Chronic Pain OneSheet Clinical Trial

Study Overview
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Brief Summary
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The purpose of the study is 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 providers in visits with patients with chronic pain conditions. The investigators will also assess whether access to the Chronic Pain OneSheet results in primary care providers 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
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The Chronic Pain OneSheet (OneSheet) is an electronic health record (EHR) based clinical support tool that was developed and built in Epic. The OneSheet is a dashboard that was designed to assist providers in treating patients with chronic pain conditions, by providing an overview of patient information needed by providers when treating these patients. The dashboard does not provide new information to providers, but rather works by aggregating and structuring information that is already being collected, and that is available in other places in the medical record. By aggregating and structuring this information in a more convenient manner, the goal of the OneSheet is to make the information that is important in clinical decision-making more readily available, and to reduce the amount of time that providers need to spend locating this information. The purpose of the study is 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 providers in visits with patients with chronic pain conditions. The investigators will also assess whether access to the Chronic Pain OneSheet results in primary care providers making chronic pain treatment decisions that are more concordant with the CDC Guideline for Prescribing Opioids for Chronic Pain. To test this, researchers will conduct a two-arm pragmatic cluster randomized controlled trial (RCT) with 80 primary care providers (PCP) across two health systems. The investigators will assess outcomes by analyzing EHR usage log files and PCP ordering records extracted from the healthcare systems' clinical data warehouses.

Official Title
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Nudging Primary Care Providers Toward Guideline-Recommended Opioid Prescribing Through Easier and More Convenient EHR Information Design

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: Chronic Pain OneSheet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary care provider (including Family Medicine, Internal Medicine, Med-Peds, and General Medicine) Is able to 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 Is not able to prescribe medication

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OneSheet access<br>Clinics or providers who receive access to, and training in the Chronic Pain OneSheet, and use it while caring for patients with chronic pain. | Behavioral: Chronic Pain OneSheet<br>* The Chronic Pain OneSheet (OneSheet) is an EHR decision support tool that uses behavioral economics to increase adoption of chronic pain guideline recommendations. The OneSheet works by aggregating and structuring information that is already collected, that providers often need while caring for patients with chronic pain conditions. By aggregating and structuring this information in a more convenient manner, the goal of the OneSheet is to make the information that is important in clinical decisionmaking more readily available, and to reduce the amount of time that providers need to spend locating this information.<br>* Other names: Pain Dashboard;|
| No Intervention: Normal practice<br>Clinics or providers who do not receive access to, or training in the Chronic Pain OneSheet, and care for patients with chronic pain as they would normally. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain and function goal-setting | Proportion of patients with chronic pain for whom the provider documented pain and/or function goals in the EHR, as assessed by data extracted from the healthcare systems' clinical data warehouse. | Up to 2 years | 
| Pain and function assessment | Proportion of patients with chronic pain for whom the provider documented the assessment of pain and/or function (e.g. Pain, Enjoyment, General Activity (PEG) scale, scale of 1-10, used to track an individual's changes over time, with effective therapy, an individual's score should decrease over time) in the EHR, as assessed by data extracted from the healthcare systems' clinical data warehouse. | Up to 2 years | 
| Opioid-related risk assessment | Proportion of patients with chronic pain for whom the provider documented the assessment of opioid-related risk (e.g. prescription drug monitoring program (PDMP) and/or urine drug screen (UDS)) in the EHR, as assessed by data extracted from the healthcare systems' clinical data warehouse. | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine drug screens (UDS) ordered | Proportion of patients with chronic opioid patients for whom the provider ordered a UDS, as assessed by data extracted from the healthcare systems' clinical data warehouse. | Up to 2 years | 
| Prescription drug monitoring program (PDMP) reports accessed | Proportion of patients with chronic opioid patients for whom the provider accessed the PDMP report, as assessed by data extracted from the healthcare systems' clinical data warehouse. | Up to 2 years | 
| Naloxone prescriptions ordered | Proportion of patients with chronic opioid patients at high risk of overdose, or on high dosages of opioid medications, for whom the provider ordered naloxone, as assessed by data extracted from the healthcare systems' clinical data warehouse. | Up to 2 years | 
| Referral for medication-assisted therapy | Proportion of patients who exhibit symptoms of opioid use disorder for whom the provider ordered medication-assisted therapy, as assessed by data extracted from the healthcare systems' clinical data warehouse. | Up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clinical Decision Support, Chronic pain care, Behavioral Economics, Provider behavior