30 Day Rehospitalization Risk in Hemodialysis Patients

A Randomized Controlled Trial of a Checklist Intervention to Reduce 30 Day Rehospitalization Risk in Hemodialysis Patients

After a hospitalization, dialysis patients have a high risk of being admitted to the hospital again within 30 days. The purpose of this research study is to test a new way of reducing the chance of patients being hospitalized again. In this study investigator will evaluate a checklist driven evaluation upon return to the dialysis facility as a method to reduce the rate of rehospitalizations in hemodialysis patients.

Study Overview

• Status: Terminated
• Conditions: Re-hospitalization Hemodialysis
• Intervention / Treatment: Other: Checklist driven clinical encounter after hospital discharge

Detailed Description

There are an excessive number of 30 day readmissions after hospital discharges of dialysis patients in the U.S. (35.2%). Investigators recent research has found that approximately 2/3 of these readmissions are potentially avoidable. Investigators believe that among the causes for the excessive number of readmissions, the most important may be that patients usually do not receive a clinical assessment upon return to dialysis after a hospitalization. An all too common practice in the U.S. is for the nephrologist to not see the patient but to give verbal orders to the dialysis nurse to resume previous orders. This increases readmission risk in that there are a number of key clinical processes that if completed on return to dialysis might greatly reduce rehospitalization risk. Nephrologists are often not available to see patients in the peri-discharge period, but there is a trend towards an increasing number of U.S. dialysis facilities now having nurse practitioners (NP) working in the units. Investigators believe that NPs using a checklist can conduct a post-discharge clinical encounter that would allow for key care processes to be carried out and to direct telephone communication with the treating nephrologist. Our objective is to reduce the risk of dialysis patient readmissions within 30 days through the use of this intervention. Our research question is whether this intervention would be effective for reducing 30 day readmission risk. Our hypothesis is that the intervention will prove to be more effective then usual care for reducing 30 day readmission risk.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Queens Village, New York, United States, 11427
      • LIJ satellite dialysis unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years of age or older
• Must have been an existing patients of the outpatient dialysis units for at least 1 month prior to the index hospitalization
• Index hospitalization must be from an acute care hospital

Exclusion Criteria:

• Hospital discharges against medical advice
• Assessment cannot be initiated within 96 hours of hospital discharge
• Primary hospital diagnosis related to cancer, renal transplant, mental health or rehabilitation
• Hospital admission was the 5th or more in the previous 12 months
• Failure to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Checklist driven clinical encounter after hospital discharge - Participant will receive standard medical care with the addition of a checklist driven clinical encounter upon return to the dialysis unit after hospital discharge. * participants in both group will be receiving standard post discharge care which includes nursing assessment, social work intervention as needed and new dialysis orders.	Other: Checklist driven clinical encounter after hospital discharge; Within 96 hours of hospital discharge an Nurse Practitioner will perform a checklist guided assessment to preventing rehospitalizations. The assessment consists of the following: The participants's hospital course will be reviewed and their clinical recovery and stability assessed.; Determination of the participants's estimated dry weight (EDW).; The participants's post discharge medications will be checked, compared to the prehospitalization medication, and discrepancies will be reviewed and corrected.; Blood tests will be ordered for the participants's first return dialysis treatment if medically appropriate after clinical assessment.; Write new dialysis orders.; Dialysis Access- review access and determine any changes required in treatment
No Intervention: Usual care group; Participant will receive standard medical care upon return to the dialysis unit after hospital discharge. * participants in both group will be receiving standard post discharge care which includes nursing assessment, social work intervention as needed and new dialysis orders.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rehospitalization rate	Percentage of patients in each group requiring readmission to an acute care hospital within 30 days of discharge after an acute care hospitalization.	Up to 5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cause of readmissions	Percentage of rehospitalizations per group for volume overload, infection or vascular access complications	Up to 5 weeks
Days to readmission	Number of days to readmission	Up to 5 weeks
Average time in minutes required to perform the intervention		Up to 5 weeks

Collaborators and Investigators

• Sponsor: Northwell Health
• Investigators: Principal Investigator: Steven Fishbane, MD, Northshore-LIJ health system

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2017
• Primary Completion (Actual): March 15, 2018
• Study Completion (Actual): March 15, 2018

Study Registration Dates

• First Submitted: September 15, 2015
• First Submitted That Met QC Criteria: September 16, 2015
• First Posted (Estimate): September 17, 2015

Study Record Updates

• Last Update Posted (Actual): April 2, 2018
• Last Update Submitted That Met QC Criteria: March 29, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: Nephrology - 06032015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No