Guiding Aging Long-Term Opioid Therapy Users Into Safer Use Patterns
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 286
- 试验地点
- 1
- 主要终点
- Referral rate to non-opioid care
研究概览
简要总结
Patients on long-term opioid therapy are aging and now face magnified risk of harm with continued high-dose opioid use. These increased risks are due to age-related changes in drug metabolism, multi-morbidity, and polypharmacy. The dominant approach to mitigate these risks is to screen for aberrant patient opioid behaviors so that clinicians can pre-empt misuse early through review of contractual opioid agreements or by lowering patient dosages. By focusing on opioid misuse alone, this strategy encourages forced opioid tapering that is associated with opioid overdose and mental health crisis. Directing clinician attention to the comorbid conditions associated with opioid misuse may promote safer and more effective care.
The objective of this study is to assess the comparative effectiveness of PainTracker, a set of questions that targets a broad range of problems associated with pain, in a randomized controlled trial involving 286 Northwestern Medicine clinicians treating Chronic Opioid Use Registry patients (n=1451).
详细描述
Using the electronic health record, patient portal, and patient-reported outcome capabilities, the investigators will develop programming logic for a randomized experimentation platform wherein two or more versions of pain surveys may be delivered to patients. This system will be used to evaluate PainTracker, delivered to half of the patient sample. Clinicians treating Chronic Opioid Use Registry patients that meet the inclusion criteria will be assigned to one of two conditions involving patient surveys: 1) Current Opioid Misuse Measure [COMM] [standard clinical care] or 2) COMM + PainTracker. Surveys will be delivered monthly and patients will be prompted 3 times to complete the survey; once completed, patients will receive a score also delivered to their physician's inbox in Epic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age 65 or older on long-term opioid therapy within the Northwestern Medicine Chronic Opioid Use registry system with at least one primary care encounter in the past 12 months.
排除标准
- •Patient visits with active cancer diagnoses
研究组 & 干预措施
Current Opioid Misuse Measure (COMM)
On a monthly basis, patients will receive the abbreviated Current Opioid Misuse Measure (COMM), a 6-item self-report screener to identify and monitor the risk of aberrant opioid-related behavior in chronic pain patients on opioid therapy. The COMM asks patients to report their behaviors over the past 30 days using a five-point Likert-type rating scale.
干预措施: Current Opioid Misuse Measure (Behavioral)
Current Opioid Misuse Measure (COMM) + PainTracker
On a monthly basis, patients will receive both the abbreviated Current Opioid Misuse Measure (COMM) and PainTracker. PainTracker tracks multiple outcomes relevant to the treatment of chronic pain: pain severity, general activity interference, enjoyment of life interference, sleep (initiating and maintaining), depression, and anxiety.
干预措施: PainTracker (Behavioral)
Current Opioid Misuse Measure (COMM) + PainTracker
On a monthly basis, patients will receive both the abbreviated Current Opioid Misuse Measure (COMM) and PainTracker. PainTracker tracks multiple outcomes relevant to the treatment of chronic pain: pain severity, general activity interference, enjoyment of life interference, sleep (initiating and maintaining), depression, and anxiety.
干预措施: Current Opioid Misuse Measure (Behavioral)
结局指标
主要结局
Referral rate to non-opioid care
时间窗: 9 months
Patient referral rate to non-opioid care that includes mental and behavioral health care, physical therapy, or sleep medicine referrals
Antidepressant orders
时间窗: 9 months
Rate of orders for antidepressant medications
Count of Referrals to Non-opioid Care
时间窗: 9 months
Count of referrals to non-opioid care during the timeframe of 8/9/2023-5/8/2024. Referrals to non-opioid care include mental and behavioral health care, physical therapy, and/or sleep medicine referrals
Count of Antidepressant Orders
时间窗: 9 months
Count of orders for antidepressant medications during the timeframe of 8/9/2023-5/8/2024.
次要结局
- Benzodiazepine prescribing(9 months)
- Clinician monthly milligram morphine equivalent (MME)(9 months)
- Clinician Monthly Milligram Morphine Equivalent (MME)(9 months)
- Benzodiazepine Prescribing(9 months)
研究者
Jason Doctor
Professor
University of Southern California