Comparing State Payer Strategies to Prevent Unsafe Opioid Prescribing

Opioid Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03932799
• Other study ID #: STUDY00006455
• Secondary ID: PCORI-UOP-2017C2
• Status: Completed
• Start date: August 6, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: November 2022
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Description:

Use and misuse of opioids is now recognized as a major U.S. public health problem, leading to significant morbidity and mortality. Prescribing of both opioids and concurrent sedative-hypnotics for acute and chronic musculoskeletal pain increased dramatically from 2001 to 2010. The clearest path to preventing transition to chronic opioid use and associated morbidity or addiction is to reduce unnecessary prescribing during the acute (0-6 weeks) and subacute (6-12 weeks) phases of pain. Both prior authorization (PA) and other insurer-based drug utilization programs are increasingly being used in an attempt to stem the tide of the opioid epidemic and to reduce unsafe opioid prescribing. Review programs have proven effective in decreasing use and overall costs of more expensive medications. Washington (WA) and Ohio (OH) offer a unique opportunity to study opioid prescribing interventions because both states have regulatory authority over health care delivery to all injured workers, and are the two largest states with a population-based exclusive State Fund. Further, both states have initiated distinct prescribing guideline-concordant opioid review programs (ORPs), allowing for a unique natural experiment to compare the effectiveness of two substantially different approaches to reducing unsafe opioid prescribing. This is an observational cohort study, with prospective and retrospective components. Aims 1 and 2 rely primarily on administrative data for a prospective cohort, with longitudinal surveys conducted among a subset of the cohort. Aim 1 also includes a retrospective time series analysis. Aim 3 relies on qualitative research, including individual in-depth interviews and key informant interviews. Specific aim 1. Examine the comparative effectiveness of prospective prior authorization (PA) with hard stops in WA versus retrospective review (RR) with prescriber notification in OH in reducing unsafe opioid prescribing. Specific aim 2. Examine the comparative effectiveness of WA's PA program versus OH's RR program with regard to patient reported outcomes (pain, function, quality of life, return to work), harms (presence of opioid use disorder, opioid poisoning events) and work disability outcomes at 6 weeks, 6 months, and 12 months from date of injury. Specific aim 2a. For injured workers in WA, examine unsafe opioid prescribing and patient-reported outcomes and work disability at 6 and 12 months for patients receiving an established, coordinated, stepped care management program during the first 12 weeks following injury plus prospective PA versus patients receiving usual care subject to PA only. Specific aim 3. Using qualitative methods, identify key environmental, programmatic and policy factors that influenced the design, implementation and impact of the PA program in WA and the RR program in OH. This information will lead to the development of an Opioid Review Tool educational module for dissemination to both public and private payers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5411
• Est. completion date: June 30, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use
• Opioid-Related Disorders

Intervention

Other:
• Prospective 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.
• Retrospective 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.

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	12 months after injury
Primary	Subacute Phase - More Than 7 Days of Opioids	More than 7 unique days of opioids within the time period	6-12 weeks after injury
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	3-6, 6-9, and 9-12 months after injury
Primary	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
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	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	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.	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.	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.	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.	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.	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.	12 months after injury
Secondary	On Time Loss (Not Working)	1 = on time loss (workers' compensation warrant data); 0 = otherwise.	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.	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.	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)	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).	12 months after injury
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).	12 months after injury