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通常面临现有的困扰 导致焦虑和抑郁症，当静止不动时，会导致痛苦和绝望增加。 家里的人面临着复杂的现有关注和意义的丧失 患有晚期疾病的卧床患者，因为它们的独立性丧失更大， 活动和社会参与的机会下降。尽管如此，该群体被描述为 由于缺乏对护理基准质量达成共识，因此“无形”。尽管有很多需求，大多数 个人没有获得心理健康服务。作为对全面，高的需求的需求 社区中优质的姑息治疗继续增长，因此需要解决这些脆弱的人 患者的现有和情感上的需求具有针对性的干预措施，这些干预措施可以在家中可行。 这项研究旨在评估简短的护士分配的社会心理干预的影响，这意味着以中心为中心 心理治疗 - 姑息治疗（MCP-PC），用于患有晚期癌症的家庭。这个务实的审判是 使用爱荷华州模型的传播和实施（D＆I）科学概念化 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，包括飞行员随机对照试验，本研究具有 三个具体目的：（1）完善护士的MCP-PC培训和研究程序 干预主义者通过单臂开放试验（n = 10名护士； n = 10名患者）； （2）评估可行性和 护士的可接受性（爱荷华州的模型知识，感知/态度，行为/实践，平衡措施） 在RCT中递送MCP-PC（n = 10名护士； n = 60名患者）； （3）评估护士分配的效率 MCP-PC与往常的治疗（TAU）相比，对患者的精神健康，心理困扰，QoL， 并在RCT中的生命绝望（爱荷华州的模型成果）。经过短暂的开放式飞行员和研究的完善 程序，我们将通过纽约的访问护士服务（VNSNY）家庭招募60名患者 护理程序并将其随机为MCP-PC或TAU。所有参与者将被要求完成简短 基线时的自我报告仪器电池，治疗后一个月的治疗（TAU）（TAU） 评估将遵循类似的时间表）。简短的定性访谈评估治疗和 MCP-PC完成后，将对患者和护士进行实施结果。 MCP- PC计划利用高批量生物保健机构的现有基础设施来解决不足 姑息治疗中的心理健康劳动力。如果证明有效，MCP-PC可以成功嵌入 现有的护理系统是一种潜在的可忽视的方法，以达到历史欠佳 在国家规模上，患者人口（例如，粗糙，少数民族）。