Comparing State Payer Strategies to Prevent Unsafe Opioid Prescribing

University of Washington

Status

Completed

Conditions

Opioid-Related Disorders

Opioid Use

Treatments

Other: Retrospective review (RR) with prescriber notification in Ohio

Other: Prospective prior authorization (PA) with hard stops in Washington

Study type

Observational

Funder types

Other

Identifiers

NCT03932799

PCORI-UOP-2017C2-8509 (Other Identifier)

STUDY00006455

Details and patient eligibility

About

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.

Full 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.

Enrollment

5,411 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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