The Washington and Ohio Worker (WOW) Study: Comparing State Payer Strategies to Prevent Unsafe Opioid Prescribing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,411
- 试验地点
- 2
- 主要终点
- Chronic Phase - Chronic Opioids (≥60 Days' Supply)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Chronic Phase - Chronic Opioids (≥60 Days' Supply)
时间窗: 3-6, 6-9, and 9-12 months after injury
60 or more unique days of opioids within the time period
Chronic Phase - High Dose (Average of ≥50 Morphine Equivalent Daily Dose [MEDD] Among All Days With Opioids)
时间窗: 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
Chronic Phase - Composite (Meeting ≥1 of the 3 Chronic Phase Metrics)
时间窗: 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 - Concurrent (Concurrent Sedatives/Hypnotics and Opioids on ≥1 Day)
时间窗: 3-6, 6-9, and 9-12 months
At least 1 overlapping day of both a sedative and an opioid within the time period
Subacute Phase - More Than 7 Days of Opioids
时间窗: 6-12 weeks after injury
More than 7 unique days of opioids within the time period
次要结局
- On Time Loss (Not Working)(12 months after injury)
- Satisfaction With Overall Treatment(12 months after injury)
- Depressive Symptoms (PHQ-4)(12 months after injury)
- Quality of Life (EuroQol EQ-5D)(12 months after injury)
- Earning Less Than Before Injury(12 months after injury)
- Global Improvement (GIC)(12 months after injury)
- Satisfaction With Pain-related Treatment(12 months after injury)
- Anxious Symptoms (PHQ-4)(12 months after injury)
- ≥30% Decrease in Pain Intensity/Interference (PEG-3)(12 months after injury)
- Disability - Activity Limitation(12 months after injury)
- Opioid Overdose/Adverse Effects(12 months after injury)
- Not Working for Pay(12 months after injury)
研究者
Gary Franklin
Research Professor, School of Public Health: Environmental & Occupational Health
University of Washington