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Comparing State Payer Strategies to Prevent Unsafe Opioid Prescribing

The Washington and Ohio Worker (WOW) Study: Comparing State Payer Strategies to Prevent Unsafe Opioid Prescribing

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03932799
Enrollment
5411
Registered
2019-05-01
Start date
2019-08-06
Completion date
2022-06-30
Last updated
2023-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid-Related Disorders, Opioid Use

Keywords

Workers' Compensation, Occupational Injuries, Drug Utilization Review, Humans, Adult, Cohort Studies, Qualitative Research

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.

Interventions

OTHERProspective prior authorization (PA) with hard stops in Washington

Under Washington regulatory procedures, payment for any opioid prescription billed beyond six weeks after the injury is denied unless the prescriber has submitted a checklist attesting to completion of all best practices from the regulations/guidelines.Thus, the Washington intervention is prospective and includes a hard stop subject to an insurer's decision based on regulatory authority.

OTHERRetrospective review (RR) with prescriber notification in Ohio

In Ohio an automated report identifies new opioid prescriptions beyond the acute phase. Ohio Workers' Compensation pharmacy and clinical staff review the medical record at 12 weeks to determine whether best practices were met. If not, the prescriber is notified via letter, and cases are reviewed again at 16 weeks. If best practices have still not been met, the prescriber and worker are notified via letter that opioid coverage will end in 4 weeks. The Ohio program relies on retrospective chart review and communication of best practices to prescribers.

Sponsors

Patient-Centered Outcomes Research Institute
CollaboratorOTHER
University of Washington
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 injuryMean MEDD of 50 or more during the days a worker received opioids (based on days' supply) within the time period
Subacute Phase - More Than 7 Days of Opioids6-12 weeks after injuryMore than 7 unique days of opioids within the time period
Chronic Phase - Composite (Meeting ≥1 of the 3 Chronic Phase Metrics)3-6, 6-9, and 9-12 months after injuryAt 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
Chronic Phase - Chronic Opioids (≥60 Days' Supply)3-6, 6-9, and 9-12 months after injury60 or more unique days of opioids within the time period
Chronic Phase - Concurrent (Concurrent Sedatives/Hypnotics and Opioids on ≥1 Day)3-6, 6-9, and 9-12 monthsAt least 1 overlapping day of both a sedative and an opioid within the time period

Secondary

MeasureTime frameDescription
Disability - Activity Limitation12 months after injuryModified 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.
Not Working for Pay12 months after injuryParticipants asked whether they worked for pay in the past week. 1 = did not work for pay in the week prior to assessment; 0 = otherwise.
On Time Loss (Not Working)12 months after injury1 = on time loss (workers' compensation warrant data); 0 = otherwise.
Earning Less Than Before Injury12 months after injuryParticipants 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.
Quality of Life (EuroQol EQ-5D)12 months after injury5-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)
Satisfaction With Overall Treatment12 months after injurySingle-item 5-point Likert scale rating of how satisfied participants were with all injury-related treatment (-2 = very dissatisfied, 2 = very satisfied).
Satisfaction With Pain-related Treatment12 months after injurySingle-item 5-point Likert scale rating of how satisfied participants were with treatment received for injury-related pain (-2 = very dissatisfied, 2 = very satisfied).
Opioid Overdose/Adverse Effects12 months after injuryQualifying 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.
≥30% Decrease in Pain Intensity/Interference (PEG-3)12 months after injuryClinically 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.
Anxious Symptoms (PHQ-4)12 months after injury2-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.
Depressive Symptoms (PHQ-4)12 months after injury2-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.
Global Improvement (GIC)12 months after injuryGlobal 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.

Other

MeasureTime frameDescription
Problematic Opioid Use (TAPS)12 months after injury3-item TAPS tool Part 2 assessing any problematic opioid use in the past 3 months. Participants asked if they used a prescription opioid not as prescribed, if they failed in cutting down on opioid use, and if anyone has expressed concern about their opioid use (0 = no, 1 = yes). The items were summed to create a summary score in which scores ≥1 represented problematic or high-risk opioid use. 1 = summed subscale score ≥1; 0 = otherwise.

