Chronic Pain OneSheet Clinical Trial

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04295135
• Other study ID #: 1911922583
• Secondary ID: 5R33DA046085-05
• Status: Completed
• Phase: N/A
• Start date: August 4, 2020
• Est. completion date: May 18, 2022

Study information

• Verified date: May 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: May 18, 2022
• Est. primary completion date: May 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Chronic Pain OneSheet
The Chronic Pain OneSheet (OneSheet) is an EHR decision support tool that uses behavioral economics to increase adoption of chronic pain guideline recommendations. OneSheet works by aggregating and structuring information that is already collected, that PCPs often need while caring for patients with chronic pain conditions. By aggregating and structuring this information in a more convenient manner, the goal of OneSheet is to make the information that is important in clinical decision making more readily available, and to reduce the amount of time that PCPs need to spend locating this information.

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (6)

Lead Sponsor	Collaborator
Indiana University	Eskenazi Health, National Institute on Drug Abuse (NIDA), University of Florida, Wake Forest University, Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain and Function Goal-setting	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.	Assessed at baseline (looked back at previous 12 months) and 18-month treatment period
Primary	Pain, Enjoyment of Life, and General Activity (PEG) Documentation	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.	Assessed at baseline (looked back at previous 12 months) and 18-month treatment period
Primary	Urine Drug Screening (UDS) Results Ordered	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.	Assessed at baseline (looked back at previous 12 months) and 18-month treatment period
Primary	Prescription Drug Monitoring Program (PDMP) Reports Reviewed	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.	Assessed at baseline (looked back at previous 12 months) and 18-month treatment period
Secondary	Naloxone Prescriptions Ordered	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.	Assessed at baseline (looked back at previous 12 months) and 18-month treatment period
Secondary	Medications for Opioid Use Disorder Prescription Ordered	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.	Assessed at baseline (looked back at previous 12 months) and 18-month treatment period