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| ID | Type | Description | Link |
|---|---|---|---|
| R33DA046084 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Care as Usual | No Intervention | Clinics assigned to this arm will continue to care for the patients as usual in regards to opioid prescribing. | |
| Choice Architecture Nudge | Experimental | Clinics in this arm will receive the choice architecture nudge intervention. |
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| PMP Integration & Nudge | Experimental | Clinics in this arm will receive the Prescription Drug Monitoring (PMP) Integration & Nudge intervention. |
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| Choice Architecture Nudge + PMP Integration & Nudge | Experimental | Clinics in this arm will receive both the choice architecture nudge and prescription drug monitoring (PMP) integration & nudge interventions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Choice Architecture Nudge | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| 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. | 12 months |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
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)
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| Name | Affiliation | Role |
|---|---|---|
| Ezra Golberstein, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Care as Usual | Clinics assigned to this arm will continue to care for the patients as usual in regards to opioid prescribing. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Data was not collected on age or race
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| ID | Title | Description |
|---|---|---|
| BG000 | Care as Usual | Clinics assigned to this arm will continue to care for the patients as usual in regards to opioid prescribing. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Not collected | Data not collected |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | proportion | 12 months |
|
Adverse events were not collected
Adverse events were not collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Care as Usual | Clinics assigned to this arm will continue to care for the patients as usual in regards to opioid prescribing. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ezra Golberstein | University of Minnesota | 612-626-2572 | egolber@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 9, 2022 | Jun 11, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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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
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| PMP Integration & Nudge | Behavioral | 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. |
|
| 12 months |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race (NIH/OMB) | Data not collected | Count of Participants | Participants |
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Clinics assigned to this arm will continue to care for the patients as usual in regards to opioid prescribing.
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
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| 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 | Not Posted | 12 months | Participants |
| 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 | Not Posted | 12 months | Participants |
| 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. | Posted | Mean | Standard Deviation | proportion | 12 months |
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| 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. | Posted | Mean | Standard Deviation | proportion | 12 months |
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|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|