Countries

United States

Participant flow

Participants by arm

ArmCount
Washington
Injured workers in the Washington Department of Labor and Industries (L&I) state fund insurance system - required to obtain prior authorization for opioids prescribed after 6 weeks from an injury.
4,632
Ohio
Injured workers in the Ohio Bureau of Workers' Compensation (BWC) state fund insurance system - subject to a retrospective review of claim if receiving opioid prescription after 6 weeks from injury. Prescriber notified if best practices are not being documented.
779
Total5,411

Baseline characteristics

CharacteristicWashingtonOhioTotal
Age, Customized
18-24
440 Participants51 Participants491 Participants
Age, Customized
25-34
1100 Participants167 Participants1267 Participants
Age, Customized
35-44
1121 Participants154 Participants1275 Participants
Age, Customized
45-54
1033 Participants175 Participants1208 Participants
Age, Customized
55-64
791 Participants187 Participants978 Participants
Age, Customized
≥65
147 Participants45 Participants192 Participants
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
1153 Participants193 Participants1346 Participants
Sex: Female, Male
Male
3479 Participants569 Participants4048 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

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

60 or more unique days of opioids within the time period

Time frame: 3-6, 6-9, and 9-12 months after injury

ArmMeasureGroupValue (NUMBER)
WashingtonChronic Phase - Chronic Opioids (≥60 Days' Supply)3-6 months0.0 % of participants
WashingtonChronic Phase - Chronic Opioids (≥60 Days' Supply)6-9 months0.0 % of participants
WashingtonChronic Phase - Chronic Opioids (≥60 Days' Supply)9-12 months0.0 % of participants
OhioChronic Phase - Chronic Opioids (≥60 Days' Supply)9-12 months1.9 % of participants
OhioChronic Phase - Chronic Opioids (≥60 Days' Supply)3-6 months1.7 % of participants
OhioChronic Phase - Chronic Opioids (≥60 Days' Supply)6-9 months2.3 % of participants
Primary

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

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

Time frame: 3-6, 6-9, and 9-12 months after injury

ArmMeasureGroupValue (NUMBER)
WashingtonChronic Phase - Composite (Meeting ≥1 of the 3 Chronic Phase Metrics)3-6 months1.2 % of participants
WashingtonChronic Phase - Composite (Meeting ≥1 of the 3 Chronic Phase Metrics)6-9 months0.9 % of participants
WashingtonChronic Phase - Composite (Meeting ≥1 of the 3 Chronic Phase Metrics)9-12 months0.8 % of participants
OhioChronic Phase - Composite (Meeting ≥1 of the 3 Chronic Phase Metrics)3-6 months2.4 % of participants
OhioChronic Phase - Composite (Meeting ≥1 of the 3 Chronic Phase Metrics)6-9 months2.4 % of participants
OhioChronic Phase - Composite (Meeting ≥1 of the 3 Chronic Phase Metrics)9-12 months2.1 % of participants
Comparison: * Primary predictor is binary (1 for Washington, 0 for Ohio)~* Outcome modeled longitudinally over the 3 time periods (3-6, 6-9, and 9-12 months)~* Time periods clustered at the individual worker level~* Exchangeable working correlation structure~* Robust variance estimatesp-value: 0.4395% CI: [0.53, 1.31]Generalized estimating equation
Primary

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

At least 1 overlapping day of both a sedative and an opioid within the time period

Time frame: 3-6, 6-9, and 9-12 months

ArmMeasureGroupValue (NUMBER)
WashingtonChronic Phase - Concurrent (Concurrent Sedatives/Hypnotics and Opioids on ≥1 Day)3-6 months0.0 % of participants
WashingtonChronic Phase - Concurrent (Concurrent Sedatives/Hypnotics and Opioids on ≥1 Day)6-9 months0.0 % of participants
WashingtonChronic Phase - Concurrent (Concurrent Sedatives/Hypnotics and Opioids on ≥1 Day)9-12 months0.0 % of participants
OhioChronic Phase - Concurrent (Concurrent Sedatives/Hypnotics and Opioids on ≥1 Day)3-6 months0.4 % of participants
OhioChronic Phase - Concurrent (Concurrent Sedatives/Hypnotics and Opioids on ≥1 Day)6-9 months0.1 % of participants
OhioChronic Phase - Concurrent (Concurrent Sedatives/Hypnotics and Opioids on ≥1 Day)9-12 months0.1 % of participants
Primary

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

Mean MEDD of 50 or more during the days a worker received opioids (based on days' supply) within the time period

