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

Completed

• Conditions: Peritoneal Dialysis
• Interventions: Other: no intervention

• Registration Number: NCT04666844
• Lead Sponsor: Satellite Healthcare

Brief Summary

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?).

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 Timeline

• Study First Submitted: 2020-11-16
• Study Start: 2020-11-20
• Study First Submitted QC: 2020-12-08
• Study First Posted: 2020-12-14
• Primary Completion: 2021-05-30
• Status Verified: 2022-07
• Study Completion: 2022-07-20
• Last Update Submitted: 2022-07-25
• Last Update Posted: 2022-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2019

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Survey	no intervention	Clinicians will be asked to provide responses to the two surprise questions for each of their PD patients.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Rate of hospitalizations in patients identified as high risk by the surprise question.	at 6 months
Performance of prediction model for transfer to HD developed from variables obtained at baseline.	at 0 months
Performance measures of the modified SQ Responses of the nurses to predict Transfers to hemodialysis	at 6 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
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
Performance measures of the mortality SQ Responses of the physician and nurses to predict death	at 6 months
Rate of peritonitis in patients identified as high risk by the surprise question.	at 6 months
Evaluating the agreement of assessments made by the primary nephrologist and the primary nurse of the patient	at baseline
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
Factors associated with predictions made by the MD and nurse.	at baseline

Trial Locations

Locations (1)

Satellite Healthcare Inc; 🇺🇸 San Jose, California, United States