PRescribing INterventions for Chronic Pain Via the Electronic Health Record Study - Primary Care Providers

Opioid Use Clinical Trial

— PRINCE  

Official title:

PRescribing INterventions for Chronic Pain Via the Electronic Health Record Study - Primary Care Providers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04601506
• Other study ID #: STUDY00006522-3
• Secondary ID: R33DA046084
• Status: Recruiting
• Phase: N/A
• Start date: August 26, 2020
• Est. completion date: September 2023

Study information

• Verified date: August 2023
• Source: University of Minnesota
• Contact: Ezra Golberstein, PhD
• Phone: 612-626-2572
• Email: egolber[@]umn.edu
• 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: Recruiting
• Enrollment: 631
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• 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
Primary Care Providers (PCPs) will be sent alerts in the Electronic Health Record 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. 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. PCPs will also be sent alerts 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
Primary	Frequency of PDMP Checks	Outcome is reported as the mean number of times an individual Primary Care Provider checks the Prescription Drug Monitoring Program per month.	12 months
Secondary	PCP Satisfaction #1	In order to assess satisfaction with the electronic health record-based decision support tools, Primary Care Providers (PCP) will be asked to answer the following question on a scale from 1 (very unsatisfied) to 5 (very satisfied): "How would you rate your overall satisfaction with the best practice (BPA) alerts (pop-ups) and clinical decision support you received in the EHR for opioid prescribing for patients with acute pain?"	12 months
Secondary	PCP Satisfaction #2	In order to assess satisfaction with the electronic health record-based decision support tools, Primary Care Providers (PCP) will be asked to answer the following question on a scale from 1 (very unsatisfied) to 5 (very satisfied): "How would you rate your overall satisfaction with the best practice (BPA) alerts (pop-ups) and clinical decision support you received in the EHR for opioid prescribing for patients with chronic pain?"	12 months
Secondary	PCP Satisfaction #3	In order to assess satisfaction with the electronic health record-based decision support tools, Primary Care Providers (PCP) will be asked to answer the following question on a scale from 1 (very unsatisfied) to 5 (very satisfied): "How would you rate your overall satisfaction with the PDMP when prescribing opioids for patients with acute pain?"	12 months
Secondary	PCP Satisfaction #4	In order to assess satisfaction with the electronic health record-based decision support tools, Primary Care Providers (PCP) will be asked to answer the following question on a scale from 1 (very unsatisfied) to 5 (very satisfied): "How would you rate your overall satisfaction with the PDMP when prescribing opioids for patients with chronic pain?"	12 months
Secondary	PCP Satisfaction #5	In order to assess satisfaction with the electronic health record-based decision support tools, Primary Care Providers (PCP) will be asked to answer the following question on a scale from 1 (very easy) to 5 (very difficult): "Over the past year, how easy or difficult was it to access information on prescription drug use for your own patients in the PDMP?"	12 months
Secondary	PCP Satisfaction #6	In order to assess satisfaction with the electronic health record-based decision support tools, Primary Care Providers (PCP) will be asked to answer the following question on a scale from 1 (not useful at all) to 5 (very useful): "Over the past year, how useful was the information that you accessed from the PDMP?"	12 months
Secondary	PCP Satisfaction #7	In order to assess satisfaction with the electronic health record-based decision support tools, Primary Care Providers (PCP) will be asked to answer the following question on a scale from 1 (a lot more) to 5 (a lot less): "Compared to 12 months ago, how frequently are you engaging patients in discussions about opioids?"	12 months