Chronic Pain OneSheet Clinical Trial

NCT04295135 | Completed Results DMC

• 2 other identifiers: 19119225835R33DA046085-05
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Pain

Keywords

Clinical Decision Support; Chronic pain care; Behavioral Economics; Provider behavior

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (2)

• Naloxone Prescriptions Ordered

  Assessed at baseline (looked back at previous 12 months) and 18-month treatment period

• Medications for Opioid Use Disorder Prescription Ordered

  Assessed at baseline (looked back at previous 12 months) and 18-month treatment period

Study Arms (2)

OneSheet access

EXPERIMENTAL

PCPs 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

Normal practice

NO INTERVENTION

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.

Interventions

Chronic Pain OneSheet BEHAVIORAL

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.

Also known as: Pain Dashboard

OneSheet access

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• Eskenazi Health: collaborator
• Wake Forest University: collaborator
• Wake Forest University Health Sciences: collaborator
• University of Florida: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27109, United States

Location

Related Publications (1)

• Mazurenko O, Sanner L, Apathy NC, Mamlin BW, Menachemi N, Adams MCB, Hurley RW, Erazo SF, Harle CA. Evaluation of electronic recruitment efforts of primary care providers as research subjects during the COVID-19 pandemic. BMC Prim Care. 2022 Apr 28;23(1):95. doi: 10.1186/s12875-022-01705-y.

  PMID: 35484491 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Christopher A. Harle
• Organization: Indiana University

charle@iu.edu

317 278 3245

Study Officials

• Christopher A Harle, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

• Olena Mazurenko, MD, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 15, 2020
• First Posted: March 4, 2020
• Study Start: August 4, 2020
• Primary Completion: May 18, 2022
• Study Completion: May 18, 2022
• Last Updated: May 24, 2024
• Results First Posted: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)