Comparative Effectiveness of Patient-Centered Strategies to Improve Pain Management and Opioid Safety for Veterans
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 820
- 试验地点
- 1
- 主要终点
- Pain Response
研究概览
简要总结
Background and significance: Treatment with opioid pain medications (like hydrocodone and morphine) is common for severe pain, but studies show these medications may not always help and can cause serious problems. High daily doses of opioids can be especially unsafe. To help patients with chronic pain have better quality of life and avoid medication toxicity, health care teams need to manage pain while helping patients reduce opioid medication doses to safer levels.
详细描述
Study aims: This study will test which of two pain treatment strategies is better for managing pain and helping patients improve safety of opioid medication. For patients on high opioid doses who want to reduce, this study will also test whether offering an extra option for tapering (buprenorphine-naloxone) helps them succeed. Finally, the study will examine patients' and clinicians' experiences with the interventions.
Study description: The study will compare two treatment strategies among patients with pain who are taking long-term opioid pain medications prescribed by VA healthcare facilities across the country. Patients who wish to enter the study will be assigned by chance to telecare collaborative management (TCM) or integrated pain team (IPT). TCM involves a pharmacist and supervising physician working together to find the best medication options for each individual patient. In IPT, a team of clinicians focuses on non-medication pain management options, in addition to pain medication.
All participants will be asked to stay in the study for 12 months. Patients for whom it would be unsafe to participate will not be invited to join. With either treatment strategy, TCM or IPT, participants will have individualized pain care tailored to their needs and preferences. Participants on high opioid medication doses who want to reduce their opioid medication dose will be assigned by chance to get either a regular step-wise taper or a choice between a regular taper or switching to a different medication (buprenorphine-naloxone).
At the end of the study, the two treatment strategies will be compared to see which worked better to (1) decrease pain severity and (2) reduce opioid medication dose. Other outcomes important to patients will also be tracked. These include quality of life, sleep, fatigue, depression, anxiety, and side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate or high-dose long-term opioid therapy (≥ 20 ME mg daily for at least 3 months) for chronic pain
- •Chronic pain of at least moderate severity (defined as pain that is present every or nearly every day for ≥ 6 months and with a score on the PEG 3-item pain measure of ≥ 5)
排除标准
- •Dementia diagnosis
- •Unstable or severe untreated psychiatric disorder, including severe untreated substance use disorder or active suicidal ideation
- •Unstable or end-stage medical disease that would interfere with participation, including cancer requiring active treatment and life expectancy < 12 months
- •Documentation of suspected controlled substance diversion
- •Inability to communicate by telephone
研究组 & 干预措施
Telecare collaborative management (TCM)
Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.
干预措施: Medication management (Other)
Integrated pain team (IPT)
Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.
干预措施: Medication management (Other)
Integrated pain team (IPT)
Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.
干预措施: Non-pharmacological pain management (Other)
Standard taper options
The standard taper options arm uses patient education and shared decision-making to guide opioid medication management.
干预措施: Medication management (Other)
Expanded taper options
The expanded taper options arm uses patient education and shared decision-making to guide opioid medication management and includes the additional option of rotation to buprenorphine-naloxone.
干预措施: Medication management (Other)
Expanded taper options
The expanded taper options arm uses patient education and shared decision-making to guide opioid medication management and includes the additional option of rotation to buprenorphine-naloxone.
干预措施: Buprenorphine-Naloxone (Drug)
结局指标
主要结局
Pain Response
时间窗: 12 months
Binary response variable defined by reduction of at least 30% in Brief Pain Inventory (BPI) total score from baseline
次要结局
- 50% Reduction in Opioid Daily Dose(12 months)
- Composite Response(12 months)
- Brief Pain Inventory (BPI) Total Score(12 months)