Chronic Pain OneSheet Clinical Trial

Indiana University

Status: Completed

Conditions: Chronic Pain

Treatments: Behavioral: Chronic Pain OneSheet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04295135

5R33DA046085-05 (U.S. NIH Grant/Contract)

1911922583

Details and patient eligibility

About

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.

Full 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.

Enrollment: 137 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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137 participants in 2 patient groups

OneSheet access

Experimental group

Description:

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

Treatment:

Behavioral: Chronic Pain OneSheet

Normal practice

No Intervention group

Description:

PCPs who do not receive access to, or training in the Chronic Pain OneSheet, and care for patients with chronic pain as they would normally.