Care Transitions in Renal Disease Patients | NCT01842776

Studies
Care Transitions in Renal Disease Patients

NCT01842776

Sponsor

Fresenius Medical Care North America

Status

Unknown status

Last Update Posted

Apr 30, 2013Estimated

Enrollment

3,300Estimated

Phase

Not provided

Conditions

Renal Disease

Interventions

Not provided

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

Apr 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Jun 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Apr 22, 2013

First Submission Date that Met QC Criteria

Apr 25, 2013

First Posted Date

Apr 30, 2013Estimated

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

Apr 25, 2013

Last Update Posted Date

Apr 30, 2013Estimated

Name	Class
Amgen	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 goal of this pilot is to reduce the 30-day hospital readmission rate for dialysis patients. It is a quality improvement project that consistent of 4 "tracks." Tracks 1 & 2: Implement use of checklists of activities for staff to complete when patients are admitted to the hospital, and post-hospitalization with emphasis on fluid assessment, nutrition management, patient coaching, and communication between institutions. Track 3: Work with physicians to develop process to individualize post-hospitalization dialysis orders and improve medication reconciliation. Track 4: Use a renal Care Transitions Case Manager to follow patients in the hospital and 30 days post-hospitalization to facilitate care and patient coaching.

Detailed Description

Not provided

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

3,300Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
30-day readmission rate	Number of hospitalizations that occur within 30 days after discharge from an initial index hospitalization (convert to percentage of 30-day readmissions).	Participants will be followed for the duration of each hospital stay and 30 days post-hospitalization, for an expected average of 37 days.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Chronic hemodialysis patients
All patients admitted to the hospital during the study period

Exclusion Criteria:

Patients <18 years old

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

Adult hemodialysis patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rebecca L Wingard, RN, MSN	Contact	615-567-4846		rebecca.wingard@fmc-na.com
Kathryn McDougall, RN, BSN	Contact	615-567-4837		kathryn.mcdougall@fmc-na.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fresenius	Recruiting	Franklin	Tennessee	37067	United States

Condition Browse Module

MeSH Terms

ID	Term
D007674	Kidney Diseases

Ancestor Terms

ID	Term
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided