Back to resultsPRescribing INterventions for Chronic Pain Via the Electronic Health Record Study - Current Opioid-User Population (PRINCE)
Primary Purpose
Opioid-use Disorder, Opioid Use, Opioid Abuse
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Choice Architecture Nudge
PMP Integration & Nudge
Sponsored by
About this trial
This is an interventional prevention trial for Opioid-use Disorder
Eligibility Criteria
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)
Sites / Locations
- University of MinnesotaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Experimental
Experimental
Experimental
Arm Label
Care as Usual
Choice Architecture Nudge
PMP Integration & Nudge
Choice Architecture Nudge + PMP Integration & Nudge
Arm Description
Clinics assigned to this arm will continue to care for the patients as usual in regards to opioid prescribing.
Clinics in this arm will receive the choice architecture nudge intervention.
Clinics in this arm will receive the Prescription Drug Monitoring (PMP) Integration & Nudge intervention.
Clinics in this arm will receive both the choice architecture nudge and prescription drug monitoring (PMP) integration & nudge interventions.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04601480
First Posted
October 19, 2020
Last Updated
August 9, 2023
Sponsor
University of Minnesota
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT04601480
Brief Title
PRescribing INterventions for Chronic Pain Via the Electronic Health Record Study - Current Opioid-User Population
Acronym
PRINCE
Official Title
PRescribing INterventions for Chronic Pain Via the Electronic Health Record Study - Current Opioid-User Population
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 26, 2020 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder, Opioid Use, Opioid Abuse
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
43 Primary Care Clinics will be randomized to be in one of 4 arms: 1) Care as usual, 2) Choice architecture nudge, 3) Prescription Drug Monitoring Program (PMP) Integration & nudge, 4) Choice architecture nudge + PMP Integration & nudge
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
631 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Care as Usual
Arm Type
No Intervention
Arm Description
Clinics assigned to this arm will continue to care for the patients as usual in regards to opioid prescribing.
Arm Title
Choice Architecture Nudge
Arm Type
Experimental
Arm Description
Clinics in this arm will receive the choice architecture nudge intervention.
Arm Title
PMP Integration & Nudge
Arm Type
Experimental
Arm Description
Clinics in this arm will receive the Prescription Drug Monitoring (PMP) Integration & Nudge intervention.
Arm Title
Choice Architecture Nudge + PMP Integration & Nudge
Arm Type
Experimental
Arm Description
Clinics in this arm will receive both the choice architecture nudge and prescription drug monitoring (PMP) integration & nudge interventions.
Intervention Type
Behavioral
Intervention Name(s)
Choice Architecture Nudge
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
PMP Integration & Nudge
Intervention Description
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.
Primary Outcome Measure Information:
Title
Opioid Tapering Rate
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Prescription Reduction vs Discontinuation Rate
Description
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
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Prescription Increase Rate
Description
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
Time Frame
12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ezra Golberstein, PhD
Phone
612-626-2572
Email
egolber@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ezra Golberstein, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ezra Golberstein, PhD
12. IPD Sharing Statement
Learn more about this trial
PRescribing INterventions for Chronic Pain Via the Electronic Health Record Study - Current Opioid-User Population
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