Physician Reimbursement Home Patients | NCT05011136

Studies
Physician Reimbursement Home Patients

NCT05011136

Sponsor

Satellite Healthcare

Status

Completed

Last Update Posted

May 11, 2022Actual

Enrollment

68Actual

Phase

Not provided

Conditions

ESRD

Interventions

No intervention. This is a qualitative study

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

May 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

Sep 1, 2021Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Dec 31, 2021Actual

First Submitted Date

Aug 11, 2021

First Submission Date that Met QC Criteria

Aug 11, 2021

First Posted Date

Aug 18, 2021Actual

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

May 9, 2022

Last Update Posted Date

May 11, 2022Actual

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

This is an observational study using an online survey to solicit information from nephrologists who care for dialysis patients about the time and effort involved in providing care to home dialysis patients.

Detailed Description

Physician reimbursement today for care of a home dialysis patient is a capitated reimbursement, defined by the age of the patient and their days on home dialysis. Due to the multiple advantages of home therapy, CMS is working on increasing home dialysis uptake; however, there is little to no data on the time and effort involved in providing care to home dialysis patients.

In this study, we will develop and distribute a survey to capture the components of home dialysis patient care and the perceived time and effort of nephrologists across the US to do so. This will provide data for CMS as they consider the adjustment of their policy values in physician reimbursement for home dialysis patient care, which is currently labeled as misvalued (Centers for Medicare and Medicaid Services, 2021).

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

68Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention. This is a qualitative study	Other	US nephrologists who care for dialysis patients will be asked to complete an internet based survey evaluating the time and effort required for home dialysis patient care.		Survey

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To provide data to facilitate a data-driven adjustment of the capitated physician payment for caring for home dialysis patients.	Compilation of survey data from US nephrologists with dialysis patients.	Day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All nephrologists in the US who care for dialysis patients.

Exclusion Criteria:

Nephrologists who have not cared for dialysis patients in the last year.

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 US nephrologists who care for dialysis patients.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wael F Hussein, MBBS	Satellite Healthcare, Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Satellite Health Care		San Jose	California	95128	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007676	Kidney Failure, Chronic

Ancestor Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided