Nationwide Observational Registry of Patient Outcomes Following Ketamine Infusion Therapy for Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Change in PROMIS Pain Interference Score From Baseline
研究概览
简要总结
Ketamine is an anesthetic drug that is sometimes used to relieve chronic pain. The goal of this observational study is to learn about how patients respond to ketamine infusions for chronic pain.
Note: This study does not provide ketamine - instead, this study uses surveys to follow patients who are already scheduled to receive ketamine infusions as part of their regular medical care.
We will also follow a second group of patients who were recommended ketamine infusions by their doctor but were denied insurance coverage for this treatment. These participants will complete the same surveys for up to 16 weeks, starting from when their treatment was originally scheduled. Comparing this group to patients who received ketamine will help researchers better understand ketamine's effects and how insurance denials affect chronic pain patients.
详细描述
Some key questions this study would like to answer:
- How do patients respond to ketamine over time? This study will use surveys to track pain, sleep, mood, function, and other experiences for up to 16 weeks after a ketamine infusion.
- Does the dose matter? This study aims to find out whether patients who get higher doses of ketamine have longer-lasting pain relief, and whether there is a point of diminishing returns.
- What makes some patients respond better than others? For example, there are some early data suggesting that patients who worry more about their pain might have more trouble reducing their opioids after ketamine treatment even if they had pain relief.
- Are ketamine infusions addictive when used for pain treatment? This study will track cravings and drug liking for up to 16 weeks after a ketamine infusion. Addiction risk is expected to be low, but this study will document this risk systematically.
- What happens to patients who were recommended ketamine but denied insurance coverage? This study will compare their outcomes to patients who received ketamine, to better understand the impact of insurance denials and the real-world effects of ketamine treatment.
STUDY PROCEDURES SUMMARY
Upon consenting to the study, eligible participants will be asked to share their contact information, some background health information, details about their scheduled infusion, prior ketamine experience, and baseline symptoms. All personal information will be kept private and secure. Participants will be assigned a unique study number, and their name and contact details will not be shared with anyone outside the core study team.
Afterwards, participants will:
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
- •Planning to receive an intravenous ketamine infusion for the treatment of chronic pain
排除标准
- •Unable to read or understand English questionnaires
研究组 & 干预措施
Denied Treatment Cohort
Observational cohort of patients who were recommended ketamine infusion therapy but did not receive this treatment due to lack of insurance coverage
Ketamine Treated Cohort
Observational cohort of patients who received ketamine infusion therapy for the treatment of chronic pain
干预措施: Ketamine (Ketalar) (Drug)
结局指标
主要结局
Change in PROMIS Pain Interference Score From Baseline
时间窗: 8, 10, and 12 weeks after the ketamine infusion
次要结局
- Change in Opioid Use From Baseline, Patient-Rated Global Assessment(From enrollment to 12 weeks after the ketamine infusion)
研究者
Theresa Lii
Instructor
Stanford University