NCT04666844

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?).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,019

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

November 20, 2020

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 14, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2022

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

6 months

First QC Date

November 16, 2020

Last Update Submit

July 25, 2022

Conditions

Keywords

Surprise Question

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (1)

Survey

Clinicians will be asked to provide responses to the two surprise questions for each of their PD patients.

Other: no intervention

Interventions

Observational Study

Survey

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Incident and prevalent PD population at Satellite Healthcare

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Satellite Healthcare Inc

San Jose, California, 95128, United States

Location

Study Officials

  • Wael Hussein

    Satellite Healthcare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Director of Clinical Research

Study Record Dates

First Submitted

November 16, 2020

First Posted

December 14, 2020

Study Start

November 20, 2020

Primary Completion

May 30, 2021

Study Completion

July 20, 2022

Last Updated

July 26, 2022

Record last verified: 2022-07

Locations