Pain Management Options for Opioid Tolerant Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Returns to Acute Care
研究概览
简要总结
Pain is a symptom that drives hospital admissions, and pain management is required by most patients during their hospital stay. Further, the use of medications such as opioids can lead to upward-spiraling doses, especially among chronic pain patients whose resource utilization rates are high. Many initiatives aim to reduce the costs of these "high-resource utilizing" patients. One exciting aspect of improving the management of pain is that this may help prevent patients from ever becoming high-cost in the first place. The purpose of this study is to examine the impacts of an early and sustained intervention pathway, in comparison to the current standard of care, for the treatment of pain in opioid tolerant patients. It is hypothesized that patients randomized to the intervention pathway, in comparison to the control, will lead to decreased costs of care, a reduction in opioid usage within 3 and 6 months, and decrease in hospital readmission rates.
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
- None
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
- •Adult patients (18 years and older)
- •Known opioid tolerant (as determined per FDA criteria)
- •Agree to sign the informed consent and HIPAA forms
排除标准
- •Patients under the age of 18 years
- •No known opioid tolerance
- •Do not agree to sign the informed consent and HIPAA forms
结局指标
主要结局
Returns to Acute Care
时间窗: Discharge through 90 days post-discharge
Hospital Readmissions and Emergency Department Utilizations
次要结局
- Hospital Length of Stay(Measured upon day of discharge from index hospitalization; up to 18 months from the date of randomization)
- Latency to Hospital Readmission(Discharge through 12 months post-discharge)
- Returns to Acute Care(Discharge through 12 months post-discharge)
- Use of Rescue Drugs(Admission through 12 months post-discharge)
- Opioid Analgesic Use(Admission through 12 months post-discharge)
- Opioid Tolerance Status(Admission through 12 months post-discharge)
- Pain at Discharge(Measured upon day of discharge from index hospitalization; up to 18 months from the date of randomization)
- Healthcare Expenditures(Admission through 12 months post-discharge)