Evaluate Serious Illness Treatment Preferences and Outcomes in the Patients Receiving Peritoneal Dialysis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Peritoneal Dialysis; ESRD
• Intervention / Treatment: Behavioral: integrated palliative 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)

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pei-Ni Chuang, M.D.; Phone Number: +886-987-650-338; Email: peinichuang@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Refuse to integrate palliative care into usual care.; Usual ESRD care team
Experimental: Agree to integrate palliative care into usual care.; Usual ESRD care + combined palliative care team	Behavioral: integrated palliative care; shared decision making with patient, and timely integrated palliative care according to patient's preference

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the preferences of end of life care in patients receiving peritoneal dialysis	Participants were asked to respond to the questions(POLST questionnaire) associated to life-sustaining treatment preference including CPR preference and other treatment preferences, and life values,	up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
compare the quality of life after receiving timely integrated palliative care to the other group	Quality of life(The EuroQol-5 Dimension 5-level (EQ-5D-5L)) The EQ-5D instrument is the most widely used generic preference-based measure of health. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.	3 moths,6 months and 12months after receiving timely integrated palliative care
compare the quality of death after receiving timely integrated palliative care to the other group	Quality of death(Good Death Scale (GDS)) Good Death Scale (GDS) is a provider assessment scale of the quality of dying of terminally ill patients. It contains 5 items including the awareness that one is dying (0 = complete ignorance, 3 = complete awareness), accepting death peacefully (0 = complete unacceptance, 3 = complete acceptance), propriety (0 = no reference to the patient's will, 1 = following the family's will alone, 2 = following the patient's will alone, 3 = following the will of both the patient and their family), death timing (0 = no preparation, 1 = the family alone had prepared, 2 = the patient alone had prepared, 3 = both the patient and their family had prepared), and degree of physical comfort (0 = a lot of suffering, 1 = suffering, 2 = a little suffering, 3 = no suffering). The score ranges from 0 to 15.	3 moths,6 months and 12months after receiving timely integrated palliative care
compare the symptoms burden after receiving timely integrated palliative care to the other group	Symptoms burden(Edmonton Symptom Assessment System. Revised Renal (ESAS-r:Renal)) The ESAS-r helps to assess nine common symptoms in palliative care patients. The ESAS-r is one valuable part of a holistic clinical assessment. It is not a complete assessment in itself. The patient should be instructed to rate the severity of each symptom on a 0 to 10 scale, where 0 represents absence (or best possible intensity) of the symptom and 10 represents the worst possible severity. The number should be circled on the scale. The circled numbers can be transcribed onto the ESAS-r graph. The patient should be instructed to rate each symptom according to how s/he feels now. The health care professional may choose to ask additional questions about the severity of symptoms at other time points (e.g. symptom severity at best and at worst over the past 24 hours)	3 moths,6 months and 12months after receiving timely integrated palliative care
compare the ICU admission frequency after receiving timely integrated palliative care to the other group	ICU admission frequency	3 moths,6 months and 12months after receiving timely integrated palliative care

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Chun-Fu Lai, M.d., National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2022
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): August 31, 2023

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: January 2, 2022
• First Posted (Actual): January 18, 2022

Study Record Updates

• Last Update Posted (Actual): January 28, 2022
• Last Update Submitted That Met QC Criteria: January 18, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 202106064RINB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No