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

Not Applicable

Completed

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

• Registration Number: NCT04601493
• 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
• Results First Submitted: 2024-04-04
• Status Verified: 2024-08
• Results First Submitted QC: 2024-08-01
• Last Update Submitted: 2024-08-01
• Results First Posted: 2024-08-26
• Last Update Posted: 2024-08-26

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	Choice Architecture 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	PMP Integration & 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 Prescription Rate	12 months	Outcome reported as the percent of Primary Care Appointments (PCAs) at each clinic during which an opioid is prescribed, without currently receiving a non-opioid alternative pain treatment (including a new order for a non-opioid pain treatment).

Secondary Outcome Measures

Name	Time	Method
Opioid Prescription MME	12 months	Outcome reported as the mean Milligram Morphine Equivalents (MME) of opioid prescriptions given during Primary Care Appointments
Rate of Non-Opioid Treatment Prescription	12 months	Outcome reported as the percent of Primary Care Appointments (PCAs) at each clinic during which a CDC-recommended non-opioid treatment in ordered
Opioid Prescription Length	12 months	Outcome reported as the mean length of opioid prescription (in days) given during Primary Care Appointments

Trial Locations

Locations (1)

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