Opioid UseNCT03932799
Comparing State Payer Strategies to Prevent Unsafe Opioid Prescribing
An observational study of Opioid Use and Opioid-Related Disorders, run by University of Washington at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use, Opioid-Related Disorders
- What is being tested?
- Prospective prior authorization (PA) with hard stops in Washington and Retrospective review (RR) with prescriber notification in Ohio
- How many people
- 5,411 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Aug 2019to 30 Jun 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Workers in the Washington Department of Labor and Industries or Ohio Bureau of Workers' Compensation state fund insurance system.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Ohio State University
Columbus, Ohio, 43210
University of Washington
Seattle, Washington, 98109
About this study
Official title: The Washington and Ohio Worker (WOW) Study: Comparing State Payer Strategies to Prevent Unsafe Opioid Prescribing
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.
Read the 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.
- Conditions
- Opioid Use, Opioid-Related Disorders
- Being tested
- Prospective prior authorization (PA) with hard stops in Washington, Retrospective review (RR) with prescriber notification in Ohio
- Keywords
- Workers' Compensation, Occupational Injuries, Drug Utilization Review, Humans, Adult, Cohort Studies, Qualitative Research
- Medical subject headings
- Opioid-Related Disorders, Occupational Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective prior authorization (PA) with hard stops in WashingtonOther
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.
Retrospective review (RR) with prescriber notification in OhioOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Washington | Workers in the Washington Department of Labor and Industries state fund insurance system. Receives: Other: Prospective prior authorization (PA) with hard stops in Washington | |
| Ohio | Workers in the Ohio Bureau of Workers' Compensation state fund insurance system. Receives: Other: Retrospective review (RR) with prescriber notification in Ohio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subacute Phase - More Than 7 Days of Opioids
More than 7 unique days of opioids within the time period
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 3-6, 6-9, and 9-12 months after injury
Secondary outcomes (12)
≥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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months after injury
On Time Loss (Not Working)
1 = on time loss (workers' compensation warrant data); 0 = otherwise.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 12 months after injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start6 Aug 2019
- Primary completion31 Mar 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,411 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Gary Franklin, University of Washington
- Investigators
- Gary M Franklin, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03932799
- Sponsor's protocol ID
- STUDY00006455
- Other IDs
- PCORI-UOP-2017C2-8509
- Status last verified
- Nov 2022
- First submitted
- 19 Apr 2019
- Last updated
- 28 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Washington and Ohio Worker (WOW) Study: Comparing State Payer Strategies to Prevent Unsafe Opioid Prescribing
- ClinicalTrials.gov ID
- NCT03932799
- Acronym / sponsor ID
- STUDY00006455
- Conditions
- Opioid Use, Opioid-Related Disorders
- Keywords
- Workers' Compensation, Occupational Injuries, Drug Utilization Review, Humans, Adult, Cohort Studies, Qualitative Research
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,411 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 6 Aug 2019 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 1 May 2019 (actual)
- Results
- Posted 28 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Washington | – | Other: Prospective prior authorization (PA) with hard stops in WashingtonWorkers in the Washington Department of Labor and Industries state fund insurance system. |
| Ohio | – | Other: Retrospective review (RR) with prescriber notification in OhioWorkers in the Ohio Bureau of Workers' Compensation state fund insurance system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Workers in the Washington Department of Labor and Industries or Ohio Bureau of Workers' Compensation state fund insurance system.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prospective prior authorization (PA) with hard stops in WashingtonUnder 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. | Other | Washington |
| Retrospective review (RR) with prescriber notification in OhioIn 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. | Other | Ohio |
Primary outcome
Subacute Phase - More Than 7 Days of Opioids
Time frame: 6-12 weeks after injury
More than 7 unique days of opioids within the time period
Chronic Phase - Composite (Meeting ≥1 of the 3 Chronic Phase Metrics)
Time frame: 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
Chronic Phase - Chronic Opioids (≥60 Days' Supply)
Time frame: 3-6, 6-9, and 9-12 months after injury
60 or more unique days of opioids within the time period
Chronic Phase - Concurrent (Concurrent Sedatives/Hypnotics and Opioids on ≥1 Day)
Time frame: 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 - High Dose (Average of ≥50 Morphine Equivalent Daily Dose [MEDD] Among All Days With Opioids)
Time frame: 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
12 secondary outcomes
≥30% Decrease in Pain Intensity/Interference (PEG-3)
Time frame: 12 months after injury
Anxious Symptoms (PHQ-4)
Time frame: 12 months after injury
Depressive Symptoms (PHQ-4)
Time frame: 12 months after injury
Global Improvement (GIC)
Time frame: 12 months after injury
Disability - Activity Limitation
Time frame: 12 months after injury
Not Working for Pay
Time frame: 12 months after injury
On Time Loss (Not Working)
Time frame: 12 months after injury
Earning Less Than Before Injury
Time frame: 12 months after injury
Opioid Overdose/Adverse Effects
Time frame: 12 months after injury
Quality of Life (EuroQol EQ-5D)
Time frame: 12 months after injury
Satisfaction With Overall Treatment
Time frame: 12 months after injury
Satisfaction With Pain-related Treatment
Time frame: 12 months after injury
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Opioid Use
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
Opioid Use Disorder
Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary M Franklin, MD principal investigator
University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Use and Opioid-Related Disorders, run by University of Washington at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subacute Phase - More Than 7 Days of Opioids (time frame: 6-12 weeks after injury). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.