ESRDNCT05193474
Evaluate Serious Illness Treatment Preferences and Outcomes in the Patients Receiving Peritoneal Dialysis
A study testing integrated palliative care in people with ESRD and Peritoneal Dialysis, run by National Taiwan University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- ESRD, Peritoneal Dialysis
- What is being tested?
- integrated palliative care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2022to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- [Patients] Diagnosis of ESRD
- [Patients] Under treatment of peritoneal dialysis
- [Patients] Age 20 years or older
- [Caregivers] Age20 years or older
Who cannot join
- [Patients] unable to understand or fill in the questionnaire
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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
- Being tested
- integrated palliative care
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
integrated palliative careBehavioural
shared decision making with patient, and timely integrated palliative care according to patient's preference
| Study group | Role | What they receive |
|---|---|---|
| Refuse to integrate palliative care into usual care. | No intervention | Usual ESRD care team |
| Agree to integrate palliative care into usual care. | Experimental | Usual ESRD care + combined palliative care team Receives: Behavioral: integrated palliative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
Measured: up to 24 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: 3 moths,6 months and 12months after receiving timely integrated palliative care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start1 Feb 2022 (estimated)
- Primary completion1 Feb 2022 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESRDStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun-Fu Lai, M.d., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193474
- Sponsor's protocol ID
- 202106064RINB
- Status last verified
- Aug 2021
- First submitted
- 8 Dec 2021
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate Serious Illness Treatment Preferences and Outcomes in the Patients Receiving Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT05193474
- Acronym / sponsor ID
- 202106064RINB
- Conditions
- ESRD, Peritoneal Dialysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Refuse to integrate palliative care into usual care. | No intervention | –Usual ESRD care team |
| Agree to integrate palliative care into usual care. | Experimental | Behavioral: integrated palliative careUsual ESRD care + combined palliative care team |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- [Patients] Diagnosis of ESRD
- [Patients] Under treatment of peritoneal dialysis
- [Patients] Age 20 years or older
- [Caregivers] Age20 years or older
Key exclusion criteria (1 listed)
- [Patients] unable to understand or fill in the questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| integrated palliative careshared decision making with patient, and timely integrated palliative care according to patient's preference | Behavioural | Agree to integrate palliative care into usual care. |
Primary outcome
the preferences of end of life care in patients receiving peritoneal dialysis
Time frame: up to 24 weeks
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,
4 secondary outcomes
compare the quality of life after receiving timely integrated palliative care to the other group
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 3 moths,6 months and 12months after receiving timely integrated palliative care
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
Related trials for ESRD
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun-Fu Lai, M.d. principal investigator
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing integrated palliative care in people with ESRD and Peritoneal Dialysis, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pei-Ni Chuang, M.D. (+886-987-650-338, peinichuang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the preferences of end of life care in patients receiving peritoneal dialysis (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.