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

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.

Secondary Outcome Measures

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?"
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?"
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?"
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?"
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?"
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?"
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?"

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
NCT04601506
Brief Title
PRescribing INterventions for Chronic Pain Via the Electronic Health Record Study - Primary Care Providers
Acronym
PRINCE
Official Title
PRescribing INterventions for Chronic Pain Via the Electronic Health Record Study - Primary Care Providers
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
Outcomes 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
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.
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
Frequency of PDMP Checks
Description
Outcome is reported as the mean number of times an individual Primary Care Provider checks the Prescription Drug Monitoring Program per month.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
PCP Satisfaction #1
Description
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?"
Time Frame
12 months
Title
PCP Satisfaction #2
Description
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?"
Time Frame
12 months
Title
PCP Satisfaction #3
Description
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?"
Time Frame
12 months
Title
PCP Satisfaction #4
Description
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?"
Time Frame
12 months
Title
PCP Satisfaction #5
Description
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?"
Time Frame
12 months
Title
PCP Satisfaction #6
Description
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?"
Time Frame
12 months
Title
PCP Satisfaction #7
Description
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?"
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

12. IPD Sharing Statement

Citations:
PubMed Identifier
35977248
Citation
Neprash HT, Vock DM, Hanson A, Elert B, Short S, Karaca-Mandic P, Rothman AJ, Melton GB, Satin D, Markowitz R, Golberstein E. Effect of Integrating Access to a Prescription Drug Monitoring Program Within the Electronic Health Record on the Frequency of Queries by Primary Care Clinicians: A Cluster Randomized Clinical Trial. JAMA Health Forum. 2022 Jun 5;3(6):e221852. doi: 10.1001/jamahealthforum.2022.1852. eCollection 2022 Jun.
Results Reference
derived

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

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