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

NCT ID: NCT05193474

Last Updated: 2022-01-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2023-08-31

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)

Conditions

ESRD; Peritoneal Dialysis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Refuse to integrate palliative care into usual care.

Usual ESRD care team

Group Type: NO_INTERVENTION

No interventions assigned to this group

Agree to integrate palliative care into usual care.

Usual ESRD care + combined palliative care team

Group Type: EXPERIMENTAL

integrated palliative care

Intervention Type: BEHAVIORAL

shared decision making with patient, and timely integrated palliative care according to patient's preference

Interventions

integrated palliative care

shared decision making with patient, and timely integrated palliative care according to patient's preference

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chun-Fu Lai, M.d.

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Central Contacts

Pei-Ni Chuang, M.D.

Role: CONTACT

peinichuang@gmail.com

+886-987-650-338

Other Identifiers

202106064RINB

Identifier Type: -

Identifier Source: org_study_id