Clinical trial NCT04601506: PRescribing INterventions for Chronic Pain Via the Electronic Health Record Study - Primary Care Providers
Official title: PRescribing INterventions for Chronic Pain Via the Electronic Health Record Study - Primary Care Providers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Opioid Use
Opioid Abuse
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-10-23
Enrollment: 472
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Frequency of PDMP Checks
timeFrame: 12 months
Secondary outcomes:
measure: PCP Satisfaction #1
timeFrame: 12 months
measure: PCP Satisfaction #2
timeFrame: 12 months
measure: PCP Satisfaction #3
timeFrame: 12 months
measure: PCP Satisfaction #4
timeFrame: 12 months
measure: PCP Satisfaction #5
timeFrame: 12 months
measure: PCP Satisfaction #6
timeFrame: 12 months
measure: PCP Satisfaction #7
timeFrame: 12 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Ezra Golberstein, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.