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| ID | Type | Description | Link |
|---|---|---|---|
| PCORI-UOP-2017C2-8509 | Other Identifier | PCORI |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Washington | Workers in the Washington Department of Labor and Industries state fund insurance system. |
| |
| Ohio | Workers in the Ohio Bureau of Workers' Compensation state fund insurance system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prospective prior authorization (PA) with hard stops in Washington | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Subacute Phase - More Than 7 Days of Opioids | More than 7 unique days of opioids within the time period | 6-12 weeks after injury |
| 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 | 3-6, 6-9, and 9-12 months after injury |
| Chronic Phase - Chronic Opioids (≥60 Days' Supply) | 60 or more unique days of opioids within the time period | 3-6, 6-9, and 9-12 months after injury |
| 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 | 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) | Mean MEDD of 50 or more during the days a worker received opioids (based on days' supply) within the time period | 3-6, 6-9, and 9-12 months after injury |
| Measure | Description | Time Frame |
|---|---|---|
| ≥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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Aims 1 and 2:
Aim 3 key informants
Aim 3 individual in-depth interviews
Exclusion Criteria (Aims 1 and 2):
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Workers in the Washington Department of Labor and Industries or Ohio Bureau of Workers' Compensation state fund insurance system.
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| Name | Affiliation | Role |
|---|---|---|
| Gary M Franklin, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43210 | United States | ||
| University of Washington |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Ohio |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Subacute Phase - More Than 7 Days of Opioids | More than 7 unique days of opioids within the time period | Posted | Number | % of participants | 6-12 weeks after injury |
|
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Adverse event data were not collected for this observational study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrea Elmore | University of Washington | 206-685-7194 | aelmore@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 1, 2022 | Nov 10, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D060051 | Occupational Injuries |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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|
| Retrospective review (RR) with prescriber notification in Ohio | Other | 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. |
|
| 12 months after injury |
| 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. | 12 months after injury |
| 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. | 12 months after injury |
| 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. | 12 months after injury |
| 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. | 12 months after injury |
| 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. | 12 months after injury |
| On Time Loss (Not Working) | 1 = on time loss (workers' compensation warrant data); 0 = otherwise. | 12 months after injury |
| 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. | 12 months after injury |
| 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. | 12 months after injury |
| 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) | 12 months after injury |
| 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). | 12 months after injury |
| 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). | 12 months after injury |
| 12 months after injury |
| Seattle |
| Washington |
| 98109 |
| United States |
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.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | 17 participants in Ohio missing data on sex. | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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|
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| 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 | Posted | Number | % of participants | 3-6, 6-9, and 9-12 months after injury |
|
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| Primary | Chronic Phase - Chronic Opioids (≥60 Days' Supply) | 60 or more unique days of opioids within the time period | Posted | Number | % of participants | 3-6, 6-9, and 9-12 months after injury |
|
|
|
| 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 | Posted | Number | % of participants | 3-6, 6-9, and 9-12 months |
|
|
|
| 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 | Posted | Number | % of participants | 3-6, 6-9, and 9-12 months after injury |
|
|
|
|
| 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. |
| Posted | Count of Participants | Participants | 12 months after injury |
|
|
|
|
| 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. |
| Posted | Count of Participants | Participants | 12 months after injury |
|
|
|
|
| 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. |
| Posted | Count of Participants | Participants | 12 months after injury |
|
|
|
|
| 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. |
| Posted | Count of Participants | Participants | 12 months after injury |
|
|
|
|
| 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. |
| Posted | Count of Participants | Participants | 12 months after injury |
|
|
|
|
| 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. |
| Posted | Count of Participants | Participants | 12 months after injury |
|
|
|
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| Secondary | On Time Loss (Not Working) | 1 = on time loss (workers' compensation warrant data); 0 = otherwise. |
| Posted | Count of Participants | Participants | 12 months after injury |
|
|
|
|
| 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. |
| Posted | Count of Participants | Participants | 12 months after injury |
|
|
|
|
| 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. |
| Posted | Count of Participants | Participants | 12 months after injury |
|
|
|
| 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) |
| Posted | Mean | Standard Deviation | index value | 12 months after injury |
|
|
|
|
| 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). |
| Posted | Mean | Standard Deviation | score on 5-point Likert scale | 12 months after injury |
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|
|
| 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). |
| Posted | Mean | Standard Deviation | score on 5-point Likert scale | 12 months after injury |
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|
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| 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. |
| Posted | Count of Participants | Participants | 12 months after injury |
|
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|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D014947 | Wounds and Injuries |
| 9-12 months |
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| 9-12 months |
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| 9-12 months |
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| 9-12 months |
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| Doing household chores |
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| Using transportation |
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| Regression, Logistic | .42 |
| Odds Ratio (OR) | 1.23 | 2-Sided | 95 | 0.74 | 2.07 | Superiority | Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life. |
|
| Regression, Logistic | .91 |
| Odds Ratio (OR) | 0.98 | 2-Sided | 95 | 0.63 | 1.51 | Superiority | Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life. |
|
| Regression, Logistic | .59 |
| Odds Ratio (OR) | 1.19 | 2-Sided | 95 | 0.64 | 2.21 | Superiority | Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life. |