Project Summary

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Acute pain is severe pain that lasts about three to six months.It is one of the most common health problems primary care providers treat. Opioids, a type of prescription medicine, can help ease acute pain. However, long-term opioid use can lead to addiction or overdose. Every day in the United States, 115 people die from opioid overdose.

In this study, the research team is comparing four ways to help providers like doctors and nurses treat acute pain and reduce unsafe opioid prescribing. The team also wants to know how these four ways affect patients’ pain, whether pain limits their ability to do daily activities when they are being treated, and how happy they are with their care.

Who can this research help?

Results from this study can help leaders of health system administrators and primary care clinic managers decide how to help providers treat acute pain safely.

What is the research team doing?

The research team is working with 48 primary care clinics in Pennsylvania and Utah.

At each clinic, the team is adding an acute pain treatment guideline to the electronic health record, or EHR. Clinical practice guidelines are recommendations for providers about when and how to test for or treat health problems. Guidelines are based on research that compares benefits and harms of different tests or treatments. For example, it is unsafe to prescribe a long-acting opioid as the first treatment for acute pain.

The team is assigning each clinic by chance to one of four ways of helping providers use the guideline when treating acute pain. The four ways are:

  • Usual care – the providers see the guideline when they want to prescribe an opioid
  • In addition to seeing the guideline, when providers prescribe an opioid, they must enter the reason into the EHR
  • Providers see the guideline and receive a monthly email on how often they prescribed opioids for acute pain compared with their peers
  • Providers see the guideline, enter a reason for prescribing opioids into the EHR, and receive monthly emails on how often they prescribed opioids compared with their peers

At the clinics, the team is looking at medical records for 10,936 patients with acute pain or headache who have never used opioids. The team is reviewing medical records from the first clinic visit and over the next 12 months. For each of the ways of treating acute pain, the team is comparing the number of patients who receive unsafe opioid treatment, non-opioid pain treatment, opioid prescriptions, and long-term opioid treatment.

The team is surveying 2,500 patients at 1, 6, and 12 months after the first clinic visit to compare patients’ reports of pain, how much pain interferes with their daily life, and how happy they are with their care.

Patients, patient advocates, primary care providers, pain medicine experts, and health insurers help design and conduct the study.

Research methods at a glance

Design Element Description
Design Randomized controlled trial
Population 10,936 opioid naïve adults who present to clinic with acute uncomplicated musculoskeletal pain or headache
Interventions/
Comparators
  • Evidence-based EHR guidelines (usual care)

  • Evidence-based EHR guidelines plus opioid justification in EHR

  • Evidence-based EHR guidelines plus monthly email with comparative prescribing information

  • Evidence-based EHR guidelines plus opioid justification in EHR and monthly email with comparative prescribing information

Outcomes

Primary: unsafe opioid prescribing (use of an extended-release or long-acting opioid for acute pain; >100 morphine milligram equivalent dose per day; or opioid prescription in patient with substance use disorder or concurrent benzodiazepine description)

Secondary: receipt of an opioid prescription, non-opioid management, transition to chronic opioid therapy (>3 months), pain, physical function, provider and patient satisfaction with interventions

Timeframe 1-year follow-up for primary outcome

Project Information

Kevin Kraemer, MD
University of Pittsburgh
$3,972,816
Provider-Targeted Behavioral Interventions to Prevent Unsafe Opioid Prescribing for Acute Non-Cancer Pain in Primary Care

Key Dates

August 2017
November 2022
2017

Study Registration Information

Tags

Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: March 15, 2022