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Clinical Trials/NCT04601506
NCT04601506CompletedNot Applicable

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

University of Minnesota1 site in 1 country472 target enrollmentStarted: August 26, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
472
Locations
1
Primary Endpoint
Frequency of PDMP Checks

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Sex
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)

Arms & Interventions

Care as Usual

No Intervention

Clinics assigned to this arm will continue to care for the patients as usual in regards to opioid prescribing.

Choice Architecture Nudge

Experimental

Clinics in this arm will receive the choice architecture nudge intervention.

Intervention: Choice Architecture Nudge (Behavioral)

PMP Integration & Nudge

Experimental

Clinics in this arm will receive the Prescription Drug Monitoring (PMP) Integration & Nudge intervention.

Intervention: PMP Integration & Nudge (Behavioral)

Choice Architecture Nudge + PMP Integration & Nudge

Experimental

Clinics in this arm will receive both the choice architecture nudge and prescription drug monitoring (PMP) integration & nudge interventions.

Intervention: Choice Architecture Nudge (Behavioral)

Choice Architecture Nudge + PMP Integration & Nudge

Experimental

Clinics in this arm will receive both the choice architecture nudge and prescription drug monitoring (PMP) integration & nudge interventions.

Intervention: PMP Integration & Nudge (Behavioral)

Outcomes

Primary Outcomes

Frequency of PDMP Checks

Time Frame: 12 months

Outcome is reported as the mean number of times an individual Primary Care Provider checks the Prescription Drug Monitoring Program per month.

Secondary Outcomes

  • PCP Satisfaction #2(12 months)
  • PCP Satisfaction #1(12 months)
  • PCP Satisfaction #5(12 months)
  • PCP Satisfaction #6(12 months)
  • PCP Satisfaction #7(12 months)
  • PCP Satisfaction #3(12 months)
  • PCP Satisfaction #4(12 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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