Expired Study
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Queens Village, New York 11427


Purpose:

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 summary:

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.


Criteria:

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 is Available At:


Original ID:

Nephrology - 06032015


NCT ID:

NCT02553564


Secondary ID:


Study Acronym:


Brief Title:

30 Day Rehospitalization Risk in Hemodialysis Patients


Official Title:

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


Overall Status:

Terminated


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Northwell Health


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Lack of enrollment as expected


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

3


Enrollment Type:

Actual


Overall Contact Information

Official Name:Steven Fishbane, MD
Principal Investigator
Northshore-LIJ health system

Study Dates

Start Date:November 22, 2017
Completion Date:March 15, 2018
Completion Type:Actual
Primary Completion Date:March 15, 2018
Primary Completion Type:Actual
Verification Date:March 2018
Last Changed Date:March 29, 2018
First Received Date:September 15, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Average time in minutes required to perform the intervention
Time Frame:Up to 5 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Days to readmission
Time Frame:Up to 5 weeks
Safety Issues:False
Description:Number of days to readmission
Outcome Type:Secondary Outcome
Measure:Cause of readmissions
Time Frame:Up to 5 weeks
Safety Issues:False
Description:Percentage of rehospitalizations per group for volume overload, infection or vascular access complications
Outcome Type:Primary Outcome
Measure:Rehospitalization rate
Time Frame:Up to 5 weeks
Safety Issues:False
Description:Percentage of patients in each group requiring readmission to an acute care hospital within 30 days of discharge after an acute care hospitalization.

Study Interventions

Intervention Type:Other
Name:Checklist driven clinical encounter after hospital
Description: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 c
Arm Name:Intervention group

Study Arms

Study Arm Type:No Intervention
Arm Name:Usual care group
Description: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.
Study Arm Type:Experimental
Arm Name:Intervention group
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Northwell Health

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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