Opioid Abuse, Opioid Use, Opioid-use Disorder
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALChoice Architecture 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 will a current opioid prescription. The alerts prompt PCPs to consider tapering the patient's opioid. The alert also displays the MME of the patient's current opioid prescription and automatically calculates what a 10% reduction in MME relative to the current prescription would be. The alert contains options to either cancel the refill order, or to continue with the order.
BEHAVIORALPMP Integration & Nudge
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.
Sponsors
National Institute on Drug Abuse (NIDA)
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Intervention model description
43 Primary Care Clinics will be randomized to be in one of 4 arms: 1) Care as usual, 2) Choice architecture nudge, 3) Prescription Drug Monitoring Program (PMP) Integration & nudge, 4) Choice architecture nudge + PMP Integration & nudge
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
\- 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Tapering Rate, Category 1 | 12 months | Outcome reported as the proportion of the opioid-refill-eligible visits per PCP that fall into each of the 3 categories: Category 1/Appropriate Taper: Whether a Primary care visit (PCV) with someone currently receiving a high risk opioid had an order that would reduce MME by no greater than 20%, relative to the current prescription, and there is documented evidence that the reduction was consistent with CDC guidelines. Category 2/Inappropriate Taper: Whether a PCV with someone currently receiving a high risk opioid had an order that would reduce MME without documented evidence that the reduction was consistent with CDC guidelines, or, decreased MME by greater amounts than recommended (\>20% relative reduction in MME). Category 3/No Taper: Whether a PCV with someone currently receiving a high risk opioid had no reduction in MME. |
| Opioid Tapering Rate, Category 2 | 12 months | Outcome reported as the proportion of the opioid-refill-eligible visits per PCP that fall into each of the 3 categories: Category 1/Appropriate Taper: Whether a Primary care visit (PCV) with someone currently receiving a high risk opioid had an order that would reduce MME by no greater than 20%, relative to the current prescription, and there is documented evidence that the reduction was consistent with CDC guidelines. Category 2/Inappropriate Taper: Whether a PCV with someone currently receiving a high risk opioid had an order that would reduce MME without documented evidence that the reduction was consistent with CDC guidelines, or, decreased MME by greater amounts than recommended (\>20% relative reduction in MME). Category 3/No Taper: Whether a PCV with someone currently receiving a high risk opioid had no reduction in MME. |
| Opioid Tapering Rate, Category 3 | 12 months | Outcome reported as the proportion of the opioid-refill-eligible visits per PCP that fall into each of the 3 categories: Category 1/Appropriate Taper: Whether a Primary care visit (PCV) with someone currently receiving a high risk opioid had an order that would reduce MME by no greater than 20%, relative to the current prescription, and there is documented evidence that the reduction was consistent with CDC guidelines. Category 2/Inappropriate Taper: Whether a PCV with someone currently receiving a high risk opioid had an order that would reduce MME without documented evidence that the reduction was consistent with CDC guidelines, or, decreased MME by greater amounts than recommended (\>20% relative reduction in MME). Category 3/No Taper: Whether a PCV with someone currently receiving a high risk opioid had no reduction in MME. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prescription Reduction vs Discontinuation Rate | 12 months | Outcome reported as the percent of Primary Care Appointments (PCAs) at each clinic that fall into one of 2 categories: Partial reduction in the MME or prescription length of refill order, versus a total opioid discontinuation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Prescription Increase Rate | 12 months | Outcome reported as the percent of Primary Care Appointments (PCAs) at each clinic during which there was an increase in the MME/day for current opioid users with at least 50 MME/day |
Countries
United States
Participant flow
Pre-assignment details
The original study protocol included a potential second randomization period after six months into the trial. This secondary randomization did not occur, per the recommendation of the Data Monitoring Committee.
Participants by arm
| Arm | Count |
|---|---|
| Care as Usual Clinics assigned to this arm will continue to care for the patients as usual in regards to opioid prescribing. | 78 |
| Choice Architecture Nudge Clinics in this arm will receive the choice architecture nudge intervention.
Choice Architecture 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 will a current opioid prescription. The alerts prompt PCPs to consider tapering the patient's opioid. The alert also displays the MME of the patient's current opioid prescription and automatically calculates what a 10% reduction in MME relative to the current prescription would be. The alert contains options to either cancel the refill order, or to continue with the order. | 72 |
| PMP Integration & Nudge Clinics in this arm will receive the Prescription Drug Monitoring (PMP) Integration & Nudge intervention.
PMP Integration & Nudge: 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. | 76 |
| Choice Architecture Nudge + PMP Integration & Nudge Clinics in this arm will receive both the choice architecture nudge and prescription drug monitoring (PMP) integration & nudge interventions.
Choice Architecture 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 will a current opioid prescription. The alerts prompt PCPs to consider tapering the patient's opioid. The alert also displays the MME of the patient's current opioid prescription and automatically calculates what a 10% reduction in MME relative to the current prescription would be. The alert contains options to either cancel the refill order, or to continue with the order.
