointments (PCAs) at each clinic during which an opioid is prescribed, without currently receiving a non-opioid alternative pain treatment (including a new order for a non-opioid pain treatment).
| percent | Care as Usual | Choice Architecture Nudge | PMP Integration & Nudge | Choice Architecture Nudge + PMP Integration & Nudge |
|---|---|---|---|---|
| Opioid Prescription Rate | 0.0159 ± 0.125 | 0.0141 ± 0.118 | 0.0161 ± 0.129 | 0.0120 ± 0.109 |
Outcome reported as the percent of Primary Care Appointments (PCAs) at each clinic during which a CDC-recommended non-opioid treatment in ordered
| percent | Care as Usual | Choice Architecture Nudge | PMP Integration & Nudge | Choice Architecture Nudge + PMP Integration & Nudge |
|---|---|---|---|---|
| Rate of Non-Opioid Treatment Prescription | 0.239 ± 0.426 | 0.227 ± 0.419 | 0.23 ± 0.421 | 0.228 ± 0.419 |
Outcome reported as the mean length of opioid prescription (in days) given during Primary Care Appointments
| Days | Care as Usual | Choice Architecture Nudge | PMP Integration & Nudge | Choice Architecture Nudge + PMP Integration & Nudge |
|---|---|---|---|---|
| Opioid Prescription Length | 9.63 ± 18.66 | 11.85 ± 21.4 | 13.43 ± 35.86 | 11.75 ± 25.39 |
Outcome reported as the mean Milligram Morphine Equivalents (MME) of opioid prescriptions given during Primary Care Appointments
| Milligram Morphine Equivalents | Care as Usual | Choice Architecture Nudge | PMP Integration & Nudge | Choice Architecture Nudge + PMP Integration & Nudge |
|---|---|---|---|---|
| Opioid Prescription MME | 23.41 ± 14.9 | 23.89 ± 18.3 | 21.6 ± 12.1 | 23.89 ± 15.9 |
Collected over Adverse events were not collected. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Care as Usual | — | — | — |
| Choice Architecture Nudge | — | — | — |
| PMP Integration & Nudge | — | — | — |
| Choice Architecture Nudge + PMP Integration & Nudge | — | — | — |
| Age, Categorical(Participants) | Care as Usual | Choice Architecture Nudge | PMP Integration & Nudge | Choice Architecture Nudge + PMP Integration & Nudge | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 0 | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Sex/Gender, Customized(Participants) | Care as Usual | Choice Architecture Nudge | PMP Integration & Nudge | Choice Architecture Nudge + PMP Integration & Nudge | Total |
|---|---|---|---|---|---|
| Female | 70 | 64 | 66 | 86 | 286 |
| Male | 49 | 44 | 38 | 42 | 173 |
| Unkown | 7 | 4 | 0 | 3 | 14 |
| Race and Ethnicity Not Collected(Participants) | Care as Usual | Choice Architecture Nudge | PMP Integration & Nudge | Choice Architecture Nudge + PMP Integration & Nudge | Total |
|---|---|---|---|---|---|
| Count of participants | — | — | — | — | 0 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.