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

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: Completed
• Conditions: Peritoneal Dialysis
• Intervention / Treatment: Other: no intervention

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: Observational
• Enrollment (Actual): 2019

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

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.	at 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Performance measures of the modified SQ Responses of the nurses to predict Transfers to hemodialysis	at 6 months
Performance measures of the mortality SQ Responses of the physician and nurses to predict death	at 6 months
Performance of prediction model for transfer to HD developed from variables obtained at baseline.	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.	at 6 month
Rate of hospitalizations in patients identified as high risk by the surprise question.	at 6 months
Rate of peritonitis in patients identified as high risk by the surprise question.	at 6 months
Proportion of patients identified as high risk who transition to HD.	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.	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	at baseline
Factors associated with predictions made by the MD and nurse.	at baseline

Collaborators and Investigators

• Sponsor: Satellite Healthcare
• Investigators: Principal Investigator: Wael Hussein, Satellite Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2020
• Primary Completion (Actual): May 30, 2021
• Study Completion (Actual): July 20, 2022

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: December 8, 2020
• First Posted (Actual): December 14, 2020

Study Record Updates

• Last Update Posted (Actual): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Surprise Question
• Other Study ID 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