Clinical trial NCT03932799: Comparing State Payer Strategies to Prevent Unsafe Opioid Prescribing
Official title: The Washington and Ohio Worker (WOW) Study: Comparing State Payer Strategies to Prevent Unsafe Opioid Prescribing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid Use
Opioid-Related Disorders
Keywords: Workers' Compensation
Occupational Injuries
Drug Utilization Review
Humans
Adult
Cohort Studies
Qualitative Research
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2019-05-01
Enrollment: 5411
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Workers in the Washington Department of Labor and Industries or Ohio Bureau of Workers' Compensation state fund insurance system.

Brief 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.

Detailed description: Use and misuse of opioids is now recognized as a major U.S. public health problem, leading to significant morbidity and mortality. Prescribing of both opioids and concurrent sedative-hypnotics for acute and chronic musculoskeletal pain increased dramatically from 2001 to 2010. The clearest path to preventing transition to chronic opioid use and associated morbidity or addiction is to reduce unnecessary prescribing during the acute (0-6 weeks) and subacute (6-12 weeks) phases of pain.

Both prior authorization (PA) and other insurer-based drug utilization programs are increasingly being used in an attempt to stem the tide of the opioid epidemic and to reduce unsafe opioid prescribing. Review programs have proven effective in decreasing use and overall costs of more expensive medications. Washington (WA) and Ohio (OH) offer a unique opportunity to study opioid prescribing interventions because both states have regulatory authority over health care delivery to all injured workers, and are the two largest states with a population-based exclusive State Fund. Further, both states have initiated distinct prescribing guideline-concordant opioid review programs (ORPs), allowing for a unique natural experiment to compare the effectiveness of two substantially different approaches to reducing unsafe opioid prescribing.

This is an observational cohort study, with prospective and retrospective components. Aims 1 and 2 rely primarily on administrative data for a prospective cohort, with longitudinal surveys conducted among a subset of the cohort. Aim 1 also includes a retrospective time series analysis. Aim 3 relies on qualitative research, including individual in-depth interviews and key informant interviews.

Specific aim 1. Examine the comparative effectiveness of prospective prior authorization (PA) with hard stops in WA versus retrospective review (RR) with prescriber notification in OH in reducing unsafe opioid prescribing.

Specific aim 2. Examine the comparative effectiveness of WA's PA program versus OH's RR program with regard to patient reported outcomes (pain, function, quality of life, return to work), harms (presence of opioid use disorder, opioid poisoning events) and work disability outcomes at 6 weeks, 6 months, and 12 months from date of injury.

Specific aim 2a. For injured workers in WA, examine unsafe opioid prescribing and patient-reported outcomes and work disability at 6 and 12 months for patients receiving an established, coordinated, stepped care management program during the first 12 weeks following injury plus prospective PA versus patients receiving usual care subject to PA only.

Specific aim 3. Using qualitative methods, identify key environmental, programmatic and policy factors that influenced the design, implementation and impact of the PA program in WA and the RR program in OH. This information will lead to the development of an Opioid Review Tool educational module for dissemination to both public and private payers.

Eligibility criteria: 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

Primary outcomes:
measure: Subacute Phase - More Than 7 Days of Opioids
timeFrame: 6-12 weeks after injury
measure: Chronic Phase - Composite (Meeting ≥1 of the 3 Chronic Phase Metrics)
timeFrame: 3-6, 6-9, and 9-12 months after injury
measure: Chronic Phase - Chronic Opioids (≥60 Days' Supply)
timeFrame: 3-6, 6-9, and 9-12 months after injury
measure: Chronic Phase - Concurrent (Concurrent Sedatives/Hypnotics and Opioids on ≥1 Day)
timeFrame: 3-6, 6-9, and 9-12 months
measure: 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
Secondary outcomes:
measure: ≥30% Decrease in Pain Intensity/Interference (PEG-3)
timeFrame: 12 months after injury
measure: Anxious Symptoms (PHQ-4)
timeFrame: 12 months after injury
measure: Depressive Symptoms (PHQ-4)
timeFrame: 12 months after injury
measure: Global Improvement (GIC)
timeFrame: 12 months after injury
measure: Disability - Activity Limitation
timeFrame: 12 months after injury
measure: Not Working for Pay
timeFrame: 12 months after injury
measure: On Time Loss (Not Working)
timeFrame: 12 months after injury
measure: Earning Less Than Before Injury
timeFrame: 12 months after injury
measure: Opioid Overdose/Adverse Effects
timeFrame: 12 months after injury
measure: Quality of Life (EuroQol EQ-5D)
timeFrame: 12 months after injury
measure: Satisfaction With Overall Treatment
timeFrame: 12 months after injury
measure: Satisfaction With Pain-related Treatment
timeFrame: 12 months after injury
Other outcomes:
measure: Problematic Opioid Use (TAPS)
timeFrame: 12 months after injury
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Gary M Franklin, MD
role: PRINCIPAL_INVESTIGATOR
References: