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?

Opioid prescribing has increased steadily over the past two decades; deaths due to overdose from prescription opioids have increased fivefold over the same period. One way to prevent long-term opioid use and opioid-related deaths is to reduce unsafe prescribing in the first three months of pain treatment. Unsafe prescribing occurs when doctors don’t follow evidence-based guidelines on how and when patients can safely take opioids. Guidelines say doctors should limit the number of days on opioids and offer other treatments.

Insurers help reduce unsafe opioid prescribing through programs such as

  • Prior authorization, or PA, with hard stops: Doctors must get approval from the insurer to continue prescribing opioids for a patient after a certain amount of time. If the doctor doesn’t meet specific guidelines for approval, the insurer stops paying for opioids.
  • Retrospective review and notification, or RR: The insurer reviews medical records and notifies the doctor of prescriptions that don’t follow guidelines. If prescriptions continue to not follow guidelines, the insurer stops paying for opioids.

In this study, the research team is comparing how well two state-funded insurance programs for workers reduce unsafe opioid prescribing. Washington’s program uses PA with hard stops. Ohio uses an RR program. The team is also studying factors that affect how the states carry out these programs.

Who can this research help?

Results may help state insurers considering programs to prevent unsafe opioid prescribing.

What is the research team doing?

The research team is comparing two existing state insurance plans for workers. Both programs have rules to prevent unsafe opioid prescribing. Both programs also use similar prescribing guidelines. The team is looking at data for 6,500 workers in the two states.

Washington’s PA program has a hard stop for opioid payment six weeks after injury. After six weeks, doctors must fill out a checklist showing that they are following prescribing guidelines.

Ohio’s RR program flags opioid prescriptions written six weeks after the patient’s injury. Pharmacy and clinical staff review the patient’s medical record after 12 weeks to see if the doctor followed prescribing guidelines. If not, the doctor gets a letter saying that they are not meeting guidelines. The record is reviewed again at 16 weeks. If the doctor still hasn’t followed guidelines, the doctor and patient get a letter saying that opioid coverage will end in four weeks.

The research team is reviewing pharmacy billing records to see how often doctors prescribe opioids in an unsafe way. The team is also surveying a sample of the workers about outcomes related to pain treatment such as physical function and quality of life. The team is comparing these outcomes between the Washington and Ohio programs up to one year after injury.

Finally, the research team is conducting interviews with policy makers and focus groups with clinicians and patients. The team hopes to learn about factors that influenced the design of the Washington and Ohio programs, how they operated, and their effects. The team is using this information to design resources to help insurers start programs on safe opioid prescribing.

People helping with the study include

  • Injured workers with chronic pain, opioid use disorder, and difficulty ending opioid treatment
  • Doctors
  • Pharmacy managers
  • Insurance industry representatives
  • National patient advocacy group representatives

Research methods at a glance

Design Elements Description
Design Observational: cohort study
Population 6,500 adults ages 18 and older covered by state-funded workers’ compensation insurance programs in Washington and Ohio
Interventions/
Comparators
  • Prospective PA with hard stops in Washington
  • RR with prescriber notification in Ohio
Outcomes

Primary: rate of unsafe opioid prescribing during subacute phase of pain (measured as prescription for >7 days’ supply of opioid); rate of unsafe opioid prescribing during chronic phase of pain (measured as prescription for ≥60 days’ supply of opioid; opioid prescription with concurrent sedatives/hypnotics; opioid prescription of ≥50 morphine equivalent dose/day; at least one of the following: 60 days’ supply, concurrent sedatives/hypnotics, or ≥50 MED/day)

Secondary: pain intensity, pain interference, anxiety and depression, global improvement since beginning treatment, disability, quality of life, overall satisfaction with treatment, satisfaction with pain-related treatment, change in work hours from before injury, change in wages from before injury, work status, opioid poisoning events

Exploratory: prevalence of opioid use disorder

Timeframe 1-year follow-up for primary outcomes

Project Information

Gary Franklin, MD, MPH
University of Washington
$4,995,467

Key Dates

36 months
August 2018
July 2023
2018

Study Registration Information

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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.

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Last updated: December 4, 2020