Clinical trial NCT06434545: Symptom Management Essentials at Home
Official title: SMEtH - Symptom Management Essentials at Home
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Symptom Management
Keywords: Symptom management
Palliative Care
Primary care
life-limiting illness
Palliative Reasoning
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Zorgbelang Inclusief
name: Comprehensive Cancer Centre The Netherlands
name: ROC Midden Nederland
name: University of Applied Sciences Utrecht
First posted: 2024-05-30
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria client:

1. The client is 18 years or older.
2. 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.
3. The client lives at home and receives homecare
4. The client suffers from at least 1 symptom identified by means of the problem list of the Distress Thermometer.

Inclusion Criteria primary caregiver:

1. The primary caregiver is 18 years or older.
2. The primary caregiver has a relative with a life-limiting illness with a life expectancy \<1 year.
3. Is able to speak and read Dutch

A nursing team is eligible when:

1. The nurses that are part of the nursing team are motivated to participate in the study.
2. The Nursing team consists of nurses that are sufficiently experienced in the work that they to effectively learn new competences during training sessions.

Exclusion Criteria:

Clients and primary caregivers that are diagnosed with cognitive impairment and/or unable to read and speak Dutch, will be excluded from the study.

Primary outcomes:
measure: Perceived symptom control of clients and family caregivers dealing with a life-limiting illness
timeFrame: One month after implementation
Secondary outcomes:
measure: Quality of life of clients dealing with a life-limiting illness
timeFrame: Assessed after one month, three months and six months after implementation.
measure: Symptom burden of clients dealing with a life-limiting illness
timeFrame: Assessed at one month, three months and six months after implementation.
measure: Primary caregiver burden
timeFrame: Assessed at one, three and six months after implementation.
Other outcomes:
measure: Client demographics
timeFrame: Questioned at baseline
measure: Primary caregiver demographics
timeFrame: Questioned at baseline
measure: Nursing team demographics
timeFrame: Questioned after baseline
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: UMC Utrecht
name: Saskia Teunissen, Prof. dr.
role: STUDY_DIRECTOR
References: