Renal DiseaseCTNCT01842776
Care Transitions in Renal Disease Patients
An observational study of Renal Disease, run by Fresenius Medical Care North America at 1 site in United States.
Trial summary
The goal of this pilot is to reduce the 30-day hospital readmission rate for dialysis patients. It is a quality improvement project that consistent of 4 "tracks." Tracks 1 \& 2: Implement use of checklists of activities for staff to complete when patients are admitted to the hospital, and post-hospitalization with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Disease
- How many people
- 3,300 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Dec 2014
- Phase
- Observational
- 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
Study population: Adult hemodialysis patients
Who may be able to join
- Chronic hemodialysis patients
- All patients admitted to the hospital during the study period
Who cannot join
- Patients <18 years old
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Fresenius
Franklin, Tennessee, 37067
Rebecca L Wingard, RN, MSN, 615-567-4846, rebecca.wingard@fmc-na.com
Franklin Maddux, MD, FACP
About this study
The goal of this pilot is to reduce the 30-day hospital readmission rate for dialysis patients. It is a quality improvement project that consistent of 4 "tracks." Tracks 1 \& 2: Implement use of checklists of activities for staff to complete when patients are admitted to the hospital, and post-hospitalization with emphasis on fluid assessment, nutrition management, patient coaching, and communication between institutions. Track 3: Work with physicians to develop process to individualize post-hospitalization dialysis orders and improve medication reconciliation. Track 4: Use a renal Care Transitions Case Manager to follow patients in the hospital and 30 days post-hospitalization to facilitate care and patient coaching.
- Conditions
- Renal Disease
- Medical subject headings
- Kidney Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day readmission rate
Number of hospitalizations that occur within 30 days after discharge from an initial index hospitalization (convert to percentage of 30-day readmissions).
Measured: Participants will be followed for the duration of each hospital stay and 30 days post-hospitalization, for an expected average of 37 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care North America
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Amgen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01842776
- Sponsor's protocol ID
- 20129159
- Acronym
- CT
- Status last verified
- Apr 2013
- First submitted
- 22 Apr 2013
- Last updated
- 30 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Care Transitions in Renal Disease Patients
- ClinicalTrials.gov ID
- NCT01842776
- Acronym / sponsor ID
- CT / 20129159
- Conditions
- Renal Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,300 participants (estimated)
- Lead sponsor
- Fresenius Medical Care North AmericaIndustry (pharma, biotech, devices)
- Collaborators
- Amgen
- Study start
- Mar 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 30 Apr 2013 (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.
The goal of this pilot is to reduce the 30-day hospital readmission rate for dialysis patients. It is a quality improvement project that consistent of 4 "tracks." Tracks 1 \& 2: Implement use of checklists of activities for staff to complete when patients are admitted to the hospital, and post-hospitalization with emphasis on fluid assessment, nutrition management, patient coaching, and communication between institutions. Track 3: Work with physicians to develop process to individualize post-hospitalization dialysis orders and improve medication reconciliation. Track 4: Use a renal Care Transitions Case Manager to follow patients in the hospital and 30 days post-hospitalization to facilitate care and patient coaching.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult hemodialysis patients
Key inclusion criteria (2 listed)
- Chronic hemodialysis patients
- All patients admitted to the hospital during the study period
Key exclusion criteria (1 listed)
- Patients <18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
30-day readmission rate
Time frame: Participants will be followed for the duration of each hospital stay and 30 days post-hospitalization, for an expected average of 37 days.
Number of hospitalizations that occur within 30 days after discharge from an initial index hospitalization (convert to percentage of 30-day readmissions).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Disease, run by Fresenius Medical Care North America 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Apr 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rebecca L Wingard, RN, MSN (615-567-4846, rebecca.wingard@fmc-na.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day readmission rate (time frame: Participants will be followed for the duration of each hospital stay and 30 days post-hospitalization, for an expected average of 37 days.). 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 30 Apr 2013.