CompletedNot Applicable

Chronic Pain OneSheet Clinical Trial

United States137 participantsStarted 2020-08-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain and Function Goal-setting

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

Pain, Enjoyment of Life, and General Activity (PEG) Documentation

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

Urine Drug Screening (UDS) Results Ordered

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

Prescription Drug Monitoring Program (PDMP) Reports Reviewed

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

Trial details

NCT IDNCT04295135

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-18

Results submitted2024-03-12

View on ClinicalTrials.gov More Chronic Pain trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Pain and Function Goal-setting

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

Pain, Enjoyment of Life, and General Activity (PEG) Documentation

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

Urine Drug Screening (UDS) Results Ordered

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

Prescription Drug Monitoring Program (PDMP) Reports Reviewed

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