SMEtH - Symptom Management Essentials at Home
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- UMC Utrecht
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Perceived symptom control of clients and family caregivers dealing with a life-limiting illness
研究概览
简要总结
A cluster Randomized Controlled Trial (cRCT) that aims to determine the effect of the Palliative Reasoning (PR) methodology on the quality of life and symptom burden of patients dealing with a life-limiting illness and their loved ones, receiving palliative care services at home. Palliative Reasoning will be implemented from the first of may 2024 to 30 april 2025 in twenty nursing teams of a large homecare organization in Utrecht, the Netherlands, and will be compared with twenty control nursing teams. The effect of PR will be measured by means of questionnaires filled out by clients with a life expectancy of less than one year according to the surprise question "Would I be surprised if this person would die within one year?" and family caregivers. Parallel to the effect study, a process evaluation will be conducted in order to understand the implications of the results and its' societal and practical impact.
详细描述
The Palliative Reasoning (PR) methodology has been developed by University Medical Centre Utrecht (UMCU) in collaboration with the Netherlands Comprehensive Cancer organization (IKNL) to support nursing teams and other HCPs with the inter- and intradisciplinary communication and the early recognition, analysis and treatment of symptoms in patients requiring palliative care. This stepwise, iterative approach starts with HCPs identifying patients with palliative care needs by asking the surprise question "Would I be surprised if this patient would die within one year?". If the answer to the previous question is no, indicating not being surprised, a patient can be marked as being in a palliative phase of life. After the identification of the patient the method follows four steps: (1) Map out current symptoms, values, wishes and needs of patient and loved ones; (2) Analyze symptoms; (3) develop a proactive treatment plan; (4) Make agreements for the evaluation of the treatment plan.
After the training twenty of the forty nursing teams working for a large homecare organization, patients and family caregivers of both intervention teams and control teams can be included. The perceived symptom control, quality of life and symptom burden of patients and symptom burden of family caregivers, will be compared between intervention and control teams, to assess the effectiveness of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •The client is 18 years or older.
- •The client is diagnosed with a life limiting illness or frailty syndrome with a life expectancy of less than a year, estimated by the nursing team, based on the Surprise Question.
- •The client lives at home and receives homecare
- •The client suffers from at least 1 symptom identified by means of the problem list of the Distress Thermometer.
- •Inclusion Criteria primary caregiver:
- •The primary caregiver is 18 years or older.
- •The primary caregiver has a relative with a life-limiting illness with a life expectancy <1 year.
- •Is able to speak and read Dutch
- •A nursing team is eligible when:
- •The nurses that are part of the nursing team are motivated to participate in the study.
- •The Nursing team consists of nurses that are sufficiently experienced in the work that they to effectively learn new competences during training sessions.
排除标准
- •Clients and primary caregivers that are diagnosed with cognitive impairment and/or unable to read and speak Dutch, will be excluded from the study.
研究组 & 干预措施
Intervention group
The intervention group consists of 20 nursing team, each recruiting 20 clients with palliative care needs. This results in a total of 400 clients for the intervention group. A nursing team consists of nurse assistants, registered nurses and specialized nurses.
干预措施: Palliative Reasoning methodology (Behavioral)
Control group
The control group consists of 20 nursing teams that will continue to provide care as previous to the start of the study. Contact persons also recruit 20 clients per nursing team, resulting in a total of 400 client for the control group.
结局指标
主要结局
Perceived symptom control of clients and family caregivers dealing with a life-limiting illness
时间窗: One month after implementation
This outcome will be measured by asking the participant "Do you feel your symptoms are under control?".
次要结局
- Quality of life of clients dealing with a life-limiting illness(Assessed after one month, three months and six months after implementation.)
- Primary caregiver burden(Assessed at one, three and six months after implementation.)
- Symptom burden of clients dealing with a life-limiting illness(Assessed at one month, three months and six months after implementation.)