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PRescribing INterventions for Chronic Pain Via the Electronic Health Record Study - Opioid-Naive 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
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Opioid-use Disorder

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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).

Secondary Outcome Measures

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
Opioid Prescription Length
Outcome reported as the mean length of opioid prescription (in days) given during Primary Care Appointments
Opioid Prescription MME
Outcome reported as the mean Milligram Morphine Equivalents (MME) of opioid prescriptions given during Primary Care Appointments

Full Information

First Posted
October 19, 2020
Last Updated
August 9, 2023
Sponsor
University of Minnesota
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04601493
Brief Title
PRescribing INterventions for Chronic Pain Via the Electronic Health Record Study - Opioid-Naive Population
Acronym
PRINCE
Official Title
PRescribing INterventions for Chronic Pain Via the Electronic Health Record Study - Opioid-Naive 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 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).
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 Prescription Rate
Description
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).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Rate of Non-Opioid Treatment Prescription
Description
Outcome reported as the percent of Primary Care Appointments (PCAs) at each clinic during which a CDC-recommended non-opioid treatment in ordered
Time Frame
12 months
Title
Opioid Prescription Length
Description
Outcome reported as the mean length of opioid prescription (in days) given during Primary Care Appointments
Time Frame
12 months
Title
Opioid Prescription MME
Description
Outcome reported as the mean Milligram Morphine Equivalents (MME) of opioid prescriptions given during Primary Care Appointments
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 Goberstein, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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