Overview

This trial is active, not recruiting.

Condition re-hospitalization hemodialysis
Treatment checklist driven clinical encounter after hospital discharge
Sponsor Northwell Health
Start date September 2015
End date March 2017
Trial size 320 participants
Trial identifier NCT02553564, Nephrology - 06032015

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
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.
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)
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.

Primary Outcomes

Measure
Rehospitalization rate
time frame: Up to 5 weeks

Secondary Outcomes

Measure
Cause of readmissions
time frame: Up to 5 weeks
Days to readmission
time frame: Up to 5 weeks
Average time in minutes required to perform the intervention
time frame: Up to 5 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Randomized Controlled Trial of a Checklist Intervention to Reduce 30 Day Rehospitalization Risk in Hemodialysis Patients
Principal investigator Steven Fishbane, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Northwell Health.