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Clinical Trials/NCT04601480
NCT04601480
Completed
Not Applicable

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

University of Minnesota1 site in 1 country309 target enrollmentAugust 26, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Opioid-use Disorder
Sponsor
University of Minnesota
Enrollment
309
Locations
1
Primary Endpoint
Opioid Tapering Rate, Category 1
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 26, 2020
End Date
October 1, 2021
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

Opioid Tapering Rate, Category 1

Time Frame: 12 months

Outcome reported as the proportion of the opioid-refill-eligible visits per PCP that fall into each of the 3 categories: Category 1/Appropriate Taper: Whether a Primary care visit (PCV) 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. Category 2/Inappropriate Taper: Whether a PCV 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). Category 3/No Taper: Whether a PCV with someone currently receiving a "high risk" opioid had no reduction in MME.

Opioid Tapering Rate, Category 2

Time Frame: 12 months

Outcome reported as the proportion of the opioid-refill-eligible visits per PCP that fall into each of the 3 categories: Category 1/Appropriate Taper: Whether a Primary care visit (PCV) 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. Category 2/Inappropriate Taper: Whether a PCV 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). Category 3/No Taper: Whether a PCV with someone currently receiving a "high risk" opioid had no reduction in MME.

Opioid Tapering Rate, Category 3

Time Frame: 12 months

Outcome reported as the proportion of the opioid-refill-eligible visits per PCP that fall into each of the 3 categories: Category 1/Appropriate Taper: Whether a Primary care visit (PCV) 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. Category 2/Inappropriate Taper: Whether a PCV 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). Category 3/No Taper: Whether a PCV with someone currently receiving a "high risk" opioid had no reduction in MME.

Secondary Outcomes

  • Prescription Reduction vs Discontinuation Rate(12 months)

Study Sites (1)

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