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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.

Prevent Unsafe Opioid Prescribing

Clinicaltrials.gov identifier NCT03932799

Recruitment Status Enrolling by invitation

First Posted May 1, 2019

Last update posted March 6, 2020

Study Description

Brief 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.

  • Condition or Disease:Opioid Use
    Opioid-Related Disorders
  • Intervention/Treatment: Other: Prospective prior authorization (PA) with hard stops in Washington
    Other: Retrospective review (RR) with prescriber notification in Ohio
  • Phase: N/A
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 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.

Study Design
  • Study Type: Observational
  • Estimated Enrollment: 10000 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: Comparative Effectiveness of Two State Payer Strategies to Prevent Unsafe Opioid Prescribing
  • Actual Study Start Date: August 2019
  • Estimated Primary Completion Date: September 2021
  • Estimated Study Completion Date: December 2021
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: Washington
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.
: Ohio
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.
Outcome Measures
  • Primary Outcome Measures: 1. Rate of unsafe opioid prescribing during subacute phase of pain, measured as prescription for >7 days supply of opioid [ Time Frame: 6-12 weeks ]
  • 2. Rate of unsafe opioid prescribing during chronic phase of pain, measured as prescription for ≥60 days supply of opioid [ Time Frame: 3-6 months ]
  • 3. Rate of unsafe opioid prescribing during chronic phase of pain, measured as prescription for ≥60 days supply of opioid [ Time Frame: 6-9 months ]
  • 4. Rate of unsafe opioid prescribing during chronic phase of pain, measured as prescription for ≥60 days supply of opioid [ Time Frame: 9-12 months ]
  • 5. Rate of unsafe opioid prescribing during chronic phase of pain, measured as opioid prescription with concurrent sedatives/hypnotics [ Time Frame: 3-6 months ]
  • 6. Rate of unsafe opioid prescribing during chronic phase of pain, measured as opioid prescription with concurrent sedatives/hypnotics [ Time Frame: 6-9 months ]
  • 7. Rate of unsafe opioid prescribing during chronic phase of pain, measured as opioid prescription with concurrent sedatives/hypnotics [ Time Frame: 9-12 months ]
  • 8. Rate of unsafe opioid prescribing during chronic phase of pain, measured as opioid prescription of ≥50 MED/day [ Time Frame: 3-6 months ]
  • 9. Rate of unsafe opioid prescribing during chronic phase of pain, measured as opioid prescription of ≥50 MED/day [ Time Frame: 6-9 months ]
  • 10. Rate of unsafe opioid prescribing during chronic phase of pain, measured as opioid prescription of ≥50 MED/day [ Time Frame: 9-12 months ]
  • 11. Rate of unsafe opioid prescribing during chronic phase of pain, measured as meeting ≥1 of the 3 chronic-phase metrics (≥60 days supply, concurrent sedatives/hypnotics, or ≥50 MED/day) [ Time Frame: 3-6 months ]
  • 12. Rate of unsafe opioid prescribing during chronic phase of pain, measured as meeting ≥1 of the 3 chronic-phase metrics (≥60 days supply, concurrent sedatives/hypnotics, or ≥50 MED/day) [ Time Frame: 6-9 months ]
  • 13. Rate of unsafe opioid prescribing during chronic phase of pain, measured as meeting ≥1 of the 3 chronic-phase metrics (≥60 days supply, concurrent sedatives/hypnotics, or ≥50 MED/day) [ Time Frame: 9-12 months ]
  • Secondary Outcome Measures: 1. Work status [ Time Frame: 6 weeks, 6 months, 12 months (change over time) ]
    Compensated time loss in workers' compensation claims data used as a proxy.
  • 2. Rate of opioid poisoning events [ Time Frame: 12 months ]
    Events specified by ICD-10-CM codes in workers' compensation billing data.
  • 3. Change in wages: Likert scale [ Time Frame: 6 weeks, 6 months, 12 months (change over time) ]
    Change in wages from before injury, on a 5 level Likert scale (1 = a lot more than before the injury; 5 = a lot less than before the injury)
  • 4. Pain intensity: scale [ Time Frame: 6 weeks, 6 months, 12 months (change over time) ]
    Pain on average in the past week, on a scale of 0-10 (0 = no pain; 10 = pain as bad as you can imagine)
