A Care Management Intervention for Non-cardiac Chest Pain: Intervention Development and Feasibility Assessment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Feasibility of adherence
研究概览
简要总结
The investigators developed and implemented an eight-week multicomponent care management intervention for non-cardiac chest pain. Team members including a cardiologist, nurse, and psychiatrist. Impressions and recommendations were shared with the patient's primary care physician. Measures of chest pain severity, frequency and impact and measures of psychological health and health-related quality of life were completed at baseline and intervention completion.
详细描述
The investigators developed and implemented an eight-week multicomponent care management intervention for non-cardiac chest pain. The care management team consisted of a nurse, cardiologist, and psychiatrist. Following a one-time consultation visit with the cardiologist and nurse, evaluation and treatment recommendations were conveyed to the participant's primary care physician. Then, the nurse completed eight weekly phone calls with the participant to provide support, introduce therapeutic principles, and assist with coordination of care, under the supervision of a psychiatrist. Intervention feasibility was assessed on several domains including adherence, recruitment, attrition, safety, and data collection. To examine preliminary efficacy, participants completed Likert scales of chest pain symptom severity, frequency and impact, and measures of psychological health (Patient Health Questionnaire-9, General Anxiety Disorder-7, Patient Health Questionnaire-15) and health-related quality of life (12-Item Short Form Survey) at baseline and intervention completion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Diagnosis of non-cardiac chest pain, defined as chest pain recurring at least once per week for two weeks with at least two of the following objective tests: (1) electrocardiogram without ischemic changes; (2) negative cardiac enzymes; (3) non-ischemic cardiac stress test.
- •Primary care physician affiliated with the institution
排除标准
- •History or subsequent diagnosis of cardiac disease
- •Objectively diagnosed alternative medical etiology of chest pain (e.g., gastroesophageal disease)
- •Resolution of chest pain prior to enrollment
- •Cognitive impairment, assessed using a six-item screen
- •Inability to communicate in English
- •Lack of telephone access (precluding weekly phone call participation).
结局指标
主要结局
Feasibility of adherence
时间窗: Week 8
A priori, feasible adherence was defined as 100% completion of the consultation visit and a mean completion of at least half of the eight phone calls over the eight-week study period.
次要结局
- Change in depressive symptoms(Change from baseline at week 8)
- Feasibility of intervention safety(Week 8)
- Change in chest pain symptom impact(Change from baseline at week 8)
- Change in anxiety symptoms(Change from baseline at week 8)
- Change in somatic symptom disorder/somatization symptoms(Change from baseline at week 8)
- Feasibility of intervention attrition(Week 8)
- Feasibility of data collection at follow-up(Week 8)
- Feasibility of data collection at baseline(Baseline)
- Change in chest pain symptom severity(Change from baseline at week 8)
- Feasibility of recruitment(Baseline)
- Change in chest pain symptom frequency(Change from baseline at week 8)
- Change in health-related quality of life(Change from baseline at week 8)
研究者
Jeff C. Huffman, MD
Associate Chief of Psychiatry
Massachusetts General Hospital