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

Opioid Use Clinical Trial

— PRINCE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04601493
• Other study ID #: STUDY00006522-2
• Secondary ID: R33DA046084
• Status: Completed
• Phase: N/A
• Start date: August 26, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: December 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 631
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Pain
• Opioid Abuse
• Opioid Use
• Opioid-Related Disorders
• Opioid-use Disorder

Intervention

Behavioral:
• 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 who has not had an opioid prescription within the past six months. The alert provides guidance language about opioid prescribing and prompts the PCP to open the "SmartSet" to order non-opioid treatment alternatives. PCPs can choose to ignore this, but opening the SmartSet is the default option. When the SmartSet is opened, PCPs can choose to click on a variety of treatment order options, including both non-opioid pharmacological options and non-pharmacological options (e.g., referral to physical therapy or pain clinic).
• 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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

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