Chronic Pain OneSheet Clinical Trial
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: OneSheet access 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
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.
Other Names:
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| No Intervention: Normal practice 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. |
Outcome Measures
Primary Outcome Measures
- Pain and function goal-setting [Up to 2 years]
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.
- Pain and function assessment [Up to 2 years]
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.
- Opioid-related risk assessment [Up to 2 years]
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.
Secondary Outcome Measures
- Urine drug screens (UDS) ordered [Up to 2 years]
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.
- Prescription drug monitoring program (PDMP) reports accessed [Up to 2 years]
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.
- Naloxone prescriptions ordered [Up to 2 years]
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.
- Referral for medication-assisted therapy [Up to 2 years]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Primary care provider (including Family Medicine, Internal Medicine, Med-Peds, and General Medicine)
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Is able to prescribe medication (i.e., Doctor of Medicine (MD), Nurse Practitioner (NP), Physicians Assistant (PA))
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Sees patients at a primary care clinic at one of the two participating hospital systems
Exclusion Criteria:
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Does not practice primary care
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Does not regularly see patients at a primary care clinic at one of the two participating hospital systems
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Is not able to prescribe medication
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Indiana University | Indianapolis | Indiana | United States | 46202 |
| 2 | Wake Forest University | Winston-Salem | North Carolina | United States | 27109 |
Sponsors and Collaborators
- Indiana University
- Eskenazi Health
- Wake Forest University
- Wake Forest University Health Sciences
- University of Florida
Investigators
- Principal Investigator: Harle Christopher, PhD, University of Florida
- Principal Investigator: Olena Mazurenko, MD, PhD, Indiana University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1911922583