Efficacy of a Personalized Modular Intervention to Promote Dignity, Meaningfulness and Mindfulness by a Palliative Care Consultation-Liaison Service in Swiss Acute Hospital Care. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Patient Dignity Inventory
研究概览
简要总结
The goal of this clinical trial is to test the benefit of a newly designed personalized therapeutic intervention compared to the standard specialized palliative care service at the swiss acute palliative hospital care.The main questions it aims to answer are:
Does an additional therapeutic support that fits the individual needs of a palliative care patient increases dignity and mental well-being as measures by a questionnaire (Patient Dignity Inventory) to a larger extent than standard palliative care alone? Is the additional therapeutic support perceived as helpful? Researchers will compare the additional therapeutic support with standard palliative care to standard palliative care alone.
Participants will:
Receive additional therapeutic support in two structured sessions a 60 minutes and/or standard palliative care Fill out questionnaires before and after therapeutic interventions and standard palliative care Provide a semi-structured interview following the therapeutic support
详细描述
Patient with a life-limiting serious illness commonly experience substantial emotional and spiritual distress, death anxieties, depressive symptoms and loss of dignity and purpose in life. Fostering dignity and meaning and relieving psychological distress have been identified as a core objective for end-of-life care. However, individual's needs for dignity and psychological support at the end of life may vary. Therefore, a personalized approach is needed. On the basis of theoretical frameworks and existing dignityfostering and meaning based interventions, and a workshop with international experts in the field of palliative care, we have developed a personalized modular intervention, consisting of three modules, including CALM Therapy, Dignity Therapy, and a mindfulness-based intervention.
The overall purpose of this study is to test the efficacy of the designed personalized modular intervention compared to the specialized palliative care service at the swiss acute palliative hospital care.
Patients are randomized to either receiving standard specialized palliative consultation (SSPC) and the modular intervention or standard palliative consultation services alone. Within the intervention group, participants can choose one of the three modules based on personal preference and the recommendation of the palliative care team (based on assessment). All three interventions consist of two structured sessions.
The control group will receive SSPC alone. According to needs standard specialized palliative care will include support of symptom control, shared decision making/ advance care planning, network planning and support of relatives.
SSPC is performed by specialized inter-professional palliative care service, including doctors and advanced nurse practitioners, certified by national standards for specialist palliative care. Other professions are involved depending on needs. Patients are seen as required at least twice a week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent
- •Patients seen by the palliative consultation-liaison service at the University Hospital Basel as an in- or outpatient
- •Suffering from a life-limiting serious illness (≤ 18 months)
- •≥ 18 years of age
- •Willingness and capacity to commit to three study visits
排除标准
- •Delirious (ICD-10: F05.9)
- •Inability to give consent (lack of decisional capacity to consent)
- •Inability to follow the procedures of the study due to psychological disorders, dementia, or other cognitively impairment of the participant,
- •Too ill to complete the requirements of the protocol
- •Unable to understand, speak and read German
结局指标
主要结局
Patient Dignity Inventory
时间窗: Baseline, after intervention, 4 week follow-up
Questionnaire (Self-reported outcome)
次要结局
未报告次要终点
