Predicting Transfers to Hemodialysis in Peritoneal Dialysis Patients Using the Surprise Question

July 25, 2022 updated by: Wael Hussein, MBBS, Satellite Healthcare
The investigators will assess the prediction performance of the modified Surprise Question (Will the participant be surprised if this patient transfers to hemodialysis in the next 6 months?) for identification of peritoneal dialysis at high risk of transfer to hemodialysis. The investigators will also assess the prediction performance of a modified mortality surprise question (Will the participant be surprised if this patient dies in the next 6 months?).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Physicians and nurses will be asked two questions regarding each of their peritoneal dialysis patients:

  1. Will the participant be surprised if this patient transfers to hemodialysis in the next 6 months?
  2. Will the participant be surprised if this patient dies in the next 6 months?

Patients will be followed for 6 months for outcomes (with two extra months for ascertainment of outcomes).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2019

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Jose, California, United States, 95128
        • Satellite Healthcare Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients on peritoneal dialysis receiving care at Satellite Healthcare facilities.

Description

Patients:

Inclusion Criteria:

  • Incident and prevalent PD population at Satellite Healthcare

Exclusion Criteria:

  • Age < 18 years
  • Patients already enrolled in hospice
  • Patients on PD training
  • Patients on backup hemodialysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Survey
Clinicians will be asked to provide responses to the two surprise questions for each of their PD patients.
Other: no intervention
Observational Study

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Performance measures of the modified surprise question answered by the physicians as a prediction instrument for transfer to hemodialysis of peritoneal dialysis patients in 6 months.
Time Frame: at 6 months
at 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Performance measures of the modified SQ Responses of the nurses to predict Transfers to hemodialysis
Time Frame: at 6 months
at 6 months
Performance measures of the mortality SQ Responses of the physician and nurses to predict death
Time Frame: at 6 months
at 6 months
Performance of prediction model for transfer to HD developed from variables obtained at baseline.
Time Frame: at 0 months
at 0 months
Comparison of performance of baseline variables model to performance of the SQ model, and to a model that combines baseline variables and the SQ.
Time Frame: at 6 month
at 6 month
Rate of hospitalizations in patients identified as high risk by the surprise question.
Time Frame: at 6 months
at 6 months
Rate of peritonitis in patients identified as high risk by the surprise question.
Time Frame: at 6 months
at 6 months
Proportion of patients identified as high risk who transition to HD.
Time Frame: At time of transfer to hemodialysis, for those who transfer to hemodialysis within the observation period, which is 6 months from response to the surprise question
At time of transfer to hemodialysis, for those who transfer to hemodialysis within the observation period, which is 6 months from response to the surprise question
Proportion of patients who transition to HD who (i) start Home HD and those who (ii) start HD with AVF/AVG - in the whole group and among those identified high or low risk by the surprise question.
Time Frame: At time of transfer to hemodialysis, for those who transfer to hemodialysis within the observation period, which is 6 months from response to the surprise question
At time of transfer to hemodialysis, for those who transfer to hemodialysis within the observation period, which is 6 months from response to the surprise question
Evaluating the agreement of assessments made by the primary nephrologist and the primary nurse of the patient
Time Frame: at baseline
at baseline
Factors associated with predictions made by the MD and nurse.
Time Frame: at baseline
at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Satellite Healthcare

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wael Hussein, Satellite Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 20, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 20, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 14, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SIH126_PD Suprise Question

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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