PMP Integration & Nudge: 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. | 83 |
| Total | 309 |
Baseline characteristics
| Characteristic | — | Total | PMP Integration & Nudge | Choice Architecture Nudge + PMP Integration & Nudge | Care as Usual | Choice Architecture Nudge |
|---|---|---|---|---|---|---|
| Age, Continuous | — years | — | — | — | — | — |
| Race (NIH/OMB) American Indian or Alaska Native | — | 0 Participants | — | — | — | — |
| Race (NIH/OMB) Asian | — | 0 Participants | — | — | — | — |
| Race (NIH/OMB) Black or African American | — | 0 Participants | — | — | — | — |
| Race (NIH/OMB) More than one race | — | 0 Participants | — | — | — | — |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | — | 0 Participants | — | — | — | — |
| Race (NIH/OMB) Unknown or Not Reported | — | 0 Participants | — | — | — | — |
| Race (NIH/OMB) White | — | 0 Participants | — | — | — | — |
| Sex/Gender, Customized Female | — | 186 Participants | 44 Participants | 55 Participants | 44 Participants | 43 Participants |
| Sex/Gender, Customized Male | — | 119 Participants | 32 Participants | 28 Participants | 33 Participants | 26 Participants |
| Sex/Gender, Customized Unknown or non-binary | — | 4 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Opioid Tapering Rate, Category 1
Outcome reported as the proportion of the opioid-refill-eligible visits per PCP that fall into each of the 3 categories: Category 1/Appropriate Taper: Whether a Primary care visit (PCV) with someone currently receiving a high risk opioid had an order that would reduce MME by no greater than 20%, relative to the current prescription, and there is documented evidence that the reduction was consistent with CDC guidelines. Category 2/Inappropriate Taper: Whether a PCV with someone currently receiving a high risk opioid had an order that would reduce MME without documented evidence that the reduction was consistent with CDC guidelines, or, decreased MME by greater amounts than recommended (\>20% relative reduction in MME). Category 3/No Taper: Whether a PCV with someone currently receiving a high risk opioid had no reduction in MME.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Care as Usual | Opioid Tapering Rate, Category 1 | 0.0193 proportion | Standard Deviation 0.138 |
| Choice Architecture Nudge | Opioid Tapering Rate, Category 1 | 0.0359 proportion | Standard Deviation 0.186 |
| PMP Integration & Nudge | Opioid Tapering Rate, Category 1 | 0.0268 proportion | Standard Deviation 0.161 |
| Choice Architecture Nudge + PMP Integration & Nudge | Opioid Tapering Rate, Category 1 | 0.0192 proportion | Standard Deviation 0.137 |
Primary
Opioid Tapering Rate, Category 2
Outcome reported as the proportion of the opioid-refill-eligible visits per PCP that fall into each of the 3 categories: Category 1/Appropriate Taper: Whether a Primary care visit (PCV) with someone currently receiving a high risk opioid had an order that would reduce MME by no greater than 20%, relative to the current prescription, and there is documented evidence that the reduction was consistent with CDC guidelines. Category 2/Inappropriate Taper: Whether a PCV with someone currently receiving a high risk opioid had an order that would reduce MME without documented evidence that the reduction was consistent with CDC guidelines, or, decreased MME by greater amounts than recommended (\>20% relative reduction in MME). Category 3/No Taper: Whether a PCV with someone currently receiving a high risk opioid had no reduction in MME.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Care as Usual | Opioid Tapering Rate, Category 2 | 0.778 proportion | Standard Deviation 0.415 |
| Choice Architecture Nudge | Opioid Tapering Rate, Category 2 | 0.186 proportion | Standard Deviation 0.387 |
| PMP Integration & Nudge | Opioid Tapering Rate, Category 2 | 0.809 proportion | Standard Deviation 0.393 |
| Choice Architecture Nudge + PMP Integration & Nudge | Opioid Tapering Rate, Category 2 | 0.801 proportion | Standard Deviation 0.399 |
Primary
Opioid Tapering Rate, Category 3
Outcome reported as the proportion of the opioid-refill-eligible visits per PCP that fall into each of the 3 categories: Category 1/Appropriate Taper: Whether a Primary care visit (PCV) with someone currently receiving a high risk opioid had an order that would reduce MME by no greater than 20%, relative to the current prescription, and there is documented evidence that the reduction was consistent with CDC guidelines. Category 2/Inappropriate Taper: Whether a PCV with someone currently receiving a high risk opioid had an order that would reduce MME without documented evidence that the reduction was consistent with CDC guidelines, or, decreased MME by greater amounts than recommended (\>20% relative reduction in MME). Category 3/No Taper: Whether a PCV with someone currently receiving a high risk opioid had no reduction in MME.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Care as Usual | Opioid Tapering Rate, Category 3 | 0.202 proportion | Standard Deviation 0.402 |
| Choice Architecture Nudge | Opioid Tapering Rate, Category 3 | 0.147 proportion | Standard Deviation 0.355 |
| PMP Integration & Nudge | Opioid Tapering Rate, Category 3 | 0.164 proportion | Standard Deviation 0.37 |
| Choice Architecture Nudge + PMP Integration & Nudge | Opioid Tapering Rate, Category 3 | 0.180 proportion | Standard Deviation 0.384 |
Secondary
Prescription Reduction vs Discontinuation Rate
Outcome reported as the percent of Primary Care Appointments (PCAs) at each clinic that fall into one of 2 categories: Partial reduction in the MME or prescription length of refill order, versus a total opioid discontinuation
Time frame: 12 months
Other Pre-specified
Prescription Increase Rate
Outcome reported as the percent of Primary Care Appointments (PCAs) at each clinic during which there was an increase in the MME/day for current opioid users with at least 50 MME/day
Time frame: 12 months