This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Healthy Transitions in Late Stage Kidney Disease

This study has been completed.
Information provided by (Responsible Party):
Steven Fishbane, Northwell Health Identifier:
First received: March 7, 2014
Last updated: January 3, 2017
Last verified: January 2017
Improve health and outcome for people with late stage chronic kidney disease by providing patient centered nursing services in addition to a Nephrologist's routine patient care.

Condition Intervention
Chronic Kidney Disease Other: Education Other: Daily weight measurement and monitoring Other: Universal Dietary education Other: Medication review Other: Focused advanced directive program Other: Countdown to fistula program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: An Open Label Randomized Controlled Study to Compare the Impact of Patient Centered Nursing Services in Addition to a Nephrologist's Usual Patient Care With Usual Nephrologist's Care in Late Stage Chronic Kidney Disease Patients.

Resource links provided by NLM:

Further study details as provided by Steven Fishbane, Northwell Health:

Primary Outcome Measures:
  • Hospitalization rate [ Time Frame: 18 months ]
    Reduction in hospitalization rate in intervention group as compare to control group.

Secondary Outcome Measures:
  • Improve hemodialysis access rates [ Time Frame: 18 months ]
    Percentage of patients with AVF, AVG or catheters

  • Home dialysis [ Time Frame: 18 months ]
    Increase choice of home dialysis as modality of treatment

Enrollment: 130
Study Start Date: October 2013
Study Completion Date: January 2016
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Healthy Transitions Group
  • Additional nursing services will be provided to this group in addition to a usual care by Nephrologist.
  • Daily weight measurement and monitoring
  • Medication review
  • Universal dietary education
  • Focused advanced directive program
  • Countdown to fistula program
Other: Education
Additional education will be provided by nurses to improve communication and reduce fragmentation of care.
Other: Daily weight measurement and monitoring
Monitor weight to avoid problems related to hypervolemia.
Other: Universal Dietary education
To improve diet and health
Other: Medication review
Medication will be reviewed by nurses to detect any discrepancies to reduce medication error.
Other: Focused advanced directive program
Education will be provided to increase awareness and encourage patients to have advanced directive.
Other: Countdown to fistula program
To reduce the number of patients starting dialysis with catheter in place, comprehensive stepwise intervention will be provided by nurses to ensure arterio-venous (AV) fistula placement in all appropriate patients, with coordinated follow up and failure recovery processes.
No Intervention: Usual Care Group
Usual care by nephrologist. No additional nursing support services will be provide to this group.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Stage 4-5 Chronic Kidney Disease (CKD), defined as estimated glomerular filtration rate (eGFR) between 0-30 ml/minute
  • 18 years of age or older

Exclusion Criteria:

  • Cognitive impairment that is clinically apparent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02085837

United States, New York
Division of Kidney diseases and Hypertension
Great Neck, New York, United States, 11021
Sponsors and Collaborators
Northwell Health
Principal Investigator: Steven Fishbane, MD Northwell Health
  More Information

Responsible Party: Steven Fishbane, Principal Investigator, Northwell Health Identifier: NCT02085837     History of Changes
Other Study ID Numbers: 13-033
Study First Received: March 7, 2014
Last Updated: January 3, 2017

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency processed this record on September 21, 2017