Clinical trial NCT04666844: Predicting Transfers to Hemodialysis in Peritoneal Dialysis Patients Using the Surprise Question
Official title: Predicting Transfers to Hemodialysis in Peritoneal Dialysis Patients Using the Surprise Question
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peritoneal Dialysis
Keywords: Surprise Question
Lead sponsor: Satellite Healthcare
Sponsor class: OTHER
First posted: 2020-12-14
Enrollment: 2019
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients on peritoneal dialysis receiving care at Satellite Healthcare facilities.

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).

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: at 6 months
Secondary outcomes:
measure: Performance measures of the modified SQ Responses of the nurses to predict Transfers to hemodialysis
timeFrame: at 6 months
measure: Performance measures of the mortality SQ Responses of the physician and nurses to predict death
timeFrame: at 6 months
measure: Performance of prediction model for transfer to HD developed from variables obtained at baseline.
timeFrame: at 0 months
measure: Comparison of performance of baseline variables model to performance of the SQ model, and to a model that combines baseline variables and the SQ.
timeFrame: at 6 month
measure: Rate of hospitalizations in patients identified as high risk by the surprise question.
timeFrame: at 6 months
measure: Rate of peritonitis in patients identified as high risk by the surprise question.
timeFrame: at 6 months
measure: Proportion of patients identified as high risk who transition to HD.
timeFrame: 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
measure: 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.
timeFrame: 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
measure: Evaluating the agreement of assessments made by the primary nephrologist and the primary nurse of the patient
timeFrame: at baseline
measure: Factors associated with predictions made by the MD and nurse.
timeFrame: at baseline
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Satellite Healthcare Inc
state: California
Study officials:
affiliation: Satellite Healthcare
name: Wael Hussein
role: PRINCIPAL_INVESTIGATOR
References: