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Completed

NCT Number: NCT04601480

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

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.

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Key information

Conditions

Opioid-use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid Abuse Opioid Use Opioid-Related Disorders Substance-Related Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. Opioid Tapering Rate, Category 1

    Time frame: 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.

  2. Opioid Tapering Rate, Category 2

    Time frame: 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.

  3. Opioid Tapering Rate, Category 3

    Time frame: 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 outcomes

  1. Prescription Reduction vs Discontinuation Rate

    Time frame: 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 outcomes

  1. Prescription Increase Rate

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: PRINCE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 23, 2020
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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