Symptom Management Essentials at Home
- Conditions
- Symptom Management
- Interventions
- Behavioral: Palliative Reasoning methodology
- Registration Number
- NCT06434545
- Lead Sponsor
- UMC Utrecht
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 800
Not provided
Clients and primary caregivers that are diagnosed with cognitive impairment and/or unable to read and speak Dutch, will be excluded from the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Palliative Reasoning methodology 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.
- Primary Outcome Measures
Name Time Method Perceived symptom control of clients and family caregivers dealing with a life-limiting illness One month after implementation This outcome will be measured by asking the participant "Do you feel your symptoms are under control?".
- Secondary Outcome Measures
Name Time Method Quality of life of clients dealing with a life-limiting illness Assessed after one month, three months and six months after implementation. EORTC QLQ C15 will be used to determine the QoL.
Primary caregiver burden Assessed at one, three and six months after implementation. The primary caregiver burden Is assessed by means of the Self Rated Burden Scale, which is a one item numerical scale answering the question "How do I perceive the care for my loved one at the moment?"(35-38). The question is answered on a scale of 0 to 10, in which 0 refers to "not at all straining" and 1 refers to "much to straining". In addition, the perceived burden of informal care (Dutch: Ervaren Druk Informele Zorg (EDIZ)) will be used, assessing aspects of informal care contributing to the perceived burden(39). The EDIZ is developed for the use in caregivers of patients suffering from dementia at home, however, this measurement instrument is widely used to assess the level of burden of caregivers of patients with a life-limiting illness. This instrument contains 9 statements to which patients must answer "no!", "no", "more or less", "yes" or "yes!".
Symptom burden of clients dealing with a life-limiting illness Assessed at one month, three months and six months after implementation. Utrecht Symptom Diary Four Dimensional (USD4D) will be used to determine symptom burden. The USD4D comprises of questions regarding the physical, psychological, social, and spiritual dimension, which are rated on a scale from 0-10 (0 = symptom is absent to 10 = severity symptom is the worst imaginable).
Trial Locations
- Locations (1)
University Medical Center Utrecht
🇳🇱Utrecht, Netherlands