Time frame: 3-6, 6-9, and 9-12 months after injury

ArmMeasureGroupValue (NUMBER)
WashingtonChronic Phase - High Dose (Average of ≥50 Morphine Equivalent Daily Dose [MEDD] Among All Days With Opioids)3-6 months1.2 % of participants
WashingtonChronic Phase - High Dose (Average of ≥50 Morphine Equivalent Daily Dose [MEDD] Among All Days With Opioids)6-9 months0.9 % of participants
WashingtonChronic Phase - High Dose (Average of ≥50 Morphine Equivalent Daily Dose [MEDD] Among All Days With Opioids)9-12 months0.8 % of participants
OhioChronic Phase - High Dose (Average of ≥50 Morphine Equivalent Daily Dose [MEDD] Among All Days With Opioids)3-6 months1.0 % of participants
OhioChronic Phase - High Dose (Average of ≥50 Morphine Equivalent Daily Dose [MEDD] Among All Days With Opioids)6-9 months0.5 % of participants
OhioChronic Phase - High Dose (Average of ≥50 Morphine Equivalent Daily Dose [MEDD] Among All Days With Opioids)9-12 months0.4 % of participants
Comparison: * Primary predictor is binary (1 for Washington, 0 for Ohio)~* Outcome modeled longitudinally over the 3 time periods (3-6, 6-9, and 9-12 months)~* Time periods clustered at the individual worker level~* Exchangeable working correlation structure~* Robust variance estimatesp-value: 0.00295% CI: [1.5, 6.14]Generalized estimating equation
Primary

Subacute Phase - More Than 7 Days of Opioids

More than 7 unique days of opioids within the time period

Time frame: 6-12 weeks after injury

ArmMeasureValue (NUMBER)
WashingtonSubacute Phase - More Than 7 Days of Opioids1.9 % of participants
OhioSubacute Phase - More Than 7 Days of Opioids12.2 % of participants
Comparison: * Primary predictor is binary (1 for Washington, 0 for Ohio)~* Robust variance estimatesp-value: <0.00195% CI: [0.16, 0.38]Regression, Logistic
Secondary

≥30% Decrease in Pain Intensity/Interference (PEG-3)

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.

Time frame: 12 months after injury

Population: * Analysis performed within a distinct survey sample of workers~* Estimates for Washington (WA) have been survey-weighted; sampling weights for Ohio (OH) were always 1.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Washington≥30% Decrease in Pain Intensity/Interference (PEG-3)1001 Participants
Ohio≥30% Decrease in Pain Intensity/Interference (PEG-3)151 Participants
Comparison: * Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimatesp-value: 0.8495% CI: [0.71, 1.32]Regression, Logistic
Secondary

Anxious Symptoms (PHQ-4)

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.

Time frame: 12 months after injury

Population: * Analysis performed within a distinct survey sample of workers~* Estimates for WA have been survey-weighted; sampling weights for OH were always 1.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
WashingtonAnxious Symptoms (PHQ-4)487 Participants
OhioAnxious Symptoms (PHQ-4)79 Participants
Comparison: * Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimatesp-value: 0.8895% CI: [0.71, 1.49]Regression, Logistic
Secondary

Depressive Symptoms (PHQ-4)

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.

Time frame: 12 months after injury

Population: * Analysis performed within a distinct survey sample of workers~* Estimates for WA have been survey-weighted; sampling weights for OH were always 1.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
WashingtonDepressive Symptoms (PHQ-4)322 Participants
OhioDepressive Symptoms (PHQ-4)64 Participants
Comparison: * Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimatesp-value: 0.1595% CI: [0.49, 1.11]Regression, Logistic
Secondary

Disability - Activity Limitation

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.

Time frame: 12 months after injury

Population: * Analysis performed within a distinct survey sample of workers~* Estimates for WA have been survey-weighted; sampling weights for OH were always 1.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
WashingtonDisability - Activity LimitationLeisure or social activities281 Participants
WashingtonDisability - Activity LimitationGetting out with friends or family220 Participants
WashingtonDisability - Activity LimitationDoing household chores246 Participants
WashingtonDisability - Activity LimitationUsing transportation137 Participants
OhioDisability - Activity LimitationUsing transportation22 Participants
OhioDisability - Activity LimitationLeisure or social activities49 Participants
OhioDisability - Activity LimitationDoing household chores56 Participants
OhioDisability - Activity LimitationGetting out with friends or family37 Participants
Comparison: * Leisure or social activities outcome~* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimatesp-value: 0.1295% CI: [0.91, 2.28]Regression, Logistic
Comparison: * Getting out with friends or family outcome~* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimatesp-value: 0.4295% CI: [0.74, 2.07]Regression, Logistic
Comparison: * Doing household chores outcome~* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimatesp-value: 0.9195% CI: [0.63, 1.51]Regression, Logistic
Comparison: * Using transportation outcome~* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimatesp-value: 0.5995% CI: [0.64, 2.21]Regression, Logistic
Secondary

Earning Less Than Before 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.

Time frame: 12 months after injury

Population: * Analysis performed within a distinct survey sample of workers~* Estimates for WA have been survey-weighted; sampling weights for OH were always 1.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
WashingtonEarning Less Than Before Injury819 Participants
OhioEarning Less Than Before Injury129 Participants
Comparison: * Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimatesp-value: 0.195% CI: [0.95, 1.83]Regression, Logistic
Secondary

Global Improvement (GIC)

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.

