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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03932799
Recruitment Status Enrolling by invitation
First Posted May 1, 2019
Last update posted March 6, 2020
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 and Ohio 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.
Workers in the Washington Department of Labor and Industries state fund insurance system.
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.
Workers in the Ohio Bureau of Workers' Compensation state fund insurance system.
Other: 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
Aims 1 and 2
- File a new State Fund claim
- Receive at least one opioid prescription during the first 6 weeks after date of injury
- The ability to speak English or Spanish (survey only)
The denominator for both time series described in the Analytical Methods section (Aim 1.
Analysis Topic A) has the same inclusion criteria, except that criterion (2) does not
apply. The same criteria—including criterion (2)—apply to the numerator for the first time
series. The numerator for the second time series described is similar, except that
criterion (2) is instead the presence of unsafe opioid prescribing during the subacute
phase (6-12 weeks).
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 WC
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 WC or whose
prescription payments have been reviewed in accordance with the state's opioid review
- Under 18 years of age (Aims 1 and 2)
United States, Ohio
The Ohio State University
United States, Washington
University of Washington
University of Washington
Patient-Centered Outcomes Research Institute
Principal Investigator: Gary M Franklin, MD University of Washington