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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02553564
Other study ID # Nephrology - 06032015
Secondary ID
Status Terminated
Phase N/A
First received September 15, 2015
Last updated March 29, 2018
Start date November 22, 2017
Est. completion date March 15, 2018

Study information

Verified date March 2018
Source Northwell Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 3
Est. completion date March 15, 2018
Est. primary completion date March 15, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States LIJ satellite dialysis unit Queens Village New York

Sponsors (1)

Lead Sponsor Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

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