PRINCE: PRescribing INterventions for Chronic Pain Via the Electronic Health Record Study - Current Opioid-User Population

Sponsor
University of Minnesota (Other)
Overall Status
Recruiting
CT.gov ID
NCT04601480
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
631
1
4
36.2
17.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Choice Architecture Nudge
  • Behavioral: PMP Integration & Nudge
N/A

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

Study Type:
Interventional
Anticipated 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 & nudge43 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 - Current Opioid-User Population
Actual Study Start Date :
Aug 26, 2020
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

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 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.

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 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.

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

Primary Outcome Measures

  1. Opioid Tapering Rate [12 months]

    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

  1. Prescription Reduction vs Discontinuation Rate [12 months]

    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

Other Outcome Measures

  1. Prescription Increase Rate [12 months]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 University of Minnesota Minneapolis Minnesota United States 55455

Sponsors and Collaborators

  • University of Minnesota
  • National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Ezra Golberstein, PhD, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Minnesota
ClinicalTrials.gov Identifier:
NCT04601480
Other Study ID Numbers:
  • STUDY00006522-1
  • R33DA046084
First Posted:
Oct 23, 2020
Last Update Posted:
Aug 4, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 4, 2022