Chronic Pain OneSheet Clinical Trial

Not Applicable

Completed

• Conditions: Chronic Pain
• Interventions: Behavioral: Chronic Pain OneSheet

• Registration Number: NCT04295135
• Lead Sponsor: Indiana University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-02-15
• Study First Submitted QC: 2020-03-02
• Study First Posted: 2020-03-04
• Study Start: 2020-08-04
• Primary Completion: 2022-05-18
• Study Completion: 2022-05-18
• Disposition First Submitted: 2022-11-21
• Disposition First Submitted QC: 2022-11-21
• Disposition First Posted: 2022-11-28
• Results First Submitted: 2024-03-12
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-22
• Last Update Submitted: 2024-05-22
• Results First Posted: 2024-05-24
• Last Update Posted: 2024-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OneSheet access	Chronic Pain OneSheet	PCPs who receive access to, and training in the Chronic Pain OneSheet, and use it while caring for patients with chronic pain.

Primary Outcome Measures

Name	Time	Method
Pain and Function Goal-setting	Assessed at baseline (looked back at previous 12 months) and 18-month treatment period	Proportion of visits for patients with chronic pain for whom the PCP documented pain and/or function goals in the EHR, as assessed by data extracted from the healthcare systems' clinical data warehouse.
Pain, Enjoyment of Life, and General Activity (PEG) Documentation	Assessed at baseline (looked back at previous 12 months) and 18-month treatment period	Proportion of visits for patients with chronic pain for whom the PCP documented the assessment of pain and/or function (e.g. Pain, Enjoyment, General Activity (PEG) scale in the EHR, as assessed by data extracted from the healthcare systems' clinical data warehouse. The PEG has a scale of 1-10, and is used to track an individual's changes over time. With effective therapy, an individual's score should decrease over time.
Urine Drug Screening (UDS) Results Ordered	Assessed at baseline (looked back at previous 12 months) and 18-month treatment period	Proportion of visits for patients with chronic pain on long term opioid therapy (LTOT) for whom the PCP ordered a UDS, as assessed by data extracted from the healthcare systems' clinical data warehouse.
Prescription Drug Monitoring Program (PDMP) Reports Reviewed	Assessed at baseline (looked back at previous 12 months) and 18-month treatment period	Proportion of visits for patients with chronic pain on LTOT for whom the PCP accessed the PDMP report, as assessed by data extracted from the healthcare systems' clinical data warehouse.

Secondary Outcome Measures

Name	Time	Method
Naloxone Prescriptions Ordered	Assessed at baseline (looked back at previous 12 months) and 18-month treatment period	Proportion of visits for patients with chronic pain on LTOT for whom the PCP ordered naloxone, as assessed by data extracted from the healthcare systems' clinical data warehouse.
Medications for Opioid Use Disorder Prescription Ordered	Assessed at baseline (looked back at previous 12 months) and 18-month treatment period	Proportion of visits for patients with chronic pain on LTOT for whom the PCP ordered a medication for opioid use disorder, as assessed by data extracted from the healthcare systems' clinical data warehouse.

Trial Locations

Locations (2)

Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States