  • 5. Physical function/pain interference: scale [ Time Frame: 6 weeks, 6 months, 12 months (change over time) ]
    Pain interference with enjoyment of life, general activity, and ability to work during the past week, on a scale of 0-10 (0 = does not interfere at all; 10 = completely interferes)
  • 6. Emotional functioning-Anxiety and Depression [ Time Frame: 6 weeks, 6 months, 12 months (change over time) ]
    Patient Health Questionnaire-4 (PHQ-4) measure of anxiety and depression over the last two weeks. Four questions measured on a scale of 0-3 (0 = not at all; 3 = nearly every day). Four questions are summed for total score, ranging from 0-12 (0-2 = normal, 3-5 = mild, 6-8 = moderate, and 9-12 = severe). Total score ≥3 for first 2 questions suggests anxiety and total score ≥3 for last 2 questions suggests depression.
  • 7. Global improvement [ Time Frame: 6 months, 12 months (change over time) ]
    Patient Global Impression of Change, measure of change in activity limitations, symptoms, emotions, and overall quality of life since beginning treatment, on a 7 point Likert scale (1 = Very much improved; 7 = Very much worse)
  • 8. Disability [ Time Frame: 6 months, 12 months (change over time) ]
    4-item measure of limitation in activities (leisure or social, getting out with friends or family, household chores, and using transportation) due to health now (1 = Yes, limited a lot, 2 = Yes, limited a little, and 3 = No, not limited at all).
  • 9. Quality of life: EQ-5D-5L [ Time Frame: 6 weeks, 6 months, 12 months (change over time) ]
    5-item measure (EQ-5D-5L) of health-related quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) in the past day, on a 5 level Likert scale, as well as a rating of current health on a scale of 0-100 (0 = the worst health you can imagine; 100 = the best health you can imagine).
  • 10. Overall patient satisfaction: Likert scale [ Time Frame: 6 weeks, 6 months, 12 months (change over time) ]
    Satisfaction with treatment received for injury, on a 5 level Likert scale (1 = very dissatisfied; 5 = very satisfied)
  • 11. Satisfaction with pain-related treatment: Likert scale [ Time Frame: 6 weeks, 6 months, 12 months (change over time) ]
    Satisfaction with treatment received for pain caused by injury, on a 5 level Likert scale (1 = very dissatisfied; 5 = very satisfied)
  • 12. Change in work hours: Likert scale [ Time Frame: 6 weeks, 6 months, 12 months (change over time) ]
    Change in work hours from before injury, on a 5 level Likert scale (1 = a lot more than before the injury; 5 = a lot less than before the injury)
  • Other Outcome Measures: 1. Prevalence of opioid use disorder [ Time Frame: 12 months ]
    The Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS) Tool (prescription opioid subset) measure of prescription opioid misuse in the past 3 months. Three Yes/No questions. Total score ≥1 suggests problem use and total score ≥2 suggests substance use disorder.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Non-Probability Sample
  • Study Population: Workers in the Washington Department of Labor and Industries or Ohio Bureau of Workers' Compensation state fund insurance system.
Criteria

Inclusion Criteria:

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
program.

Exclusion Criteria:

- Under 18 years of age (Aims 1 and 2)

Contacts and Locations
Contacts
Locations

United States, Ohio
The Ohio State University
Columbus

United States, Washington
University of Washington
Seattle

Sponsors and Collaborators

University of Washington

Patient-Centered Outcomes Research Institute

Investigators

Principal Investigator: Gary M Franklin, MD University of Washington

More Information
  • Responsible Party: University of Washington
  • ClinicalTrials.gov Identifier: NCT03932799 History of Changes
  • Other Study ID Numbers: STUDY00006455, PCORI-UOP-2017C2-8509
  • First Posted: May 1, 2019 Key Record Dates
  • Last Update Posted: March 6, 2020
  • Last Verified: March 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Undecided
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by University of Washington: Workers' Compensation
    Occupational Injuries
    Drug Utilization Review
    Humans
    Adult
    Cohort Studies
    Qualitative Research
  • Additional relevant MeSH terms: Opioid-Related Disorders