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

Peritoneal Dialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04666844
• Other study ID #: SIH126_PD Suprise Question
• Status: Completed
• Start date: November 20, 2020
• Est. completion date: July 20, 2022

Study information

• Verified date: July 2022
• Source: Satellite Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2019
• Est. completion date: July 20, 2022
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peritoneal Dialysis

Intervention

Other:
• no intervention
Observational Study

Locations

Country	Name	City	State
United States	Satellite Healthcare Inc	San Jose	California

Sponsors (1)

Lead Sponsor	Collaborator
Satellite Healthcare

Country where clinical trial is conducted

United States, 

Outcome

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