A Pragmatic Randomized Control Trial of Nurse-Delivered Brief Meaning Centered Psychotherapy for Homebound Palliative Care Patients

护士为居家姑息治疗患者提供简短意义中心心理治疗的实用随机对照试验

• 批准号: 10302511
• 负责人: Allison Applebaum
• 金额: $ 21.55万
• 依托单位: SLOAN-KETTERING INST CAN RESEARCH
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10302511
• 关键词: Address; Adult; Advanced Malignant Neoplasm; Aftercare; Anxiety; Attitude; Behavior; Benchmarking; Cancer Patient; Caring; Clinical; Communities; Community Practice; Complex; Consensus; Dissemination and Implementation; Distress; Dose; Emotional; Employee; Ensure; Equilibrium; Evaluation; Evidence based practice; Face; Feasibility Studies; Feedback; Feeling hopeless; Health; Health Personnel; Home; Home Health Agency; Home Nursing Care; Hour; Individual; Infrastructure; Intervention; Interview; Iowa; Knowledge; Left; Length; Manuals; Measures; Medical; Mental Depression; Mental Health; Mental Health Services; Methods; Mission; Modeling; New York; Nurses; Nursing Services; Outcome; Palliative Care; Participant; Patient Care; Patient Self-Report; Patients; Perception; Personal Satisfaction; Pilot Projects; Positioning Attribute; Procedures; Psychotherapy; Quality of Care; Quality of life; Randomized; Registered nurse; Reporting; Research; Rural; Strategic Planning; Structure; Symptoms; Testing; Time; Training; Treatment outcome; Visiting Nurse; acceptability and feasibility; advanced disease; arm; base; care systems; clinically significant; community setting; control trial; cost effectiveness; depressive symptoms; design; end of life; ethnic minority population; evidence base; experience; implementation outcomes; implementation science; implementation strategy; improved; instrument; lens; multiple chronic conditions; novel; patient population; pragmatic trial; programs; psychologic; psychological distress; psychosocial; recruit; satisfaction; social engagement; symptom management; treatment as usual; treatment effect

Project Summary/Abstract: Patients with serious illness are often confronted with existential distress that contributes to anxiety and depression and when left unaddressed, leads to increased suffering and despair. Homebound individuals face compounded existential concerns and loss of meaning above and beyond ambulatory patients with advanced illnesses, as they contend with an even greater loss of independence and declining opportunities for activities and social engagement. Nonetheless, this group has been described as “invisible” due to a lack of consensus on quality of care benchmarks. Despite this great need, most of these individuals do not receive mental health services. As the demand for the delivery of comprehensive, high quality palliative care in the community continues to grow, so too does the need to address these vulnerable patients’ existential and emotional needs with targeted interventions that can be feasibly delivered in the home. This study seeks to evaluate the impact of a brief nurse-delivered psychosocial intervention, Meaning Centered Psychotherapy – Palliative Care (MCP-PC), to homebound adults with advanced cancer. This pragmatic trial is conceptualized through the lens of dissemination and implementation (D&I) science using the Iowa Model of Evidence Based Practice indicators (i.e., knowledge, perception/attitude, behavior/practice, outcomes, balancing measures). Using a mixed methods design, including a pilot randomized control trial, this study has three specific aims: (1) To refine the MCP-PC training and study procedures for homecare delivery by nurse interventionists through a single arm open pilot (n=10 nurses; n=10 patients); (2) To evaluate the feasibility and acceptability (Iowa Model knowledge, perception/attitude, behavior/practice, balancing measures) of nurse- delivered MCP-PC in an RCT (n=10 nurses; n=60 patients); and (3) To assess the efficacy of nurse-delivered MCP-PC compared to treatment as usual (TAU) on patients’ spiritual well-being, psychological distress, QOL, and end of life despair (Iowa Model outcomes) in an RCT. After a brief open pilot and refinement of study procedures, we will recruit 60 patients through the Visiting Nurse Service of New York (VNSNY) home-based care program and randomize them to either MCP-PC or TAU. All participants will be asked to complete a short battery of self-report instruments at baseline, after treatment, and one-month post-treatment (TAU assessments will follow a similarly spaced time line). Brief qualitative interviews evaluating the treatment and implementation outcomes will be conducted with patients and nurses upon completion of MCP-PC. The MCP- PC program leverages the existing infrastructure of a high-volume homecare agency to address the insufficient mental health workforce in palliative care. If proven effective, MCP-PC can be successfully embedded in existing systems of care as a potentially widely disseminable approach to reaching historically underserved patient populations (e.g., rural, ethnic minorities) on a national scale.

项目摘要/摘要：严重疾病患者经常面临生存困境， 会导致焦虑和抑郁，如果不加以解决，会导致更多的痛苦和绝望。 呆在家里的人面临着复杂的生存担忧和意义的丧失 患有晚期疾病的门诊患者，因为他们正在与更严重的独立性和 活动机会和社会参与度不断下降。尽管如此，这个组织被描述为 由于在护理质量基准上缺乏共识，因此“看不见”。尽管有这种巨大的需求，但其中大多数 个人不接受心理健康服务。随着交付需求的全面、高 社区中优质的姑息治疗继续增长，解决这些弱势群体的需要也在继续增长。 通过可以在家中可行的有针对性的干预措施，满足患者的生存和情感需求。 这项研究试图评估护士提供的短暂心理社会干预的影响，即以 心理治疗-姑息治疗(MCP-PC)，适用于患有晚期癌症的居家成年人。这场务实的审判是 通过传播和实施(D&I)科学的镜头概念化，使用爱荷华州模式 基于证据的实践指标(即知识、感知/态度、行为/实践、结果、 平衡措施)。使用混合方法设计，包括试点随机对照试验，这项研究 三个具体目标：(1)完善护士在家分娩的MCP-PC培训和学习程序 单臂开放试验干预者(n=10名护士；n=10名患者)；(2)评估可行性和 护士的可接受性(爱荷华州榜样知识、认知/态度、行为/实践、平衡措施)- 随机对照试验(n=10名护士；n=60名患者)；(3)评估护士接生的效果 MCP-PC与常规治疗(TAU)对患者精神幸福感、心理困扰、生活质量、 和随机对照试验中的生命终结绝望(爱荷华州模型结果)。经过简短的开放试点和研究提炼 程序，我们将通过纽约访问护士服务(VNSNY)以家庭为基础招募60名患者 CARE计划并将他们随机分配到MCP-PC或TAU。所有参与者将被要求完成一份简短的 基线、治疗后和一个月后(TAU)的一整套自我报告工具 评估将遵循类似的间隔时间线)。简短的定性访谈，评估治疗和 在MCP-PC完成后，将与患者和护士一起进行实施结果。MCP- PC计划利用大量家庭护理机构的现有基础设施来解决不足 姑息治疗中的精神卫生工作者。如果被证明有效，MCP-PC可以成功地嵌入到 现有的护理系统作为一种潜在的可广泛传播的方法，以达到历史上服务不足的程度 全国范围内的患者群体(例如，农村、少数民族)。