Symptom Management Essentials at Home

NCT06434545 | Active Not Recruiting

• 1 other identifier: 80-86300-98-060
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Symptom Management

Keywords

Symptom management; Palliative Care; Primary care; life-limiting illness; Palliative Reasoning

Outcome Measures

Primary Outcomes (1)

• Perceived symptom control of clients and family caregivers dealing with a life-limiting illness

  This outcome will be measured by asking the participant "Do you feel your symptoms are under control?".

  One month after implementation

Secondary Outcomes (3)

• Quality of life of clients dealing with a life-limiting illness

  Assessed after one month, three months 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.

• Primary caregiver burden

  Assessed at one, three and six months after implementation.

Other Outcomes (3)

• Client demographics

  Questioned at baseline

• Primary caregiver demographics

  Questioned at baseline

• Nursing team demographics

  Questioned after baseline

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Behavioral: Palliative Reasoning methodology

Control group

NO INTERVENTION

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.

Interventions

Palliative Reasoning methodology BEHAVIORAL

Twenty nursing teams will be trained in the Palliative Reasoning methodology during a four hour training, split into two sessions. Additionally, teams receive a coaching session ones a month and practice with a real life case every week or two weeks during a one hour team meeting. This will be compared with 20 other nursing teams that will continue to provide care as usual.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• UMC Utrecht: lead
• Zorgbelang Inclusief: collaborator
• Comprehensive Cancer Centre The Netherlands: collaborator
• ROC Midden Nederland: collaborator
• University of Applied Sciences Utrecht: collaborator

Study Sites (1)

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

Study Officials

• Saskia Teunissen, Prof. dr.

  UMC Utrecht

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: May 30, 2024
• Study Start: November 1, 2021
• Primary Completion: March 31, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

NL (1)