Trial Outcomes & Findings for Comparing State Payer Strategies to Prevent Unsafe Opioid Prescribing (NCT NCT03932799)

NCT ID: NCT03932799

Last Updated: 2023-09-28

Results Overview

More than 7 unique days of opioids within the time period

• Recruitment status: COMPLETED
• Target enrollment: 5411 participants
• Primary outcome timeframe: 6-12 weeks after injury
• Results posted on: 2023-09-28

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	4632	779
Overall Study COMPLETED	4632	779
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

17 participants in Ohio missing data on sex.

Baseline characteristics by cohort

Measure	Washington n=4632 Participants 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.	Ohio n=779 Participants 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.	Total n=5411 Participants Total of all reporting groups
Age, Customized 18-24	440 Participants n=4632 Participants	51 Participants n=779 Participants	491 Participants n=5411 Participants
Age, Customized 25-34	1100 Participants n=4632 Participants	167 Participants n=779 Participants	1267 Participants n=5411 Participants
Age, Customized 35-44	1121 Participants n=4632 Participants	154 Participants n=779 Participants	1275 Participants n=5411 Participants
Age, Customized 45-54	1033 Participants n=4632 Participants	175 Participants n=779 Participants	1208 Participants n=5411 Participants
Age, Customized 55-64	791 Participants n=4632 Participants	187 Participants n=779 Participants	978 Participants n=5411 Participants
Age, Customized ≥65	147 Participants n=4632 Participants	45 Participants n=779 Participants	192 Participants n=5411 Participants
Sex: Female, Male Female	1153 Participants n=4632 Participants • 17 participants in Ohio missing data on sex.	193 Participants n=762 Participants • 17 participants in Ohio missing data on sex.	1346 Participants n=5394 Participants • 17 participants in Ohio missing data on sex.
Sex: Female, Male Male	3479 Participants n=4632 Participants • 17 participants in Ohio missing data on sex.	569 Participants n=762 Participants • 17 participants in Ohio missing data on sex.	4048 Participants n=5394 Participants • 17 participants in Ohio missing data on sex.
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 6-12 weeks after injury

More than 7 unique days of opioids within the time period

Outcome measures

Measure	Washington n=4632 Participants 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.	Ohio n=779 Participants 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.
Subacute Phase - More Than 7 Days of Opioids	1.9 % of participants	12.2 % of participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Washington n=4632 Participants 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.	Ohio n=779 Participants 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.
Chronic Phase - Composite (Meeting ≥1 of the 3 Chronic Phase Metrics) 3-6 months	1.2 % of participants	2.4 % of participants
Chronic Phase - Composite (Meeting ≥1 of the 3 Chronic Phase Metrics) 6-9 months	0.9 % of participants	2.4 % of participants
Chronic Phase - Composite (Meeting ≥1 of the 3 Chronic Phase Metrics) 9-12 months	0.8 % of participants	2.1 % of participants

PRIMARY outcome

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

60 or more unique days of opioids within the time period

Outcome measures

Measure	Washington n=4632 Participants 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.	Ohio n=779 Participants 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.
Chronic Phase - Chronic Opioids (≥60 Days' Supply) 3-6 months	0.0 % of participants	1.7 % of participants
Chronic Phase - Chronic Opioids (≥60 Days' Supply) 6-9 months	0.0 % of participants	2.3 % of participants
Chronic Phase - Chronic Opioids (≥60 Days' Supply) 9-12 months	0.0 % of participants	1.9 % of participants

PRIMARY outcome

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

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

Outcome measures

Measure	Washington n=4632 Participants 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.	Ohio n=779 Participants 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.
Chronic Phase - Concurrent (Concurrent Sedatives/Hypnotics and Opioids on ≥1 Day) 3-6 months	0.0 % of participants	0.4 % of participants
Chronic Phase - Concurrent (Concurrent Sedatives/Hypnotics and Opioids on ≥1 Day) 6-9 months	0.0 % of participants	0.1 % of participants
Chronic Phase - Concurrent (Concurrent Sedatives/Hypnotics and Opioids on ≥1 Day) 9-12 months	0.0 % of participants	0.1 % of participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Washington n=4632 Participants 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.	Ohio n=779 Participants 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.
Chronic Phase - High Dose (Average of ≥50 Morphine Equivalent Daily Dose [MEDD] Among All Days With Opioids) 3-6 months	1.2 % of participants	1.0 % of participants
Chronic Phase - High Dose (Average of ≥50 Morphine Equivalent Daily Dose [MEDD] Among All Days With Opioids) 6-9 months	0.9 % of participants	0.5 % of participants
Chronic Phase - High Dose (Average of ≥50 Morphine Equivalent Daily Dose [MEDD] Among All Days With Opioids) 9-12 months	0.8 % of participants	0.4 % of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Washington n=1976 Participants 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.	Ohio n=319 Participants 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.
≥30% Decrease in Pain Intensity/Interference (PEG-3)	1001 Participants	151 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Washington n=1976 Participants 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.	Ohio n=319 Participants 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.
Anxious Symptoms (PHQ-4)	487 Participants	79 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Washington n=1976 Participants 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.	Ohio n=319 Participants 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.
Depressive Symptoms (PHQ-4)	322 Participants	64 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Washington n=1976 Participants 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.	Ohio n=319 Participants 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.
Global Improvement (GIC)	1413 Participants	222 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Washington n=1976 Participants 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.	Ohio n=319 Participants 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.
Disability - Activity Limitation Leisure or social activities	281 Participants	49 Participants
Disability - Activity Limitation Getting out with friends or family	220 Participants	37 Participants
Disability - Activity Limitation Doing household chores	246 Participants	56 Participants
Disability - Activity Limitation Using transportation	137 Participants	22 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Washington n=1976 Participants 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.	Ohio n=319 Participants 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.
Not Working for Pay	599 Participants	107 Participants

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Washington n=1976 Participants 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.	Ohio n=319 Participants 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.
On Time Loss (Not Working)	209 Participants	43 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Washington n=1976 Participants 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.	Ohio n=319 Participants 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.
Earning Less Than Before Injury	819 Participants	129 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Washington n=1976 Participants 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.	Ohio n=319 Participants 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.
Opioid Overdose/Adverse Effects	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

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)

Outcome measures

Measure	Washington n=1976 Participants 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.	Ohio n=319 Participants 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.
Quality of Life (EuroQol EQ-5D)	0.81 index value Standard Deviation 0.16	0.79 index value Standard Deviation 0.16

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Washington n=1976 Participants 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.	Ohio n=319 Participants 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.
Satisfaction With Overall Treatment	0.98 score on 5-point Likert scale Standard Deviation 1.17	0.81 score on 5-point Likert scale Standard Deviation 1.32

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	Washington n=1976 Participants 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.	Ohio n=319 Participants 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.
Satisfaction With Pain-related Treatment	0.88 score on 5-point Likert scale Standard Deviation 1.26	0.66 score on 5-point Likert scale Standard Deviation 1.34

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Washington n=1976 Participants 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.	Ohio n=319 Participants 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.
Problematic Opioid Use (TAPS)	113 Participants	22 Participants

Adverse Events

Washington

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ohio

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Andrea Elmore

University of Washington

Phone: 206-685-7194

Email: aelmore@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place