Clinical trial NCT04295135: Chronic Pain OneSheet Clinical Trial
Official title: Nudging Primary Care Providers Toward Guideline-Recommended Opioid Prescribing Through Easier and More Convenient EHR Information Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Clinical Decision Support
Chronic pain care
Behavioral Economics
Provider behavior
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Eskenazi Health
name: Wake Forest University
name: Wake Forest University Health Sciences
name: University of Florida
name: National Institute on Drug Abuse (NIDA)
First posted: 2020-03-04
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of the study is to determine whether and how having access to the Chronic Pain OneSheet clinical decision support tool in Epic affects the ordering, prescribing, goal-setting, risk monitoring, and outcome measuring behavior of participating primary care providers (PCPs) in visits with patients with chronic pain conditions. The investigators will also assess whether access to the Chronic Pain OneSheet results in PCPs making chronic pain treatment decisions that are more concordant with the Centers for Disease Control and Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain.

Detailed description: The Chronic Pain OneSheet (OneSheet) is an electronic health record (EHR) based clinical support tool developed and built in Epic. The OneSheet is a dashboard designed to assist PCPs in treating patients with chronic pain conditions by providing an overview of patient information needed by PCPs when treating these patients. The dashboard does not provide new information to PCPs. Instead, it works by aggregating and structuring information already being collected, available in other places in the medical record. By aggregating and structuring this information more conveniently, the goal of the OneSheet is to make important information in clinical decision-making more readily available and reduce the time PCPs need to spend locating this information.

The study aimed to determine whether and how having access to the Chronic Pain OneSheet activity in Epic affects the ordering, prescribing, goal-setting, risk monitoring, and outcome-measuring behavior of participating PCPs in visits with patients with chronic pain conditions. The investigators also assessed whether access to the Chronic Pain OneSheet results in PCPs making chronic pain treatment decisions that are more concordant with the CDC Guideline for Prescribing Opioids for Chronic Pain.

To test this, researchers conducted a two-arm pragmatic randomized controlled trial (RCT), enrolling PCPs across two health systems. The randomization occurred at the PCP level; the analysis occurred at the patient-visit level. The PCPs signed an informed consent form, while the data from patient visits was obtained through a waiver of informed consent. The investigators assessed outcomes by analyzing EHR usage log files and PCP ordering records extracted from the healthcare systems' clinical data warehouses.

Eligibility criteria: Inclusion Criteria:

* Primary care provider (including Family Medicine, Internal Medicine, Med-Peds, and General Medicine)
* Can prescribe medication (i.e., Doctor of Medicine (MD), Nurse Practitioner (NP), Physicians Assistant (PA))
* Sees patients at a primary care clinic at one of the two participating hospital systems

Exclusion Criteria:

* Does not practice primary care
* Does not regularly see patients at a primary care clinic at one of the two participating hospital systems
* Cannot prescribe medication

Primary outcomes:
measure: Pain and Function Goal-setting
timeFrame: Assessed at baseline (looked back at previous 12 months) and 18-month treatment period
measure: Pain, Enjoyment of Life, and General Activity (PEG) Documentation
timeFrame: Assessed at baseline (looked back at previous 12 months) and 18-month treatment period
measure: Urine Drug Screening (UDS) Results Ordered
timeFrame: Assessed at baseline (looked back at previous 12 months) and 18-month treatment period
measure: Prescription Drug Monitoring Program (PDMP) Reports Reviewed
timeFrame: Assessed at baseline (looked back at previous 12 months) and 18-month treatment period
Secondary outcomes:
measure: Naloxone Prescriptions Ordered
timeFrame: Assessed at baseline (looked back at previous 12 months) and 18-month treatment period
measure: Medications for Opioid Use Disorder Prescription Ordered
timeFrame: Assessed at baseline (looked back at previous 12 months) and 18-month treatment period
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
Study officials:
affiliation: Indiana University
name: Christopher A Harle, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University
name: Olena Mazurenko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mazurenko O, Sanner L, Apathy NC, Mamlin BW, Menachemi N, Adams MCB, Hurley RW, Erazo SF, Harle CA. Evaluation of electronic recruitment efforts of primary care providers as research subjects during the COVID-19 pandemic. BMC Prim Care. 2022 Apr 28;23(1):95. doi: 10.1186/s12875-022-01705-y.