Care Management for the Effective Use of Opioids (CAMEO)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 261
- 试验地点
- 1
- 主要终点
- Brief Pain Inventory Pain Intensity Score at Baseline and Each Follow-up Time Point
研究概览
简要总结
The CAre Management for the Effective use of Opioids (CAMEO) trial is a 2-arm randomized clinical trial to compare the effectiveness of pharmacological vs. behavioral approaches for chronic lower back pain. The study aims are to compare the interventions' (PHARM vs. BEH) effects on pain intensity, pain interference, function, and other pain relevant outcomes over 12 months.
详细描述
The general purpose of the CAre Management for the Effective use of Opioids (CAMEO) study is to develop, test, and implement novel treatments and care delivery models that address barriers to effective pain management and that can be practicably applied in VA primary care settings for chronic low back pain (CLBP). The CAMEO trial is a 2-arm randomized clinical trial to compare the effectiveness of pharmacological vs. behavioral approaches for CLBP.
The investigators' study sample will target 272 Veterans with moderate to severe CLBP despite long-term opioid therapy. Patients from five primary care clinics at the Roudebush VA Medical Center and two community based outpatient clinics will be recruited to participate in CAMEO and randomized to one of two treatment arms. The pharmacological arm will involve guideline-concordant opioid management coupled with algorithm-based co-analgesic treatment (MED). Patients in the behavioral arm (CBT) will receive pain self-management/coping skills training. The trial will last 12-months and all participants will undergo comprehensive outcome assessments at baseline, 3, 6, 9, and 12 months.
Study Aims: Among Veterans with chronic low back pain refractory to long-term opioid therapy
- To compare the interventions' (MED vs. CBT) effects on pain intensity and function over 12 months
- To compare the interventions' effects (MED vs. CBT) on other relevant outcomes
- Health-related quality of life
- Pain Catastrophizing
- Depression
- Anxiety
- Disability
- Opioid misuse and opioid dose
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
- Single (Outcomes Assessor)
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
- •Veterans will be eligible if they have:
- •chronic lower back pain of at least moderate intensity
- •pain for 6 months
- •on chronic opioid therapy
- •and access to a working telephone
排除标准
- •Exclusion criteria includes:
- •severe medical conditions
- •active psychosis
- •schizophrenia
- •active suicidal ideation
- •pending back surgery
- •moderately severe cognitive impairment
- •involvement in ongoing pain trials
- •and pregnant or trying to become pregnant
- •The investigators will exclude Veterans with an active substance use disorder (i.e., those currently in treatment), but to maximize generalizability the investigators will not exclude those with a past history of substance abuse.
研究组 & 干预措施
Arm 1: Pharmacological (MED)
Subjects in the Pharmacological (MED) arm will receive at least 8 contacts with the nurse care managers (NCM) over the trial period. Participants will have an initial visit at baseline to assess their current and past treatments for chronic lower back pain, pain intensity, and pain-related limitations. Patients' opioids will be adjusted and/or co-analgesics (or adjuvants) will be initiated. During follow-up calls, patients' pain severity, response to treatment, adherence, adverse effects, and desire to change current treatment will be assessed. Follow-up NCM telephone contacts will occur at 2 and 4 weeks after baseline, and months 2, 3, 4, 6, and 9 months. On average, these calls last between 10 to 20 minutes. Detailed logs will be kept of the timing and content of patient contacts.
干预措施: Pharmacological (MED) (Drug)
Arm 2: Behavioral treatment (CBT)
Veterans randomized to behavioral treatment arm (CBT) will receive a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists. Since optimal application of non-pharmacological interventions for pain involves tailoring to patient needs, participants will be introduced to a menu of self-management and coping skills rather than receive a prescribed program. Delivery of the behavioral intervention will employ a flexible approach that is easily adapted to individual preferences and perceived need for learning specific pain coping skills. Tailoring will include the selection of relevant content and skills and assessment of readiness to change behaviors.
干预措施: Behavioral treatment (CBT) (Behavioral)
结局指标
主要结局
Brief Pain Inventory Pain Intensity Score at Baseline and Each Follow-up Time Point
时间窗: Baseline and 3, 6, 9, and 12 months
The Brief Pain Inventory pain intensity score is scored from 0 (no pain) to 10 (worst pain imaginable). We report below the baseline score on the 0 to 10 scale. At each follow-up time point (3, 6, 9, and 12 months) we report the change from baseline to follow-up. This value was calculated as the baseline score minus the follow-up score.
Brief Pain Inventory Total Score at Baseline and Change Score From Baseline at 3, 6, 9, and 12 Months
时间窗: Baseline and 3, 6, 9, and 12 months
The Brief Pain Inventory Total Score combines scores from the BPI Pain Intensity subscale and the BPI Pain Interference subscale. This scale provides a total score from 0 (no pain/no pain interference) to 10 (worst pain imaginable/completely interferes). We report below the baseline score on the 0 to 10 scale. At each follow-up time point (3, 6, 9, and 12 months) we report the change from baseline to follow-up. This value was calculated as the baseline score minus the follow-up score.
Brief Pain Inventory Pain Interference Scale Score
时间窗: Baseline and 3, 6, 9, and 12 months
The Brief Pain Inventory Pain Interference Scale score assesses if pain interferes with 7 common activities. This scale is score 0 (no interference) to 10 (high interference). The 7-items are averaged to give a score.
次要结局
- AUDIT-C(Baseline, 6 months, and 12 months)
- Current Opioid Misuse Measure (COMM)(Baseline, 6 months, and 12 months)
- Roland Morris Disability Scale(Baseline, 3 months, 6 months, 9 months, and 12 months)
- Pain Catastrophizing Scale(Baseline, 6 months, and 12 months)
- Patient Health Questionnaire-9(Baseline, 3 months, 6 months, 9 months, and 12 months)
- Generalized Anxiety Disorder 7-item (GAD-7) Scale(Baseline, 3 months, 6 months, 9 months, and 12 months)
- SF-36 Vitality Scale(Baseline, 6 months, and 12 months)
- SF-36 General Health Perception(Baseline, 6 months, and 12 months)
- SF-36 Social Functioning Scale(Baseline, 6 months, and 12 months)