Real-World Data to Assess Variation in Opioid Prescribing and Use for Acute Pain in Diverse Populations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,709
- 试验地点
- 5
- 主要终点
- Opioid Pain medication use
研究概览
简要总结
This study will characterize patient pain and opioid use after an initial opioid prescription for acute pain.
详细描述
The purpose of this study is to characterize patient pain and opioid use after an initial opioid prescription for acute pain. The investigators aim to enroll a total of 300 patients receiving a prescription for an opioid in primary and urgent care, inpatient care (child birth and total knee arthroplasty), and in the emergency department. Patients not currently using opioids who receive a new short-acting opioid prescription for acute pain will be recruited and followed prospectively for 180 days to assess pain trajectories, analgesic and non-pharmacologic treatment use, activity, and health care service use. The patient-centered health data sharing platform (Hugo) will be used to collect patient-reported outcomes and structured data from pharmacy and electronic health records patient portals as well as patient-generated data collected through personal digital devices (Fitbit).
Specific aims
- To assess patients' pain and opioid use patterns in episodes of acute pain for which opioids were prescribed, characterizing pain severity and persistence, as well as other prescription and over-the-counter pain medication use
- To examine associations between patient demographic, clinical and emotional characteristics and outcomes of pain severity and persistence, opioid and non-opioid treatment patterns, satisfaction with care, and barriers to care
- To assess how patients handled unused opioids
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
- •English- or Spanish-speaking
- •Experiencing acute pain of less than 8 weeks duration at the time the opioid is prescribed
- •Received prescription for opioid analgesic at visit; opioids included in the study will be all FDA-approved enteral, transdermal, and transmucosal opioid analgesics including the most common: hydrocodone (except cough and anti-diarrheal medications), oxycodone, codeine (except cough medications), tramadol, morphine, hydromorphone. Receipt of a prescription for the following is not an exclusion: buprenorphine (as an analgesic), butorphanol, dihydrocodeine, fentanyl, meperidine, methadone (as an analgesic), oxymorphone, pentazocine, sufentanil, and tapentadol. All of these opioids are included in any combinations with acetaminophen, aspirin, ibuprofen, naloxone, etc.
- •Self-report of no opioid use (no use of prescribed opioids or illicit opioids, including medical or non-medical use) in the past 6 months
- •Willing and able to give consent and participate in study
- •Able to access a device with web access (laptop, desktop, smartphone, or tablet) daily to complete study surveys
- •Willing to connect Fitbit to a mobile device (smartphone or tablet) that can regularly link to Hugo for data transfer
- •Willing to use the health data sharing platform
- •Released/discharged to home after their visit.
排除标准
- •Pain thought to be caused by a systemic disease very likely to progress to chronic pain (e.g., sickle cell disease, fibromyalgia, lupus, multiple sclerosis, etc.);
- •Cancer or end-of-life pain;
- •Unable to give consent and be enrolled within 3 days of their visit.
研究组 & 干预措施
Patients given short-acting opioid prescription
Patients not currently using opioids who receive a new short-acting opioid prescription for acute pain will be recruited.
干预措施: Short-acting opioid prescription for acute pain (Drug)
结局指标
主要结局
Opioid Pain medication use
时间窗: From baseline up to 180 days
Number of days using any opioid medications
Non-Opioid pain medication and treatment use
时间窗: From baseline up to 180 days
Number of days using any non-opioid drugs/treatments
Pain medication use concordant with directions for use
时间窗: From baseline up to 180 days
Comparison of directions for use and actual use: For each day the person takes opioids, measure whether the number of pills taken falls within the range prescribed, below the prescribed range, or above the prescribed range. The overall proportion of days taking less than the prescribed range, within the prescribed range, and over the prescribed range will be calculated for each patient and the distribution of these measures will be plotted as histograms and reported as the median, 25th percentile and 75th percentile.
次要结局
- Average activity levels(From baseline up to 180 days)
- Treatment satisfaction(From baseline up to 180 days)
- Barriers to treatment(From baseline up to 180 days)
- Time to pain resolution(From baseline up to 180 days)
- Time to opioid discontinuation(From initial opioid use to the day on which the last opioid was taken, up to 180 days.)
- Estimated Opioid Use(From baseline up to 180 days)
- Opioid Disposal(From baseline up to 180 days)
- Motivations for disposing or keeping leftover drugs(From baseline up to 180 days)
- Description of pain medications used(From baseline up to 180 days)
- Patient opioid use progression(From baseline up to 180 days)
- Patient chronic pain progression(From baseline up to 180 days)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Prescription Pain Medication Misuse short-form; selected items(From baseline up to 180 days)
- Storage and disposal guidance(From baseline up to 180 days)
- Opioid Storage Methods(From baseline up to 180 days)
- Unused Opioids(From baseline up to 180 days)