Clinical trial NCT05193474: Evaluate Serious Illness Treatment Preferences and Outcomes in the Patients Receiving Peritoneal Dialysis
Official title: Evaluate Serious Illness Treatment Preferences and Outcomes in the Patients Receiving Peritoneal Dialysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ESRD
Peritoneal Dialysis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-01-18
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The goal of this clinical research study is to study the cardiopulmonary resuscitation (CPR) preferences of patients receiving peritoneal dialysis and how these preferences are associated with their responses to questions about aspects of end-of-life care.

This prospective cohort clinical trial aims to provide evidence on the preferences of end of life care in patients receiving peritoneal dialysis, thereby provide optimal care according to patients' preferences and choices through effective communication and clear goals of care.

Detailed description: This is a prospective cohort study to survey cardiopulmonary resuscitation (CPR) preferences of patients receiving peritoneal dialysis and how these preferences are associated with their responses to questions about aspects of end-of-life care for end stage renal disease(ESRD) patients, and actively survey their palliative care need to share decision making with ESRD patient whether to receive standardized palliative care interventions by the interdisciplinary palliative care team, including treatment of suffering symptoms, non-pharmacologic therapies. The investigators will enroll 500 patients. The eligibility criteria are shown later part. After obtaining consent from the patient, the investigators will conduct baseline assessments and start the patient on a 10minutes questionnaire. The questionnaire was cited from 2016-CA-POLST, which is in Chinese version for better understanding. POLST is an approach to end-of-life planning based on conversations between patients, loved ones, and health care professionals designed to ensure the patient only receive the care that patients themselves wish to. After that, the investigators will active survey the patient who had higher mortality rate within one year by using 1. Palliative Care Screening Tool (PCST)， 2."Surprise" Question，3. Integrated model risk≥10%. For the patient who had higher mortality rate within one year (\>10%), the investigators would evaluate the degree of symptoms burden by using ESAS-r: Renal. For the patient who had moderate to severe symptoms burden, the investigators would share decision making with them to discuss whether to receive combined palliative care. The investigators would divide the patients to two group according to patient decision. (1) Usual ESRD care team (2) Usual ESRD care + combined palliative care team. And the investigators would compare the quality of life and quality of death, and symptoms burden after 3/6/12 months receiving timely integrated palliative care to the other group Evaluate outcomes including quality of life (EQ-5D-5L), quality of death (GDS), symptoms burden(ESAS-r:Renal)

Eligibility criteria: Inclusion Criteria:

1. \[Patients\] Diagnosis of ESRD
2. \[Patients\] Under treatment of peritoneal dialysis
3. \[Patients\] Age 20 years or older
4. \[Caregivers\] Age20 years or older

Exclusion Criteria:

* \[Patients\] unable to understand or fill in the questionnaire

Primary outcomes:
measure: the preferences of end of life care in patients receiving peritoneal dialysis
timeFrame: up to 24 weeks
Secondary outcomes:
measure: compare the quality of life after receiving timely integrated palliative care to the other group
timeFrame: 3 moths,6 months and 12months after receiving timely integrated palliative care
measure: compare the quality of death after receiving timely integrated palliative care to the other group
timeFrame: 3 moths,6 months and 12months after receiving timely integrated palliative care
measure: compare the symptoms burden after receiving timely integrated palliative care to the other group
timeFrame: 3 moths,6 months and 12months after receiving timely integrated palliative care
measure: compare the ICU admission frequency after receiving timely integrated palliative care to the other group
timeFrame: 3 moths,6 months and 12months after receiving timely integrated palliative care
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Chun-Fu Lai, M.d.
role: PRINCIPAL_INVESTIGATOR
References: