Predicting Transfers to Hemodialysis in Peritoneal Dialys... | NCT04666844

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

NCT04666844

Sponsor

Satellite Healthcare

Status

Completed

Last Update Posted

Jul 26, 2022Actual

Enrollment

2,019Actual

Phase

Not provided

Conditions

Peritoneal Dialysis

Interventions

no intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 20, 2020Actual

Primary Completion Date

May 30, 2021Actual

Completion Date

Jul 20, 2022Actual

First Submitted Date

Nov 16, 2020

First Submission Date that Met QC Criteria

Dec 8, 2020

First Posted Date

Dec 14, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2022

Last Update Posted Date

Jul 26, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wael Hussein, MBBS, Senior Director of Clinical Research, Satellite HealthcarePrincipal Investigator

Lead Sponsor

Satellite HealthcareOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

Will the participant be surprised if this patient transfers to hemodialysis in the next 6 months?
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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,019Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Survey		Clinicians will be asked to provide responses to the two surprise questions for each of their PD patients.	Other: no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	Observational Study	Survey

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wael Hussein	Satellite Healthcare	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Satellite Healthcare Inc		San Jose	California	95128	United States