CompletedNot Applicable

Comparing State Payer Strategies to Prevent Unsafe Opioid Prescribing

United States5,411 participantsStarted 2019-08-06

Plain-language summary

This study examines the comparative effectiveness of opioid review programs in reducing unsafe opioid prescribing in two states: prospective prior authorization (PA) with hard stops in Washington and retrospective review (RR) with prescriber notification in Ohio.

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: Aims 1 and 2: * File a new accepted State Fund claim * Fill at least one opioid prescription, paid for by workers' compensation, during the first 6 weeks after date of injury Aim 3 key informants * Policy makers and stakeholders who were involved in the creation and implementation of the Washington or Ohio opioid review program. Aim 3 individual in-depth interviews * Providers that had at least one patient whose opioid prescriptions paid for through workers' compensation had been reviewed in accordance with the state's opioid review program. * Patients that had an opioid prescription for at least 6 weeks paid for by workers' compensation or whose prescription payments have been reviewed in accordance with the state's opioid review program. Exclusion Criteria (Aims 1 and 2): * Under 18 years of age * Current cancer diagnosis * Surveys only: do not speak English or Spanish, physically or mentally incapable of completing the survey, incarcerated, deceased

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

Subacute Phase - More Than 7 Days of Opioids

Timeframe: 6-12 weeks after injury

Chronic Phase - Composite (Meeting ≥1 of the 3 Chronic Phase Metrics)

Timeframe: 3-6, 6-9, and 9-12 months after injury

Chronic Phase - Chronic Opioids (≥60 Days' Supply)

Timeframe: 3-6, 6-9, and 9-12 months after injury

Chronic Phase - Concurrent (Concurrent Sedatives/Hypnotics and Opioids on ≥1 Day)

Timeframe: 3-6, 6-9, and 9-12 months

Chronic Phase - High Dose (Average of ≥50 Morphine Equivalent Daily Dose [MEDD] Among All Days With Opioids)

Timeframe: 3-6, 6-9, and 9-12 months after injury

Trial details

NCT IDNCT03932799

SponsorUniversity of Washington

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-03-31

Results submitted2022-11-10

View on ClinicalTrials.gov More Opioid Use trials

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

Subacute Phase - More Than 7 Days of Opioids

Timeframe: 6-12 weeks after injury

Chronic Phase - Composite (Meeting ≥1 of the 3 Chronic Phase Metrics)

Timeframe: 3-6, 6-9, and 9-12 months after injury

Chronic Phase - Chronic Opioids (≥60 Days' Supply)

Timeframe: 3-6, 6-9, and 9-12 months after injury

Chronic Phase - Concurrent (Concurrent Sedatives/Hypnotics and Opioids on ≥1 Day)

Timeframe: 3-6, 6-9, and 9-12 months

Chronic Phase - High Dose (Average of ≥50 Morphine Equivalent Daily Dose [MEDD] Among All Days With Opioids)

Timeframe: 3-6, 6-9, and 9-12 months after injury