PRescribing INterventions for Chronic Pain Via the Electronic Health Record Study - Current Opioid-User Population

NCT04601480 | Completed Results

• 2 other identifiers: STUDY00006522-1R33DA046084
• Study Type: interventional
• Target: 309
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-use Disorder; Opioid Use; Opioid Abuse

Outcome Measures

Primary Outcomes (3)

• 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.

  12 months

Secondary Outcomes (1)

• Prescription Reduction vs Discontinuation Rate

  12 months

Other Outcomes (1)

• Prescription Increase Rate

  12 months

Study Arms (4)

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.

Behavioral: Choice Architecture Nudge

PMP Integration & Nudge

EXPERIMENTAL

Clinics in this arm will receive the Prescription Drug Monitoring (PMP) Integration \& Nudge intervention.

Behavioral: PMP Integration & Nudge

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.

Behavioral: Choice Architecture Nudge; Behavioral: PMP Integration & Nudge

Interventions

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.

Choice Architecture Nudge; Choice Architecture Nudge + PMP Integration & Nudge

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.

Choice Architecture Nudge + PMP Integration & Nudge; PMP Integration & Nudge

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- All primary care providers from all of the Fairview and University of Minnesota Physicians study clinics

You may not qualify if:

• \- Primary care providers who work less than 20% full time equivalent (FTE)

Sponsors & Collaborators

• University of Minnesota: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Ezra Golberstein
• Organization: University of Minnesota

egolber@umn.edu

612-626-2572

Study Officials

• Ezra Golberstein, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 23, 2020
• Study Start: August 26, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: January 30, 2025
• Results First Posted: January 30, 2025

Record last verified: 2025-01

Locations

US (1)