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：
9307092
负责人：
Jeff C Huffman
金额：
$ 77.35万
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/9307092
关键词：
Academic Medical Centers Address Adherence Admission activity Adverse event 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 Comorbidity Comprehensive Health Care Consult Cost Analysis 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 behavior Healthcare Systems Heart Diseases Heart failure Hospitals 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 risk Patient-Focused Outcomes Patients Pharmaceutical Preparations Phonation Physical Function Physical activity Population Provider Psychiatrist Psychotherapy Public Health Quality of life Quality-Adjusted Life Years Recommendation Research Research Infrastructure Resources Site Smoking Specialist System Telephone Training Weight Work acute coronary syndrome adverse outcome anxious clinical care cohort collaborative care cost cost effective cost effectiveness effective intervention efficacy trial feeding flexibility health related quality of life high risk high risk population improved inclusion criteria innovation medication compliance mortality motivational enhancement therapy novel novel strategies online resource outcome forecast patient home care 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.

因急性冠脉综合征 (ACS) 或心力衰竭 (HF) 住院的患者中，抑郁症焦虑症很常见，并且与功能不良、再入院和针对这些疾病的单一干预措施（例如抗抑郁药）并没有改善医疗结果，新颖、可行且有效的典型临床方法（例如专家转诊）的参与率很低。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顾问来管理这些计划的标准版本可以改善患有疾病的患者的精神状况。健康，但并没有持续改善心脏结果然而，精神疾病和心脏疾病对医疗结果产生了良好的影响。通常对患有稳定心脏病的门诊患者进行抑郁症治疗，而不是针对更广泛和更广泛的目标此外，之前的混合护理模式仅包括有限的健康行为。尽管此类行为对心脏预后具有重要影响，但这些行为仍是其干预措施的组成部分。为了解决这些局限性，我们提出了一项增强混合的实用随机试验该试验将招募 260 名在学术或社区医院接受治疗的患者。患有抑郁症或焦虑症的 ACS 或 HF 为期 26 周的干预将由护士护理。经理与医院的参与者进行接触，并在出院后通过电话与他们进行协调。将提供心理治疗，特别是通过动机访谈促进健康行为的坚持，协助进行医疗自我监测（例如体重、血压）。护士还将传递药物。研究小组的恐慌和心脏病专家向患者的医疗提供者提出的建议，他们将因此，患者将获得融入其现有医疗护理的专家指导。该试验的创新包括：（1）从入院时开始的医院到家庭护理管理并持续到出院后的高风险期，(2) 纳入患有多种精神或疾病的患者心脏疾病，(3) 灵活的三管齐下（精神、行为、心脏）方法，具有更稳健的方法健康行为干预比之前任何协作护理计划都要多，以及 (4) 通过 iPad 收集数据- 互联网系统完全集成到临床记录中，以便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，该试验的主要结果指标将是： 26 周时的身体功能，考虑到功能低下可以独立预测新的心脏事件。针对 ACS/HF 患者功能低下的多种因素的方法应该对此产生强烈的影响我们还将检查患者报告的其他关键结果和成本的组间差异。指标，我们将评估整个研究期间干预措施对主要心脏事件的影响。