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

Not Applicable

Completed

• Conditions: Opioid Use; Opioid Abuse; Opioid-use Disorder
• Interventions: Behavioral: PMP Integration & Nudge; Behavioral: Choice Architecture Nudge

• Registration Number: NCT04601480
• Lead Sponsor: University of Minnesota

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-08-26
• Study First Submitted: 2020-10-19
• Study First Submitted QC: 2020-10-19
• Study First Posted: 2020-10-23
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-15
• Last Update Posted: 2023-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 631

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PMP Integration & Nudge	PMP Integration & Nudge	Clinics in this arm will receive the Prescription Drug Monitoring (PMP) Integration \& Nudge intervention.
Choice Architecture Nudge + PMP Integration & 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	Choice Architecture Nudge	Clinics in this arm will receive the choice architecture nudge intervention.
Choice Architecture Nudge + PMP Integration & Nudge	Choice Architecture Nudge	Clinics in this arm will receive both the choice architecture nudge and prescription drug monitoring (PMP) integration \& nudge interventions.

Primary Outcome Measures

Name	Time	Method
Opioid Tapering Rate	12 months	Outcome reported as the percent of Primary Care Appointments (PCAs) at each clinic that fall into each of 3 categories: Appropriate Taper: Whether a PCA 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.; Inappropriate Taper: Whether a PCA 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).; No Taper: Whether a PCP with someone currently receiving a "high risk" opioid had no reduction in MME.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States