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

Opioid Use Clinical Trial

— PRINCE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04601480
• Other study ID #: STUDY00006522-1
• 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 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
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
Other	Prescription Increase Rate	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	12 months
Primary	Opioid Tapering Rate	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.	12 months
Secondary	Prescription Reduction vs Discontinuation Rate	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	12 months