Comparing State Payer Strategies to Prevent Unsafe Opioid Prescribing

Completed

Conditions: Opioid Use
Opioid-Related Disorders

Interventions: Other: Prospective prior authorization (PA) with hard stops in Washington
Other: Retrospective review (RR) with prescriber notification in Ohio

Registration Number: NCT03932799

Lead Sponsor: University of Washington

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 5411

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

Exclusion Criteria

Not provided

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Washington	Prospective prior authorization (PA) with hard stops in Washington	Workers in the Washington Department of Labor and Industries state fund insurance system.
Ohio	Retrospective review (RR) with prescriber notification in Ohio	Workers in the Ohio Bureau of Workers' Compensation state fund insurance system.

Primary Outcome Measures

Name	Time	Method
Chronic Phase - Chronic Opioids (≥60 Days' Supply)	3-6, 6-9, and 9-12 months after injury	60 or more unique days of opioids within the time period
Chronic Phase - High Dose (Average of ≥50 Morphine Equivalent Daily Dose [MEDD] Among All Days With Opioids)	3-6, 6-9, and 9-12 months after injury	Mean MEDD of 50 or more during the days a worker received opioids (based on days' supply) within the time period
Chronic Phase - Concurrent (Concurrent Sedatives/Hypnotics and Opioids on ≥1 Day)	3-6, 6-9, and 9-12 months	At least 1 overlapping day of both a sedative and an opioid within the time period
Chronic Phase - Composite (Meeting ≥1 of the 3 Chronic Phase Metrics)	3-6, 6-9, and 9-12 months after injury	At least 1 instance of either chronic opioid prescribing, concurrent opioid and sedative prescribing, or high dose opioid prescribing attributed to a worker within the time period
Subacute Phase - More Than 7 Days of Opioids	6-12 weeks after injury	More than 7 unique days of opioids within the time period

Secondary Outcome Measures

Name	Time	Method
On Time Loss (Not Working)	12 months after injury	1 = on time loss (workers' compensation warrant data); 0 = otherwise.
Satisfaction With Overall Treatment	12 months after injury	Single-item 5-point Likert scale rating of how satisfied participants were with all injury-related treatment (-2 = very dissatisfied, 2 = very satisfied).
Depressive Symptoms (PHQ-4)	12 months after injury	2-item PHQ-4 subscale assessing how often participant was bothered by depressive symptoms on 4-point scale (0 = not at all, 3 = nearly every day). 1 = summed subscale score ≥3; 0 = otherwise.
Quality of Life (EuroQol EQ-5D)	12 months after injury	5-item scale in which participants were asked to rate the extent to which they experienced problems with mobility, self-care, usual activities, pain/discomfort, and anxiety/depression on a 5-point scale (1 = no problems, 5 = extreme problems). Individual item responses were used to create score profiles (range 11111 to 55555), which were then converted to an index value using a US-based value set. -0.573 (worst health state) to 1 (best health state)
Earning Less Than Before Injury	12 months after injury	Participants asked to rate on a 5-point Likert scale the extent to which earnings differed from earnings at time of injury (1 = a lot more than before the injury, 5 = a lot less than before the injury). 1 = "somewhat less than before", "a lot less than before the injury", or not working; 0 = otherwise.
Global Improvement (GIC)	12 months after injury	Global Impression of Change on 7-point Likert scale. Participants asked to rate how they compared now to immediately after their injury (1 = very much improved, 7 = very much worse) 1 = "much improved" or "very much improved"; 0 = otherwise.
Satisfaction With Pain-related Treatment	12 months after injury	Single-item 5-point Likert scale rating of how satisfied participants were with treatment received for injury-related pain (-2 = very dissatisfied, 2 = very satisfied).
Anxious Symptoms (PHQ-4)	12 months after injury	2-item PHQ-4 subscale assessed how often participant was bothered by anxious symptoms on 4-point scale (0 = not at all, 3 = nearly every day). 1 = summed subscale score ≥3; 0 = otherwise.
≥30% Decrease in Pain Intensity/Interference (PEG-3)	12 months after injury	Clinically important improvement in pain intensity/interference defined as obtaining a ≥30% reduction in pain intensity and interference from baseline. This was assessed with the PEG-3, which is comprised of 3 items assessing pain intensity and pain interference with enjoyment of life/general activity on a 0 to 10 numerical rating scale (0 = no pain/does not interfere, 10 = pain as bad as you can imagine/completely interferes). 1 = ≥30% reduction in mean PEG-3 summary score from baseline; 0 = otherwise.
Disability - Activity Limitation	12 months after injury	Modified activity limitation items from the National Health Interview Survey (NHIS) 2011 Adult Functioning Supplement. Participants were asked to rate on a 3-point scale (limited a lot, limited a little, not limited at all) whether their health was limited in four domains: participating in leisure or social activities, getting out with friends or family, doing household chores such as cooking and cleaning, and using transportation to get to places you want to go. 1 = "limited a lot" ; 0 = otherwise.
Opioid Overdose/Adverse Effects	12 months after injury	Qualifying International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnosis codes: first 3 digits = "T40" and 5th digit = ("0","1","2","3","4","6") and 7th digit not = "6" (excludes underdosing). 1 = presence of qualifying ICD-10-CM diagnosis code; 0 = otherwise.
Not Working for Pay	12 months after injury	Participants asked whether they worked for pay in the past week. 1 = did not work for pay in the week prior to assessment; 0 = otherwise.