Comprehensive vs. Assisted Management of Mood and Pain Symptoms (CAMMPS) Trial

情绪和疼痛症状综合与辅助管理 (CAMMPS) 试验

• 批准号: 8481806
• 负责人: KURT KROENKE
• 金额: --
• 依托单位: RLR VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-06-01 至 2016-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8481806
• 关键词: Adverse effects; Algorithms; Analgesics; Antidepressive Agents; Anxiety; Anxiety Disorders; Attention; Caring; Chronic; Clinic; Clinical; Clinical Trials Design; Comorbidity; Complex; Coupling; Disease; Dose; Effectiveness; Enrollment; Future; Greek; Health; Health Care Costs; Healthcare; Healthcare Systems; High Prevalence; Individual; Informed Consent; Internet; Intervention; Link; Medical; Medication Management; Mental Depression; Mental Health; Mental disorders; Mind; Monitor; Mono-S; Moods; Nurses; Outcome; Outpatients; Pain; Pain management; Patients; Perception; Pharmaceutical Preparations; Physicians; Post-Traumatic Stress Disorders; Primary Care Physician; Primary Health Care; Provider; Psychologist; Quality of life; Randomized; Relative (related person); Research Design; Resources; Self Management; Services; Severities; Site; Specialist; Symptoms; Testing; Triad Acrylic Resin; Veterans; Voice; arm; base; chronic pain; clinically significant; comparative effectiveness; depressive symptoms; disability; effectiveness trial; evidence base; functional status; head-to-head comparison; health care service utilization; health information technology; health related quality of life; improved; innovation; medical specialties; ovid; primary care setting; primary outcome; programs; psychologic; response; satisfaction; secondary outcome; symptom management; telehealth; treatment as usual; treatment response; trial comparing

DESCRIPTION (provided by applicant): Background. Pain is the most common presenting somatic symptom in medical outpatients, and depression and anxiety are the two most common mental disorders. All three conditions are often inadequately treated and result in substantial disability, reduced health-related quality of life, and increased health care costs and utilization. Additionally, pain, anxiety, and depression (PAD) are frequently comorbid with one another and have reciprocal negative effects on treatment response and additive effects on adverse health outcomes. The PAD triad is especially burdensome in Veterans, with their high prevalence of chronic pain, depression, PTSD, and other anxiety disorders. Objectives. The Comprehensive vs. Assisted Management of Mood and Physical Symptoms (CAMMPS) study is a randomized comparative effectiveness trial designed to test the relative effectiveness of a lower-resource vs. a higher-resource enhancement of usual primary care in the management of veterans suffering from with pain plus anxiety and/or depression. Research Design. This will be a single-site study enrolling Veterans. Patients followed in primary care clinics at the Roudebush VAMC will be eligible if they have clinically significant levels of pain plus comorbid anxiety and/or depression. A total of 300 eligible patients who provide informed consent will be randomized to one of two treatment arms. One group (n=150) will receive assisted symptom management (ASM) consisting of automated symptom monitoring by interactive voice recording or Internet and prompted pain self-management guided by symptom levels. The second group (n=150) will receive comprehensive symptom management (CSM) which combines ASM with optimized medication management delivered by a nurse-physician specialist team and facilitated mental health care. This team will partner with both VA primary care physicians/PACTs and psychologists embedded in primary care to monitor and adjust treatments using evidence-based analgesic and antidepressant algorithms, reinforced self-management, and care coordination. We postulate that although both interventions are likely to be beneficial, CSM will be superior to ASM. In short, this trial compares: 1) usual care plus assisted symptom management (ASM) vs. 2) usual care plus ASM plus optimized medication and facilitated mental health care (CSM). Outcomes will be assessed at 1, 3, 6, and 12 months. The primary outcome is a composite pain-anxiety- depression severity score. Secondary outcomes include individual pain, anxiety, and depression scores; functional status and health-related quality of life; treatment satisfaction; and perceived barrier and facilitators of the CSM and ASM interventions. The rationale for ASM is preliminary evidence of its effectiveness and its lower use of resources. The rationale for CSM is that the addition of optimized medication management, facilitated mental health care, and coordination with both primary care physicians/PACTS and psychologists for the PAD symptoms should substantially enhance the benefits of ASM. Innovation. CAMMPS provides an integrated approach to PAD symptom comorbidity rather than fragmented care of single symptoms; coordinated symptom management in partnership with both primary care clinicians and psychologists embedded in primary care; the efficient use of health information technology; attention to physical and psychological symptom comorbidity; and the coup- ling of self-management with optimized medication management and facilitated mental health care.

描述（由申请人提供）： 背景疼痛是内科门诊患者最常见的躯体症状，抑郁和焦虑是最常见的两种精神障碍。所有这三种疾病往往得不到充分治疗，导致严重残疾，降低与健康有关的生活质量，增加保健费用和利用。此外，疼痛、焦虑和抑郁（PAD）经常相互共病，对治疗反应有相互的负面影响，对不良健康结果有累加效应。PAD三联征在退伍军人中尤其沉重，他们的慢性疼痛、抑郁、PTSD和其他焦虑症患病率很高。目标.情绪和身体症状的综合与辅助管理（CAMMPS）研究是一项随机比较有效性试验，旨在测试较低资源与较高资源的相对有效性。研究设计。这将是一项招募退伍军人的单中心研究。在Roudebush VAMC的初级保健诊所接受随访的患者，如果他们有临床显著水平的疼痛加上共病焦虑和/或抑郁，将有资格参加。提供知情同意书的共计300例合格患者将被随机分配至两个治疗组之一。一组（n=150）将接受辅助症状管理（ASM），包括通过交互式语音记录或互联网进行自动症状监测，并根据症状水平进行提示性疼痛自我管理。第二组（n=150）将接受综合症状管理（CSM），该管理将ASM与由护士-医生专家团队提供的优化药物管理相结合，并促进心理健康护理。该团队将与VA初级保健医生/PACTs和嵌入初级保健的心理学家合作，使用循证镇痛和抗抑郁算法，加强自我管理和护理协调来监测和调整治疗。我们假设，虽然这两种干预措施可能是有益的，CSM将优于ASM上级。简而言之，这项试验比较了：1）常规护理加辅助症状管理（ASM）与2）常规护理加ASM加优化药物和促进心理健康护理（CSM）。将在1、3、6和12个月时评估结局。主要结局是疼痛-焦虑-抑郁综合严重程度评分。次要结局包括个体疼痛、焦虑和抑郁评分;功能状态和健康相关生活质量;治疗满意度;以及CSM和ASM干预措施的感知障碍和促进因素。个体和小型作业的理由是其有效性和较低的资源使用的初步证据。CSM的基本原理是，增加优化的药物管理，促进心理健康护理，并与初级保健医生/PADI和心理医生协调PAD症状，应大大提高ASM的好处。创新CAMMPS为PAD症状合并症提供了一种综合方法，而不是单一症状的零散护理;与初级保健临床医生和初级保健中的心理学家合作进行协调的症状管理;有效利用健康信息技术;关注身体和心理症状合并症;以及自我管理与优化药物管理和促进心理健康护理的结合。