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

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ClinicalTrials.gov Identifier: NCT04601493
Recruitment Status : Recruiting
First Posted : October 23, 2020
Last Update Posted : August 4, 2022
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Minnesota

Study Description
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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.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Opioid Use Opioid Abuse Behavioral: Choice Architecture Nudge Behavioral: PMP Integration & Nudge Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 631 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: PRescribing INterventions for Chronic Pain Via the Electronic Health Record Study - Opioid-Naive Population
Actual Study Start Date : August 26, 2020
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Care as Usual
Clinics assigned to this arm will continue to care for the patients as usual in regards to opioid prescribing.
Experimental: Choice Architecture Nudge
Clinics in this arm will receive the choice architecture nudge 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).
Experimental: PMP Integration & Nudge
Clinics in this arm will receive the Prescription Drug Monitoring (PMP) Integration & Nudge intervention.
 Behavioral: 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.
Experimental: Choice Architecture Nudge + PMP Integration & Nudge
Clinics in this arm will receive both the choice architecture nudge and prescription drug monitoring (PMP) integration & nudge interventions.
 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).

Behavioral: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Opioid Prescription Rate [ Time Frame: 12 months ]
    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 :
  1. Rate of Non-Opioid Treatment Prescription [ Time Frame: 12 months ]
    Outcome reported as the percent of Primary Care Appointments (PCAs) at each clinic during which a CDC-recommended non-opioid treatment in ordered

  2. Opioid Prescription Length [ Time Frame: 12 months ]
    Outcome reported as the mean length of opioid prescription (in days) given during Primary Care Appointments

  3. Opioid Prescription MME [ Time Frame: 12 months ]
    Outcome reported as the mean Milligram Morphine Equivalents (MME) of opioid prescriptions given during Primary Care Appointments


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04601493


Contacts
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Contact: Ezra Golberstein, PhD 612-626-2572 egolber@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Ezra Goberstein, PhD         
Sponsors and Collaborators
University of Minnesota
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Ezra Golberstein, PhD University of Minnesota
More Information
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT04601493    
Other Study ID Numbers: STUDY00006522-2
R33DA046084 ( U.S. NIH Grant/Contract )
First Posted: October 23, 2020    Key Record Dates
Last Update Posted: August 4, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Opioid-Related Disorders
Pain
Neurologic Manifestations
 Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders