Patient Activation to Address Chronic Pain and Opioid Management in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 376
- 试验地点
- 4
- 主要终点
- Patient Activation
研究概览
简要总结
Will a primary care-based behavioral intervention for patient activation and engagement and self-management, for patients with chronic pain who are taking opioid pain medication, result in better patient outcomes than Usual Care?
详细描述
Patients with chronic pain (PWCP) typically have multiple chronic conditions, and many points of contact with the health system. They can feel disempowered, and experience fragmented care and poor outcomes. PWCP report concerns about under-treatment of pain, difficulties in obtaining medication, and stigma. Prescription opioids are a very common, and controversial, pain treatment. PWCP often lack the skills and knowledge to talk to their physicians about their pain and opioid use, and to navigate the health care system. The study's aims compare the effectiveness of an innovative behavioral Patient Activation plus Usual Care (PA+UC) intervention to Usual Care (UC) only on patient-centered outcomes among PWCP. While most studies have focused on chronic opioid users, this takes an upstream approach, focusing on patients as they start regular opioid use. The overarching research question is: Can patients' increased activation improve their quality of life? With our stakeholder group of patient, clinical, and operational advisors, we propose a pragmatic, randomized trial to examine the comparative effectiveness of a group-based PA intervention in two large primary care clinics in Kaiser Permanente Northern California (KPNC). We will randomize 324 PWCP to either the PA+UC arm or UC only arm. The curriculum will cover patient activation and empowerment, how to talk to doctors about prescription opioid use, and self-management of chronic pain, including how to navigate the health care system and a patient portal. We will further develop the study questions, intervention curriculum, outcome measures, and dissemination plan with our stakeholder groups. We will examine effects over 12 months using follow-up patient interviews combined with electronic health records and a mixed effects modeling approach. Patient outcomes include patient-reported activation, quality of life, prescription opioid use, pain severity and function, patient-provider communication, patient satisfaction, knowledge of opioid use risks and benefits, self-care, including use of health information technology, and service utilization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Patient Activation Group Intervention
The experimental procedure is a behavioral based treatment model, plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions.
干预措施: Behavioral Based Treatment Model (Behavioral)
Usual Care
Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.
结局指标
主要结局
Patient Activation
时间窗: Baseline and 6 and 12 months post randomization
The Patient Activation Measure (PAM) is a 13-item instrument for measuring patient beliefs, knowledge and confidence for engaging in a wide range of health behaviors.Each item is rated 1-4 (strongly disagree =1 to strongly agree=4) and a total raw score is generated (0-52). Raw scores are converted to activation scores using a published conversion table. PAM scores are reported on a 1-100 scale, with higher scores associated with positive health outcomes such as participation in health care and treatment adherence.
次要结局
- Quality of Life: Physical Health(Baseline and 6 and 12 months post randomization)
- Quality of Life: Mental Health(Baseline and 6 and 12 months post randomization)
- Overall Health(Baseline and 6 and 12 months post randomization)
- PHQ-9 Depression(Baseline and 6 and 12 months post randomization)
- Satisfaction With Care(Baseline and 6 and 12 months post randomization)
- Opioid Misuse SOAPP(Baseline and 6 and 12 months post randomization)
- Opioid Misuse COMM(Baseline and 6 and 12 months post randomization)
- Pain Coping(6 and 12 months post randomization)
- Self-Efficacy(Baseline and 6 and 12 months post randomization)
- Pain Intensity(Baseline and 6 and 12 months post randomization)
- Function: Everyday Physical Activities(Baseline and 6 and 12 months post randomization)
- Function: Social Activities and Roles(Baseline and 6 and 12 months post randomization)
- Patient Provider Communication(Baseline and 6 and 12 months post randomization)
- Patient Provider Interactions(Baseline and 6 and 12 months post randomization)
- Health Care Utilization Service Visits (EHR)(Baseline and 6 and 12 months post randomization)
- Health Care Utilization Portal Use (EHR)(Baseline and 6 and 12 months post randomization)
- Use of Online Health and Wellness Resources (Self-reported)(Baseline and 6 and 12 months post randomization)
- Attendance at Health Education Classes (Self-reported)(Baseline and 6 and 12 months post randomization)
- Prescription Opioid Use (EHR)(Baseline and 6 and 12 months post randomization)
- Pain Management Strategies- Mindfulness, Meditation and Relaxation(Baseline and 6 and 12 months post randomization)
- Pain Management Strategies- Exercise, Stretching or Physical Therapy(Baseline and 6 and 12 months post randomization)
- Goals for Opioid Use at Baseline(baseline)
- Met Baseline Goals for Opioid Use at 6 and 12 Months(6 and 12 months post-randomization)
- Substance Use(Baseline and 6 and 12 month post-randomization)
- Alcohol Use(Baseline and 6 and 12 months post-randomization)
- Tobacco Use(Baseline and 6 and 12 months post-randomization)