Trial Outcomes & Findings for PRescribing INterventions for Chronic Pain Via the Electronic Health Record Study - Current Opioid-User Population (NCT NCT04601480)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

309 participants

Primary outcome timeframe

12 months

Results posted on

2025-01-30

Participant Flow

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.

Unit of analysis: clinic

Participant milestones

Participant milestones
Measure	Care as Usual Clinics assigned to this arm will continue to care for the patients as usual in regards to opioid prescribing.	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.	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.	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.
Overall Study STARTED	78 7	72 9	76 8	83 9
Overall Study COMPLETED	78 7	72 9	76 8	83 9
Overall Study NOT COMPLETED	0 0	0 0	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data not collected

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Care as Usual n=78 Participants Clinics assigned to this arm will continue to care for the patients as usual in regards to opioid prescribing.	Choice Architecture Nudge n=72 Participants 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.	PMP Integration & Nudge n=76 Participants 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.	Choice Architecture Nudge + PMP Integration & Nudge n=83 Participants 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.	Total n=309 Participants Total of all reporting groups
Sex/Gender, Customized Female	44 Participants n=78 Participants	43 Participants n=72 Participants	44 Participants n=76 Participants	55 Participants n=83 Participants	186 Participants n=309 Participants
Sex/Gender, Customized Male	33 Participants n=78 Participants	26 Participants n=72 Participants	32 Participants n=76 Participants	28 Participants n=83 Participants	119 Participants n=309 Participants
Sex/Gender, Customized Unknown or non-binary	1 Participants n=78 Participants	3 Participants n=72 Participants	0 Participants n=76 Participants	0 Participants n=83 Participants	4 Participants n=309 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	—	—	—	0 Participants Data not collected
Race (NIH/OMB) Asian	—	—	—	—	0 Participants Data not collected
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	—	—	—	0 Participants Data not collected
Race (NIH/OMB) Black or African American	—	—	—	—	0 Participants Data not collected
Race (NIH/OMB) White	—	—	—	—	0 Participants Data not collected
Race (NIH/OMB) More than one race	—	—	—	—	0 Participants Data not collected
Race (NIH/OMB) Unknown or Not Reported	—	—	—	—	0 Participants Data not collected

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Care as Usual n=74 Participants Clinics assigned to this arm will continue to care for the patients as usual in regards to opioid prescribing.	Choice Architecture Nudge n=62 Participants 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.	PMP Integration & Nudge n=70 Participants 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.	Choice Architecture Nudge + PMP Integration & Nudge n=77 Participants 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.
Opioid Tapering Rate, Category 1	0.0193 proportion Standard Deviation 0.138	0.0359 proportion Standard Deviation 0.186	0.0268 proportion Standard Deviation 0.161	0.0192 proportion Standard Deviation 0.137

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Care as Usual n=74 Participants Clinics assigned to this arm will continue to care for the patients as usual in regards to opioid prescribing.	Choice Architecture Nudge n=62 Participants 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.	PMP Integration & Nudge n=70 Participants 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.	Choice Architecture Nudge + PMP Integration & Nudge n=77 Participants 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.
Opioid Tapering Rate, Category 2	0.778 proportion Standard Deviation 0.415	0.186 proportion Standard Deviation 0.387	0.809 proportion Standard Deviation 0.393	0.801 proportion Standard Deviation 0.399

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Care as Usual n=74 Participants Clinics assigned to this arm will continue to care for the patients as usual in regards to opioid prescribing.	Choice Architecture Nudge n=62 Participants 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.	PMP Integration & Nudge n=70 Participants 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.	Choice Architecture Nudge + PMP Integration & Nudge n=77 Participants 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.
Opioid Tapering Rate, Category 3	0.202 proportion Standard Deviation 0.402	0.147 proportion Standard Deviation 0.355	0.164 proportion Standard Deviation 0.37	0.180 proportion Standard Deviation 0.384

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome data not reported

Adverse Events

Care as Usual

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Choice Architecture Nudge

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PMP Integration & Nudge

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Choice Architecture Nudge + PMP Integration & Nudge

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ezra Golberstein

University of Minnesota

Phone: 612-626-2572

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place