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：患有严重疾病的患者经常面临存在的痛苦， 导致焦虑和抑郁，如果不加以解决，会导致痛苦和绝望的增加。 无家可归的人面临着复杂的生存问题和超越意义的丧失 患有晚期疾病的非卧床患者，因为他们面临着更大的独立性丧失， 活动和社会参与的机会减少。尽管如此，这一群体被描述为 由于缺乏对护理质量基准的共识，这是“无形的”。尽管有这种巨大的需求，但大多数 个人得不到心理健康服务。由于交付要求全面、高 社区中高质量的姑息治疗持续增长，解决这些脆弱群体的需求也在增长。 通过有针对性的干预措施来满足患者的生存和情感需求，这些干预措施可以在家中进行。 本研究旨在评估一个简短的护士提供的心理社会干预的影响，意义为中心 心理治疗-姑息治疗（MCP-PC），针对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）科学的透镜概念化，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）。本研究采用混合方法设计，包括一项初步随机对照试验， 三个具体目标：（1）完善MCP-PC培训和学习护士提供家庭护理的程序 （2）评估介入医生通过单臂开放试点（n=10名护士; n=10例患者）的可行性， 护士的可接受性（爱荷华州模型知识、感知/态度、行为/实践、平衡措施）- 随机对照试验（n=10名护士; n=60例患者）中提供的MCP-PC;（3）评估护士提供的MCP-PC的疗效 MCP-PC与常规治疗（TAU）相比，对患者的精神健康、心理困扰、QOL， 和临终绝望（爱荷华州模型结果）。经过短暂的开放试点和细化研究 程序，我们将通过纽约探访护士服务（VNSNY）居家招募60名患者 护理计划，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个简短的 基线、治疗后和治疗后1个月（TAU）的一组自我报告工具 评估将按照类似的时间间隔进行）。简短的定性访谈评估治疗和 在完成MCP-PC后，将与患者和护士进行实施结果的评估。MCP- PC计划利用高容量家庭护理机构的现有基础设施来解决 精神卫生工作者在姑息治疗。如果证明有效，MCP-PC可以成功嵌入到 现有的护理系统作为一种可能广泛传播的方法，以达到历史上服务不足的目标 患者群体（例如，农村、少数民族）。