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Pragmatic collaborative care for cardiac inpatients with depression or anxiety

对患有抑郁或焦虑的心脏病住院患者进行务实的协作护理

基本信息

批准号：
9912183
负责人：
Jeff C Huffman
金额：
$ 75.27万
依托单位：
MASSACHUSETTS GENERAL HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-07-01 至 2022-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9912183
关键词：
Academic Medical Centers Address Adherence Admission activity Affect Antidepressive Agents Anxiety Anxiety Disorders Behavior Behavior Therapy Behavioral Blood Pressure Cardiac Cardiac health Care given by nurses Caring Case Manager Characteristics Cholesterol Client satisfaction Clinical Clinical Nursing Community Hospitals Comprehensive Health Care Consult Cost Analysis Cost Measures Custom Data Data Collection Death Rate Depressed mood Diabetes Mellitus Diagnosis Diet Disease Effectiveness Electronic Health Record Enrollment Event Exclusion Criteria Feeds Generalized Anxiety Disorder Goals Health Benefit Health Care Costs Health Promotion Health behavior Healthcare Systems Heart Diseases Heart failure Hospitals Infrastructure Inpatients Internet Intervention Intervention Trial Lead Link Measures Medical Mental Depression Mental Health Mental disorders Modeling Monitor Moods Nurses Outcome Outcome Assessment Outcome Measure Outcome Study Outpatients Panic Disorder Participant Patient Care Patient Outcomes Assessments Patient-Focused Outcomes Patients Pharmaceutical Preparations Physical Function Physical activity Population Provider Psychiatrist Psychotherapy Public Health Quality of life Quality-Adjusted Life Years Recommendation Research Resources Site Smoking Specialist System Telephone Training Weight Work acute coronary syndrome adverse event risk adverse outcome anxious behavioral adherence care coordination clinical care clinical implementation cohort collaborative care comorbidity comparison intervention cost cost effective cost effectiveness effective intervention efficacy trial flexibility health related quality of life high risk high risk population hospital readmission improved inclusion criteria indexing innovation medication compliance mortality motivational enhancement therapy novel novel strategies online resource outcome forecast patient home care practice setting pragmatic trial primary outcome programs psychiatric symptom randomized trial treatment as usual treatment trial

项目摘要

Among patients hospitalized for an acute coronary syndrome (ACS) or heart failure (HF), depression and anxiety disorders are common and independently associated with poor function, readmissions, and mortality. Single interventions (e.g., antidepressants) for these disorders have not improved medical outcomes, and typical clinical approaches (such as specialist referral) are poorly attended. Novel, feasible, and effective interventions are badly needed to improve clinical outcomes in this high-risk population. Collaborative care programs use a non-physician care manager and consulting psychiatrists to manage psychiatric conditions in patients with medical illness. Standard versions of these programs improve mental health but have not consistently improved cardiac outcomes. New ‘blended’ care models targeting both psychiatric and cardiac conditions have had promising effects on medical outcomes. However, such programs have typically managed depression in outpatients with stable cardiac illness, rather than targeting broader and higher-risk cohorts. Furthermore, prior blended care models have only included limited health behavior components in their interventions, despite the vital effects of such behaviors on cardiac prognosis. To address these limitations, we propose a pragmatic randomized trial of an enhanced blended collaborative care program. The trial will enroll 260 patients admitted to an academic or community hospital for ACS or HF who have depression or an anxiety disorder. The 26-week intervention will use a nurse care manager to engage participants in the hospital and coordinate with them by phone post-discharge. The nurse will provide psychotherapy, specifically promote health behavior adherence using motivational interviewing, and assist with medical self-monitoring (e.g., weight, blood pressure). The nurse will also transmit medication recommendations from study team psychiatrists and cardiologists to patients’ medical providers, who will prescribe all treatments. Patients will thus receive expert guidance integrated into their existing medical care. The trial’s innovations include: (1) hospital-to-home care management that begins during admission and continues through the high-risk post-discharge period, (2) inclusion of patients with multiple psychiatric or cardiac conditions, (3) a flexible three-pronged (psychiatric, behavioral, cardiac) approach with a more robust health behavior intervention than in any prior collaborative care program, and (4) data collection via an iPad- internet system that is fully integrated into the clinical record to allow use of this data in patient care decisions. The program will be compared to enhanced usual care. The trial’s primary outcome measure will be physical function at 26 weeks, given that low function independently predicts new cardiac events. Our novel approach targeting multiple contributors to low function in ACS/HF patients should have strong effects on this main outcome. We will also examine group differences on additional key patient-reported outcomes and cost metrics, and we will assess the intervention’s impact on major cardiac events throughout the study period.

在因急性冠状动脉综合征（ACS）或心力衰竭（HF）住院的患者中，和焦虑症是常见的，与功能不良、再入院和 mortality.单一干预措施（例如，抗抑郁药）并没有改善医疗结果，并且典型的临床方法（例如专家转诊）很少得到关注。新颖、可行、有效迫切需要采取干预措施来改善这一高危人群的临床结果。协作护理计划使用非医生护理经理和咨询精神科医生来管理患有内科疾病的患者的精神状况。这些程序的标准版本可以提高心理健康，但并没有持续改善心脏结果。新的“混合”护理模式，精神病和心脏病对医疗结果产生了有希望的影响。然而，这些方案通常在患有稳定心脏病的门诊患者中管理抑郁症，而不是针对更广泛的，高风险人群此外，先前的混合护理模式仅包括有限的健康行为尽管这些行为对心脏预后有重要影响，但他们的干预措施中仍然存在这些因素。为了解决这些局限性，我们提出了一个务实的随机试验的增强混合协作护理计划。该试验将招募260名在学术或社区医院住院的患者，患有抑郁症或焦虑症的ACS或HF患者。为期26周的干预将使用护士护理经理在出院后通过电话与医院的参与者进行沟通和协调。护士将提供心理治疗，特别是促进健康行为的坚持使用动机访谈，并辅助医疗自我监测（例如，体重、血压）。护士也会把药物研究小组精神病学家和心脏病学家向患者的医疗提供者提出建议，所有的治疗方法。因此，患者将获得专家指导，并将其纳入现有的医疗护理。该试验的创新包括：（1）从入院时开始的医院到家庭的护理管理并持续到出院后的高风险期，（2）纳入患有多种精神疾病或（3）灵活的三管齐下（精神，行为，心脏）方法，健康行为干预比任何以前的合作护理计划，和（4）通过iPad收集数据- 互联网系统完全集成到临床记录中，以允许在患者护理决策中使用这些数据。该计划将与增强的常规护理进行比较。试验的主要结果指标将是考虑到低功能独立预测新的心脏事件，26周时的身体功能。我们的新型针对ACS/HF患者功能低下的多个因素的方法应该对此有很强的影响主要成果。我们还将检查其他关键患者报告结果和成本的组间差异指标，我们将评估干预措施对整个研究期间主要心脏事件的影响。