Re-hospitalization HemodialysisNCT02553564
30 Day Rehospitalization Risk in Hemodialysis Patients
A study testing Checklist driven clinical encounter after hospital discharge in people with Re-hospitalization Hemodialysis, run by Northwell Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Re-hospitalization Hemodialysis
- What is being tested?
- Checklist driven clinical encounter after hospital discharge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2017to 15 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
LIJ satellite dialysis unit
Queens Village, New York, 11427
About this study
Official title: 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.
Read the 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.
- Conditions
- Re-hospitalization Hemodialysis
- Being tested
- Checklist driven clinical encounter after hospital discharge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Checklist driven clinical encounter after hospital dischargeOther
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | 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. Receives: Other: Checklist driven clinical encounter after hospital discharge |
| Usual care group | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 5 weeks
Secondary outcomes (3)
Cause of readmissions
Percentage of rehospitalizations per group for volume overload, infection or vascular access complications
Measured: Up to 5 weeks
Days to readmission
Number of days to readmission
Measured: Up to 5 weeks
Average time in minutes required to perform the intervention
Measured: Up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study start22 Nov 2017
- Primary completion15 Mar 2018
- Study completion15 Mar 2018
Why it stopped: Lack of enrollment as expected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Re-hospitalization HemodialysisStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Fishbane, Northwell Health
- Investigators
- Steven Fishbane, MD, Principal investigator, Northshore-LIJ health system
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02553564
- Sponsor's protocol ID
- Nephrology - 06032015
- Status last verified
- Mar 2018
- First submitted
- 15 Sep 2015
- Last updated
- 2 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Checklist Intervention to Reduce 30 Day Rehospitalization Risk in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT02553564
- Acronym / sponsor ID
- Nephrology - 06032015
- Conditions
- Re-hospitalization Hemodialysis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment as expected
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 22 Nov 2017 (actual)
- Primary completion
- 15 Mar 2018 (actual)
- Study completion
- 15 Mar 2018 (actual)
- First posted
- 17 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Checklist driven clinical encounter after hospital dischargeChecklist 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. |
| Usual care group | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Checklist driven clinical encounter after hospital dischargeWithin 96 hours of hospital discharge an Nurse Practitioner will perform a checklist guided assessment to preventing rehospitalizations. The assessment consists of the following: 1. The participants's hospital course will be reviewed and their clinical recovery and stability assessed. 2. Determination of the participants's estimated dry weight (EDW). 3. The participants's post discharge medications will be checked, compared to the prehospitalization medication, and discrepancies will be reviewed and corrected. 4. Blood tests will be ordered for the participants's first return dialysis treatment if medically appropriate after clinical assessment. 5. Write new dialysis orders. 6. Dialysis Access- review access and determine any changes required in treatment | Other | Intervention group |
Primary outcome
Rehospitalization rate
Time frame: Up to 5 weeks
Percentage of patients in each group requiring readmission to an acute care hospital within 30 days of discharge after an acute care hospitalization.
3 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Lack of enrollment as expected). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Fishbane, MD principal investigator
Northshore-LIJ health system
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Checklist driven clinical encounter after hospital discharge in people with Re-hospitalization Hemodialysis, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of enrollment as expected). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rehospitalization rate (time frame: Up to 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2018.