Time frame: 12 months after injury

Population: * Analysis performed within a distinct survey sample of workers~* Estimates for WA have been survey-weighted; sampling weights for OH were always 1.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
WashingtonGlobal Improvement (GIC)1413 Participants
OhioGlobal Improvement (GIC)222 Participants
Comparison: * Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimatesp-value: 0.3895% CI: [0.6, 1.21]Regression, Logistic
Secondary

Not Working for Pay

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.

Time frame: 12 months after injury

Population: * Analysis performed within a distinct survey sample of workers~* Estimates for WA have been survey-weighted; sampling weights for OH were always 1.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
WashingtonNot Working for Pay599 Participants
OhioNot Working for Pay107 Participants
Comparison: * Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimatesp-value: 0.2295% CI: [0.88, 1.75]Regression, Logistic
Secondary

On Time Loss (Not Working)

1 = on time loss (workers' compensation warrant data); 0 = otherwise.

Time frame: 12 months after injury

Population: * Analysis performed within a distinct survey sample of workers~* Estimates for WA have been survey-weighted; sampling weights for OH were always 1.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
WashingtonOn Time Loss (Not Working)209 Participants
OhioOn Time Loss (Not Working)43 Participants
Comparison: * Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimatesp-value: 0.0295% CI: [1.12, 3.47]Regression, Logistic
Secondary

Opioid Overdose/Adverse Effects

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.

Time frame: 12 months after injury

Population: * Analysis performed within a distinct survey sample of workers~* Estimates for WA have been survey-weighted; sampling weights for OH were always 1.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
WashingtonOpioid Overdose/Adverse Effects2 Participants
OhioOpioid Overdose/Adverse Effects0 Participants
Secondary

Quality of Life (EuroQol EQ-5D)

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)

Time frame: 12 months after injury

Population: * Analysis performed within a distinct survey sample of workers~* Estimates for WA have been survey-weighted; sampling weights for OH were always 1.

ArmMeasureValue (MEAN)Dispersion
WashingtonQuality of Life (EuroQol EQ-5D)0.81 index valueStandard Deviation 0.16
OhioQuality of Life (EuroQol EQ-5D)0.79 index valueStandard Deviation 0.16
Comparison: * Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimatesp-value: 0.5395% CI: [-0.03, 0.01]Regression, Logistic
Secondary

Satisfaction With Overall Treatment

Single-item 5-point Likert scale rating of how satisfied participants were with all injury-related treatment (-2 = very dissatisfied, 2 = very satisfied).

Time frame: 12 months after injury

Population: * Analysis performed within a distinct survey sample of workers~* Estimates for WA have been survey-weighted; sampling weights for OH were always 1.

ArmMeasureValue (MEAN)Dispersion
WashingtonSatisfaction With Overall Treatment0.98 score on 5-point Likert scaleStandard Deviation 1.17
OhioSatisfaction With Overall Treatment0.81 score on 5-point Likert scaleStandard Deviation 1.32
Comparison: * Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimatesp-value: 0.05395% CI: [0, 0.32]Regression, Logistic
Secondary

Satisfaction With Pain-related Treatment

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).

Time frame: 12 months after injury

Population: * Analysis performed within a distinct survey sample of workers~* Estimates for WA have been survey-weighted; sampling weights for OH were always 1.

ArmMeasureValue (MEAN)Dispersion
WashingtonSatisfaction With Pain-related Treatment0.88 score on 5-point Likert scaleStandard Deviation 1.26
OhioSatisfaction With Pain-related Treatment0.66 score on 5-point Likert scaleStandard Deviation 1.34
Comparison: * Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimatesp-value: 0.0195% CI: [0.05, 0.38]Regression, Logistic
Other Pre-specified

Problematic Opioid Use (TAPS)

3-item TAPS tool Part 2 assessing any problematic opioid use in the past 3 months. Participants asked if they used a prescription opioid not as prescribed, if they failed in cutting down on opioid use, and if anyone has expressed concern about their opioid use (0 = no, 1 = yes). The items were summed to create a summary score in which scores ≥1 represented problematic or high-risk opioid use. 1 = summed subscale score ≥1; 0 = otherwise.

Time frame: 12 months after injury

Population: * Analysis performed within a distinct survey sample of workers~* Estimates for WA have been survey-weighted; sampling weights for OH were always 1.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
WashingtonProblematic Opioid Use (TAPS)113 Participants
OhioProblematic Opioid Use (TAPS)22 Participants
Comparison: * Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimatesp-value: 0.3595% CI: [0.42, 1.35]Regression, Logistic

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026