Multicomponent Intervention to Decrease COPD-Related Hospitalizations

描述（由申请人提供）：慢性阻塞性肺疾病（COPD）是全球最常见的慢性疾病之一，是入院和再入院的常见原因。因COPD急性加重而住院是患者的重要事件，因为它可能标志着疾病终末期的开始，并与生活质量和生存机会的显著下降相关。 这是医疗保健系统的一个重要事件，因为在美国，住院费用占COPD相关费用的70%。基于经验证的理论框架、既往文献和我们的初步数据，我们设计了一种COPD多组分干预，将在出院时启动，旨在减少再次住院。干预措施将包括永久获得一名护士，将整合肺康复，将通过使用动机访谈提高自我效能来促进自我管理，并将增加患者/家庭连续体与初级护理团队之间的沟通。本研究计划采用随机对照试验（RCT）设计检验以下假设：（1）干预组的住院率和住院次数将比对照组至少低20%（2）在6个月和12个月的随访中，以平均步数衡量的体力活动水平，干预组每天中等强度（METS>2.5）体力活动的分钟数和活动能量消耗均高于对照组。目标1：确定COPD急性加重出院时开始的干预对12个月随访后住院率和住院次数的影响。目标二：通过活动监测仪在3个月、6个月和12个月时评估，确定干预对COPD急性加重住院后增加和维持体力活动的影响。目的3：确定干预对3个月、6个月和12个月时身体活动和疾病管理自我效能的影响。目的4：确定干预措施对3、6和12个月时健康状况的影响。目标5（探索性）：确定住院、低体力活动的预测因素以及体力活动、自我效能和健康状况变化的预测因素。确定预测因素将允许更强有力的干预措施，并关注那些缺乏活动或再次住院风险较高的患者。变化的预测因子将识别出对类似干预有更高应答机会的患者（研究结局随时间的变化更大）。 公共卫生相关性：这是一种干预措施，旨在减少住院治疗，并通过持续的患者动机增加和维持体力活动。我们预计，如果成功，这种干预的效果不仅对患者很重要（具有临床意义），而且非常具有成本效益，因为美国70%的COPD成本仅来自住院治疗。这种干预措施要求对COPD患者的护理方式进行结构性改变，以及护士和患者本身的参与。这项试验的积极结果可能会改变重度COPD患者的护理标准，并改变多年来根深蒂固的做法。对直接来自患者的不同健康状况感知（患者报告结局）的轨迹分析对于设计未来的COPD干预措施至关重要。

DESCRIPTION (provided by applicant): Chronic obstructive pulmonary disease (COPD) is one of the most common chronic diseases worldwide and is a frequent cause of hospital admissions and readmissions. Hospitalization for a COPD exacerbation is an important event for patients because it may signal the beginning of the terminal phase of illness and is associated with a significant decline in the quality of life and chances of survival. It is an important event for the healthcare system because hospitalization accounts for 70% of COPD-related costs in the United States. Based on a validated theoretical framework, previous literature and on our preliminary data we designed a multi-component intervention for COPD which will be initiated at hospital discharge aimed to decrease re- hospitalization. The intervention will include permanent access to a nurse that will integrate pulmonary rehabilitation, will promote self-management by increasing self efficacy using motivational interviewing and will increase communication between the patient/family continuum and the primary care team. This study plan to test the following hypotheses using a randomized control trial (RCT)design: (1) The rate and number of hospitalizations will be at least 20% lower in the intervention group than in the control group (2) At 6-month and 12-month follow-ups, the physical activity level measured in terms of the average number of steps , minutes spent in physical activities of moderate intensity (METS>2.5) per day and active energy expenditure will be higher in the intervention group than in the control group. Aim 1: To determine the impact of the intervention initiated at the time of hospital discharge from a COPD exacerbation on the rate and number of hospitalizations after 12 months of follow-up. Aim 2: To determine the impact of the intervention on increasing and maintaining physical activity after a hospitalization for a COPD exacerbation assessed by an activity monitor at 3, 6 and 12 months. Aim 3: To determine the impact of the intervention on self efficacy for physical activity and disease management at 3, 6 and 12 months. Aim 4: To determine the impact of the intervention on health status at 3, 6 and 12 months. Aim 5 (exploratory): To determine predictors of hospitalization, low physical activity and predictors of the change in physical activity, self efficacy and health status. Identifying predictors will allow stronger interventions and attention to those patients with higher risk for inactivity or re-hospitalizations. Predictors of change will identify patients with higher chance to respond to similar interventions (higher change over time in study outcomes). PUBLIC HEALTH RELEVANCE: This is an intervention aiming to decrease hospitalization and to increase and maintain physical activity by consistent patient motivation. We anticipate that the effect of this intervention if successful will be not only important to patients (clinically meaningful) but also extremely cost effective as 70% of the cost of the COPD in the US comes from hospitalizations alone. This intervention calls for a structural change in the way people with COPD are cared for, and the participation of nurses, and patients themselves. Positive results from this trial may change the standard of care for patients with severe COPD and modify practices that have been entrenched for many years. The trajectory analysis of the different perceptions of health status coming directly from patients (patient reported outcomes) will be of critical importance to design future COPD interventions.