NCT01842776

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
3,300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 30, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 30, 2013

Status Verified

April 1, 2013

Enrollment Period

1.3 years

First QC Date

April 22, 2013

Last Update Submit

April 25, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

Eligibility Criteria

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

Adult hemodialysis patients

You may qualify if:

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

You may not qualify if:

  • Patients \<18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fresenius

Franklin, Tennessee, 37067, United States

RECRUITING

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Rebecca L Wingard, RN, MSN

CONTACT

Kathryn McDougall, RN, BSN

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2013

First Posted

April 30, 2013

Study Start

March 1, 2013

Primary Completion

June 1, 2014

Study Completion

December 1, 2014

Last Updated

April 30, 2013

Record last verified: 2013-04

Locations